Measurement equivalence of the paper-based and electronic version of the Integrated Palliative care Outcome Scale (IPOS): A randomised crossover trial.

BACKGROUND: The Integrated Palliative Care Outcome Scale (IPOS) validly and reliably measures symptoms and concerns of those receiving palliative care. AIM: To determine the equivalence of the paper version with an electronic version of the IPOS (eIPOS). DESIGN: Multicentre randomised crossover trial (NCT03879668) with a within-subject comparison of the two modes (washout period 30 min). SETTING/PARTICIPANTS: Convenience sample of specialist inpatient and palliative home care patients aged over 18 years with cancer and non-cancer conditions was recruited. Scores were compared using intraclass correlation coefficients (ICC), Bland-Altman plots and via a mixed-effects analysis of variance. RESULTS: Fifty patients were randomised to complete paper-electronic (n = 24) and electronic-paper (n = 26) IPOS with median age 69 years (range 24-95), 56% male, 16% non-cancer. The ICCs showed very high concordance for the total score (ICC 0.99, 95% CI 0.98-1.00), lowest ICCs being observed for symptoms 'Appetite loss' and 'Drowsiness' (ICC 0.95, 95% CI 0.92-0.97). Nine of seventeen items had ICCs above 0.98, as did all subscales. No statistically significant mode, order, age, and interaction effects were observed for IPOS total score and subscales, except for 'Communication' (Fmode = 5.9, p = 0.019). Fifty-eight percent preferred the electronic version. In the group 75+ years, 53% preferred the paper version. Only three entries in the free-text main problems differed between the versions. CONCLUSION: The very high equivalence in scores and free text between the IPOS and the eIPOS demonstrates that eIPOS is feasible and reliable in an older palliative population.

Challenges developing an electronic patient-reported outcome measurement for palliative home care: A qualitative interview and focus group study.

BACKGROUND: Patient-reported outcome measures have the potential to improve outcomes, quality, and effectiveness of care. Digital use of patient-reported outcome measures could be an option to foster implementation in palliative care. The Palli-MONITOR study focused on developing and testing an electronic patient-reported outcome measure in specialised palliative home care. As part of this study, we examined setting-specific challenges for the development of the measure. AIM: We aimed to identify and explore challenges for the development of electronic patient-reported outcome measures as standardised assessment in specialised palliative home care. DESIGN: Qualitative approach with semi-structured interviews and focus groups. Data were thematically analysed using the framework method. SETTING/PARTICIPANTS: Patients and professionals from five German palliative home care teams. RESULTS: Patients described potential problems in using electronic questionnaires due to their deteriorating health. Answering the electronic questionnaire encouraged patients to reflect on their current palliative situation, which was partly perceived as burdensome. Identified concerns and questions regarding the future roll-out of electronic patient-reported outcome measurement addressed the process of receiving and using the provided information in clinical care routine. Challenging factors on organisational and structural level were the potential undermining of the established 24-h emergency call system and the potential use for patients. CONCLUSIONS: Our results provide a multifaceted picture of challenges developing electronic systems for patient-reported outcome measurement in palliative home care on the individual and organisational level. The study underpins the benefit of stakeholder involvement creating digital health innovations and emphasises the importance to therefore mind setting specific culture.

Breathlessness services as a new model of support for patients with respiratory disease.

The complexity of breathlessness in advanced disease requires a diversity of measures ideally tailored to the individual patient needs. 'Breathlessness services' have been systematically developed and tested to provide specific interventions and support for patients and their carers. The aim of this article is (1) to identify and describe components of breathlessness services and (2) to describe the clinical model of one specific service in more detail. This article is based on a systematic review evaluating randomized controlled trials (RCTs) and quasi-RCTs which examine the effectiveness of services aiming to improve breathlessness of patients with advanced disease. The Munich Breathlessness Service (MBS) is described in detail as an example of a recently set-up specialist service. Five service models were identified which were tested in six RCTs. Services varied regarding structure and composition with face-to-face meetings, some with additional telephone contacts. Service duration was median 6 weeks (range 2-12 weeks). Involved professions were nurses, various therapists and, in two models, also physicians. The breathing-thinking-functioning model was targeted by various service components. The MBS is run by a multi-professional team mainly with physicians and physiotherapists. Patients are seen weekly over 5-6 weeks with an individualized management plan. Breathlessness services are a new model for patients with advanced disease integrating symptom management and early access to palliative care.

