G437 Validity of the washington group module on child functioning in 2-year-old children; disability outcome of the shine trial

This article describes proceedings from a meeting of the National Multiple Sclerosis Society (NMSS) Task Force on Clinical Disability Measures (the TF). The TF was appointed by the NMSS Research Programs Advisory Committee with the goal of pooling and analyzing existing datasets to explore the utility of novel disability outcome measures based on the Multiple Sclerosis Functional Composite (MSFC) approach. The TF seeks to determine the suitability of the MSFC approach as a primary clinical outcome measure for registration trials in MS. The TF met in Washington, DC, Dec. 14 and 15, 2011, and provided unanimous support for a collaborative approach involving representatives from academic medicine, the pharmaceutical industry, regulatory agencies, the NMSS and the Critical Path Institute. There was also unanimous agreement that analysis of existing datasets would be useful in making progress toward the objective. The TF placed high value on determining the clinical meaning of individual component measures for the MSFC, and in establishing optimal analysis methods for MSFC so that scores would be more interpretable than the originally recommended z-score method. The background for a collaborative project aimed at developing an improved disability outcome measure is described in this paper.

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Does Apolipoprotein e4 Status Moderate the Association of Family Environment with Long-Term Child Functioning following Early Moderate to Severe Traumatic Brain Injury? A Preliminary Study

Journal of the International Neuropsychological Society ◽

10.1017/s1355617716000631 ◽

2016 ◽

Vol 22 (8) ◽

pp. 859-864 ◽

Cited By ~ 8

Author(s):

Amery Treble-Barna ◽

Huaiyu Zang ◽

Nanhua Zhang ◽

Lisa J. Martin ◽

Keith Owen Yeates ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Executive Functioning ◽

Parenting Style ◽

Family Environment ◽

Adaptive Functioning ◽

Behavioral Adjustment ◽

Child Functioning ◽

E4 Allele

AbstractObjectives:To examine whether apolipoprotein e4 (APOE) status moderates the association of family environment with child functioning following early traumatic brain injury (TBI).Methods:Sixty-five children with moderate to severe TBI and 70 children with orthopedic injury (OI) completed assessments 6, 12, 18 months, and 3.5 and 6.8 years post injury. DNA was extracted from saliva samples and genotyped for APOE e4 status. Linear mixed models examined moderating effects of APOE e4 status on associations between two family environment factors (parenting style, home environment) and three child outcomes (executive functioning, behavioral adjustment, adaptive functioning).Results:Children with TBI who were carriers of the e4 allele showed poorer adaptive functioning relative to non-carriers with TBI and children with OI in the context of low authoritarianism. At high levels of authoritarianism, non-carriers with TBI showed the poorest adaptive functioning among groups. There were no main effects or interactions involving APOE and executive functioning or behavioral adjustment.Conclusions:The APOE e4 allele was detrimental for long-term adaptive functioning in the context of positive parenting, whereas in less optimal parenting contexts, being a non-carrier was detrimental. We provide preliminary evidence for an interaction of APOE e4 status and parenting style in predicting long-term outcomes following early TBI. (JINS, 2016,22, 859–864)

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Comparison of the EDSS, Timed 25-Foot Walk, and the 9-Hole Peg Test as Clinical Trial Outcomes in Relapsing-Remitting Multiple Sclerosis

Neurology ◽

10.1212/wnl.0000000000012690 ◽

2021 ◽

pp. 10.1212/WNL.0000000000012690

Author(s):

Marcus W. Koch ◽

Jop P. Mostert ◽

Jerry S. Wolinsky ◽

Fred D. Lublin ◽

Bernard Uitdehaag ◽

...

Keyword(s):

Multiple Sclerosis ◽

Controlled Trial ◽

Cross Sectional ◽

Link Type ◽

Kaplan Meier ◽

Relapsing Remitting ◽

Disability Outcome ◽

Remitting Multiple Sclerosis ◽

Presentation Methods ◽

Relapsing Remitting Multiple Sclerosis

Background:Clinical trials in relapsing-remitting multiple sclerosis (RRMS) usually use the Expanded Disability Status Scale (EDSS) as their primary disability outcome measure, while the more recently developed outcomes timed 25 foot walk (T25FW) and nine hole peg test (NHPT) may be more useful and patient-relevant.Objective:To compare the EDSS to the T25FW and NHPT in a large RRMS randomized controlled trial (RCT) dataset.Methods:We used the dataset from CombiRx (clinicaltrials.gov identifier NCT00211887), a large phase 3 RCT, to compare the EDSS to the alternative outcomes T25FW and NHPT. We investigated disability worsening versus similarly defined improvement, unconfirmed versus confirmed and sustained disability change, and the presentation methods cumulative Kaplan-Meier survival curves versus cross-sectional disability worsening.Results:CombiRx included 1,008 participants. A comparison of confirmed versus sustained worsening events showed that throughout the trial, there were substantially fewer sustained than confirmed events, with a positive predictive value of confirmed for sustained worsening at 24 months of 0.73 for the EDSS, 0.73 for the T25FW, and 0.8 for the NHPT. More concerning was the finding that worsening on the EDSS occurred as frequently as similarly defined improvement throughout the three years of follow up, and that improvement rates increased in parallel with worsening rates. The T25FW showed low improvement rates of below 10% throughout the trial. We also found that Kaplan-Meier survival analysis, the standard presentation and analysis method in modern RRMS trials, yields exaggerated estimates of disability worsening. Using the Kaplan-Meier method, the proportion of patients with worsening events steadily increases, until it reaches several fold the number of events seen with more conservative analysis methods. For 3 month CDW at 36 months the ‘Kaplan-Meier’ method yields 2.6 fold higher estimates for the EDSS, 2.9 fold higher estimates for the T25FW and 5.1 fold higher estimates for the NHPT compared to a more conservative presentation of the same data.Discussion:Our analyses raise concerns about using the EDSS as the standard disability outcome in RRMS trials, and suggest that the T25FW may be a more useful measure. These findings are relevant for the design and critical appraisal of RCTs.

