Outcome Measure In Intervention Studies Research Articles

P948 Hand Grip Strength is a useful objective measure associated with fatigue and impaired quality of life in patients with inflammatory bowel disease

Abstract Background Hand grip strength (HGS) is a recognised tool for diagnosis / screening of muscle impairment and sarcopenia, however it remains underutilised in IBD cohorts. The aim of the study was to measure the prevalence of muscle impairment by HGS and association with quality of life in a cohort of UC patients in disease remission. Methods Potential subjects were prospectively identified for selection from the Gastroenterology Department in St. Vincent’s University Hospital Outpatient Department. All patients had a confirmed diagnosis of UC for >3 month with stable, quiescent disease (no escalation of medical therapy in the previous 3 months with a documented Faecal Calprotectin (FCP) <100 μg/g). Along with anthropometry data, HGS measurements were performed using the Jamar®Plus+Dynamometer. Quality of life scores were measured using 36-item Short Form Survey (SF-36), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and Short Health Scale questionnaires were measured. Linear regression was used to calculate standardised β-coefficients for correlation analysis. Non-parametric data was analysed using algorithms including Kruskal-Wallis and Wilcoxon rank-sum test. Results 60% (n=18) of subjects had a HGS outside the lower limit of the 95% confidence interval of age and sex matched normative values, indicative of impaired grip strength. This was significantly more prevalent in subjects with normal BMI than BMI>30 (p=0.035). Prevalence of fatigue was 43.3% according to SIBDQ question 2a and ’Energy/Fatigue’ scores of SF-36 were significantly lower compared to normal Irish population data (51.0 v 64.8, p = 0.0002). Composite scores of fatigue in both SIBDQ (question 2a) and SF-36 were compared, resulting in a standardized β-coefficient of 0.52 of statistical significance (p value = 0.003).Significant correlation was demonstrated between predicted HGS and ’Energy/Fatigue’ SF-36 scores (standardised β-coefficient = 0.4, p value = 0.027). Conclusion HGS is a convenient means of measuring muscle function in an IBD population and correlates significantly with ’Energy/fatigue’ SF-36 scores. These results suggest sarcopenia as a potentially important contributor to fatigue in patients with IBD and suggest HGS is an objective, easily applied objective measure which merits validation as an outcome measure for intervention studies to improve fatigue in patients with IBD.

Parent Perspectives on Complex Needs in Patients With MCT8 Deficiency: An International, Prospective, Registry Study.

Monocarboxylate transporter 8 (MCT8) deficiency is a rare neurodevelopmental and metabolic disorder, with daily care posing a heavy burden on caregivers. A comprehensive overview of these complex needs and daily care challenges is lacking. We established an international prospective registry to systemically capture data from parents and physicians caring for patients with MCT8 deficiency. Parent-reported data on complex needs and daily care challenges were extracted. Between July 17, 2018, and May 16, 2022, 51 patients were registered. Difficulties in daily life care were mostly related to feeding and nutritional status (17/33 patients), limited motor skills (12/33 patients), and sleeping (11/33 patients). Dietary advice was provided for 11/36 patients. Two of 32 patients were under care of a cardiologist. Common difficulties in the diagnostic trajectory included late diagnosis (20/35 patients) and visiting a multitude of specialists (15/35 patients). Median diagnostic delay was significantly shorter in patients born in or after 2017 vs before 2017 (8 vs 19 months, P < .0001). Feeding and sleeping problems and limited motor skills mostly contribute to difficulties in daily care. The majority of patients did not receive professional dietary advice, although being underweight is a key disease feature, strongly linked with poor survival. Despite sudden death being a prominent cause of death, potentially related to the cardiovascular abnormalities frequently observed, patients were hardly seen by cardiologists. These findings can directly improve patient-centered multidisciplinary care and define patient-centered outcome measures for intervention studies in patients with MCT8 deficiency.

