scholarly journals Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e041695
Author(s):  
Catherine Elliott ◽  
Caroline Alexander ◽  
Alison Salt ◽  
Alicia J Spittle ◽  
Roslyn N Boyd ◽  
...  

IntroductionThe current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life.Method and analysisEarly Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies’ GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739).Trial registration numberACTRN12619001422112.

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e038681
Author(s):  
Imran Ahmed ◽  
Mike Bowes ◽  
Charles E Hutchinson ◽  
Nicholas Parsons ◽  
Sophie Staniszewska ◽  
...  

IntroductionThis study is designed to explore the baseline characteristics of patients under 55 years of age with a meniscal tear, and to describe the relationship between the baseline characteristics and patient-reported outcome measures (PROMs) over 12 months. Research has highlighted the need for a trial to investigate the effectiveness of arthroscopic meniscectomy in younger patients. Before this trial, we need to understand the patient population in greater detail.Methods and analysisThis is a multicentre prospective cohort study. Participants aged between 18 and 55 years with an MRI confirmed meniscal tear are eligible for inclusion. Baseline characteristics including age, body mass index, gender, PROMs duration of symptoms and MRI will be collected. The primary outcome measure is the Western Ontario Meniscal Evaluation Tool at 12 months. Secondary outcome measures will include PROMs such as EQ5D, Knee Injury and Osteoarthritis Outcome Score and patient global impression of change score at 3, 6 and 12 months.Ethics and disseminationThe study obtained approval from the National Research Ethics Committee West Midlands—Black Country research ethics committee (19/WM/0079) on 12 April 2019. The study is sponsored by the University of Warwick. The results will be disseminated via peer-reviewed publication.Trial registration numberUHCW R&D Reference: IA428119. University of Warwick Sponsor ID: SC.08/18–19


BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e028747
Author(s):  
Hayley Thomson ◽  
Kerrie Evans ◽  
Jonathon Dearness ◽  
John Kelley ◽  
Kylie Conway ◽  
...  

IntroductionPrognostic screening of people with low back pain (LBP) improves utilisation of primary healthcare resources. Whether this also applies to secondary healthcare remains unclear. Therefore, this study aims to develop prognostic models to determine at baseline which patients with persistent LBP are likely to have a good and poor outcome to a 5-week programme of combined education and exercise (‘UPLIFT’) delivered in a secondary healthcare setting.Methods and analysisA prospective cohort study of 246 people with persistent LBP will be conducted in a secondary healthcare outpatient setting. Patients will be recruited from a physiotherapy-led neurosurgical screening clinic. Demographic data, medical history and psychosocial characteristics will be recorded at baseline. Fear avoidance beliefs, pain self-efficacy, LBP treatment beliefs, pain catastrophising, perceived injustice, depression, anxiety and stress, disability level, pain intensity and interference, health status and social connectedness will be considered as potential prognostic variables, which will be assessed using self-reported questionnaires. Participants will attend the UPLIFT programme, consisting of weekly 90 min group sessions that combine interactive education sessions and a graded exercise programme. The outcome measure to identify good and poor outcome is the Global Rating of Change scale, assessed at completion of the UPLIFT programme and at 6 months follow-up. Multiple imputation analyses will be performed for missing values. Prognostic models will be developed using multivariable logistic regression analyses, with bootstrapping techniques for internal validation. We will calculate the explained variance of the models and the area under the receiver operating characteristic curve. Furthermore, we will determine whether participation in the UPLIFT programme is associated with changes in psychosocial characteristics.Ethics and disseminationGold Coast Health Service Human Research Ethics Committee (HREC/18/QGC/41) and the Griffith University Human Research Ethics Committee (GU Ref No: 2018/408) approved the study. Dissemination of findings will occur via peer-reviewed publications and conference presentations.Trial registration numberACTRN12618001525279.


2021 ◽  
pp. 1-8
Author(s):  
Xiao Liu ◽  
Ayiguli Abudukeremu ◽  
Yuan Jiang ◽  
Zhengyu Cao ◽  
Maoxiong Wu ◽  
...  

