PURPOSE: To evaluate the feasibility and outcomes of a tailored, goal-directed, and exercise-based physical therapy program for patients with metastatic breast cancer (MBC).METHODS: This was an observational, uncontrolled feasibility study. The physical therapy intervention was highly tailored to the individual patient's goals, abilities, and preferences and could include functional, strength, aerobic, and relaxation exercises. Feasibility outcomes were participation rate (expected: 25%), safety, and adherence (percentage of attended sessions relative to scheduled sessions). Additional outcomes were goal attainment, self-reported physical functioning, fatigue, health-related quality of life, and patient and physical therapist satisfaction with the program.RESULTS: Fifty-five patients (estimated participation rate: 34%) were enrolled. Three patients did not start the intervention due to early disease progression. An additional 22 patients discontinued the program prematurely, mainly due to disease progression. Median intervention adherence was 90% and no major intervention-related adverse events occurred. A goal attainment score was available for 42 patients (of whom 29 had completed the program and 13 had prematurely dropped out). Twenty-two (52%) of these patients achieved their main goal fully or largely and an additional 15 patients (36%) partially. Eighty-five percent would "definitely recommend" the program to other patients with MBC. We observed a modest improvement in patient satisfaction with physical activities (Cohen's dz 0.33).CONCLUSION: The tailored intervention program was feasible in terms of uptake, safety, and outcomes and was highly valued by patients and physical therapists. However, disease progression interfered with the program, leading to substantial dropout.TRIAL REGISTRATION: NTR register: NTR6475.
Background: Advanced medical technologies (AMTs), such as respiratory support or suction devices, are increasingly used in home settings and incidents may well result in patient harm. Information about risks and incidents can contribute to improved patient safety, provided that those are reported and analysed systematically. Objectives: To identify the frequency of incidents when using AMTs in home settings, the effects on patient outcomes and the actions taken by nurses following identification of incidents. Methods: A cross-sectional study of 209 home care nurses in the Netherlands working with infusion therapy, parenteral nutrition or morphine pumps, combining data from a questionnaire and registration forms covering more than 13 000 patient contacts. Descriptive statistics were used. Results: We identified 140 incidents (57 adverse events; 83 near misses). The frequencies in relation to the number of patient contacts were 2.7% for infusion therapy, 1.3% for parenteral nutrition and 2.6% for morphine pumps. The main causes were identified as related to the product (43.6%), the organisation of care (27.9%), the nurse as a user (15.7%) and the environment (12.9%). 40% of all adverse events resulted in mild to severe harm to the patient. Incidents had been discussed in the team (70.7%), with the patient/informal caregiver(s) (50%), or other actions had been taken (40.5%). 15.5% of incidents had been formally reported according to the organisation's protocol. Conclusions: Most incidents are attributed to product failures. Although such events predominantly cause no harm, a significant proportion of patients do suffer some degree of harm. There is considerable underreporting of incidents with AMTs in home care. This study has identified a discrepancy in quality circles: learning takes place at the team level rather than at the organisational level.
Background: Clinicians are currently challenged to support older adults to maintain a certain level of Functional Independence (FI). FI is defined as "functioning physically safely and independent from another person, within one's own context". A Core Outcome Set was developed to measure FI. The purpose of this study was to assess discriminative validity of the Core Outcome Set FI (COSFI) in a population of Dutch older adults (≥ 65 years) with different levels of FI. Secondary objective was to assess to what extent the underlying domains 'coping', 'empowerment' and 'health literacy' contribute to the COSFI in addition to the domain 'physical capacity'. Methods: A population of 200 community-dwelling older adults and older adults living in residential care facilities were evaluated by the COSFI. The COSFI contains measurements on the four domains of FI: physical capacity, coping, empowerment and health literacy. In line with the COSMIN Study Design checklist for Patient-reported outcome measurement instruments, predefined hypotheses regarding prediction accuracy and differences between three subgroups of FI were tested. Testing included ordinal logistic regression analysis, with main outcome prediction accuracy of the COSFI on a proxy indicator for FI. Results: Overall, the prediction accuracy of the COSFI was 68%. For older adults living at home and depending on help in (i)ADL, prediction accuracy was 58%. 60% of the preset hypotheses were confirmed. Only physical capacity measured with Short Physical Performance Battery was significantly associated with group membership. Adding health literacy with coping or empowerment to a model with physical capacity improved the model significantly (p < 0.01). Conclusions: The current composition of the COSFI, did not yet meet the COSMIN criteria for discriminative validity. However, with some adjustments, the COSFI potentially becomes a valuable instrument for clinical practice. Context-related factors, like the presence of a spouse, also may be a determining factor in this population. It is recommended to include context-related factors in further research on determining FI in subgroups of older people.
