Concurrent validity of the PROMIS® pediatric global health measure

Purpose

To evaluate the concurrent validity of the PROMIS Pediatric Global Health measure (PGH-7), child-report and parent-proxy versions.

Methods

Surveys were administered via home computer on two separate occasions (December, 2011 and August/September, 2012) to a convenience sample of 4636 children 8–17 years old and 2609 parents who participated in a national Internet panel. Data analysis included: (1) evaluations of differences in PGH-7 scores between groups defined by sociodemographics, clinical characteristics, and access to health care; (2) associations with 15 PROMIS pediatric measures; and (3) correlations with two health-related quality-of-life instruments, the KIDSCREEN-10 and PedsQL-15.

Results

PGH-7 scores were lower for children with chronic conditions, Hispanic ethnicity, low socioeconomic status, and barriers to accessing health care. The PGH-7 showed excellent convergent and discriminant validity with PROMIS pediatric measures of physical, mental, and social health. The PGH-7 was strongly correlated with the KIDSCREEN-10, which assesses positive health, and moderately correlated with the PedsQL-15, which assesses problems with a child’s health.

Conclusions

The PGH-7 measures global health, summarizing a child’s physical, mental, and social health into a single score. These properties make it a useful clinical, population health, and research tool for applications that require an efficient, precise, and valid summary measure of a children’s self-reported health status. Future research should prospectively evaluate the PGH-7’s capacity to detect change that results from alterations in clinical status, transformations of the healthcare delivery system, and children’s health development.

     

The Worker Role Interview—Preliminary Data on the Predictive Validity of Return to Work of Clients After an Insurance Medicine Investigation

The aim was to investigate the predictive validity of the Worker Role Interview (WRI) for return to work at a 2-year follow-up of clients who attended an insurance medicine investigation center. The WRI identifies psychosocial and environmental factors that influence a person's abilities to return to work. Forty-eight of 202 consecutively selected clients constituted the study group. The Mann-Whitney U test was used to test the statistically significant differences in WRI ratings between those who were working (n = 6) and those who were not (n = 42) 2 years after their investigations. Five of the 17 items in WRI had a tentative predictive validity of return to work. The content area "personal causation" in WRI, had the best predictive validity. The results emphasize the importance of considering the unique individual's beliefs and expectations of his/her effectiveness at work when assessing clients' work ability and planning for further rehabilitation.     

The effects of the organophosphorous insecticides Dursban™ and Lorsban™ on the ciliated epithelium of the frog palate In Vitro

The ciliotoxic potential of the organophosphorous insecticides Dursban and Lorsban, their active ingredient, chlorpyrifos, and their carrier ingredients (Blanks) were assessed. Since chlorpyrifos inhibits acetylcholinesterase, the acetylcholine-innervated ciliated epithelial cultures of frog palate were used as the model. All compounds caused a decrease in frequency of ciliary beat over time. EC₅₀ values followed the same order as the time to inhibition. The orders were Lorsban > Dursban > chlorpyrifos, and Lorsban > Dursban Lorsban Blank > Dursban Blank. Stimulation of ciliary beating occurred immediately after exposure to all compounds, followed by inhibition. Dursban, Lorsban, and both Blanks elicited stimulatory effects in the presence of atropine. Atropine only blocked the initial stimulatory response with chlorpyrifos. In addition to chlorpyrifos, some component(s) of the inert ingredients were initially stimulatory but ultimately inhibitory to ciliary beating in the frog palate model. All compounds caused mitochondrial damage, including swelling, disruption of cristae, and loss of matrix.     

