Family member reported symptom burden, predictors of caregiver burden and treatment effects in a goal-oriented community-based randomized controlled trial in the chronic phase of traumatic brain injury.

BACKGROUND: Family members are often affected by the long-term consequences of traumatic brain injury, but are rarely involved in rehabilitation programs in the chronic phase. We thus do not know what family members´ main concerns are in the chronic phase, what factors are associated with perceived caregiver burden, and whether family members´ health and functioning improves due to rehabilitation efforts received by the patients. This study explored family-members` functioning, predictors of caregiver burden and effect for family members of a goal-oriented intervention in the chronic phase of traumatic brain injury. METHODS: Family members self-reported data measuring their caregiver burden, depression, general health, loneliness, and their evaluation of patient competency in everyday life, patient awareness levels, main problem areas (target outcomes) for the patient related to the brain injury, and demographic data were collected. Regression models were used to explore predictors of caregiver burden, and mixed models analysis was used to explore treatment effects. RESULTS: In total, 73 family members were included, 39 in the intervention group and 34 in the control group. Moderate to high caregiver burden was reported by 40% of family members, and 16% experienced clinical levels of depression. Family member loneliness and their evaluation of the patient`s level of functional competency explained 57% of the variability in caregiver burden. There were no treatment-related changes in caregiver burden, family member depression or general health. At T2 there was however a significant reduction in how family members rated severity of target outcomes that the family members had nominated at baseline (-0.38, 95% CI, -0.75 to -0.02, p = 0.04), but not for the target outcomes the patients had nominated. CONCLUSIONS: A significant proportion of family members to patients in the chronic phase of TBI continue to experience challenging caregiver burden and emotional symptoms. Both family member-related and patient factors contribute to caregiver burden. Interventions targeting patient complaints do not automatically alleviate family members´ burden. It is important to address social support for family members early after injury, and there is a need for more interventions specifically targeting family members´ needs. TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov, NCT03545594 on the 4th of June 2018.

"Psychometric properties of the Norwegian foot function index revised short form".

BACKGROUND: Foot disorders affect up to one quarter of the adult population. Plantar fasciopathy is a common cause of foot pain associated with decreased activity level and quality of life. Patient-reported outcome measures are important in assessing the burden of a condition as well as in research on the effects of interventions. The Foot Function Index revised short form (FFI-RS) is a region specific questionnaire frequently used in research. This study aimed to cross-culturally adapt the FFI-RS into Norwegian and to test its psychometric properties. METHODS: The FFI-RS was translated into Norwegian (FFI-RSN) following international guidelines. 139 patients with foot disorders (88% with plantar fasciopathy) were included at baseline to measure internal consistency, explorative factor analysis, construct validity and floor and ceiling effects. 54 patients were included after 1 week for test-retest reliability and smallest detectable change analyses. 100 patients were included for responsiveness and minimal important change at 3 months. RESULTS: Cronbach's alpha for internal consistency was 0.97 and factor analysis supported the use of the total score of the FFI-RSN. Two out of three predefined hypotheses were confirmed by assessing the construct validity with Spearman's correlation coefficient. Quadratic weighted Kappa for test-retest reliability showed 0.91 (95% CI 0.86-0.96) and the smallest detectable change was 6.5%. The minimal important change was 8.4% and the area under the receiver operating characteristic curve for responsiveness was 0.78 (95% CI 0.69-0.87). We found no floor or ceiling effects on the total score of the FFI-RSN. CONCLUSIONS: The present study showed excellent reliability of the FFI-RSN and supports the use of the total score of the questionnaire. Furthermore, we found the FFI-RSN to have acceptable responsiveness in relation to change in general health. Smallest detectable change, minimal important change and responsiveness were presented as novel results of the total score of the FFI-RS. FFI-RSN can be used to evaluate global foot health in clinical or research settings with Norwegian patients suffering from plantar fasciopathy. TRIAL REGISTRATION: Clinical Trials.gov NCT04207164 . Initial release 01.11.19.

User involvement in the making: Positions and types of knowledge enacted in the interaction between service users and researchers in user panel meetings.

