Evaluation of a short instrument for measuring health-related quality of life in oncological patients in routine care (HELP-6): an observational study.

Purpose: Patient-reported outcomes have not been sufficiently implemented into the routine care of cancer patients because the existing instruments are often too long and complex or not cancer-specific. The aim of this study is the determination of psychometric properties and item reduction of a newly developed health-related quality of life (HrQoL) questionnaire for use in oncological clinical routines. Methods: This observational study with a repeated measurements design included oncological inpatients and outpatients. A total of 630 patients participated at the first point of measurement and 404 at the second point of measurement. To evaluate the instrument, we conducted hierarchical confirmative factor analyses and for further validation correlated the resulting factors with standardized and validated HrQoL measurements. Test-retest reliability and responsiveness to change were tested. Results: The developed questionnaire "HELP-6" ("Hamburg Inventory for Measuring Quality of Life in Oncological Patients") has a six-factor structure and has moderate-to-good convergent validity (r= -0.25 --0.68). Test-retest reliability was moderate-to-good (r =0.56-0.81, p < 0.001). Indications for responsiveness to change were found for three dimensions. The final version of the questionnaire HELP-6 has six dimensions with one item each. Conclusion: With the HELP-6 instrument for measuring HrQoL in cancer patients, we provide a short and practical patient-reported outcome instrument. Though responsiveness to change could not be confirmed for all dimensions in this study, the HELP-6 includes time-efficient completion and evaluation and is informative in relevant HrQoL dimensions of cancer patients. Therefore, the HELP-6 poses an important addition to inpatient and outpatient routine cancer care. Trial registration: This study was registered at Open Science Framework (https://osf.io/y7xce/), on 9 June 2018.

Predictors of Discharge Destination After Stroke.

BACKGROUND: Determining the discharge destination after acute stroke care is important to prevent long-term disabilities and improve cost efficiency. OBJECTIVE: The aim of this study was to investigate where stroke patients are discharged to after acute treatment and to identify personal, social, stroke-related, and clinical predictors of discharge destination. METHODS: The present study included a secondary exploratory analysis of a prospective observational study. Patients with acute ischemic stroke, transient ischemic attack, or intracerebral hemorrhage were recruited consecutively over a 15-month period. A hierarchical multinomial logistic regression was performed to identify predictors of the primary outcome of discharge destination. RESULTS: We included 1026 stroke patients (48.7% female) with a mean age of 73.3 years (standard deviation 12.9 years) in the analysis. Overall, 55% of the patients were discharged home, 33% to a rehabilitation center, 3% to a residential facility, and 8% to another acute care hospital. Predictors that statistically significantly influenced the odds of the discharge destination were age, living situation pre-stroke, living location pre-stroke, stroke type, stroke severity, treatment type, and length of stay. Higher stroke severity was associated with discharge to all four inpatient facilities. CONCLUSIONS: In line with previous research, predictors such as stroke severity and living situation pre-stroke significantly influenced the odds of the discharge destination. In contrast, pre-existing conditions and functional impairment pre-stroke had no significant impact on the primary outcome. This discrepancy could be due to a rather functional study sample before stroke and the use of clinical and patient-reported outcome measures.

Identification and Determination of Dimensions of Health-Related Quality of Life for Cancer Patients in Routine Care - A Qualitative Study.

Purpose: Continuous patient-reported outcomes (PROs) to identify and address patients' needs represent an important addition to current routine care. The aim of this study was to identify and determine important dimensions of health-related quality of life (HrQoL) in routine oncological care. Methods: In a cross-sectional qualitative study, interviews and focus groups were carried out and recorded. The interviewees were asked for their evaluation on HrQoL in general and specifically regarding cancer treatment. The material was transcribed and analyzed using qualitative content analysis based on Mayring. The results were reviewed in an expert discussion. Results: Interviews with patients (N = 28) and clinicians (N = 4), as well as five focus groups with clinicians (N = 18) were conducted. Initially, nine deductive and two inductive categories on HrQoL were built. Four categories (partnership/sexuality, spirituality/religiousness, health perception, and overall health) were excluded following the qualitative content analysis because they were hardly or not at all mentioned by participants. Following on from the analysis of the expert discussion, one dimension was added (dignity), and two further categories were excluded (mobility and feeling of security in treatment). The resulting system consisted of six dimensions: emotional health, physical ailments, autonomy, social functionality, dignity, and resources. Conclusion: The identified dimensions of HrQoL in routine oncological care were found to differ from those used in existing HrQoL measurements for (cancer) patients. Further research is needed to test and evaluate the presented structure in a larger sample of cancer patients to further assess its psychometric properties.

