umu.sePublications
Change search
Link to record
Permanent link

Direct link
BETA
Alternative names
Publications (10 of 83) Show all publications
Garoff, M., Ahlqvist, J., Edin, L.-T., Jensen, S., Levring Jäghagen, E., Petäjäniemi, F., . . . Johansson, E. (2019). Bilateral vessel-outlining carotid artery calcifications in panoramic radiographs: an independent risk marker for vascular events. BMC Cardiovascular Disorders, 19(1), Article ID 225.
Open this publication in new window or tab >>Bilateral vessel-outlining carotid artery calcifications in panoramic radiographs: an independent risk marker for vascular events
Show others...
2019 (English)In: BMC Cardiovascular Disorders, ISSN 1471-2261, E-ISSN 1471-2261, Vol. 19, no 1, article id 225Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: In odontology, panoramic radiographs (PRs) are regularly performed. PRs depict the teeth and jaws as well as carotid artery calcifications (CACs). Patients with CACs on PRs have an increased risk of vascular events compared to healthy controls without CACs, but this association is often caused by more vascular events and risk factors at baseline. However, the risk of vascular events has only been analyzed based on the presence of CACs, and not their shape. Thus, this study determined if the shape of CACs in PRs affects the risk of future vascular events.

METHODS: The study cohort included 117 consecutive patients with CACs in PRs and 121 age-matched controls without CACs. CAC shape in PRs was dichotomized into bilateral vessel-outlining CACs and other CAC shapes. Participants were followed prospectively for an endpoint of vascular events including myocardial infarction, stroke, and vascular death.

RESULTS: Patients with bilateral vessel-outlining CACs had more previous vascular events than those with other CAC shapes and the healthy controls (p < 0.001, χ2). The mean follow-up duration was 9.5 years. The endpoint was reached in 83 people. Patients with bilateral vessel-outlining CACs had a higher annual risk of vascular events (7.0%) than those with other CAC shapes (4.4%) and the controls (2.6%) (p < 0.001). In multivariate analysis, bilateral vessel-outlining CACs (hazard ratio: 2.2, 95% confidence interval: 1.1-4.5) were independent risk markers for the endpoint.

CONCLUSIONS: Findings of bilateral vessel-outlining CACs in PRs are independent risk markers for future vascular events.

Place, publisher, year, edition, pages
BioMed Central, 2019
Keywords
Cardiovascular disease, Carotid atherosclerosis, Panoramic radiography
National Category
Medical and Health Sciences Clinical Medicine
Research subject
Medicine; Odontology
Identifiers
urn:nbn:se:umu:diva-164795 (URN)10.1186/s12872-019-1211-3 (DOI)000490832600004 ()31619183 (PubMedID)
Funder
Swedish Heart Lung FoundationVästerbotten County CouncilKnut and Alice Wallenberg Foundation
Available from: 2019-11-01 Created: 2019-11-01 Last updated: 2019-11-19Bibliographically approved
Bråndal, A., Eriksson, M., Glader, E.-L. & Wester, P. (2019). Effect of early supported discharge after stroke on patient reported outcome based on the Swedish Riksstroke registry. BMC Neurology, 19, Article ID 40.
Open this publication in new window or tab >>Effect of early supported discharge after stroke on patient reported outcome based on the Swedish Riksstroke registry
2019 (English)In: BMC Neurology, ISSN 1471-2377, E-ISSN 1471-2377, Vol. 19, article id 40Article in journal (Refereed) Published
Abstract [en]

Background: The efficacy of early supported discharge (ESD) has not been tested in current stroke care setting, which provide relatively short hospital stays, access to hyper-acute therapies and early carotid stenosis interventions. This study aimed to compare patient-reported outcome measures (PROM) among patients with stroke that received modern stroke unit care with or without ESD.

Methods: Observational study of 30,232 patients with first-ever stroke registered in the Riksstroke registry in Sweden, between 1 January 2010 and 31 December 2013. Patient characteristics were collected from the Riksstroke and Statistics Sweden databases. The primary outcome was satisfaction with the rehabilitation at 3 months after discharge. Secondary outcome were information about stroke provided, tiredness/fatigue, pain, dysthymia/ depression, general health status and dependence in activities of daily living (mobility, toileting and dressing) at 3 months after the stroke. We used separate multivariable logistic regression models for each PROM variable to analyze associations between PROMs and ESD/no ESD.