BACKGROUND: Numerous studies of user involvement in research have been conducted. However, there is a lack of studies applying observational methods and addressing the concrete practice of involvement. OBJECTIVE: To determine what knowledge types and competences users apply when involved in the research process through user panel meetings. DESIGN: User panel meetings in a qualitative project in rehabilitation were sound-recorded and transcribed verbatim. Data analysis applied an abductive approach framed by positioning theory. SETTING AND PARTICIPANTS: Six rehabilitation service users and a similar number of researchers met 20 times during a six-year project period. They discussed various issues in the research process such as interview guides, analysis and dissemination of results. FINDINGS: The service users combined their respective knowledge and competence into six positions enacted in the panel interactions. They engaged as co-researchers, based their contributions on their respective personal histories, represented an NGO and peers, applied their respective professional and educational backgrounds and, finally, engaged as concerned citizens. DISCUSSION AND CONCLUSION: The findings add to the discussion of professionalization of user involvement by introducing a wider array of positions enacted than do the findings of previous studies. Researchers recruiting user panel members, as well as NGOs appointing candidates for user panels, are advised to consider a wide competence profile for possible candidates. A panel is also considered as a resource in confirming and elaborating on a study's findings. PATIENT AND PUBLIC CONTRIBUTION: A service user panel contributed to the study.

The effects of vestibular rehabilitation on dizziness and balance problems in patients after traumatic brain injury: a randomized controlled trial.

OBJECTIVE:: To investigate the effects of group-based vestibular rehabilitation in patients with traumatic brain injury. DESIGN:: A single-blind randomized controlled trial. SETTING:: University Hospital (recruitment and baseline assessments) and Metropolitan University (experimental intervention). SUBJECTS:: A total of 65 patients (45 women) with mild-to-moderate traumatic brain injury (mean age 39.4 ± 13.0 years) were randomly assigned to intervention ( n = 33) or control group ( n = 32). INTERVENTION:: Group-based vestibular rehabilitation for eight weeks. Participants were tested at baseline (3.5 ± 2.1 months after injury) and at two post-intervention follow-ups (2.7 ± 0.8 and 4.4 ± 1.0 months after baseline testing). MAIN MEASURES:: Primary outcome: Dizziness Handicap Inventory. Secondary outcome: High-Level Mobility Assessment Tool. Other outcomes: Vertigo Symptom Scale; Rivermead Post-concussion Symptoms Questionnaire; Hospital Anxiety and Depression Scale; and Balance Error Scoring System. Between-group differences were analyzed with a linear mixed-model analysis for repeated measurements. RESULTS:: At baseline, no group differences were revealed (personal factors, clinical characteristics and outcome measures). At the first follow-up, statistically significant mean differences in favor of the intervention were found in the primary (-8.7, 95% confidence interval (CI): -16.6 to -0.9) and secondary outcomes (3.7 points, 95% CI: 1.4-6.0). At the second follow-up, no significant between-group differences were found. No significant between-group differences in the other outcomes were found at the two follow-ups. CONCLUSION:: The intervention appeared to speed up recovery for patients with dizziness and balance problems after traumatic brain injury. However, the benefits had dissipated two months after the end of the intervention.

The Norwegian version of the QOLIBRI - a study of metric properties based on a 12 month follow-up of persons with traumatic brain injury.

BACKGROUND: Consequences after Traumatic brain injury (TBI) affect the injured person's self-image and quality of life. The purpose was to assess the health related quality of life (HRQoL) at 12 months after a TBI in patients admitted to regional trauma centres, and to evaluate the metric properties of the Norwegian version of the Quality of Life After Brain Injury (QOLIBRI) questionnaire. METHODS: Two hundred four patients with TBI of all severities were included. HRQoL at 12 months post-injury was measured by the QOLIBRI. It has a total scale and 6 subscales (satisfied with Cognition, Self, Daily Life and Autonomy and Social Relationships, and bothered by Emotions and Physical Problems). Demographic and injury related data were registered. Disability was registered by Glasgow Outcome Scale Extended (GOSE) and Rivermead Post-Concussion Questionnaire, and mental health by Hospital Anxiety and Depression Scale. Descriptive statistics, internal consistency by Cronbach's alpha and Corrected Item-Total Correlations were calculated. Rasch analysis, Principal Component Analysis (PCA) and Structural Equation Modelling (SEM) were applied. RESULTS: Mean age was 37.6 (SD 15.4) years; 72% were men, and 41% had higher education. Over 60% were severely injured. Mean Glasgow Coma Scale score was 9.3 (SD 4.5). According to the GOSE 5.9% had severe disability, 45.5% had moderate disability, and 48.5% had good recovery at 12 months post-injury. The QOLIBRI scales had a high internal consistency (α = 0.75-0.96), and only Physical Problems had an α < 0.85. In the Rasch analysis all subscales and their items fit the Rasch model, except for the depression item in the Emotion subscale. PCA and SEM analyses supported a six-factor structure in a second-order latent model. The QOLIBRI supports an underlying unidimensional HRQoL model. The SEM model fit statistics of the second-order model indicated a moderate fit to the observed data (CFI = 0.86, TLI = 0.85, RMSEA = 0.076, SRMR = 0.061, χ2 = 1315.76, df = 623, p-value < 0.001). CONCLUSION: The Norwegian QOLIBRI has favourable psychometric properties, but there were some weaknesses related to its measurement properties of the total score when tested on a TBI population where many had severe TBI, and many had good recovery.

