scholarly journals HIT-6 and EQ-5D-5L in patients with migraine: assessment of common latent constructs and development of a mapping algorithm

2021 ◽  
Author(s):  
Ana Sofia Oliveira Gonçalves ◽  
Dimitra Panteli ◽  
Lars Neeb ◽  
Tobias Kurth ◽  
Annette Aigner
Keyword(s):  
Factor Analysis ◽  
Exploratory Factor Analysis ◽  
Controlled Trial ◽  
Ceiling Effect ◽  
Repeated Measurements ◽  
Economic Evaluations ◽  
Floor Effect ◽  
Mapping Algorithm ◽  
Latent Constructs ◽  
Randomised Controlled

Abstract Objective The aims of this study were to assess whether there is a conceptual overlap between the questionnaires HIT-6 and EQ-5D and to develop a mapping algorithm allowing the conversion of HIT-6 to EQ-5D utility scores for Germany. Methods This study used data from an ongoing randomised controlled trial for patients suffering from migraine. We assessed the conceptual overlap between the two instruments with correlation matrices and exploratory factor analysis. Linear regression, tobit, mixture, and two-part models were used for mapping, accounting for repeated measurements, tenfold cross-validation was conducted to validate the models. Results We included 1010 observations from 410 patients. The EQ-5D showed a substantial ceiling effect (47.3% had the highest score) but no floor effect, while the HIT-6 showed a very small ceiling effect (0.5%). The correlation between the instruments’ total scores was moderate (− 0.30), and low to moderate among each domain (0.021–0.227). The exploratory factor analysis showed insufficient conceptual overlap between the instruments, as they load on different factors. Thus, there is reason to believe that the instruments’ domains do not capture the same latent constructs. To facilitate future mapping, we provide coefficients and a variance–covariance matrix for the preferred model, a two-part model with the total HIT-6 score as the explanatory variable. Conclusion This study showed that the German EQ-5D and the HIT-6 lack the conceptual overlap needed for appropriate mapping. Thus, the estimated mapping algorithms should only be used as a last resort for estimating utilities to be employed in economic evaluations.

scholarly journals Analysis of the components of cancer risk perception and links with intention and behaviour: A UK-based study

PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0262197
Author(s):  
Christiane Riedinger ◽  
Jackie Campbell ◽  
William M. P. Klein ◽  
Rebecca A. Ferrer ◽  
Juliet A. Usher-Smith
Keyword(s):  
Factor Analysis ◽  
Risk Perception ◽  
Cancer Risk ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Distinct Component ◽  
Cancer Risk Perception ◽  
Before And After ◽  
Randomised Controlled ◽  
The Uk

Risk perception refers to how individuals interpret their susceptibility to threats, and has been hypothesised as an important predictor of intentions and behaviour in many theories of health behaviour change. However, its components, optimal measurement, and effects are not yet fully understood. The TRIRISK model, developed in the US, conceptualises risk perception as deliberative, affective and experiential components. In this study, we aimed to assess the replicability of the TRIRISK model in a UK sample by confirmatory factor analysis (CFA), explore the inherent factor structure of risk perception in the UK sample by exploratory factor analysis (EFA), and assess the associations of EFA-based factors with intentions to change behaviour and subsequent behaviour change. Data were derived from an online randomised controlled trial assessing cancer risk perception using the TRIRISK instrument and intention and lifestyle measures before and after communication of cancer risk. In the CFA analysis, the TRIRISK model of risk perception did not provide a good fit for the UK data. A revised model developed using EFA consisted of two separate “numerical” and “self-reflective” factors of deliberative risk perception, and a third factor combining affective with a subset of experiential items. This model provided a better fit to the data when cross-validated. Using multivariable regression analysis, we found that the self-reflective and affective-experiential factors of the model identified in this study were reliable predictors of intentions to prevent cancer. There were no associations of any of the risk perception factors with behaviour change. This study confirms that risk perception is clearly a multidimensional construct, having identified self-reflective risk perception as a new distinct component with predictive validity for intention. Furthermore, we highlight the practical implications of our findings for the design of interventions incorporating risk perception aimed at behaviour change in the context of cancer prevention.