The DrivingHealth® Inventory as a Clinical Screening Tool—Assessment of Face Validity and Acceptance

ABSTRACT

To investigate the use and potential for patient acceptance of the DrivingHealth^® Inventory (DHI) in clinical practice, we administered the DHI to 360 community dwelling volunteers over age 50 at a Southeastern US rehabilitation hospital. Volunteers also completed surveys to document their health, driving habits, and impressions of the DHI. Volunteers reported strong agreement with statements that indicated that they believe the DHI measures abilities important for safe driving and that they would be willing to listen to advice about driving and safe mobility from medical professionals; however, responses to some items were more positive among drivers whose DHI results indicated no apparent loss of function that could impair driving. These results support the use of the DHI in clinical practice as a tool to raise awareness of factors that correlate to driving; however, further research will be necessary to investigate how the DHI may benefit diverse clinical populations. Experiences with using DHI as part of clinical practice are also discussed.     

The sound of operation and the acoustic attenuation of the Ohmeda Medical Giraffe OmniBed™

The neonatal intensive care unit (NICU) is an environment that provides premature and fragile infants with health provisions needed to make a complete recovery. Premature infants are often born before their auditory systems have had an opportunity to fully mature. Research has shown that the ambient acoustic environment in the NICU exceeds the maximum noise level recommended by the American Academy of Pediatrics, even after measures have been taken to decrease noise levels. The purpose of this study is to evaluate noise levels inside an Ohmeda Medical Giraffe? OmniBed?, the natural attenuation of the incubator, and the effects of modifications on attenuation and reverberation within the Giraffe TM OmniBed?. The normal operation of the Giraffe? OmniBed? is 41.7 dBA which indicates a lower noise of operation than previous studies. The Giraffe? OmniBed? naturally attenuates 12 dBA. Leaving an access latch or portal door open causes a statistically significant (P=.001) increase in sound within the bassinet. All modifications in the no-noise and the noise conditions showed a statistically significant (P=.001) drop in L(eq) when compared to baseline.     

Reliability and Validity of the PedsQL™ Oral Health Scale: Measuring the Relationship Between Child Oral Health and Health-Related Quality of Life

This study examined the reliability and validity of the Pediatric Quality of Life Inventory? (PedsQL) Oral Health Scale, a 5-item measure of child self-reported and parent-proxy reported pediatric oral health. One hundred twenty-six families participated during Phase 1 of the study, and 34 during Phase 2. Internal consistency and agreement between parent and child reports were examined. The construct, criterion-related, and convergent validity of the measure was supported by the results of this study. Using the PedsQL Oral Health Scale and the PedsQL 4.0 Generic Core Scales provide a generic health-related quality of life assessment that captures the physical, emotional, social, school, and oral domains of health.     

The Mental Capacity Act 2005: promoting the citizenship of people with dementia?

The Mental Capacity Act 2005 came into force in England and Wales during 2007. The Act enshrines a legal right to autonomy (negative and positive) of people lacking decision-making capacity, such as people with dementia. This paper examines the extent to which the legislation promotes the social citizenship of people with dementia, focusing on its effectiveness in protecting liberty and promoting self-determination and in providing social rights to facilitate autonomy. In particular, the author considers the degree to which the Act will facilitate decision-making by people with dementia, centring on decisions relating to where to live (at home or in an institution). In addition, the historical detention (usually informal) of people with dementia in institutional care, and the role of the Act in promoting recognition of their right to liberty, is highlighted. However, the author points out that the civil rights to liberty and self-determination accorded under the Act--particularly the right to decide where to live--are restricted rights only, as the views of the person lacking capacity can be over-ridden by the decisions of others. In addition, the facilitation of these civil rights is constrained by a lack of access to social rights, particularly the availability of domiciliary and community services to avoid institutional admission. Consequently, whilst the legislation promotes the social citizenship of people with dementia, it has limited capacity to facilitate their full citizenship status.     

Validity and reliability of the Japanese version of the FIM + FAM in patients with cerebrovascular accident

Background and aim: The study aim was to investigate the validity and reliability of the Functional Independence Measure and Functional Assessment Measure (FIM?+?FAM), which is unfamiliar in Japan, by using its Japanese version (FIM?+?FAM-j) in patients with cerebrovascular accident (CVA).