Results: The ESD group comprised 1495 participants: the control group comprised 28,737 participants. Multivariable logistic regression models of PROMs showed that, compared to controls, the ESD group was more satisfied with rehabilitation after discharge (OR: 1.78, 95% CI: 1.17–2.49), experienced less dysthymia/depression (OR: 0.68, 95% 0.55–0.84) and showed more independence in mobility (OR: 1.50, 95% CI: 1.17–1.92), toileting (OR: 1.30, 95%CI: 1.05–1.61), and dressing (OR: 1.23, 95%CI: 1.02–1.48).

Conclusion: In the setting of modern stroke unit care, ESD appeared to have positive effects on stroke rehabilitation, in the subacute phase.

Place, publisher, year, edition, pages
BioMed Central, 2019
Keywords
Stroke, Early supported discharge, Rehabilitation, Patient reported outcome measurement
National Category
Cardiac and Cardiovascular Systems Neurology Nursing
Identifiers
urn:nbn:se:umu:diva-120124 (URN)10.1186/s12883-019-1268-8 (DOI)000461384100001 ()30866844 (PubMedID)2-s2.0-85062847136 (Scopus ID)
Note

Originally included in thesis  in manuscript form with title: "Effect of early supported discharge after stroke on patient reported outcome: observational study from the Swedish Riksstroke registry".

Available from: 2016-05-09 Created: 2016-05-09 Last updated: 2019-04-04Bibliographically approved
Hägglund, P., Hägg, M., Wester, P. & Levring Jäghagen, E. (2019). Effects of oral neuromuscular training on swallowing dysfunction among older people in intermediate care: a cluster randomized, controlled trial. Age and Ageing, 48, 533-540
Open this publication in new window or tab >>Effects of oral neuromuscular training on swallowing dysfunction among older people in intermediate care: a cluster randomized, controlled trial
2019 (English)In: Age and Ageing, ISSN 0002-0729, E-ISSN 1468-2834, Vol. 48, p. 533-540Article in journal (Refereed) Published
Abstract [en]

Objectives: this prospective, cluster randomised, controlled trial investigated the effect of oral neuromuscular training among older people in intermediate care with impaired swallowing.

Methods: older people (≥65 years) with swallowing dysfunction were cluster randomised according to care units for 5 weeks of neuromuscular training of the orofacial and pharyngeal muscles or usual care. The primary endpoint was the change in swallowing rate (assessed with a timed water swallow test) from baseline to the end-of-treatment and 6 months post-treatment. The secondary endpoints were changes in signs of aspiration during the water swallow test, and swallowing-related quality of life (QOL). An intention-to-treat principle was followed, and mixed-effects models were used for data analysis with the clustered study design as a random factor.

Results: in total, 385 participants from 36 intermediate care units were screened, and 116 participants were randomly assigned to oral neuromuscular training (intervention; n = 49) or usual care (controls; n = 67). At the end of treatment, the geometric mean of the swallowing rate in the intervention group had significantly improved 60% more than that of controls (P = 0.007). At 6 months post-treatment, the swallowing rate of the intervention group remained significantly better (P = 0.031). Signs of aspiration also significantly reduced in the intervention group compared with controls (P = 0.01). No significant between-group differences were found for swallowing-related QOL.

Conclusions: oral neuromuscular training is a new promising swallowing rehabilitation method among older people in intermediate care with impaired swallowing.

Trial registration: ClinicalTrials.gov: NCT02825927.

Place, publisher, year, edition, pages
Oxford University Press, 2019
Keywords
swallowing disorders, dysphagia, rehabilitation, quality of life, elderly care, nursing homes
National Category
Dentistry
Research subject
Medicine; Geriatrics; Odontology
Identifiers
urn:nbn:se:umu:diva-157339 (URN)10.1093/ageing/afz042 (DOI)000493371900015 ()31062842 (PubMedID)
Funder
The Kamprad Family Foundation, 20132115
Note

Originally included in thesis in manuscript form.