scholarly journals Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e018409 ◽  
Author(s):  
Sarah G Dean ◽  
Leon Poltawski ◽  
Anne Forster ◽  
Rod S Taylor ◽  
Anne Spencer ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cognitive Capacity ◽  
Economic Evaluations ◽  
Control Group ◽  
Rehabilitation Training ◽  
One To One ◽  
Randomised Controlled

ObjectivesTo assess acceptability and feasibility of trial processes and the Rehabilitation Training (ReTrain) intervention including an assessment of intervention fidelity.DesignA two-group, assessor-blinded, randomised controlled trial with parallel mixed methods process and economic evaluations.SettingCommunity settings across two sites in Devon.ParticipantsEligible participants were: 18 years old or over, with a diagnosis of stroke and with self-reported mobility issues, no contraindications to physical activity, discharged from National Health Service or any other formal rehabilitation programme at least 1 month before, willing to be randomised to either control or ReTrain and attend the training venue, possessing cognitive capacity and communication ability sufficient to participate. Participants were individually randomised (1:1) via a computer-generated randomisation sequence minimised for time since stroke and level of functional disability. Only outcome assessors independent of the research team were blinded to group allocation.InterventionsReTrain comprised (1) an introductory one-to-one session; (2) ten, twice-weekly group classes with up to two trainers and eight clients; (3) a closing one-to-one session, followed by three drop-in sessions over the subsequent 3 months. Participants received a bespoke home-based training programme. All participants received treatment as usual. The control group received an exercise after stroke advice booklet.Outcome measuresCandidate primary outcomes included functional mobility and physical activity.ResultsForty-five participants were randomised (ReTrain=23; Control=22); data were available from 40 participants at 6 months of follow-up (ReTrain=21; Control=19) and 41 at 9 months of follow-up (ReTrain=21; Control=20). We demonstrated ability to recruit and retain participants. Participants were not burdened by the requirements of the study. We were able to calculate sample estimates for candidate primary outcomes and test procedures for process and health economic evaluations.ConclusionsAll objectives were fulfilled and indicated that a definitive trial of ReTrain is feasible and acceptable.Trial registration numberNCT02429180; Results.

scholarly journals Integrated Sustainable Childhood Pneumonia and Infectious Disease Reduction in Nigeria (INSPIRING) Through Whole System Strengthening in Jigawa, Nigeria: Study Protocol For a Cluster Randomised Controlled Trial

2021 ◽  
Author(s):  
Carina King ◽  
Rochelle Burgess ◽  
Ayobami Bakare ◽  
Funmilayo Shittu ◽  
Julius Salako ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Health System ◽  
Child Mortality ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Health System Strengthening ◽  
Economic Evaluations ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
Whole Systems

Abstract BackgroundChild mortality remains unacceptably high, with Northern Nigeria reporting some of the highest rates globally (e.g. 192/1000 live births in Jigawa State). Coverage of key protect and prevent interventions, such as vaccination and clean cooking fuel use, are low. Additionally, knowledge, care-seeking and health system factors are poor. Therefore, a whole systems approach is needed for sustainable reductions in child mortality.MethodsThis is a cluster randomised controlled trial, with integrated process and economic evaluations, conducted from January 2021 – September 2022. The trial will be conducted in Kiyawa Local Government Area, Jigawa State, Nigeria, with an estimated population of 230,000. Clusters are defined as primary government health facility catchment areas (n=33). The 33 clusters will be randomly allocated (1:1) in a public ceremony, and 32 clusters included in the impact evaluation. The trial will evaluate a locally adapted ‘whole systems strengthening’ package of three evidence-based methods: community men’s and women’s groups; Partnership Defined Quality Scorecard; healthcare worker training, mentorship and provision of basic essential equipment and commodities. The primary outcome is mortality of children aged 7 days to 59 months. Mortality will be recorded prospectively using a cohort design, and secondary outcomes measured through baseline and endline cross-sectional surveys. Assuming the following, we will have a minimum detectable effect size of 30%: a) baseline mortality of 100 per 1000 livebirths; b) 4,480 compounds with 3 eligible children per compound; c) 80% power; d) 5% significance; e) intra-cluster correlation of 0.007; f) coefficient of variance of cluster size of 0.74. Analysis will be by intention-to-treat, comparing intervention and control clusters, adjusting for compound and trial clustering. DiscussionThis study will provide robust evidence of the effectiveness and cost-effectiveness of community-based participatory learning and action, with integrated health system strengthening and accountability mechanisms, to reduce child mortality. The ethnographic process evaluation will allow for a rich understanding of how the intervention works in this context. However, we encountered a key challenge in calculating the sample size, given the lack of timely and reliable mortality data, and the uncertain impacts of the COVID-19 pandemic. Trial registrationISRCTN 39213655, registered 11th December 2019