Epidemiology and Real-World Treatment of Incident Diffuse Large B-cell Lymphoma (DLBCL): A German Claims Data Analysis.

INTRODUCTION: The objective of this study was to investigate the prevalence, incidence, and treatment patterns (treatment regimens, switches, duration) for diffuse large B-cell lymphoma (DLBCL) in a real-world setting. METHODS: This was a retrospective German claims data analysis of patients with DLBCL diagnosed between January 1, 2012, and December 31, 2020. The prevalence and cumulative incidence of DLBCL were found for 2019/2020. Line of treatment  (LOT) and treatment setting from first DLBCL diagnosis to end of follow-up were described. Kaplan-Meier overall survival (OS) estimates since DLBCL diagnosis and start of treatment lines were calculated. RESULTS: Overall, 2633 incident DLBCL cases were identified (median age 75 years, 51% male). Of these, 2119 patients received at least one DLBCL-related treatment (LOT1), and 1567 patients died during follow-up. In 2019/2020, the prevalence and cumulative incidence of DLBCL was 34.8/36.7 per 100,000 patients and 14.0/12.7 per 100,000 patients, respectively. For LOT1, 1922 patients were given a chemotherapy-based regimen (1530 with CD20 antibodies). A total of 403 patients were administered a second line (LOT2), of which 183 patients received a CD20 antibody-containing chemotherapy regimen and 100 patients received stem cell transplantation or chimeric antigen receptor (CAR)-T therapy. Of the 136 LOT3+ treatments, 74 were chemotherapy regimens (54 with CD20 antibodies) and 18 were kinase inhibitors. The median time between treatment lines was less than 6 months. Among patients with at least LOT2, approximately 50% received more than one LOT during the first year after diagnosis. Approximately 25% of treated patients died within 6 months of treatment initiation. Of the 2633 included patients, the median OS from diagnosis was 31.0 months (treated patients: 46.8 months, untreated patients: 3.0 months). CONCLUSIONS: Despite advances in the field, high unmet medical need in DLBCL remains. The treatment landscape is very heterogeneous, particularly in second- or later-line treatments, with few patients receiving potentially curative treatment beyond the first line. Treatment for DLBCL, particularly for transplant-ineligible patients, remains challenging.

Sedatives and sedation at the end of life: a nursing home retrospective cohort study.

OBJECTIVES: Sedatives are frequently used at the end of life in specialist palliative care. There is scarce information about their use in nursing homes. Therefore, we aimed to assess the use of (1) sedatives generally and (2) 'sedatives with continuous effect', based on objective operational criteria, within the last week of life in a nursing home. METHODS: This was a retrospective cohort study of residents who died in a German nursing home between 1/2015 and 12/2017, using the nursing home's medical records, which contained drug sheets and nurses' notes. Sedatives analysed were those recommended by guidelines for 'palliative sedation': benzodiazepines, levomepromazine, haloperidol (≥5 mg/day) and propofol. Exploratory statistical analysis was conducted using R V.3.6.1. RESULTS: 46/165 (28%) deceased residents received a sedative during the last week of life, all without use of the term 'sedation'. 26/165 residents (16%) received 'sedatives with continuous effect', for median 4 days (range 1-7). Oral lorazepam was used most frequently, mainly for agitation, anxiety and dyspnoea, but also due to palliative status and patients wish. The median total daily dose of lorazepam within the last week of life was 1.5 mg (range 0.5-7.5). The term 'palliative' was significantly more often used for residents receiving sedatives (p=0.001). CONCLUSIONS: Compared with published data on continuous deep sedation, moderate or deep sedation was less frequent in this nursing home and never labelled as 'sedation'. Multicentre mixed-methods research is needed to gain representative and more detailed data on sedation practices at the end of life in nursing homes.

Monitoring of Palliative Care Symptoms and Concerns in Specialized Palliative Home Care Using an Electronic Version of the Integrated Palliative care Outcome Scale (Palli-MONITOR): protocol for a mixed-methods study.