Available from: 2019-03-14 Created: 2019-03-14 Last updated: 2019-11-28Bibliographically approved
Hägglund, P., Susanne, K., Olai, L., Ståhlnacke, K., Wester, P. & Levring Jäghagen, E. (2019). Older people with swallowing dysfunction and poor oral health are at greater risk of early death. Community Dentistry and Oral Epidemiology
Open this publication in new window or tab >>Older people with swallowing dysfunction and poor oral health are at greater risk of early death
Show others...
2019 (English)In: Community Dentistry and Oral Epidemiology, ISSN 0301-5661, E-ISSN 1600-0528Article in journal (Refereed) Epub ahead of print
Abstract [en]

Objectives: We investigated the associations between swallowing dysfunction, poor oral health and mortality among older people in intermediate care in Sweden.

Methods: This prospective cohort study investigated 391 older people in 36 intermediate care units (clusters). Swallowing function was assessed with the timed water swallow test (TWST), and oral health with the revised oral assessment guide (ROAG) at baseline. Data were collected on age, sex, education level, multimorbidity, cognitive impairment, care dependency and body mass index (BMI). Time to mortality was recorded during the following year. The mixed effects Cox regression model with cluster as a random factor was used to estimate hazards ratios (HR) with 95% confidence intervals (CI).

Results: The median age of the participants was 84 years (interquartile range [IQR]: 11), and 53.3% were females. Mortality within one year was 25.1%. In the adjusted model, swallowing dysfunction and poor oral health were both independently associated with mortality (adjusted HR [aHR]: 1.67, 95% CI 1.02‐2.75; P = .041 and aHR: 1.98, 95% CI 1.07‐3.65; P = .029, respectively). Participants with combined swallowing dysfunction and poor oral health showed the highest mortality (35.0%) and 2.6 (95% CI 1.15‐5.89; P = .022) times higher mortality risk than those with normal swallowing function and good oral health (13.0%).

Conclusions: Swallowing dysfunction and poor oral health were identified as independent risk factors for mortality in older people in intermediate care. Although further studies are required to verify these findings, they suggest that systematic assessment of swallowing function and oral health status should be performed for care considerations.

Keywords
mortality, swallowing disorders, oral hygiene, oral care, elderly care
National Category
Geriatrics Dentistry
Identifiers
urn:nbn:se:umu:diva-157340 (URN)10.1111/cdoe.12491 (DOI)000482105300001 ()
Note

Originally included in thesis in manuscript form

Available from: 2019-03-14 Created: 2019-03-14 Last updated: 2019-09-16
Hägglund, P., Fält, A., Hägg, M., Wester, P. & Levring Jäghagen, E. (2019). Swallowing dysfunction as risk factor for undernutrition in older people admitted to Swedish short-term care: a cross-sectional study. Aging Clinical and Experimental Research, 31(1), 85-94
Open this publication in new window or tab >>Swallowing dysfunction as risk factor for undernutrition in older people admitted to Swedish short-term care: a cross-sectional study
Show others...
2019 (English)In: Aging Clinical and Experimental Research, ISSN 1594-0667, E-ISSN 1720-8319, Vol. 31, no 1, p. 85-94Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Swallowing dysfunction and risk of undernutrition increase the risk of pneumonia, morbidity, and mortality. Short-term care is an unexplored care context, where many older people stay yearly.

AIM: This cross-sectional study aimed to describe and analyze the relationship between swallowing dysfunction and risk of undernutrition among older people in short-term care, including potential gender-related differences.

METHODS: In total, 391 people (209 women), aged ≥ 65 years (median age 84 years) and admitted to short-term care in five Swedish counties participated. They went through a timed water swallow test to assess swallowing dysfunction, including abnormal swallowing capacity and signs of aspiration (i.e., cough and voice change). Risk for undernutrition was assessed using the Minimal Eating Observation and Nutrition Form-version II.

RESULTS: Swallowing dysfunction was observed in 248 of 385 (63%) participants, including abnormal swallowing capacity in 213 of 385 (55%) and aspiration signs in 127 of 377 (34%). Abnormal swallowing capacity was more frequent among women (p = 0.030), whereas men with normal swallowing capacity exhibited signs of aspiration more frequently (cough p = 0.038, voice change p = 0.004). Risk of undernutrition was found in 91 of 390 (23%) participants, more frequently among women (p = 0.007). A logistic regression model revealed an increased risk of undernutrition among older people with abnormal swallowing capacity (OR 1.74, 95% CI 1.04-2.92, p = 0.034).

CONCLUSIONS: The high prevalence of swallowing dysfunction and risk of undernutrition highlight the need for a systematic screening program and feasible treatment to improve swallowing function for adequate and safe food intake among older people in short-term care.