Factor Analysis

2021 ◽  
pp. 115-119
Author(s):  
Ulf Liebe
Keyword(s):  
Factor Analysis ◽  
Confirmatory Factor Analysis ◽  
Exploratory Factor Analysis ◽  
Quantitative Research ◽  
General Intelligence ◽  
Latent Constructs ◽  
The Social ◽  
Confirmatory Factor ◽  
Mental Abilities ◽  
Data Reduction Method

This chapter examines factor analysis, which is used to test whether a set of observable or manifest variables can measure one or more unobservable or latent constructs that they have in common. Such constructs are called factors. Factor analysis is therefore a data reduction method. In its foundation period, factor analysis was often applied to the study of general intelligence and mental abilities. Nowadays factor analysis is a workhorse for quantitative research in the social sciences, humanities, and natural sciences. There are two types of factor analysis: exploratory factor analysis and confirmatory factor analysis. Exploratory factor analysis is used for examining the underlying structures in a set of variables. Confirmatory factor analysis is used to test theoretical hypotheses; the researcher assumes that variables are interrelated in a specific way and uses factor analysis to find out whether the assumption is supported by the data — i.e. to what extent the data fits the predefined structure.

scholarly journals Psychosocial functioning before and after surgical treatment for morbid obesity: reliability and validation of the Norwegian version of obesity-related problem scale

2015 ◽  
Author(s):  
Anny Aasprang ◽  
John Roger Andersen ◽  
Villy Våge ◽  
Ronette L Kolotkin ◽  
Gerd Karin Natvig
Keyword(s):  
Factor Analysis ◽  
Exploratory Factor Analysis ◽  
Psychosocial Functioning ◽  
Related Problem ◽  
Ceiling Effect ◽  
Post Surgery ◽  
Norwegian Version ◽  
Sf 36 ◽  
The Mean ◽  
One Year

Background: The aims of this study were to translate the Obesity-Related Problem scale (OP scale) into the Norwegian language and test its reliability, validity and responsiveness in a Norwegian sample. Method: The questionnaire (OP scale) was translated from the original language (Swedish) into Norwegian. Patients completed the questionnaire prior to and one year after sleeve gastrectomy. Internal consistency was evaluated using Cronbach`s α. Floor and ceiling effect were calculated as percentages. Construct validity was tested by correlating the OP-scale with the SF-36 and the Cantril Ladder using the Pearson correlation coefficient. Exploratory factor analysis, using principal component analysis with varimax rotation, was used to test the unidimensionality of the OP scale. Responsiveness was tested by assessing changes in the OP scale from baseline to one year post-surgery using the paired sample t-test. Result: A total of 181 patients (123 women) accepted for bariatric surgery was included in the study. The mean age was 43.1 ± 12.5 years, and mean body mass index (BMI) before surgery was 45 ± 6.9. The mean value of the OP scale at baseline was 63.30 ± 24.43 (severe impairment) and 21.01 ± 20.98 at one year follow-up (mild impairment). Cronbach`s α was high at baseline (0. 91), as well as one year after surgery (0.88). The floor effect was small at baseline and moderate at one year. The ceiling effect was small at baseline and at one year. Exploratory factor analysis showed one factor with a high percent of explained variance (baseline and post-surgery). Correlations between OP scale at baseline, SF-36, Cantril Ladder and BMI were statistically significant and in the predicted direction to support validity of the Norwegian OP scale . After one year correlations between the change in OP scale and the change in SF-36 scores, Cantril Ladder and BMI were also statistically significant, except for the change in the Role Physical-scale. The OP scale showed greater responsiveness than either the SF-36 or Cantril Ladder. Conclusion: These results confirm that the Norwegian version of the OP scale is a valid and reliable instrument for measuring psychosocial functioning in patients with clinically severe obesity.