Profiles of patients' self-reported health after acute stroke.

BACKGROUND: We aimed to identify groups of patients with similar health status after stroke, assessed by patient reported outcome measures (PROMs), to improve initial risk stratification. METHODS: In a prospective study, inpatients were recruited during acute stroke treatment. Demographics, history, and cardio-vascular risk factors were assessed at baseline. Self-reported functional status, physical and mental health as well as anxiety and depressive symptoms were assessed 3 and 12 months after stroke and used to identify latent classes. The association of patient characteristics with latent class membership was investigated with multinomial logistic regression. RESULTS: Of the 650 patients included with a mean age of 75 years and 48% female, 70% had ischemic, 6% hemorrhagic strokes, and 24% transient ischemic attacks. Median NIHSS on admission was 2 (IQR:0,5). Values of PROMs remained comparable at 3 and 12 months. A three-class model was developed, differentiating between patients with mildly (75%), moderately (17%), and severely (8%) impaired self-reported health status. Adjusted for univariately significant baseline characteristics, initial NIHSS distinguished mild- from moderate-, and moderate- from severe-class-membership (p < 0.001). Length of inpatient stay (p < 0.001;OR = 1.1), diabetes (p = 0.021;OR = 1.91), and atrial fibrillation (p = 0.004;OR = 2.20) predicted allocation to the moderately vs. mildly affected class. CONCLUSIONS: Grading stroke patients by a standard set of PROMs up to 1 year after stroke allows to distinguish the diverse impact of baseline characteristics on differently affected groups. In addition to initial stroke severity, longer inpatient stay, presence of diabetes and atrial fibrillation correlate with greater impairment of self-reported health in the less affected groups. TRIAL REGISTRATION: http://www.ClinicalTrials.gov ; Unique identifier: NCT03795948 .

Rationale and design of an interventional study of cross-sectoral, coordinated treatment of stroke patients with patient-orientated outcome measurement (StroCare).

INTRODUCTION: Stroke has a long-term impact on functional status and quality of life in multiple health domains. A well-coordinated managed care program for stroke patients is crucial for ameliorating patients' health and cost-efficient use of resources. The aim of this study is the implementation and evaluation of an optimised cross-sectoral, coordinated and managed care program for stroke patients bridging secondary and tertiary care. METHODS: In this multi-center mixed method sequentially controlled intervention study, stroke patients with ischemic stroke (I63), transient ischemic attack and related syndromes (G45), or intracerebral haermorrhage (I64) will be invited to participate. For a 12-months period, 235 consecutive patients are expected to be enrolled and assigned standard of care treatment as an active control group. During the following 12 months, 235 consecutive patients will be enrolled and assigned to a post stroke intervention program. The StroCare intervention consists of repeated outpatient visits with specialized stroke teams, the implementation of a case manager, the use of an electronical tool for communication between acute care, rehabilitation facilities, and out-patient care, and the definition of individualized treatment targets. Patients will be followed up for 24 months. The primary outcome is health-related quality of life measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10) at 12 months after the index event, i.e. stroke or TIA. For the qualitative survey of the implementation process, 21 patients in the intervention group will be interviewed after implementation of the interventions. In addition, 20 health care providers and staff members will be interviewed before and after implementation. Additionally, economic outcomes will be evaluated after 6 and 12 months. PERSPECTIVE: The study will not only provide information about the tested intervention but is likely to be helpful for clinicians, suppliers of reimbursement, and researchers in implementing and evaluating complex interventions in stroke care in general. With this program, the health care system will have a reference model at its disposal for transfer to other regions and settings. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov ( NCT04159324 ). Approval of the local ethics committee (Ethik-Kommission der Ärztekammer Hamburg, Niedersachsen, Schleswig-Holstein) has been obtained.

Mental distress and need for psychosocial support in prostate cancer patients: An observational cross-sectional study.