CLINICAL TRIAL REGISTRATION: This study was registered with ClinicalTrials.gov on July 4, 2016, under NCT02825927.

Place, publisher, year, edition, pages
Springer, 2019
Keywords
Aspiration, Dysphagia, Elderly care, Gender, Malnutrition, Swallowing disorders
National Category
Geriatrics Dentistry Nutrition and Dietetics
Research subject
Geriatrics; Odontology; Caring Sciences
Identifiers
urn:nbn:se:umu:diva-146928 (URN)10.1007/s40520-018-0944-7 (DOI)000457534400011 ()29663160 (PubMedID)2-s2.0-85045421560 (Scopus ID)
Funder
Forte, Swedish Research Council for Health, Working Life and Welfare, 2013-2127The Kamprad Family Foundation, 20132115
Available from: 2018-12-01 Created: 2018-12-01 Last updated: 2019-03-14Bibliographically approved
Näslund, U., Ng, N., Lundgren, A., Fhärm, E., Grönlund, C., Johansson, H., . . . Norberg, M. (2019). Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA): a pragmatic, open-label, randomised controlled trial. The Lancet, 393(10167), 133-142
Open this publication in new window or tab >>Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA): a pragmatic, open-label, randomised controlled trial
Show others...
2019 (English)In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 393, no 10167, p. 133-142Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Primary prevention of cardiovascular disease often fails because of poor adherence among practitioners and individuals to prevention guidelines. We aimed to investigate whether ultrasound-based pictorial information about subclinical carotid atherosclerosis, targeting both primary care physicians and individuals, improves prevention.

METHODS: Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA) is a pragmatic, open-label, randomised controlled trial that was integrated within the Västerbotten Intervention Programme, an ongoing population-based cardiovascular disease prevention programme in northern Sweden. Individuals aged 40, 50, or 60 years with one or more conventional risk factors were eligible to participate. Participants underwent clinical examination, blood sampling, and ultrasound assessment of carotid intima media wall thickness and plaque formation. Participants were randomly assigned 1:1 with a computer-generated randomisation list to an intervention group (pictorial representation of carotid ultrasound plus a nurse phone call to confirm understanding) or a control group (not informed). The primary outcomes, Framingham risk score (FRS) and European systematic coronary risk evaluation (SCORE), were assessed after 1 year among participants who were followed up. This study is registered with ClinicalTrials.gov, number NCT01849575.

FINDINGS: 3532 individuals were enrolled between April 29, 2013, and June 7, 2016, of which 1783 were randomly assigned to the control group and 1749 were assigned to the intervention group. 3175 participants completed the 1-year follow-up. At the 1-year follow-up, FRS and SCORE differed significantly between groups (FRS 1·07 [95% CI 0·11 to 2·03, p=0·0017] and SCORE 0·16 [0·02 to 0·30, p=0·0010]). FRS decreased from baseline to the 1-year follow-up in the intervention group and increased in the control group (-0·58 [95% CI -0·86 to -0·30] vs 0·35 [0·08 to 0·63]). SCORE increased in both groups (0·13 [95% CI 0·09 to 0·18] vs 0·27 [0·23 to 0·30]).

INTERPRETATION: This study provides evidence of the contributory role of pictorial presentation of silent atherosclerosis for prevention of cardiovascular disease. It supports further development of methods to reduce the major problem of low adherence to medication and lifestyle modification.

Place, publisher, year, edition, pages
Elsevier, 2019
National Category
Public Health, Global Health, Social Medicine and Epidemiology Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:umu:diva-154318 (URN)10.1016/S0140-6736(18)32818-6 (DOI)000455437100026 ()30522919 (PubMedID)
Funder
Västerbotten County Council, Dnr ALFVLL-298001Swedish Research Council, Dnr 521-2013-2708Swedish Research Council, 2016-01891Swedish Heart Lung Foundation, Dnr 20150369Swedish Heart Lung Foundation, 20170481
Available from: 2018-12-17 Created: 2018-12-17 Last updated: 2019-02-22Bibliographically approved
Gustafsson, N., Ahlqvist, J. B., Näslund, U., Wester, P., Buhlin, K., Gustafsson, A. & Levring Jäghagen, E. (2018). Calcified carotid artery atheromas in panoramic radiographs are associated with a first myocardial infarction: a case-control study. Oral surgery, oral medicine, oral pathology and oral radiology, 125(2), 199-205
Open this publication in new window or tab >>Calcified carotid artery atheromas in panoramic radiographs are associated with a first myocardial infarction: a case-control study
Show others...
2018 (English)In: Oral surgery, oral medicine, oral pathology and oral radiology, ISSN 2212-4403, E-ISSN 2212-4411, Vol. 125, no 2, p. 199-205Article in journal (Refereed) Published
Abstract [en]