Plasticity of visual evoked potentials in patients with neurofibromatosis type 1

ObjectiveThe inability to properly process visual information has been frequently associated with neurofibromatosis type 1 (NF1). Based on animal studies, the cause of cognitive disabilities in NF1 is hypothesized to arise from decreased synaptic plasticity. Visual cortical plasticity in humans can be investigated by studying visual evoked potentials (VEPs) in response to visual stimulation. MethodsVEP plasticity was assessed by measuring the increase of the peak amplitudes C1, P1, and N1 induced by 10-min modulation of checkerboard reversals in 22 adult NF1 patients and 30 controls. VEP signals were recorded pre-modulation, during modulation, and at 2, 7, 12, 17, 22, 27 min post-modulation. ResultsThe P1 amplitude increased significantly comparing post-modulation to pre-modulation in the control group. This potentiation was not observed in the NF1 group. ConclusionsVisual cortical plasticity could be measured using VEPs in response to visual stimulation in the control group. Individuals with NF1 may have reduced visual cortical plasticity, as indicated by their non-potentiated response to VEP induction. These findings should be interpreted with caution due to high inter-subject variability. SignificanceThe present study contributes to an improved assessment of the feasibility for using neurophysiological outcome measures in intervention studies of cognitive deficits among patients with NF1.

Wearables for Measuring the Physical Activity and Sedentary Behavior of Patients With Axial Spondyloarthritis: Systematic Review.

BackgroundAxial spondyloarthritis (axSpA) is an inflammatory rheumatic disease associated with chronic back pain and restricted mobility and physical function. Increasing physical activity is a viable strategy for improving the health and quality of life of patients with axSpA. Thus, quantifying physical activity and sedentary behavior in this population is relevant to clinical outcomes and disease management. However, to the best of our knowledge, no systematic review to date has identified and synthesized the available evidence on the use of wearable devices to objectively measure the physical activity or sedentary behavior of patients with axSpA.ObjectiveThis study aimed to review the literature on the use of wearable activity trackers as outcome measures for physical activity and sedentary behavior in patients with axSpA.MethodsPubMed, PEDro, and Cochrane electronic databases were searched in July 2021 for relevant original articles, with no limits on publication dates. Studies were included if they were original articles, targeted adults with a diagnosis of axSpA, and reported wearable device–measured physical activity or sedentary behavior among patients with axSpA. Data regarding the study’s characteristics, the sample description, the methods used for measuring physical activity and sedentary behavior (eg, wearable devices, assessment methods, and outcomes), and the main results of the physical activity and sedentary behavior assessments were extracted.ResultsA total of 31 studies were initially identified; 13 (13/31, 42%) met the inclusion criteria, including 819 patients with axSpA. All the studies used accelerometer-based wearable devices to assess physical activity. Of the 13 studies, 4 (4/31, 31%) studies also reported outcomes related to sedentary behavior. Wearable devices were secured on the wrists (3/13 studies, 23%), lower back (3/13, 23%), right hip (3/13, 23%), waist (2/13, 15%), anterior thigh (1/13, 8%), or right arm (1/13, 8%). The methods for reporting physical activity and sedentary behavior were heterogeneous. Approximately 77% (10/13) of studies had a monitoring period of 1 week, including weekend days.ConclusionsTo date, few studies have used wearable devices to quantify the physical activity and sedentary behavior of patients with axSpA. The methodologies and results were heterogeneous, and none of these studies assessed the psychometric properties of these wearables in this specific population. Further investigation in this direction is needed before using wearable device–measured physical activity and sedentary behavior as outcome measures in intervention studies in patients with axSpA.Trial RegistrationPROSPERO CRD42020182398; https://tinyurl.com/ec22jzktInternational Registered Report Identifier (IRRID)RR2-10.2196/23359

A Psychometric Evaluation of the Family Collaboration Scale and an Investigation of How the Close Family of Frail Older Patients Perceive the Collaboration with Healthcare Professionals on Acute Medical Wards at Hospitals in Sweden.

The inclusion of family members in the acute care of older persons with complex needs results in better coordination of care and reduces the frequency and/or duration of rehospitalisation. Therefore, healthcare professionals need a tool to assess the collaboration with family members on acute hospital wards. The aims were to test the psychometric properties of the Swedish version of the Family Collaboration Scale (FCS), to investigate family members’ perception of collaboration with healthcare professionals on acute medical wards in Sweden and to compare the data with the corresponding Danish results. Three hundred and sixty family members of frail patients aged 65 or older from 13 acute medical wards answered the FCS questionnaire. In addition to descriptive statistics, psychometric methods were applied. The internal consistency of the Swedish version of the FCS was excellent, and confirmatory factor analysis revealed that its factor structure was equivalent to that of the original Danish FCS. The respondents’ ratings indicated better perceived collaboration than in the Danish case. Older age than 60 was associated with worse collaboration with healthcare professionals regarding Influence on discharge than younger respondents. Those with compulsory and health or nursing education showed better collaboration. The Swedish version of the FCS should be further evaluated for its retest reliability and as an outcome measure in intervention studies.