Background: Several kinds of motor dysfunction can predict future cognitive impairment in elderly individuals. However, the ability of the fine motor index (FINEA) and gross motor index (GROSSA) to predict the risk of cognitive impairment has not been assessed. Objective: We investigated the associations between FINEA/GROSSA and cognitive impairment. Methods: The data of 4,745 participants from The Irish Longitudinal Study on Ageing (TILDA) were analyzed. Cognitive function was assessed using the Mini-Mental State Examination (MMSE). We first assessed the correlation between the FINEA GROSSA and MMSE in a cross-sectional study. Then, we further investigated the predictive role of the incidence of cognitive impairment in a prospective cohort study. Results: We found that both FINEA and GROSSA were negatively correlated with MMSE in both the unadjusted (FINEA: B = –1.00, 95%confidence intervals (CI): –1.17, –0.83, t = –11.53, p <  0.001; GROSSA: B = –0.85, 95%CI: –0.94, –0.76, t = –18.29, p <  0.001) and adjusted (FINEA: B = –0.63, 95%CI: –0.79, –0.47, t = –7.77, p <  0.001; GROSSA: B = –0.57, 95%CI: –0.66, –0.48, t = –12.61, p <  0.001) analyses in a cross-sectional study. In a prospective cohort study, both high FINEA and high GROSSA were associated with an increased incidence of cognitive function impairment (FINEA: adjusted odds ratios (OR) = 2.35, 95%CI: 1.05, 5.23, p = 0.036; GROSSA adjusted OR = 3.00, 95%CI: 1.49, 6.03, p = 0.002) after 2 years of follow-up. Conclusion: Higher FINEA and GROSSA scores were both associated with an increased incidence of cognitive impairment. FINEA or GROSSA might be a simple tool for identifying patients with cognitive impairment.


BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e030052 ◽  
Author(s):  
Kenneth Lo ◽  
Qing Liu ◽  
Tracy Madsen ◽  
Steve Rapp ◽  
Jiu-Chiuan Chen ◽  
...  

ObjectiveTo examine the associations of dietary and supplemental magnesium (Mg) as assessed by a semi-quantitative food frequency questionnaire with cognitive outcomes among ageing women.DesignThis work conducts a prospective cohort study of participants enrolled in the Women’s Health Initiative Memory Study (WHIMS), which was subsequently extended and named WHIMS-Epidemiology of Cognitive Health.SettingForty clinical centres in the USA.ParticipantsPostmenopausal women aged 65–79 years without dementia on enrolment.Main outcome measuresPhysician-adjudicated mild cognitive impairment (MCI) and/or probable dementia (PD).ResultsParticipants were excluded (n=1006) if they had extreme values of dietary energy intake, had missing or extreme body mass index values, with prevalent MCI/PD at baseline, received only one cognitive assessment or had been followed up for <1 year. During >20 years of follow-up, 765 (11.8%) out of 6473 participants developed MCI/PD. For MCI/PD and MCI, the risks tended to be lower among participants in quintiles Q2–Q5 of Mg consumption compared with those in the lowest quintile. Participants in Q3 had a significantly lower risk of MCI/PD (HR 0.69, 95% CI 0.53 to 0.91) and MCI (HR 0.63, 95% CI 0.45 to 0.87) after multivariate adjustments. No significant association was observed between total Mg intake and PD. The association between total Mg intake, MCI/PD and MCI was non-linear as suggested by the likelihood test.ConclusionsTotal Mg intake between the estimated average requirement and the recommended dietary allowances may associate with a lower risk of MCI/PD and MCI.Trial registration numberNCT00685009.


2018 ◽  
Vol 6 (3) ◽  
pp. 213-222 ◽  
Author(s):  
Timothy D Girard ◽  
Jennifer L Thompson ◽  
Pratik P Pandharipande ◽  
Nathan E Brummel ◽  
James C Jackson ◽  
...  

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