Material and methods: Forty-two CVA patients participated. Criterion validity was examined by correlating the full scale and subscales of FIM?+?FAM-j with several well-established measurements using Spearman’s correlation coefficient. Reliability was evaluated by internal consistency (tested by Cronbach’s alpha coefficient) and intra-rater reliability (tested by Kendall’s tau correlation coefficient).

Results: Good-to-excellent criterion validity was found between the full scale and motor subscales of the FIM?+?FAM-j and the Barthel Index, National Institutes of Health Stroke Scale, modified Rankin Scale, and lower extremity Brunnstrom Recovery Stage. High internal consistency was observed within the full-scale FIM?+?FAM-j and the motor and cognitive subscales (Cronbach’s alphas were 0.968, 0.954, and 0.948, respectively). Additionally, good intra-rater reliability was observed within the full scale and motor subscales, and excellent reliability for the cognitive subscales (taus were 0.83, 0.80, and 0.98, respectively).

Conclusion and significance: This study showed that the FIM?+?FAM-j demonstrated acceptable levels of validity and reliability when used for CVA as a measure of disability.     

Maximum Weights of Handling Acceptable to People Aged 55–74 Years: Part I. Lifting

The primary objective of this work was to investigate dynamic psychophysical (acceptable) material handling strengths (capabilities) of an older population (aged 55–74 years; n = 20). The findings are presented in two parts. Part I deals with manual lifting capabilities; Part II deals with manual carrying capabilities. In order to determine dynamic psychophysical strengths, routine everyday tasks were simulated in the laboratory. Lifting activities simulating work-related tasks included eight sequences of lifting (two lifting heights × four lifting frequencies); for each sequence, the maximum acceptable weight of lift (MAWL) was determined. Psychophysical lifting strengths of a younger population (18–35 years; n = 20) were also determined to find how the MAWL of the older population differed from that of the younger population. In addition to the MAWL, a number of responses at the MAWL were recorded: heart rate (HR), oxygen uptake (VO₂), and category-ratio ratings of perceived exertion (CRRPE). The results indicated no practically significant age-related differences in responses between either the older and younger males, or older and younger females. Based on the limited data collected in this study, it appears that age has no significant influence on people's capability to lift loads. Consequences of these findings on design are discussed.     

Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™

BackgroundCo-administration of an investigational quadrivalent meningococcal serogroups A, C, W and Y tetanus toxoid conjugate vaccine (MenACWY-TT) with the fourth dose of diphtheria–tetanus–acellular pertussis vaccine (DTaP) at age 15–18 months was investigated in 3-dose Haemophilus influenzae type b-meningococcal serogroups C/Y conjugate vaccine (HibMenCY-TT)-primed toddlers.MethodsInfants were randomized (5:1) and primed at 2, 4 and 6 months of age with HibMenCY-TT and DTaP-hepatitis B-inactivated poliovirus (DTaP-HBV-IPV) vaccine, or Hib-TT and DTaP-HBV-IPV (Control). HibMenCY-TT+ DTaP-HBV-IPV vaccinees were re-randomized (2:2:1) to receive MenACWY-TT at 12–15 months and DTaP at 15–18 months (MenACWY-TT group); MenACWY-TT co-administered with DTaP at 15–18 months (Coad group); or HibMenCY-TT at 12–15 months and DTaP at 15–18 months (HibMenCY-TT group). Controls received DTaP at 15–18 months. Only children in the HibMenCY-TT group received a fourth dose of Hib conjugate vaccine due to Hib conjugate vaccine shortage at the time of the study. DTaP immunogenicity and reactogenicity were assessed one month post-vaccination.ResultsPre-defined statistical non-inferiority criteria between Coad and Control groups were met for diphtheria, tetanus and filamentous haemagglutinin but not pertussis toxoid and pertactin. Following vaccination ≥99% of children had anti-diphtheria/anti-tetanus concentrations ≥1.0 IU/ml. Pertussis GMCs were lower in all investigational groups versus Control. In post hoc analyses, pertussis antibody concentrations were above those in infants following 3-dose DTaP primary vaccination in whom efficacy against pertussis was demonstrated (Schmitt, von König, et al., 1996; Schmitt, Schuind, et al., 1996). The reactogenicity profile of the Coad group was similar to DTaP administered alone.ConclusionRoutine booster DTaP was immunogenic with an acceptable safety profile when co-administered with MenACWY-TT vaccine in HibMenCY-TT-primed toddlers. These data support the administration of a fourth DTaP dose following a 4-dose HibMenCY-TT vaccination series, or co-administered with MenACWY-TT in HibMenCY-TT-primed children.     