A Contribution to Scientific Creativity: A Validation Study Measuring Divergent Problem Solving Ability

ABSTRACT Creativity in science education and research on scientific creativity are becoming increasingly significant. Several domain-specific assessment tools focusing on different aspects of scientific creativity have been developed. Some of these tools consider a wide range of aspects, while others focus on very specific science-related aspects, thereby lacking an explicit focus on problem solving. Therefore, the authors developed the novel divergent problem solving ability in science test (DPAS) to assess students’ potential to design different possible solutions for a particular scientific problem. The test was created as an outcome measure in intervention studies. It consists of two subtests and 13 subject-specific items. This study aims to broadly assess the construct validity and reliability of the DPAS and investigate the factorial longitudinal invariance and group invariance (group receiving interventions aimed at fostering divergent problem solving vs. control group) of the DPAS. Using data from 1,106 secondary school students from Austria, we found support for the construct validity and reliability of the DPAS scores. Moreover, we established robust longitudinal and group invariance of the DPAS, demonstrating its suitability for intervention studies.

A framework for identification of a resting-bold connectome associated with cognitive reserve

The concept of cognitive reserve proposes that specific life experiences result in more flexible or resilient cognitive processing allowing some people to cope better with age- or disease-related brain changes than others. Imaging studies seeking to understand the neural implementation of cognitive reserve have most often used task-related fMRI studies. Using that approach, we recently described a task-invariant cognitive-reserve network whose expression correlated with IQ and that moderated between cortical thickness and cognitive performance. Here we sought to identify a pattern of resting BOLD connectivity related to cognitive reserve. We identified a connectome pattern whose connectivity correlated with IQ in both the derivation sample and a separate replication sample. The majority of the edges showing positive relationships with IQ implicate frontal regions. In the derivation sample, connectivity either moderated the relationship between mean cortical thickness and a set of cognitive outcomes or accounted for unique variance in cognitive performance after accounting for cortical thickness. In a replication sample we found that expression of this connectome correlated significantly with the primary endpoint of IQ, and also accounted for unique variance in cognitive performance beyond cortical thickness. Our findings represent an intermediate level of replication and are unlikely to have arisen purely by type-I error. This connectivity pattern therefore meets some of our theoretical criteria for a cognitive reserve-related network and provides insight into the neural implementation of cognitive reserve. Further, expression of this connectome could potentially be used as a direct measure of cognitive reserve, and as an outcome measure for intervention studies that seek to influence cognitive reserve. Future validation of and re-derivation of the pattern in expanded data sets by our and other groups will lead to further improved estimates of cognitive reserve in resting functional connectivity.

Motor cortical excitability and plasticity in patients with neurofibromatosis type 1

ObjectiveNeurofibromatosis type 1 (NF1) is an autosomal dominant genetic disorder that is associated with cognitive disabilities. Based on studies involving animals, the hypothesized cause of these disabilities results from increased activity of inhibitory interneurons that decreases synaptic plasticity. We obtained transcranial magnetic stimulation (TMS)-based measures of cortical inhibition, excitability and plasticity in individuals with NF1. MethodsWe included 32 NF1 adults and 32 neurotypical controls. Cortical inhibition was measured with short-interval intracortical inhibition (SICI) and cortical silent period (CSP). Excitability and plasticity were studied with intermittent theta burst stimulation (iTBS). ResultsThe SICI and CSP response did not differ between NF1 adults and controls. The response upon iTBS induction was significantly increased in controls (70%) and in NF1 adults (83%). This potentiation lasted longer in controls than in individuals with NF1. Overall, the TMS response was significantly lower in NF1 patients (F(1, 41) = 7.552, p = 0.009). ConclusionsIndividuals with NF1 may have reduced excitability and plasticity, as indicated by their lower TMS response and attenuation of the initial potentiated response upon iTBS induction. However, our findings did not provide evidence for increased inhibition in NF1 patients. SignificanceThese findings have potential utility as neurophysiological outcome measures for intervention studies to treat cognitive deficits associated with NF1.

