Factors Determining Not Returning to Full-Time Work 12 Months After Mild Ischemic Stroke.

Objective: To evaluate prevalence and factors determining not returning to full-time work 1 year after first-ever mild ischemic stroke. Design: Prospective, observational cohort study with 12-month follow-up. Setting: Stroke units and outpatient clinics at 2 Norwegian hospitals. Participants: We included 84 (N=84) full-time working, cognitively healthy patients aged 70 years or younger who suffered an acute first-ever mild ischemic stroke, defined as National Institutes of Health Stroke Scale (NIHSS) score ≤3 points. Interventions: Not applicable. Main Outcome Measures: Vascular risk factors, sociodemographic factors, stroke localization, and etiology were recorded at inclusion. Cognitive impairment, anxiety, depression, fatigue, and apathy 12 months after stroke were assessed with validated instruments. Logistic regression analyses were performed to find correlates of not returning to full-time employment. Results: Of 78 patients assessed 1 year after stroke, 63 (81%) had returned to work, 47 (60%) to full-time employment status. Modified Rankin scale score >1 (adjusted odds ratio, 12.44 [95% confidence interval, 2.37-65.43], P=.003) at follow-up was significantly associated, and diabetes (adjusted odds ratio, 10.56 [95% confidence interval, 0.98-113.47], P=.052) was borderline significantly associated with not returning to full-time work. Female sex, NIHSS at discharge, anxiety per point on the anxiety scale, depression per point on the depression scale, and fatigue per point on the fatigue scale were significantly associated with not returning to full-time work after 1 year, but these associations were only seen in the unadjusted models. Conclusions: Low functional level that persists 12 months after stroke is related to not returning to full-time work. Patients with diabetes mellitus, female patients, and patients with a higher score on fatigue, anxiety, and depression scales may also be at risk of not returning to full-time work post stroke. Working patients should be followed up with a particular focus on factors determining participation in work and social life.

Predictors of cognitive and emotional symptoms 12 months after first-ever mild stroke.

Even mild strokes may affect the patients' everyday life by impairing cognitive and emotional functions. Our aim was to study predictors of such impairments one year after first-ever mild stroke. We included cognitively healthy patients ≤ 70 years with acute mild stroke. Vascular risk factors, sociodemographic factors and stroke classifications were recorded. At one-year post-stroke, different domains related to cognitive and emotional function were assessed with validated instruments. Logistic regression analyses were performed to identify predictors of cognitive and emotional outcome. Of 117 patient assessed at follow-up, only 21 patients (18%) scored within the reference range on all cognitive and emotional assessments. Younger age, multiple infarcts, and being outside working life at stroke onset were independent predictors of cognitive impairments (psychomotor speed, attention, executive and visuospatial function, memory). Female gender and a higher National Institutes of Health Stroke Scale (NIHSS) score at discharge were significantly associated with emotional impairments (anxiety, depressive symptoms, fatigue, apathy, emotional lability) after one year, but these associations were only seen in the unadjusted models. In conclusion, patients in working age may profit from a follow-up during the post-stroke period, with extra focus on cognitive and emotional functions.

Perceived study-induced influence on the control group in a randomized controlled trial evaluating a complex intervention to promote psychosocial well-being after stroke: a process evaluation.

BACKGROUND: A commonly applied control condition in trials evaluating complex interventions in rehabilitation research is "usual care." The main challenge is to ensure that the control group receives genuine usual care as delivered in everyday clinical practice. The assessment interviews and dialogues with the data collectors may influence the control group participants' reflections on their condition and adjustments. This represents a threat to the internal validity of the trial. Thus, the aim of this study was to explore the perceived study-induced influence of assessment interviews on the adjustment of the members of a control group in a randomized clinical trial. The aim of the trial was to test a dialogue-based psychosocial intervention aiming at promoting the psychosocial well-being and adjustment of stroke survivors. METHODS: Fifteen participants in the control group of a multicenter stroke rehabilitation trial participated in narrative semi-structured interviews. Ricoeur's interpretation theory guided the analysis. RESULTS: The perceived study-induced influence of the assessment interviews on the adjustment process of members of the control group varied considerably. The results demonstrated that the assessment interviews facilitated some participants' feelings of control and their ability to cope. Other participants' statements indicate that they relied on their existing personal capacity to cope and adjust and that the assessment interviews did not make any difference either on their coping ability or on their process of adjustment. Five themes were identified that described the perceived study-induced influence of the assessment interviews in the control group. The themes illustrated that the assessments served as a safety net, enhanced awareness and understanding, encouraged seeking support, allowed the opportunity to vent disappointment, or did not make any difference either way. CONCLUSIONS: RCT assessment interviews may influence the adjustment process and represent a serious problem in measuring interventions over time in trials of complex interventions in rehabilitation research. To uphold rigor and stringency, the usual care control conditions should be thoroughly assessed and described. Informing participants only about the treatment they were allocated to receive might counteract the potential to dilute the difference between the two arms of the trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT02338869. Registered on October 4, 2014.