INTRODUCTION: Over the last decades, patient-reported outcome (PRO) measures have been developed to better understand the patient's perspective and enable patient-centred care. In palliative care, the Integrated Palliative care Outcome Scale (IPOS) is recommended as a PRO tool. Its implementation in specialised palliative home care (SPHC) would benefit from an electronic version validated for the setting.Following the Medical Research Council (MRC) guidance, the study Palli-MONITOR is developing (phase 1) and testing the feasibility (phase 2) of implementing the electronic version of IPOS (eIPOS) in the SPHC setting to inform a cluster-randomised phase 3 trial. METHODS AND ANALYSIS: Palli-MONITOR is a multicentre, sequential mixed-methods, two-phase development and feasibility study. The study consists of four substudies. In phase 1 (MRC development phase), qualitative patient interviews and focus groups with SPHC professionals are used to identify barriers and facilitators of eIPOS (substudy I). Substudy II tests the equivalence of eIPOS and IPOS in a crossover randomised controlled trial. Phase 2 (MRC feasibility/piloting phase) includes a quasi-experimental study with two control groups (substudy III), and qualitative interviews as well as focus groups to explore the feasibility and acceptability of the developed intervention (substudy IV).Qualitative data will be analysed with thematic analysis following the framework approach. Quantitative analysis uses a two-way intraclass correlation coefficients model for the equivalence testing. Quantitative analysis of the quasi-experimental study will focus on the primary outcomes, recruitment rates and completeness of eIPOS. Secondary outcomes will include intraindividual change in palliative symptoms and concerns, quality of life and symptom burden. ETHICS AND DISSEMINATION: Approval of the ethics committee of the Ludwig Maximilian University Munich was received for all study parts. Results and experiences will be presented at congresses and in written form. Additionally, participating SPHC teams will receive summarised results. TRIAL REGISTRATION NUMBER: NCT03879668.

Sedatives and Sedation at the End of Life in Nursing Homes: A Retrospective Multicenter Cohort Study.

OBJECTIVES: There is scarce information about sedation in nursing homes at the end of life. We aimed to assess (1) the use of sedatives generally and "sedatives with continuous effect," based on objective operational criteria, within the last week of life in nursing homes and (2) factors associated with this treatment. DESIGN: Retrospective cohort study, using the nursing homes' medical records. SETTING AND PARTICIPANTS: Residents who died in 4 German nursing homes from January 2015 to December 2017 and whose medical records were available (n = 512). METHODS: Sedatives analyzed were those recommended by guidelines for "palliative sedation": benzodiazepines, levomepromazine, haloperidol (≥5 mg/d), and propofol. The definition of "sedatives with continuous effect" and doses judged as at least moderately sedating were consented by palliative care clinicians and pharmacists, based on the literature. Descriptive statistics and multivariate logistic regression analysis were performed (R version 3.6.1). RESULTS: Overall, 110/512 (21%) deceased residents received a sedative at least once during the last week of life, 46/512 (9%) "sedatives with continuous effect." Oral lorazepam was used most frequently. Eleven of 512 (2%) residents received doses judged as at least moderately sedating. The term sedation was not used. Most frequent indications were agitation (58/110; 53%) and anxiety (35/110; 32%); no indication was noted for 36/110 (33%) residents. The resident's involvement in the decision for sedatives was documented in 3/110 (3%). Multivariate logistic regression analysis showed significant associations between use of sedatives and age (OR = 0.94, P < .001) as well as institution (P < .001). CONCLUSIONS AND IMPLICATIONS: Our data indicate a lower prevalence of sedation compared to international data and considerable differences regarding prevalence between institutions. These differences, potential setting-specific challenges, and need for support measures for consistent best practice of sedation in nursing homes should be further explored.

Forced vital capacity and cross-domain late-onset Pompe disease outcomes: an individual patient-level data meta-analysis.