Cognitive deficits and psychosocial functioning in adult ADHD: Bridging the gap between objective test measures and subjective reports

ABSTRACT Introduction Self-reported cognitive deficits in adult Attention-Deficit/Hyperactivity-Disorder (ADHD) are often not corroborated by standardized tests. Tests and reports also differ in their correspondence to aspects of psychosocial functioning. Executive function tasks (EF-tasks) using material close to daily life, may provide a more ecologically-valid assessment of cognitive deficits. Method 36 adults with ADHD and 36 healthy controls performed standardized EF-tasks and corresponding EF-tasks using material close to daily life and gave self-reports on cognitive functioning. The study investigated performance differences and the predictive utility of cognitive measures for psychosocial functioning. Results While all the self-reports showed substantial cognitive impairments for the ADHD group, this was only shown in some of task measures. For two domains, the deficits in EF-tasks with material close to daily life were similar or smaller than assessed with traditional measures. However, three tasks, which used material of daily life, revealed more deficits than the corresponding more standardized tasks. Beyond cognitive self-reports the new tasks did not contribute substantial to psychosocial functioning, similar to the standardized tasks. Conclusions Tasks using material close to daily life have the potential to objectify reported everyday life deficits better than more standardized tests, at least in single EF-domains. When relevant methodical aspects of these tasks will be more targeted and considered systematically in future research, the tasks might contribute to assessments of psychosocial functioning. Then they could also be used as outcome measures in intervention studies.

Psychometric properties of the 10-item Connor–Davidson resilience scale among Finnish older adults

Objectives Resilience, the ability to bounce back after adverse events may be an important factor in active aging. The 10-item version of the Connor–Davidson Resilience Scale (CD-RISC10) seems suitable for aging research owing to its low participant burden; however, its psychometric properties have not been comprehensively reported for older people. For example, no estimate exists of the test–retest reliability of the scale when used with older adults. Hence, this study evaluated the psychometric properties of the CD-RISC10 in a large population-based sample of community-dwelling older people. Method The scale’s internal consistency, factor structure, construct validity, test-retest reliability, and user experience were analyzed among 1018 Finnish older adults (57% women) aged 75 (45%), 80 (33%) and 85 years (22%). Results The internal consistency of the CD-RISC10 was good (Cronbach’s α = 0.85), test-retest reliability moderate (ICC = 0.61), and the scale was unidimensional. However, a two-factor solution was found among the 75-year-olds, where the ability to deal positively with change (e.g. using humor) explained an additional part of resilience. While no differences by gender, age, or education were observed in total scores, very good perceived financial situation was associated with higher resilience. The scale showed good construct validity, and user feedback indicated that administering the scale in research is quick and easy. Conclusion In general, the CD-RISC10 is a valid method to study older adults’ psychological resilience. However, the present test–retest reliability values suggest caution in using the scale as an outcome measure in intervention studies.

A language-based sum score for the course and therapeutic intervention in primary progressive aphasia

BackgroundWith upcoming therapeutic interventions for patients with primary progressive aphasia (PPA), instruments for the follow-up of patients are needed to describe disease progression and to evaluate potential therapeutic effects. So far, volumetric brain changes have been proposed as clinical endpoints in the literature, but cognitive scores are still lacking. This study followed disease progression predominantly in language-based performance within 1 year and defined a PPA sum score which can be used in therapeutic interventions.MethodsWe assessed 28 patients with nonfluent variant PPA, 17 with semantic variant PPA, 13 with logopenic variant PPA, and 28 healthy controls in detail for 1 year. The most informative neuropsychological assessments were combined to a sum score, and associations between brain atrophy were investigated followed by a sample size calculation for clinical trials.ResultsSignificant absolute changes up to 20% in cognitive tests were found after 1 year. Semantic and phonemic word fluency, Boston Naming Test, Digit Span, Token Test, AAT Written language, and Cookie Test were identified as the best markers for disease progression. These tasks provide the basis of a new PPA sum score. Assuming a therapeutic effect of 50% reduction in cognitive decline for sample size calculations, a number of 56 cases is needed to find a significant treatment effect. Correlations between cognitive decline and atrophy showed a correlation up to r = 0.7 between the sum score and frontal structures, namely the superior and inferior frontal gyrus, as well as with left-sided subcortical structures.ConclusionOur findings support the high performance of the proposed sum score in the follow-up of PPA and recommend it as an outcome measure in intervention studies.

