AbstractBackgroundStudies have found that presence of challenging behaviours and mental health problems limits employment for people with intellectual disabilities. This study investigates the associations between age, gender, living condition, level of intellectual disability, diagnoses, behaviour, mental health, and employment in adults with intellectual disabilities in Norway.MethodA cross‐sectional community‐based survey including 214 adult participants (56% men) with intellectual disabilities.ResultsIn our sample, 25% had no organised day activity, 27% attended non‐work day care, 19% attended sheltered employment, or day care with production, without pay and 29% worked in paid sheltered employment. One participant attended mainstream employment. Moderate and severe/profound level of intellectual disability, possible organic condition and irritability significantly reduced the odds of employment (paid and unpaid).ConclusionFindings suggest unequal access to the sheltered employment that was meant to be inclusive. More individualised evaluation of prerequisites is suggested to further facilitate employment for this group.
AbstractBackgroundIdentifying barriers that can be modified to promote physical activity is important for informing health interventions for adults with intellectual disabilities.ObjectivesExploring participation in physical activity considering age, sex, living conditions, and health conditions. Further, identifying barriers significantly associated with sedentary activity after adjustment for physical activity correlates.MethodsA cross‐sectional study including physical activity and barrier questions from the POMONA‐15 health indicators. Multivariate logistic regression analysis with sedentary activity level as dependent variable.ResultsAmong 213 participants with intellectual disabilities, 36% reported predominately sedentary activities, 53% light and 11% moderate/vigorous physical activity. Barriers related to sedentary activity after adjustment were transportation, health conditions, mobility impairment, and lack of activities at the day activity centre.ConclusionsThe findings highlight the need to enhance physical activity opportunities at day activity centres, tailor programmes for wheelchair users, and improve access to physical activity facilities for adults with intellectual disabilities.
AbstractBackgroundThis study investigated the completion rates, scores and factors associated with non‐completion and low scores on physical capability tests in a health survey administered to adults with intellectual disabilities.MethodAssessment comprised body mass index (BMI), the Short Physical Performance Battery (SPPB), the timed up‐and‐go (TUG) test, the one‐legged stance (OLS) test; and gross motor, communication and behavioural functioning tests.ResultsThe completion rates among 93 participants (aged 17–78) were 46% for the SPPB, 42% for the TUG, and 31% for the OLS. More severe intellectual disability (OR = 3.12, p < .001) and lower BMI (OR = 0.859, p = .001) were related to test non‐completion. The SPPB scores were below the reference values from the general population. Lower scores were associated with older age, motor disabilities and intellectual disability severity.ConclusionsIncluding physical capability tests in health surveys among adults with intellectual disabilities is important to monitor functional status and guide prevention strategies.
Background: Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods: We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n= 118) or type II (n=62) were randomised to 3-months oral treatment with 750mg amoxicillin (n=89) or placebo (n=91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results: None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40years the difference in mean RMDQ score between the treatment groups was −4.0 (95%CI, −6.9 to −1.2), compared to −0.5 (95%CI, −2.3 to 1.3) in patients 40years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions: We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies. ; The trial was funded by governmental organisations (Helse Sør-Øst and Helse Vest), which had no part in the planning, performing, or reporting of the results. ; publishedVersion
Objective: To assess the efficacy of three months of antibiotic treatment compared with placebo in patients with chronic low back pain, previous disc herniation, and vertebral endplate changes (Modic changes). Design: Double blind, parallel group, placebo controlled, multicentre trial. Setting: Hospital outpatient clinics at six hospitals in Norway. Participants: 180 patients with chronic low back pain, previous disc herniation, and type 1 (n=118) or type 2 (n=62) Modic changes enrolled from June 2015 to September 2017. Interventions: Patients were randomised to three months of oral treatment with either 750 mg amoxicillin or placebo three times daily. The allocation sequence was concealed by using a computer generated number on the prescription. Main outcome measures: The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (range 0-24) at one year follow-up in the intention to treat population. The minimal clinically important between group difference in mean RMDQ score was predefined as 4. Results: In the primary analysis of the total cohort at one year, the difference in the mean RMDQ score between the amoxicillin group and the placebo group was −1.6 (95% confidence interval −3.1 to 0.0, P=0.04). In the secondary analysis, the difference in the mean RMDQ score between the groups was −2.3 (−4.2 to−0.4, P=0.02) for patients with type 1 Modic changes and −0.1 (−2.7 to 2.6, P=0.95) for patients with type 2 Modic changes. Fifty patients (56%) in the amoxicillin group experienced at least one drug related adverse event compared with 31 (34%) in the placebo group. Conclusions: In this study on patients with chronic low back pain and Modic changes at the level of a previous disc herniation, three months of treatment with amoxicillin did not provide a clinically important benefit compared with placebo. Secondary analyses and sensitivity analyses supported this finding. Therefore, our results do not support the use of antibiotic treatment for chronic low back pain and Modic changes. ; Funding was granted by governmental organisations Helse Sør-Øst (grant No 2015090) and Helse Vest (grant No 911938 and 911891), which had no part in the planning, performing, or reporting of the trial. The trial protocol is available atClinicalTrials.gov. ; publishedVersion
Background The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75–224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.
In: Timmers , M , Van Dijck , J T J M , Van Wijk , R P J , Legrand , V , Van Veen , E , Maas , A I R , Menon , D K , Citerio , G , Stocchetti , N , Kompanje , E J O , Åkerlund , C , Amrein , K , Andelic , N , Andreassen , L , Anke , A , Antoni , A , Audibert , G , Azouvi , P , Azzolini , M L , Bartels , R , Barzó , P , Beauvais , R , Beer , R , Bellander , B M , Belli , A , Benali , H , Berardino , M , Beretta , L , Blaabjerg , M , Bragge , P , Brazinova , A , Brinck , V , Brooker , J , Brorsson , C , Buki , A , Bullinger , M , Cabeleira , M , Caccioppola , A , Calappi , E , Calvi , M R , Cameron , P , Lozano , G C , Carbonara , M , Cavallo , S , Chevallard , G , Chieregato , A , Ceyisakar , I , Coburn , M , Coles , J , Kondziella , D & The CENTER-TBI investigators and participants 2020 , ' How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study ' , BMC Medical Ethics , vol. 21 , no. 1 , 36 . https://doi.org/10.1186/s12910-020-00480-8
Background: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.
Abstract: Background: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75–224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.