Nurses' and occupational therapists' experiences of conducting a home-based psychosocial intervention following stroke: a qualitative process evaluation.

BACKGROUND: Persons with stroke are susceptible to psychosocial problems, and express disappointment at how health care professionals fail to meet their psychosocial needs following discharge to home. The responsibility of nurses and occupational therapists in stroke rehabilitation is to assist the persons and their families during the recovery and adjustment process. A home-based dialogical intervention aiming to enhance psychosocial support was therefore developed and tested in a randomized controlled trial. This study is a part of the process evaluation conducted alongside the trial. The aim was to explore the nurses' and occupational therapists' experiences of conducting the intervention. METHODS: Eighteen nurses and four occupational therapists participated in six focus groups to explore their experiences when providing the intervention. The themes discussed in the focus groups were the aspects that facilitated the delivering of the intervention and the challenges they encountered during the study period. The interviews were analysed using qualitative content analysis. RESULTS: The analysis generated two themes. The theme Developing a supportive relationship to facilitate the adjustment process following stroke had two subthemes: Getting personally involved and Handling challenges. This theme reveals how the nurses and occupational therapists experienced their relationship with the persons with stroke and potential threats which challenged them while conducting the intervention. The theme Developing professional skills in providing psychosocial support had two subthemes: Becoming confident in conducting dialogues and Integrating psychosocial topics. This theme reveals the aspects that the nurses and occupational therapists perceived as facilitating the development of their professional skills in conducting the dialogues. CONCLUSION: Delivering the psychosocial intervention was perceived as deeply meaningful and increased the nurses' and occupational therapists' understanding of how to support stroke survivors to live with the consequences of stroke. However, balancing the professional and the personal relationship was challenging. A basic educational programme, training, supervision and having dedicated time were crucial elements to instil confidence in professionals conducting theme-based dialogues to promote post-stroke psychosocial well-being. Individual clinical experience and knowledge of stroke care were considering important to enable professionals to integrate psychosocial rehabilitation into community health care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02338869 , registered 10/04/2014.

Cognitive and emotional symptoms in patients with first-ever mild stroke: The syndrome of hidden impairments.

OBJECTIVE: To evaluate the prevalence of cognitive and emotional impairments one year after first-ever mild stroke in younger patients Design: Prospective, observational, cohort study. SUBJECTS: A consecutive sample of 117 previously cognitively healthy patients aged 18-70 years with mild stroke (National Institutes of Health Stroke Scale score ≤ 3) were included in 2 hospitals in Norway during a 2-year period. METHODS: At 12-month follow-up, patients were assessed using validated instruments for essential cognitive domains, fatigue, depression, anxiety, apathy and pathological laughter and crying. RESULTS: In total, 78 patients (67%) had difficulty with one or a combination of the cognitive domains psychomotor speed, attention, executive and visuospatial function, and memory. Furthermore, 50 patients (43%) had impairment in either one or a combination of the emotional measures for anxiety, depressive symptoms, fatigue, apathy or emotional lability. A total of 32 patients (28%) had both cognitive and emotional impairments. Only 21 patients (18%) scored within the reference range in all the cognitive and emotional tools. CONCLUSION: Hidden impairments are common after first-ever mild stroke in younger patients. Stroke physicians should screen for hidden impairments using appropriate tools.

The effects of a dialogue-based intervention to promote psychosocial well-being after stroke: a randomized controlled trial.