The Moral Injury Symptom Scale-Military Version.

The purpose of this study was to develop a multi-dimensional measure of moral injury symptoms that can be used as a primary outcome measure in intervention studies that target moral injury (MI) in Veterans and Active Duty Military with PTSD. This was a multi-center study of 427 Veterans and Active Duty Military with PTSD symptoms recruited from VA Medical Centers in Augusta, Los Angeles, Durham, Houston, and San Antonio, and from Liberty University in Lynchburg. Internal reliability of the Moral Injury Symptom Scale-Military Version (MISS-M) was examined along with factor analytic, discriminant, and convergent validity. Participants were randomly split into two equal samples, with exploratory factor analysis conducted in the first sample and confirmatory factor analysis in the second. Test-retest reliability was assessed in a subsample of 64 Veterans. The 45-item MISS-M consists of 10 theoretically grounded subscales assessing guilt, shame, moral concerns, religious struggles, loss of religious faith/hope, loss of meaning/purpose, difficulty forgiving, loss of trust, and self-condemnation. The Cronbach's alpha of the overall scale was .92 and of individual subscales ranged from .56 to .91. The test-retest reliability was .91 for the total scale and ranged from .78 to .90 for subscales. Discriminant validity was demonstrated by relativelyweak correlations with other psychosocial, religious, and physical health constructs, and convergent validitywas indicated by strong correlations with PTSD, depression, and anxiety symptoms. The MISS-M is a reliable and valid multi-dimensional symptom measure of moral injury that can be used in studies targeting MI in Veterans and Active Duty Military with PTSD symptoms and may also be used by clinicians to identify those at risk.

PP-19 Quantification of gait in children with mitochondrial disease: a validation study

Background Validated, clinically meaningful outcome measures should be used to detect clinically relevant effects of treatments. Since the clinical heterogeneity in mitochondrial disorders is extremely wide, the selection and validation of outcome measures is challenging. Espe-cially for children, whom are developing and growing and even have a larger phenotypic heterogeneity compared to adults, this challenge has so far resulted in a lack of val-idated outcome measures. Gait analysis is an emerging method to quantify subtle changes in walking patterns of adults with neurological disorders and can provide in-sight in the effects of a therapeutic intervention. Based on the results of a validation study in m.3243A>G carriers, we included gait quantification as the primary outcome measure for the adult randomised, placebo-controlled, cross-over, phase 2 trial performed in this population in our centre (the KHENERGY trial). We hypothesise that gait analysis is also a feasible and reliable outcome measure for intervention studies in ambulatory children with mi-tochondrial disease. Methods The aim of this study was to select the opti-mal protocol to quantify gait patterns with the Gaitrite in paediatric mitochondrial patients, comparing a normal walking protocol and a post-exercise protocol. Ambula-tory children with a genetically confirmed mitochondrial disease are asked to walk across the Gaitrite three times for each trial and two times for each condition to estimate test-retest variability. First, the normal walking condition is tested. Subsequently, a 3-minte walking test is performed, followed by a post-exercise protocol. After 10 min of rest, a recovery condition is tested. Secondly, the gait patterns of the mitochondrial patients are compared to 5 age-and gender matched healthy controls to gain more insight in which walking parameters were affected by mi-tochondrial disorders. Results and conclusion The results of this validation study will be presented.

Developing an Informant Questionnaire for Cognitive Abilities in Down Syndrome: The Cognitive Scale for Down Syndrome (CS-DS).