Objective. The aim of this case-control study was to investigate whether patients with a first myocardial infarction (MI) had a higher prevalence of calcified carotid artery atheromas (CCAAs) on panoramic radiographs (PRs) than age-, gender-, and residential area-matched controls without MI. Study Design. Six hundred ninety-six cases with a first MI and 696 controls were included in this substudy of the Swedish multicentre PAROKRANK study. All participants underwent panoramic radiography, and the PRs were evaluated for CCAAs. Results. The prevalence of CCAAs detected by PR was 33.8% (235 of 696) in cases and 27.6% (192 of 696) in controls (odds ratio [OR] 1.24; 95% confidence interval [CI] 1.04-1.44; P = .012). Among males, 32.7% of cases (184 of 562) and 26.5% of controls (149 of 562) displayed CCAAs on PRs (OR 1.24; 95% CI 1.03-1.48; P = .022). Among both genders, bilateral CCAAs were significantly more common among cases than among controls (P = .002). Conclusions. Cases with recent MIs had a significantly higher prevalence of CCAAs on PRs compared with controls without MIs. This difference between groups was more pronounced for bilateral CCAAs. These findings supported the hypothesis that CCAA detection could serve as a risk indicator for future MIs.

Place, publisher, year, edition, pages
ELSEVIER SCIENCE INC, 2018
National Category
Dentistry
Identifiers
urn:nbn:se:umu:diva-144341 (URN)10.1016/j.oooo.2017.10.009 (DOI)000422751700018 ()29242130 (PubMedID)
Available from: 2018-02-08 Created: 2018-02-08 Last updated: 2019-05-21Bibliographically approved
Jashari, F., Ibrahimi, P., Johansson, E., Grönlund, C., Wester, P. & Henein, M. Y. (2018). Carotid IM-GSM is better than IMT for identifying patients with multiple arterial disease. Scandinavian Cardiovascular Journal, 52(2), 93-99
Open this publication in new window or tab >>Carotid IM-GSM is better than IMT for identifying patients with multiple arterial disease
Show others...
2018 (English)In: Scandinavian Cardiovascular Journal, ISSN 1401-7431, E-ISSN 1651-2006, Vol. 52, no 2, p. 93-99Article in journal (Refereed) Published
Abstract [en]

Objective. Atherosclerosis is a systemic inflammatory disease that can affect more than one arterial bed simultaneously. The aim of this study was to determine the relationship between ultrasound markers of atherosclerosis and multiple arterial disease. Design. We have included 87 currently asymptomatic carotid disease patients (mean age 69 +/- 6 year, 34% females) in this study. Intima media thickness (IMT) and intima media-grey scale median (IM-GSM) were measured in the common carotid artery (CCA), and correlated with previous and/or current atherosclerotic vascular disease in the coronary, carotid and lower extremities. Patients were divided into three groups: (1) asymptomatic, (2) previous symptoms in one arterial territory and (3) previous symptoms in multiple arterial territories. Results. Patients with previous disease in the coronary arteries had higher IMT (p=.034) and lower IM-GSM (p<.001), and those with prior stroke had lower IM-GSM (p=.007). Neither IMT nor IM-GSM was different between patients with and without previous lower extremity vascular disease. IM-GSM was significantly different between groups, it decreased significantly with increasing number of arterial territories affected (37.7 +/- 15.4 vs. 29.3 +/- 16.4 vs. 20.7 +/- 12.9) p<.001, for asymptomatic, symptoms in one and in multiple arterial systems, respectively. Conventional IMT was not significantly different between groups p=.49. Conclusion. Carotid IMT was higher and IM-GSM lower in patients with symptomatic nearby arterial territories but not in those with peripheral disease. In contrast to conventional IMT, IM-GSM can differentiate between numbers of arterial territories affected by atherosclerosis, suggesting that it is a better surrogate for monitoring multiple arterial territory disease.