Test–Retest Reliability of the Isernhagen Work Systems Functional Capacity Evaluation in Patients with Chronic Low Back Pain

The aim of this study was to investigate test–retest reliability of the Isernhagen Work System Functional Capacity Evaluation (IWS FCE) in a sample of patients (n = 30) suffering from Chronic Low Back Pain (CLBP) and selected for rehabilitation treatment. The IWS FCE consists of 28 tests that reflect work-related activities like lifting, carrying, bending, etc. In this study, a slightly modified IWS FCE was used. Patients were included in the study if they were still at work or were less than 1 year out of work because of CLBP. Participants' mean age was 40 years, the duration of low back pain ranged between 5 and 10 years. Fifteen patients (50%) were out of work for a mean of 17 weeks, and they all received financial compensation. Two FCE sessions were held with a 2-week interval in between. Means per session, 95% confidence intervals of the mean difference, one-way random Intra Class Correlations (ICC), limits of agreement, Cohen's kappa and percentage of absolute agreement were calculated where appropriate. An ICC of 0.75 or more, a kappa value of more than 0.60 and a percentage of absolute agreement of 80% were considered as an acceptable reliability. Tests of the IWC FCE were divided into tests with and tests without an acceptable test–retest reliability on the basis of the kappa values, the percentage of absolute agreement and the ICC values. Fifteen tests (79%) showed an acceptable test–retest reliability based on Kappa values and percentage of absolute agreement. Eleven tests (61%) showed an acceptable test–retest reliability based on ICC values.     

The Impact of the Concentration and Dose of Palatinjt® in Foods and Diets on Energy Value

Selenium concentration and bioavailability were assessed in a common Mato Grosso urban regional diet (RUDMT), using 52 Wistar male weanling rats, weighing 56.2 ± 1.4 g. Thirty-two rats were fed a casein diet that was free of selenium, vitamin E and methionine and contained anti-oxidant-free oil for a 30 day period in order to induce a selenium deficiency. The remaining rats were fed on a casein diet, forming control group I, with 0.10μg of selenium per gram of diet. After selenium deficiency had been established, 24 rats were divided into three groups which were fed on three different diets for 25 days: (i) RUDMT group, with 0.02 μg of selenium per gram of diet; (ii) control group II, with 0.10μg of selenium per gram of diet; and (iii) pair-feeding group, with 0.04 μg of selenium per gram of diet. During this latter period, the control group I without depletion continued to be fed on the casein diet with 0.10 μg of selenium per gram of diet. Apparent selenium absorption, selenium concentration and the enzymatic activity of the glutathione peroxidase (GSH Px) in plasma, liver and kidney were determined in order to assess the selenium bioavailability. The RUDMT group showed low selenium bioavailability than the control groups. The low concentration of selenium and other components in the RUDMT diet might have contributed to this result.     