Down syndrome (DS) is the most common genetic cause of intellectual disability (ID). Abilities relating to executive function, memory and language are particularly affected in DS, although there is a large variability across individuals. People with DS also show an increased risk of developing dementia. While assessment batteries have been developed for adults with DS to assess cognitive abilities, these batteries may not be suitable for those with more severe IDs, dementia, or visual / hearing difficulties. Here we report the development of an informant rated questionnaire, the Cognitive Scale for Down Syndrome (CS-DS), which focuses on everyday abilities relating to executive function, memory and language, and is suitable for assessing these abilities in all adults with DS regardless of cognitive ability. Complete questionnaires were collected about 128 individuals with DS. After final question selection we found high internal consistency scores across the total questionnaire and within the executive function, memory and language domains. CS-DS scores showed a wide range, with minimal floor and ceiling effects. We found high interrater (n = 55) and test retest (n = 36) intraclass correlations. CS-DS scores were significantly lower in those aged 41+ with significant cognitive decline compared to those without decline. Across all adults without cognitive decline, CS-DS scores correlated significantly to measures of general abilities. Exploratory factor analysis suggested five factors within the scale, relating to memory, self-regulation / inhibition, self-direction / initiation, communication, and focussing attention. The CS-DS therefore shows good interrater and test retest reliability, and appears to be a valid and suitable informant rating tool for assessing everyday cognitive abilities in a wide range of individuals with DS. Such a questionnaire may be a useful outcome measure for intervention studies to assess improvements to cognition, in addition to detecting dementia-related cognitive decline. The CS-DS may also be a useful tool for other populations with ID.

Upper Limb Outcome Measures Used in Stroke Rehabilitation Studies: A Systematic Literature Review.

BackgroundEstablishing which upper limb outcome measures are most commonly used in stroke studies may help in improving consensus among scientists and clinicians.ObjectiveIn this study we aimed to identify the most commonly used upper limb outcome measures in intervention studies after stroke and to describe domains covered according to ICF, how measures are combined, and how their use varies geographically and over time.MethodsPubmed, CinHAL, and PeDRO databases were searched for upper limb intervention studies in stroke according to PRISMA guidelines and477 studies were included.ResultsIn studies 48different outcome measures were found. Only 15 of these outcome measures were used in more than 5% of the studies. The Fugl-Meyer Test (FMT)was the most commonly used measure (in 36% of studies). Commonly used measures covered ICF domains of body function and activity to varying extents. Most studies (72%) combined multiple outcome measures: the FMT was often combined with the Motor Activity Log (MAL), the Wolf Motor Function Test and the Action Research Arm Test, but infrequently combined with the Motor Assessment Scale or the Nine Hole Peg Test. Key components of manual dexterity such as selective finger movements were rarely measured. Frequency of use increased over a twelve-year period for the FMT and for assessments of kinematics, whereas other measures, such as the MAL and the Jebsen Taylor Hand Test showed decreased use over time. Use varied largely between countries showing low international consensus.ConclusionsThe results showed a large diversity of outcome measures used across studies. However, a growing number of studies used the FMT, a neurological test with good psychometric properties. For thorough assessment the FMT needs to be combined with functional measures. These findings illustrate the need for strategies to build international consensus on appropriate outcome measures for upper limb function after stroke.

The effect of active travel interventions conducted in work settings on driving to work: A systematic review

Abstract Background There is increasing interest in promoting active travel for transport and health benefits. Whilst epidemiological evidence of associations between active travel and health outcomes exists intervention studies are lacking. Systematic reviews have been conducted on the effectiveness of active travel interventions, but none have focused on interventions in the work setting only. Objective The objective of this study is to systematically assess the effectiveness of active travel interventions, only including randomised controlled trials or controlled longitudinal studies, conducted in a work setting for increasing employee physical activity levels and decreasing relatively inactive forms of transport (e.g. driving) to inform interventions promoting active travel. Methods Data were sourced from English and non-English articles using 10 databases and by contacting experts. Unpublished literature was sought via databases including conference proceedings, doctoral theses and a text book. Data were extracted independently by two authors and a third author adjudicated where there was no consensus. The same two authors assessed studies for risk of bias. Findings Twelve articles were identified for inclusion. Results could not be pooled for a meta-analysis since outcome measures were heterogeneous. Given that 10 out of the 12 studies found positive results for increasing active travel or decreasing driving to work, workplace active travel interventions look promising. However, the evidence was not strong since the small number of controlled studies included were at high risk of bias. Conclusions Evaluations of active travel interventions with robust study designs such as controlled before–after studies and cluster-randomised controlled trials are needed to provide stronger evidence, and pragmatic approaches to implementing controlled trials will need to be considered. Consensus on outcome measures for intervention studies would assist future reviews and meta-analyses. Since most active travel interventions at present are not controlled studies, reviews which include uncontrolled studies are another important source of evidence to inform policy and practice.