OBJECTIVE: To evaluate the effect of a dialogue-based intervention targeting psychosocial well-being at 12 months post-stroke. DESIGN: Multicenter, prospective, randomized, assessor-blinded, controlled trial with two parallel groups. SETTING: Community. SUBJECTS: Three-hundred and twenty-two adults (⩾18 years) with stroke within the last four weeks were randomly allocated into intervention group (n = 166) or control group (n = 156). INTERVENTIONS: The intervention group received a dialogue-based intervention to promote psychosocial well-being, comprising eight individual 1-1½ hour sessions delivered during the first six months post-stroke. MAIN MEASURES: The primary outcome measure was the General Health Questionnaire-28 (GHQ-28). Secondary outcome measures included the Stroke and Aphasia Quality of Life Scale-39g, the Sense of Coherence scale, and the Yale Brown single-item questionnaire. RESULTS: The mean (SD) age of the participants was 66.8 (12.1) years in the intervention group and 65.7 (13.3) years in the control group. At 12 months post-stroke, the mean (SE) GHQ-28 score was 20.6 (0.84) in the intervention group and 19.9 (0.85) in the control group. There were no between-group differences in psychosocial well-being at 12 months post-stroke (mean difference: -0.74, 95% confidence interval (CI): -3.08, 1.60). The secondary outcomes showed no statistically significant between-group difference in health-related quality of life, sense of coherence, or depression at 12 months. CONCLUSION: The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke.

Are cancer patients better off if they participate in clinical trials? A mixed methods study.

BACKGROUND: Research and cancer care are closely intertwined; however, it is not clear whether physicians and nurses believe that clinical trials offer the best treatment for patients and, if so, whether this belief is justified. The aim of this study was therefore: (i) to explore how physicians and nurses perceive the benefits of clinical trial participation compared with standard care and (ii) whether it is justified to claim that clinical trial participation improves outcomes for cancer patients. METHODS: A mixed methods approach was used employing semi-structured interviews with 57 physicians and nurses in oncology and haematology and a literature review of the evidence for trial superiority, i.e. the idea that receiving treatment in a clinical trial leads to a better outcome compared with standard care. Inductive thematic analysis was used to examine the interview data. A literature review comprising nine articles was conducted according to a conceptual framework developed by Peppercorn et al. and evaluated recent evidence on trial superiority. RESULTS: Our findings show that many physicians and nurses make claims supporting trial superiority, however very little evidence is available in the literature comparing outcomes for trial participants and non-participants that supports their assertions. CONCLUSIONS: Despite the recent rapid development and use of targeted therapy and immunotherapy, we find no support for trial participation to provide better outcomes for cancer patients than standard care. Hence, our present results are in line with previous results from Peppercorn et al. A weaker version of the superiority claim is that even if a trial does not bring about a direct positive effect, it brings about indirect positive effects. However, as the value of such indirect effects is dependent on the individual's specific circumstances and preferences, their existence cannot establish the general claim that treatment in trials is superior. Belief in trial superiority is therefore unfounded. Hence, if such beliefs are communicated to patients in a trial recruitment context, it would provide misleading information. Instead emphasis should be on patients volunteering to give an altruistic contribution to the furthering of knowledge and to the potential benefit of future patients.

Effect of a dialogue-based intervention on psychosocial well-being 6 months after stroke in Norway: A randomized controlled trial.

OBJECTIVE: To evaluate the effect of a dialogue-based intervention on psychosocial well-being 6 months after stroke. DESIGN: Multicentre, prospective, randomized controlled trial. SUBJECTS: Adults (aged ≥ 18 years) who had their first or recurrent stroke within the last month, were medically stable, had sufficient cognitive functioning to participate and understood and spoke Norwegian. METHODS: A total of 322 participants were randomly assigned to the intervention (n = 166) or control (n = 156) group. Participants in the intervention group received up to 8 individual sessions aimed at supporting the coping and life skills of stroke survivors in addition to usual care. The primary outcome was the proportion of participants with normal mood measured by the General Health Questionnaire-28 (GHQ-28). The secondary outcomes included health-related quality of life (Stroke and Aphasia Quality of Life Scale; SAQOL-39g), depression (Yale-Brown single-item questionnaire; Yale) and sense of coherence (SOC-13). RESULTS: After controlling for the baseline values, no significant benefit was found in the intervention group over the control group (odds ratio (OR): 0.898: 95% confidence interval (95% CI): 0.54-1.50, p = 0.680) 6 months post-stroke. CONCLUSION: Psychosocial well-being improved during the first 6 months after stroke in both arms of the trial, but no statistically significant benefit of the dialogue-based intervention was found compared with usual care.