scholarly journals Evaluating the effectiveness of the smartphone app, Drink Less, compared with the NHS alcohol advice webpage, for the reduction of alcohol consumption among hazardous and harmful adult drinkers in the UK at six-month follow-up: protocol for a randomised controlled trial

2020 ◽  
Author(s):  
Claire Garnett ◽  
Melissa Oldham ◽  
Colin Angus ◽  
Emma Beard ◽  
Robyn Burton ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Alcohol Consumption ◽  
Large Scale ◽  
Controlled Trial ◽  
Economic Evaluations ◽  
Intention To Treat ◽  
Randomised Controlled ◽  
The Uk

AbstractBackground and AimsDigital interventions are effective for reducing alcohol consumption but evidence is limited regarding smartphone apps. Drink Less is a theory- and evidence-informed app to help people reduce their alcohol consumption that has been refined in terms of its content and design for usability across the socio-demographic spectrum. We aim to evaluate the effectiveness and cost-effectiveness of recommending Drink Less at reducing alcohol consumption compared with usual digital care.DesignTwo-arm individually randomised controlled trial.SettingOnline trial in the UK.ParticipantsHazardous or harmful drinkers (Alcohol Use Disorders Identification Test score >=8) aged 18+, and want to drink less alcohol (n=5,562). Participants will be recruited from July 2020 to May 2022 using multiple strategies with a focus on remote digital methods.Intervention and comparatorParticipants will be randomised to receive either an email recommending that they use Drink Less (intervention) or view the NHS webpage on alcohol advice (comparator).MeasurementsThe primary outcome is change in self-reported weekly alcohol consumption between baseline and 6-month follow-up. Secondary outcomes include the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life, and use of health services assessed at 6-month follow-up. Effectiveness will be examined with one-way ANCOVAs, adjusting for baseline alcohol consumption, and using an intention-to-treat approach. A mixed-methods process evaluation will assess engagement, acceptability and mechanism of action. Economic evaluations will be conducted using both a short- and longer-term time horizon.CommentsThis study will establish the effectiveness and cost-effectiveness of the Drink Less app at reducing alcohol consumption among hazardous and harmful adult drinkers and will be the first RCT of an alcohol reduction app for the general population in the UK. This study will inform the decision on whether it is worth investing resources in large-scale implementation.

scholarly journals SaeboGlove therapy for upper limb disability and severe hand impairment after stroke (SUSHI): Study protocol for a randomised controlled trial

2021 ◽  
pp. 239698732110365
Author(s):  
Jen Alexander ◽  
Peter Langhorne ◽  
Lisa Kidd ◽  
Olivia Wu ◽  
Alex McConnachie ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Upper Limb ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Economic Evaluations ◽  
Limb Function ◽  
Upper Limb Function ◽  
Randomised Controlled ◽  
Hand Impairment

Background Impaired active digital extension is common after stroke, hindering functional rehabilitation, and predicting poor recovery. The SaeboGlove assists digital extension and may improve outcome after stroke. We recently performed a single group, open, pilot trial of the SaeboGlove early after stroke which demonstrated satisfactory safety, feasibility and acceptability. An adequately powered randomised clinical trial is now needed to assess the clinical effectiveness of the SaeboGlove. Methods SUSHI is a pragmatic, multicentre, parallel-group, randomised controlled trial with blinded outcome assessment, and embedded process and economic evaluations. Adults, 7–60 days post-stroke, with upper limb disability and severe hand impairment, including reduced active digital extension, will be recruited from NHS inpatient stroke services in Scotland. Participants will be randomised on a 1:1 basis to receive 6 weeks of self-directed, repetitive, functional-based practice involving a SaeboGlove plus usual care, or usual care only. The primary outcome is upper limb function measured by the Action Research Arm Test (ARAT) at 6 weeks. Secondary outcomes will be measured at 6 and 14 weeks. A process evaluation will be performed via interviews with ‘intervention’ participants, and their carers and clinical therapists. A within-trial cost-effectiveness analysis will be performed. 110 participants are required to detect a difference between groups of 9 in the ARAT with 90% power at a 5% significance level allowing for 11% attrition. Discussion SUSHI will determine if SaeboGlove self-directed, repetitive, functional-based practice improves upper limb function after stroke, whether it is acceptable to stroke survivors and whether it is cost-effective.

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