Naturalistic Action Performance Distinguishes Amnestic Mild Cognitive Impairment from Healthy Aging.

Individuals with amnestic mild cognitive impairment (aMCI) show minor decrements in their instrumental activities of daily living (IADL). Sensitive measures of IADL performance are needed to capture the mild difficulties observed in aMCI groups. Routine naturalistic actions (NAs) are familiar IADL-type activities that require individuals to enact everyday tasks such as preparing coffee. In the current study we examined the extent to which NAs could be used to help facilitate differential diagnosis of aMCI relative to composite measures of episodic memory, semantic knowledge, and executive function. Healthy older adults (n=24) and individuals with aMCI (n=24) enacted two highly familiar NAs and completed tests of episodic memory, semantic knowledge, and executive function. Binary logistic regression was used to predict group membership (aMCI vs. control participants). The regression analyses indicated that NA performance could reliably predict group membership, over and above measures of cognitive functioning. These findings indicated that NA performance can be used to help facilitate differential diagnosis of healthy aging and aMCI and used as an outcome measure in intervention studies.

The life changes in epilepsy scale: development and establishment of content and face validity.

Epilepsy is the most common chronic neurological disease in the United States. Adults with epilepsy suffer downturns in quality of life. The development of self-management interventions aimed at improving the quality of life of adults with epilepsy is hindered by the lack of a sensitive, patient-centered outcome measure. The purpose of this study was to develop the Life Changes in Epilepsy Scale (LCES); a second purpose was to establish evidence of the content and face validity of the LCES. The LCES was developed based on existing qualitative data and a theoretical framework derived from the literature; items were developed to measure perceived changes in the areas of social functioning, somatic health, and subjective well-being since epilepsy onset. Content validity indices were calculated based on evaluation of the scale by 3 experts in the field of epilepsy, whereas face validity was evaluated by 5 adults with epilepsy who were recruited from a Midwestern epilepsy clinic; qualitative data regarding the appropriateness of outcomes included in the LCES were also collected. The initial version of the LCES included 41 items. Following review of the LCES by experts in which both scale- and item-content validity indices of 1.0 were achieved, the number of items was reduced to 35. All 35 items were maintained following review of the LCES by adults with epilepsy. Qualitative comments from participants supported the inclusion of outcomes measured by the LCES. Results of this study provide evidence of both content and face validity of the LCES. Further psychometric testing of the scale is ongoing. In addition to being used as an outcome measure in intervention studies, the psychometrically tested LCES can serve as a valuable tool for advanced practice nurses caring for adults with epilepsy in inpatient, outpatient, and community settings. The LCES can allow for a brief assessment of ways in which patients' lives have been affected by epilepsy, thus allowing nurses to develop targeted nursing interventions for these patients.

Outcome Measures in Randomized-controlled Trials of Neuropathic Pain Conditions

Neuropathic pain (NeP) is a prevalent, disabling, multidimensional condition with significant morbidity; however, there appears to be a variable approach in the use of outcome measures in NeP trials. A search of systematic reviews of interventional randomized-controlled trials for NeP was undertaken to investigate the range and types of outcome measures used to determine treatment effects. Keywords and MESH searches were conducted in 5 electronic databases from inception to January 31, 2012. Full-text English-language reviews based on various acute and chronic NeP conditions were included. Two independent reviewers screened papers for inclusion, extracted data, and assessed the quality of reviews. Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines were used to critically appraise the reviews. A total of 46 studies were identified: the majority of reviews (n=28/46, 61%) scored well on the PRISMA (PRISMA scores of 20-27/27). Change in levels or intensity of pain were used by the majority of studies as the primary outcome measure in intervention studies (n=40/46 studies, 87%). Few studies used a functional outcome measure as either a primary or secondary outcome measure (n=7/46, 15% of studies). These results demonstrate that measures of pain are predominantly used in trials of NeP conditions and highlight the scant usage of functional outcome measures. The lack of standardization for the diagnostic criteria in NeP trials is also an issue that needs to be considered for future research and guideline development.

One side or two?

One side or two?