BACKGROUND: Late-onset Pompe disease (LOPD) is a rare, metabolic disease primarily affecting the musculoskeletal and respiratory systems. Forced vital capacity (FVC) is commonly used to measure pulmonary function; however, associations between FVC and other LOPD outcomes remain unclear. METHODS: A systematic literature review was conducted on November 2015, updated September 2016 and supplemented with clinical trial data from the sponsor. Outcomes included: 6-min walk test distance (6MWT), FVC, maximal inspiratory/expiratory pressure (MIP/MEP), Medical Research Council-skeletal muscle strength score (MRC), 36-item short-form survey-physical component score (SF-36), Rotterdam Handicap Scale (RHS), Fatigue Severity Scale (FSS) and survival. Individual patient data meta-analysis was used for cross-sectional analyses and longitudinal analyses to determine associations between percent of predicted FVC and LOPD measures and outcomes. RESULTS: Fifteen studies were selected. From cross-sectional analyses, FVC and MRC were most strongly associated. Specifically, patients with 10% higher FVC (a round number for illustrative purposes only) were associated with a 4.72% (95% confidence interval [CI]: 3.37, 6.07) higher MRC score, indicating a positive association. Similarly, slopes for the 6MWT and SF-36 relative to a 10% higher FVC were estimated at 33.2 meters (95% CI 24.0, 42.4) and 1.2% (95% CI 0.24, 2.16%), respectively. From longitudinal analyses, a 10% incremental increase in predicted FVC was associated with an average increase of 4.12% in MRC score (95% CI 1.29, 6.95), 35.6 m in the 6MWT (95% CI 19.9, 51.6), and 1.34% in SF-36 (95% CI 0.08, 2.60). There was insufficient data to conduct analyses for RHS, FSS and survival. CONCLUSIONS: FVC is positively associated with LOPD measures and outcomes across multiple domains. Additionally, longitudinal changes in FVC are positively associated with changes in the 6MWT, MRC and SF-36.

Integrated breathlessness services for people with chronic conditions.

PURPOSE OF REVIEW: Optimal management of breathlessness requires generally more than one component. Breathlessness services aim to provide specific interventions and support for patients suffering from breathlessness due to any advanced disease and their carers. This review aims to describe recent studies evaluating the effects of breathlessness services for patients with advanced chronic conditions. RECENT FINDINGS: Various breathlessness services have been tested and vary regarding structure, duration, frequency and professionals involved. Four randomized controlled trials demonstrated a positive and significant effect on distress due to breathlessness or mastery of breathlessness or breathlessness severity. In the fifth randomized controlled trial, quantitative results were NS, but in the qualitative interviews, patients stressed the positive experience with the breathlessness service and the benefits they gained. The caring, holistic, respectful and integrated approaches were valued by patients. SUMMARY: Breathlessness services combine a variety of evidence-based nonpharmacological interventions and some services also pharmacological interventions when physicians are involved. As the prevalence of breathlessness due to advanced disease is high and increasing, more such services should be provided to support patients throughout the course of their disease.

Serum Uric Acid and the Risk of Incident and Recurrent Gout: A Systematic Review.

OBJECTIVE: Lowering serum uric acid (SUA) levels can essentially cure gout; however, this is not widely practiced. To summarize epidemiologic evidence related to this causal link, we conducted a systematic review of the published literature reporting the association between SUA level and incident and recurrent gout (i.e., gout flares). METHODS: We systematically searched Medline, EMBASE, and the Cochrane Database of Systematic Reviews using separate search strategies for incident gout and recurrent gout. We screened 646 abstracts to identify 8 eligible articles reporting gout incidence and 913 abstracts to identify 18 articles reporting recurrent gout. RESULTS: For both gout incidence and recurrence, a graded trend was observed where the risk was increased with higher SUA levels. Gout incidence rates per 1000 person-years from population-based studies ranged from 0.8 (SUA ≤ 6 mg/dl) to 70.2 cases (SUA ≥ 10 mg/dl). Recurrent gout risk in clinical cohorts ranged from 12% (SUA ≤ 6 mg/dl) to 61% (SUA ≥ 9 mg/dl) among those receiving urate-lowering therapy (ULT), and 3.7% (SUA 6-7 mg/dl) to 61% (SUA > 9.3 mg/dl) after successful ULT. Retrospective database studies also showed a graded relationship, although the strength of the association was weaker. Studies reporting mean flares or time-to-flare according to SUA showed similar findings. CONCLUSION: This systematic review confirms that higher SUA levels are associated with increased risk of incident and recurrent gout in a graded manner. Although few prospective cohorts have evaluated incident and recurrent gout according to SUA, the existing evidence underscores the need to treat to SUA targets, as recommended by the American College of Rheumatology and the European League Against Rheumatism.