Implementation fidelity in a complex intervention promoting psychosocial well-being following stroke: an explanatory sequential mixed methods study.

BACKGROUND: Evaluation of complex interventions should include a process evaluation to give evaluators, researchers, and policy makers greater confidence in the outcomes reported from RCTs. Implementation fidelity can be part of a process evaluation and refers to the degree to which an intervention is delivered according to protocol. The aim of this implementation fidelity study was to evaluate to what extent a dialogue-based psychosocial intervention was delivered according to protocol. A modified conceptual framework for implementation fidelity was used to guide the analysis. METHODS: This study has an explanatory, sequential two-phase mixed methods design. Quantitative process data were collected longitudinally along with data collection in the RCT. Qualitative process data were collected after the last data collection point of the RCT. Descriptive statistical analyses were conducted to describe the sample, the intervention trajectories, and the adherence measures. A scoring system to clarify quantitative measurement of the levels of implementation was constructed. The qualitative data sources were analyzed separately with a theory-driven content analysis using categories of adherence and potential moderating factors identified in the conceptual framework of implementation fidelity. The quantitative adherence results were extended with the results from the qualitative analysis to assess which potential moderators may have influenced implementation fidelity and in what way. RESULTS: The results show that the core components of the intervention were delivered although the intervention trajectories were individualized. Based on the composite score of adherence, results show that 80.1% of the interventions in the RCT were implemented with high fidelity. Although it is challenging to assess the importance of each of the moderating factors in relation to the other factors and to their influence on the adherence measures, participant responsiveness, comprehensiveness of policy description, context, and recruitment appeared to be the most prominent moderating factors of implementation fidelity in this study. CONCLUSIONS: This evaluation of implementation fidelity and the discussion of what constitutes high fidelity implementation of this intervention are crucial in understanding the factors influencing the trial outcome. The study also highlights important methodological considerations for researchers planning process evaluations and studies of implementation fidelity. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02338869; registered 10/04/2014.

Finding the Way Forward: The Lived Experience of People With Stroke After Participation in a Complex Psychosocial Intervention.

Stroke patients' well-being is threatened after stroke. A psychosocial intervention was developed for Norwegian stroke patients living in the community. Eight individual sessions between people with stroke and a trained health care professional were conducted 1 to 6 months post-stroke with one group of participants and 6 to 12 months post-stroke with another group. Subsequently, 19 of these stroke patients were interviewed to gain an in-depth understanding of their lived experience of the influence of the intervention on their adjustment process. Interview texts were analyzed using Ricoeur's interpretation theory. Two participants did not personally find the intervention useful. The remaining participants greatly appreciated dialogues with the empathetic intervention personnel, feeling free to discuss their fears and worries. The intervention raised these participants' awareness of their needs and resources. They were guided to resume their everyday life and adopt a future-oriented attitude. The intervention facilitated their meaning-making endeavors and post-stroke adjustment.

When Nursing Care and Clinical Trials Coincide: A Qualitative Study of the Views of Nordic Oncology and Hematology Nurses on Ethical Work Challenges.

This study investigated the kinds of ethical challenges experienced by nurses in oncology and hematology when nursing care and research overlap in clinical trials, and how the nurses handle such challenges. Individual interviews with 39 nurses from Sweden, Denmark, and Finland indicated that all nurses were positive about research, considering it essential for developing the best care. Ethical challenges exist, however; the most difficult were associated with the end-of-life patients, no longer responsive to standard therapy, who eagerly volunteer for cutting-edge drug trials in the hope of gaining therapeutic benefit. Many nurses lacked systematic strategies for addressing such challenges but found support from their nursing colleagues and relied on the research protocols to guide them.

Promoting psychosocial well-being following stroke: study protocol for a randomized, controlled trial.