Place, publisher, year, edition, pages
Taylor & Francis Group, 2018
Keywords
Atherosclerosis, carotid artery, intimal-media complex, IMT, IM-GSM
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:umu:diva-146595 (URN)10.1080/14017431.2018.1435903 (DOI)000428305000006 ()29402147 (PubMedID)
Available from: 2018-05-08 Created: 2018-05-08 Last updated: 2019-05-20Bibliographically approved
Khangure, S. R., Benhabib, H., Machnowska, M., Fox, A. J., Grönlund, C., Herod, W., . . . Johansson, E. (2018). Carotid near-occlusion frequently has high peak systolic velocity on Doppler ultrasound. Neuroradiology, 60(1), 17-25
Open this publication in new window or tab >>Carotid near-occlusion frequently has high peak systolic velocity on Doppler ultrasound
Show others...
2018 (English)In: Neuroradiology, ISSN 0028-3940, E-ISSN 1432-1920, Vol. 60, no 1, p. 17-25Article in journal (Refereed) Published
Abstract [en]

Purpose: Carotid near-occlusion is a tight atherosclerotic stenosis of the internal carotid artery (ICA) resulting in decrease in diameter of the vessel lumen distal to the stenosis. Near-occlusions can be classified as with or without full collapse, and may have high peak systolic velocity (PSV) across the stenosis, mimicking conventional > 50% carotid artery stenosis. We aimed to determine how frequently near-occlusions have high PSV in the stenosis and determine how accurately carotid Doppler ultrasound can distinguish high-velocity near-occlusion from conventional stenosis.

Methods: Included patients had near-occlusion or conventional stenosis with carotid ultrasound and CT angiogram (CTA) performed within 30 days of each other. CTA examinations were analyzed by two blinded expert readers. Velocities in the internal and common carotid arteries were recorded. Mean velocity, pulsatility index, and ratios were calculated, giving 12 Doppler parameters for analysis.

Results: Of 136 patients, 82 had conventional stenosis and 54 had near-occlusion on CTA. Of near-occlusions, 40 (74%) had high PSV (≥ 125 cm/s) across the stenosis. Ten Doppler parameters significantly differed between conventional stenosis and high-velocity near-occlusion groups. However, no parameter was highly sensitive and specific to separate the groups.

Conclusion: Near-occlusions frequently have high PSV across the stenosis, particularly those without full collapse. Carotid Doppler ultrasound does not seem able to distinguish conventional stenosis from high-velocity near-occlusion. These findings question the use of ultrasound alone for preoperative imaging evaluation.

Keywords
Carotid stenosis, Ultrasonography, X-ray computed tomography, Angiography, Internal carotid artery, LONG ER, 1988, BIOMETRICS, V44, P837 ftus IM, 1998, EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, V16, P489 rst J., 2015, AMERICAN JOURNAL OF NEURORADIOLOGY, V36, P1978 n Reutern Gerhard-Michael, 2012, STROKE, V43, P916 clerc X, 1999, RADIOLOGY, V210, P673 naboldo C, 1991, European journal of vascular surgery, V5, P415
National Category
Radiology, Nuclear Medicine and Medical Imaging
Identifiers
urn:nbn:se:umu:diva-144100 (URN)10.1007/s00234-017-1938-4 (DOI)000419127000004 ()29177789 (PubMedID)
Available from: 2018-02-02 Created: 2018-02-02 Last updated: 2019-11-19Bibliographically approved
Lundström, E., Isaksson, E., Wester, P., Laska, A.-C. & Näsman, P. (2018). Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial. Trials, 19, Article ID 14.
Open this publication in new window or tab >>Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial
Show others...
2018 (English)In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, article id 14Article in journal (Refereed) Published
Abstract [en]

Background: Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT.

Methods: ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n=27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT.

Discussion: EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the future. It might also be useful in clinical settings outside the field of stroke.

Place, publisher, year, edition, pages
BioMed Central, 2018
Keywords
Stroke, Randomised controlled trial, RCT, Recruitment, Randomised stepped-wedge cluster trial
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:umu:diva-144399 (URN)10.1186/s13063-017-2367-8 (DOI)000419608100004 ()29310679 (PubMedID)
Available from: 2018-02-13 Created: 2018-02-13 Last updated: 2019-05-24Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0001-8522-1707

Search in DiVA

Show all publications