Shoulder MRI features with clinical correlations in subacromial pain syndrome: a cross-sectional and prognostic study.

BACKGROUND: Previous studies on shoulder patients have suggested that the prevalence of rotator cuff or bursa abnormalities are weakly related to symptoms and that similar findings are often found in asymptomatic persons. In addition, it is largely unknown whether structural changes identified by magnetic resonance imaging (MRI) affect outcome after treatment for shoulder pain. The purpose of this study was therefore to evaluate the presence of structural changes on MRI in patients with subacromial pain syndrome and to determine to what extent these changes are associated with symptoms and predict outcome after treatment (evaluated by the Shoulder Pain and Disability Index (SPADI)). METHODS: A prospective, observational assessment of a subset of shoulder patients who were included in a randomized study was performed. All participants had an MRI of the shoulder. An MRI total score for findings at the AC joint, subacromial bursa and rotator cuff was calculated. Multiple linear regression analysis was applied to examine the relationship between the MRI total score and the outcome measure at baseline and to examine to what extent the MRI total score was associated with the change in the SPADI score from baseline to the one year follow-up. RESULTS: There was a weak, inverse association between the SPADI score at baseline and the MRI total score (ß = -3.1, with 95% CI -5.9 to -0.34; p = 0.03), i.e. the SPADI score was higher for patients with a lower MRI total score. There was an association between the change in the SPADI score from baseline to the one year follow-up and the MRI total score (ß = 8.1, 95% CI -12.3 to -3.8; p < 0.001), with a poorer outcome for patients with a higher MRI total score. Both tendinosis (p = 0.01) and bursitis (p = 0.04) were associated with a poorer outcome after one year. CONCLUSIONS: In this study, MRI findings were significantly associated with the change in the SPADI score from baseline and to one year follow-up, with a poorer outcome after treatment for the patients with higher MRI total score, tendinosis and bursitis on MRI. TRIAL REGISTRATION: Clinicaltrials.gov no NCT01441830 . September 28, 2011.

Is radial Extracorporeal Shock Wave Therapy (rEWST) combined with supervised exercises (SE) more effective than sham rESWT and SE in patients with subacromial shoulder pain? Study protocol for a double-blind randomised, sham-controlled trial.

BACKGROUND: Subacromial shoulder pain is a common complaint. Radial Extracorporeal Shock Wave Therapy (rESWT) has being increasingly used to treat calcific and non-calcific tendinosis, although there is no evidence of the effectiveness of rESWT in non-calcific tendinosis of the rotator cuff. A randomised single blind study showed that the short-term effect of supervised exercises (SE) was significantly better than rESWT on subacromial shoulder pain, but both groups improved. In a clinical trial on achilles tendinopathy rESWT improved the effectiveness of treatment with eccentric loading. The objective of this present study is to evaluate if rESWT in addition to SE is more effective in improving shoulder pain and function compared with sham rESWT and SE in patients with subacromial shoulder pain. METHODS/DESIGN: This is a double blind, randomised sham-controlled trial which is performed at the shoulder clinic at the Department of Physical Medicine and Rehabilitation in Oslo University Hospital, Norway. One-hundred-forty-four patients with subacromial shoulder pain lasting at least 3 months, age from 25 to 70 years old are included in the trial. Patients are randomly allocated in 1:1 ratio to receive either rESWT or sham rESWT once a week in addition to SE once a week for the initial 4 weeks. Subsequently SE are provided twice a week for 8 weeks. The primary outcome measure is a change in the Shoulder Pain and Disability Index (SPADI) at 24 weeks follow-up. Secondary outcomes include return to work, pain at rest and on activity, function, and health related quality of life. The patients, the physiotherapist providing the exercise regimen and the outcome assessor are blinded to group assignment. The physiotherapist providing the rESWT is not blinded. DISCUSSION: Because of the extensive use of rESWT in the treatment of subacromial shoulder pain the results of this trial will be of importance and have impact on clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT01441830.

A Prospective Intervention Study With 6 Months Follow-up of the Effect of Reablement in Home Dwelling Elderly: Patient-reported and Observed Outcomes.