OBJECTIVE: Prostate cancer is the most common cancer in German men and associated with various physical and psychosocial problems. This study investigated the association between mental distress and the subjective need for psychosocial support comparing subgroups of patients with different treatments and disease stages. METHOD: We performed an observational, cross-sectional study including patients with four medical conditions: Active Surveillance, radical prostatectomy, biochemical relapse, metastasized disease. Mental distress (NCCN Distress-Thermometer), symptoms of depression and anxiety (PHQ-9, GAD-7), psychosocial needs and coping resources (self-designed questionnaire) were assessed. RESULTS: N = 130 patients were included. 33.3% showed distress, 16.5% symptoms of moderate depression and 13% symptoms of moderate anxiety. We found no significant differences between the four groups. An association was present between distress and wish for psychosocial support (χ2 = 4.3; p < 0.05; ϕ = 0.19). Almost 90% lived with a partner, which represents a resource. CONCLUSIONS: Prostate cancer patients showed low levels of mental distress, depression and anxiety with no difference in terms of disease stage and treatment modality. Therefore, careful psychosocial screening of all patients is essential to identify those in need for support. Distressed patients express a need for psychosocial support more often. Interpersonal relationships, most often wives and children, represent important coping resources.

Development of a Short Instrument for Measuring Health-Related Quality of Life in Oncological Patients for Clinical Use: Protocol for an Observational Study.

BACKGROUND: Cancer patients often suffer from the physical and psychological burden of their disease and its treatment. This is frequently insufficiently identified and addressed in clinical practice. In the context of improving patient-centered care in oncological patients, patient-reported outcomes (PROs) represent an important addition to current routine care. So far, available PRO questionnaires for cancer patients are unsuitable for routine procedures due to their length and complexity. OBJECTIVE: This study aimed to develop and psychometrically test a short questionnaire to measure health-related quality of life (HrQoL) in cancer patients for use in routine care. METHODS: This observational study consists of two parts: (1) a qualitative study to develop a short questionnaire measuring HrQoL and (2) a quantitative study to psychometrically test this questionnaire in five oncological departments of a comprehensive cancer center. In part 1 of the study, semistructured interviews with 28 cancer patients, as well as five focus groups with 22 clinicians and nurses, were conducted to identify clinically relevant dimensions of HrQoL. The identified dimensions were complemented with related dimensions from empirical studies and reviewed via expert discussion. Based on this, a short instrument was developed. In part 2 of the study, the developed questionnaire was tested in cancer in- and outpatients at five participating oncological clinics using additional standardized questionnaires assessing HrQoL and other important PROs. The questionnaire was presented to more than 770 patients twice during treatment. RESULTS: The project started in May 2017 with recruitment for study phase I beginning in December 2017. Recruitment for study phases I and II ended in April 2018 and February 2019, respectively. After study phase II and psychometrical analyses, the newly developed questionnaire measuring the HrQoL of all cancer entities in routine care was finalized. CONCLUSIONS: With five to six dimensions and one item per dimension, the developed questionnaire is short enough to not disrupt routine procedures during treatment and is profound enough to inform clinicians about the patient's HrQoL impairments and status. TRIAL REGISTRATION: Open Science Framework Registries 10.17605/OSF.IO/Y7XCE; https://osf.io/y7xce/. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/17854.

Implementation analysis of patient reported outcomes (PROs) in oncological routine care: an observational study protocol.

BACKGROUND: The successful implementation of patient-reported outcomes (PROs) in clinical routine faces many challenges, first and foremost the lack of consideration thereof in the patient care process. The aim of this study will be to first identify relevant barriers and facilitators and then design suitable implementation strategies which will be evaluated to improve the effectiveness of a PRO measure assessment in inpatient and outpatient cancer routine care. METHODS: During the preparation phase, interviews with oncological patients (N = 28) and medical staff (N = 4) as well as focus groups with medical staff (N = 18) across five different departments caring for cancer patients were conducted. On the basis of these, qualitative content analysis revealed relevant barriers and facilitators for implementation of PROs in cancer care. Subsequently, implementation strategies and a model of implementation were developed. In the study phase, implementation strategies will be evaluated based on nine different implementation outcomes in five different oncological clinics. Evaluation of the implementation process will take place during three months in each clinic and data will be conducted pre, while and post implementation of the PRO measure. Therefore a sample size of 60 participants of whom 30 staff members and 30 participants will be questioned using existing and newly developed implementation outcome evaluation instruments. DISCUSSION: Key to improving the effectiveness of PRO assessment in the time-critical clinical environment is the utilization of easy-to-use, electronic PRO questionnaires directly linked to patients' records thereby improving consideration of PROs in patient care. In order to validate the effectiveness of this implementation process further, an evaluation parallel to implementation following an observational study design with a mixed-methods approach will be conducted. This study could contribute to the development of adequate evaluation processes of implementation of PROs to foster sustainable integration of PRO measures into routine cancer care. TRIAL REGISTRATION: This study was registered at Open Science Framework (https://osf.io/y7xce/).