Obstacles to and Facilitators of Return to Work After Work-Disabling Back Pain: The Workers’ Perspective

Introduction Back pain entails considerable costs, particularly because many injured workers are absent from work for long periods. Factors that influence return to work among workers with back pain are still, however, not well understood. This qualitative study aimed at documenting affected workers’ perspective on the: 1—difficulties caused by back pain, and 2—most important obstacles to and facilitators of return to work. Methods Two focus groups composed of workers having suffered from work-disabling back pain were held: a group of participants who had returned to work (n = 9) and a group of participants who had not returned or had recently returned to work (n = 10). The verbatim accounts of the discussions were transcribed and a content analysis was carried out that included a ranking of items. Results Difficulties caused by back pain were related to: (1) personal, (2) family, (3) social, (4) occupational, and (5) financial factors, and (6) health services. Obstacles to and facilitators of return to work were of 4 different types: (1) occupational factors, (2) factors associated with the utilization of health services, (3) clinical, and (4) personal factors. Persistent pain, lack of access to information or support groups, and lack of collaboration and understanding from employer were the most important obstacles identified, whereas knowledge of one’s limits and physical training were perceived to be the most important facilitators of return to work, ahead of work-related factors. Differences between groups’ perceptions were attributed mainly to control beliefs. Conclusions Personal, clinical, occupational and health services factors are perceived by workers with back pain to play a crucial role in determining whether they return to work or not.     

Injured Workers’ Construction of Expectations of Return to Work with Sub-Acute Back Pain: The Role of Perceived Uncertainty

Introduction: Little is known about the formation of expectations of return to work (RTW) from the perspective of injured workers with back injuries. This modified grounded theory study uses a biopsychosocial approach that considers the workers’ complex social circumstances, to unpack the multidimensional construct of expectations of RTW from the injured worker’s perspective. Method: Initial semi-structured interviews were conducted with 18 individuals with sub-acute back pain, who were off work between 3 and 6 months. Follow-up interviews were conducted with 7 participants for the purposes of member checking. The interview data was coded, compared and analyzed over the course of data collection, until saturation was reached. Results: Data analysis revealed that expectations of return-to-work are constructed based on perceived uncertainty which subsumes five inter-related categories (1) perceived lack of control over the return-to-work process, (2) perceived lack of recognition by others of the impact of the injury, (3) perceived inability to perform the pre-injury job, (4) fear of re-injury, and (5) perceived need for workplace accommodations. Expectations, once formed, were influenced by the worker’s experience of coping with perceived uncertainty. Conclusion: Perceived uncertainty plays a key role in injured workers’ formation of expectations of return-to-work. Implications are discussed regarding how this perceived uncertainty plays a role in the development of (re)injury prevention and rehabilitation programs. The importance of further research on perceived uncertainty is presented, along with potential future research considerations.     

Toxicity of Guthion® and Guthion® 2S to Xenopus laevis embryos

The development of Xenopus laevis (African clawed frog) embryos exposed to the pesticide Guthion^® (technical grade) and Guthion^® 2S (commercial formulation) was evaluated in modified Frog Embryo Teratogenesis Assay—Xenopus (FETAX) tests. The embryos were exposed to five or six increasing concentrations of pesticide in 10- and 100-ml exposure volumes of test solution for 96 h. Embryos exposed in 10-ml volumes of Guthion exhibited increased mortality, increased deformation, and decreased size as compared to those exposed in 100-ml volumes. LC50s for embryos exposed in the 10-ml Guthion tests ranged from 6.1 to 6.3 mg/L as compared to 10.6 to 11.9 mg/L for those in the 100-ml tests. The percentage of deformities at 3 mg/L Guthion in test survivors in 10-ml tests ranged from 73 to 89%, while in the 100-ml tests less than 2% were deformed at the same concentration. Mean control embryo lengths at test completion were 8.2 and 10.6 mm, respectively, for 10- and 100-ml tests. The LC50 for embryos in 100 ml Guthion 2S was 1.6 mg/L active ingredient, indicating a much greater toxicity of the commercial formulation. NOAEL (No Observed Adverse Effect Level) values for Guthion and Guthion 2S ranged from 0.48 to 7.96 mg/L, depending upon basis (length, deformity, mortality) and pesticide formulation, and were many times greater than the existing water quality criterion of 0.01 g/L.