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Dispute over contact with a child as the result of unresolved divorce-related conflicts

Problemy Opiekuńczo-Wychowawcze ◽

10.5604/01.3001.0014.8176 ◽

2021 ◽

Vol 598 (3) ◽

pp. 30-40

Author(s):

Anna Zalewska

Keyword(s):

Family Relationships ◽

Main Issue ◽

Court Cases ◽

Child Functioning ◽

Minor Children ◽

The Relationship

Parting and divorce are situations that are not only the result of conflicts, but also their causes, especially if they concern parents of minor children. A problem then arises regarding the establishment of contact between the secondary parent and the child, which may be difficult if the disputes that led to the separation remain unresolved or other court cases are pending at the same time. The parties, during or after divorce, often submit a request to the court to regulate the frequency and form of meetings between the secondary parent and the child, which seems to be the main issue of misunderstandings. After a deeper analysis of the relationship between former partners, it turns out, that the lack of ability to establish contact with the child is the result of the accumulation of other disputes and unresolved misunderstandings. The presented fragments of qualitative analyzes of psychological and pedagogical opinions prepared by the Opinion Team of Forensic Specialists, illustrating the assumption that the dispute over contact may be related to other conflicts between former spouses, are part of a qualitative project focused around divorce-related conflicts. The aim of the research is to identify the effects of strong conflict between parents and the lack of communication between them after divorce for family relationships and the child functioning.

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Psychological factors addressed in cognitive behaviour therapy for paediatric functional abdominal pain: Which are most important to target?

Journal of Health Psychology ◽

10.1177/1359105317694488 ◽

2017 ◽

Vol 24 (9) ◽

pp. 1282-1292 ◽

Cited By ~ 4

Author(s):

Shelley MC van der Veek ◽

Else de Haan ◽

HHF Derkx ◽

Marc A Benninga ◽

Frits Boer

Keyword(s):

Abdominal Pain ◽

Psychological Functioning ◽

Cognitive Behaviour Therapy ◽

Behaviour Therapy ◽

Child Functioning ◽

Functional Abdominal Pain ◽

Negative Cognitions ◽

Passive Coping ◽

Cognitive Behaviour ◽

Positive Cognitions

The effectiveness of cognitive behaviour therapy for paediatric functional abdominal pain leaves room for improvement. We studied which factors addressed in cognitive behaviour therapy relate most strongly to the physical and psychological functioning of children with functional abdominal pain and are thus most important to target. Questionnaires were filled out by 117 children with functional abdominal pain and their parents. Multiple regression analyses showed that children’s passive coping and parental and children’s positive cognitions relate to child functioning. Negative cognitions and parental solicitous behaviour were unrelated to child functioning. Cognitive behaviour therapy for functional abdominal pain may benefit most from changing children’s passive coping and promoting positive cognitions.

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Child, Family, and Early Intervention Characteristics Related to Family Quality of Life in Spain

Journal of Early Intervention ◽

10.1177/1053815118803772 ◽

2018 ◽

Vol 41 (1) ◽

pp. 44-61 ◽

Cited By ~ 5

Author(s):

Pau García-Grau ◽

R. A. McWilliam ◽

Gabriel Martínez-Rico ◽

Catalina P. Morales-Murillo

Keyword(s):

Quality Of Life ◽

Early Intervention ◽

Implementation Process ◽

Family Quality Of Life ◽

Child Functioning ◽

Individual Family ◽

Family Centeredness ◽

Families With Children ◽

Family Centered

Family quality of life (FQoL) is considered one of the aims of early intervention (EI) services and a good indicator of service quality. Families were recruited from EI centers in 12 of 17 communities (states) in Spain. This study describes the FQoL of 250 Spanish families with children aged 0 to 6 years in EI services during a family-centered implementation process. We used an EI-specific FQoL scale that includes families’ perception of their child’s functioning as one factor. We also describe the relationships among individual, family, and service variables as well as FQoL. Type of disability, socioeconomic status, and family-centered practices impacted Child Functioning, Overall Life Situation, and Access to Information and Services factors, respectively. Fewer number of professionals involved was related with greater perception of child’s functionality. Family-centeredness, type of family, and type of disability were the most influencing variables for the Total score. Implications for practice are discussed.

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