Objectives: To investigate the effect of a reablement intervention (a person-centered, interdisciplinary rehabilitation approach) compared with usual care services in home-dwelling elderly experiencing functional declines in activities of daily living. Design: A non-randomized controlled trial comparing a reablement intervention with usual care; outcomes were measured at baseline, after intervention, and at a 6-month from baseline in both groups. Setting: Municipal public health service. Participants: Sixty-five home-dwelling elderly with functional decline were assigned by the participants home care service zone to a reablement group (n=35), or a usual care group (n=30). The mean participant age was 80±11 years in the reablement group and 78±12 in the usual care group. Intervention: The reablement group received a person-centered and tailored reablement program provided by an interdisciplinary team, consisting of a physiotherapist, an occupational therapist, and a nurse. The usual care group received standard home care services. Main Outcome Measures: The dimension "Your health today" from the European Quality of Life-Visual Analog Scale (HRQOL), the patient-specific functional scale for goals in ADL (PSFS), the short physical performance battery (SPPB), and home care services in hours per week. Results: There were significant differences over time in favor of the reablement group with between-group effect sizes of Cohen h2=0.36 (P=.001) for HRQOL, h2=0.60 (P=.001) for PSFS, h2=0.30 (P=.001) for SPPB, and h2=0.10 (P=.013) for hours of home care services per week. The within-group effect size for PSFS was h2=0.15 (P=.010) in favor of the reablement group. The mean number of hours of home care services per week was mean 0.38±1.07 (P=.001) in the reablement group and mean 30.38±64.13 (P=.023) in the usual care group. Conclusions: The participants in the reablement group achieved and maintained better physical function, a higher HRQOL and needed considerably less home care services than the usual care group participants. Thus, reablement appears to be a more beneficial and sustainable approach than the usual care services for the home-dwelling elderly with functional decline.

Individualized goals expressed by patients undergoing stroke rehabilitation: an observational study.

OBJECTIVES: To explore the rehabilitation goals measured with the Patient-Specific Functional Scale (PSFS) in patients undergoing acute and subacute stroke rehabilitation. In addition, to assess whether PSFS goals corresponded to impairments and activity limitations, as identified by standardized measures. DESIGN: Observational study. PARTICIPANTS: A total of 71 participants undergoing inpatient stroke rehabilitation. METHODS: The PSFS goals were linked to second-level categories in the International Classification of Functioning, Disability and Health (ICF), using established linking rules. Frequencies of the linked ICF categories were calculated. Frequencies of participants with limitations in walking, activities of daily living (ADL), vision, language, and cognition, were calculated, along with goals in corresponding areas of functioning. RESULTS: The participants' goals were linked to 50 second-level ICF categories, comprising areas such as walking and moving, ADL, language, vision, and cognition. The most frequent ICF categories were "Moving around in different locations" (n = 24), "Walking" (n = 23), "Toileting" (n = 16), "Hand and arm use (n = 12) and "Fine hand use (n = 12)". Of participants with limitations in walking, cognition, and vision, 85%, 10%, and 16%, respectively, had goals in these areas. CONCLUSION: Participants' goals included walking, ADL, language, vision, and cognition. Few with impairments in cognition or vision had goals in these corresponding areas on the PSFS.

Return to Work One Year after Moderate to Severe Traumatic Injury in a Working Age Population.

Background/Objectives: Physical trauma may cause long-term disabilities. The importance of place of residence in the return to work after injuries is little researched. The primary aims of this study were to describe return to work or school (RTW) at 6 and 12 months after moderate to severe traumatic injury and to investigate demographic and injury-related predictors for RTW with an initial focus on geographic centrality of residency. The secondary aim was to investigate the association between RTW and functioning. Methods: A prospective cohort study conducted at two Norwegian trauma centres. Inclusion criteria: age 18 to 70 years, at least a two-day hospital stay and a New Injury Severity Score > 9. Information about centrality, demographics, injuries, and return to work were collected. Associations between possible predictors and RTW were assessed using binary logistic regression. Results: Of the 223 participants, 68% had returned to work after 6 months and 77% after 12 months. Twelve-month RTW was 89% after thorax/abdomen injuries, 78% after extremity/spine injuries and 73% after head injuries. More central residency was a significant predictor for RTW in univariable but only within the extremity/spine injury subgroup in multivariable analysis. Negative factors were age, having a blue-collar job, number of injuries and rehabilitation complexity. Function 12 months post-injury was associated with RTW in the multivariable model. Conclusions: RTW after one year was high in all major trauma groups. Demographic and injury-related factors were more important predictors of RTW than centrality of residency. Blue-collar workers and patients with multiple injuries and high rehabilitation complexity should be given special attention to support RTW.