BACKGROUND: Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia. METHODS: The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity. DISCUSSION: The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex interventions. It combines classical effectiveness evaluation with a thorough process evaluation. The results from this study may inform the development of further trials aimed at promoting psychosocial well-being following stroke as well as inform the psychosocial follow up of stroke patients living at home. TRIAL REGISTRATION: NCT02338869 ; registered 10/04/2014 (On-going trial).

LQTS parents' reflections about genetic risk knowledge and their need to know or not to know their children's carrier status.

Long QT syndrome (LQTS) is a contributor to unexplained deaths in infants (SIDS), children, teenagers and young adults. A gene test result may allow for individual tailored treatment, but also pose a burden of knowing one's carrier status, with no treatment recommendation. Genetic risk knowledge in the case of LQTS can promote adjustment and coping, but also fear anxiety, ambivalence and moral dilemmas. This makes it challenging to respect both the right to know and the right not to know. The purpose of this study was to explore LQTS parents' perception of genetic knowledge, and their need to know or not to know about their children's carrier status. Qualitative, semi structured interviews were conducted with thirteen parents of LQTS-children. Results show that parents found it important to know the result of a gene test for LQTS including their children's carrier status. The risk was framed and incorporated into their everyday life and their life perspectives. Pertinent moral dilemmas concerned information disclosure to children and relatives. Parents thought that early and gradual disclosure to children would promote coping. Parents' moral dilemmas were rarely addressed during encounters with healthcare providers. The participants had several suggestions for improvement in that regard.

'We're just sick people, nothing else': ... factors contributing to elderly stroke patients' satisfaction with rehabilitation.

OBJECTIVE: To identify factors contributing to elderly stroke patients' satisfaction with rehabilitation following stroke. DESIGN: Qualitative study using semi-structured interviews. SETTING: Interviews conducted in two phases, once in a stroke rehabilitation unit and once after hospital discharge. SUBJECTS: Twelve elderly stroke patients (seven women and five men, aged 60-87 years). RESULTS: One main category: 'To be treated with respect and dignity' was identified as a core factor contributing to patients' satisfaction with the rehabilitation services. This main factor was divided into five subcategories: (1) Being treated with humanity, (2) Being acknowledged as individuals, (3) Having their autonomy respected, (4) Having confidence and trust in professionals, (5) Dialogue and exchange of information. The statements covered a continuum from satisfaction via indifference to dissatisfaction. Expressions of satisfaction emerged mainly as general statements while expressions of dissatisfaction described situations in greater detail. Satisfaction was merely connected to daily care experiences and fulfillment of basic needs. Trust in providers and being dignified seemed more closely associated with satisfaction than being involved in treatment decisions. The findings demonstrate how the quality of patient-professional interaction influences patients' satisfaction with stroke rehabilitation. CONCLUSION: To be treated with respect and dignity seems to be a core element influencing vulnerable elderly stroke patients' satisfaction with rehabilitation. A merely functional definition of the success of rehabilitation should be expanded into an approach encompassing patients' perceptions and personal preferences. The meaning of dignity for elderly stroke patients in the rehabilitation setting should be further clarified and given practical substance.

[Patient autonomy and informed consent in clinical practice]. / Pasientautonomi og informert samtykke i klinisk arbeid.

BACKGROUND: Patient autonomy and informed consent is increasingly emphasized in clinical practice, professional ethics and health care legislation. MATERIAL AND METHODS: Literature on patient autonomy and informed consent was assembled, analyzed, and common norms compared with Norwegian legal regulations. RESULTS: The procedure of obtaining informed consent may increase patient participation and prevent unwanted treatment and care. Such a practice is in line with the principle of patient autonomy. An act is normally considered autonomous when the following three criteria are fulfilled: Sufficient understanding, competence to consent and that the consent is given voluntarily. In clinical practice it is sometimes impossible to meet all these criteria. Furthermore, it is often demanding to tailor the information and the decision-making process to the individual patient's background and preferences. When the patient lacks competence to consent, the Norwegian health care legislation assigns an especially large responsibility to the health care personnel. Recently, health care personnel's authority to use force in such situations have been expanded. INTERPRETATION: The increased emphasis on patient autonomy and informed consent places high demands on health care personnel's moral considerations, ability to communicate, and understanding of roles and responsibilities. Assessment of competence to consent will probably become an important challenge to Norwegian health care personnel in the near future.