Psychometric evaluation of the electronic faces thermometer scale for pain assessment in children 8-17 years old: A study protocol.

It is often a challenge for a child to communicate their pain, and their possibilities to do so should be strengthened in healthcare settings. Digital self-assessment provides a potential solution for person-centered care in pain management and promotes child participation when a child is ill. A child's perception of pain assessment differs when it is assessed using digital or analog formats. As we move into the digital era, there is an urgent need to validate digital pain assessment tools, including the newly developed electronic Faces Thermometer Scale (eFTS). This study protocol describes three studies with the overall aim to evaluate psychometric properties of the eFTS for assessing pain in children 8-17 years of age. A multi-site project design combining quantitative and qualitative methods will be used for three observational studies. Study 1: 100 Swedish-speaking children will report the level of anticipated pain from vignettes describing painful situations in four levels of pain and a think-aloud method will be used for data collection. Data will be analyzed with phenomenography as well as descriptive and comparative statistics. Study 2: 600 children aged 8-17 years at pediatric and dental settings in Sweden, Denmark, Iceland, and USA will be included. Children will assess their pain intensity due to medical or dental procedures, surgery, or acute pain using three different pain Scales for each time point; the eFTS, the Faces Pain Scale Revised, and the Coloured Analogue Scale. Descriptive and comparative statistics will be used, with subanalysis taking cultural context into consideration. Study 3: A subgroup of 20 children out of these 600 children will be purposely included in an interview to describe experiences of grading their own pain using the eFTS. Qualitative data will be analyzed with content analysis. Our pilot studies showed high level of adherence to the study procedure and rendered only a small revision of background questionnaires. Preliminary analysis indicated that the instruments are adequate to be used by children and that the analysis plan is feasible. A digital pain assessment tool contributes to an increase in pain assessment in pediatric care. The Medical Research Council framework for complex interventions in healthcare supports a thorough development of a new scale. By evaluating psychometric properties in several settings by both qualitative and quantitative methods, the eFTS will become a well-validated tool to strengthen the child's voice within healthcare.

No association of primary Sjögren's syndrome with Fcγ receptor gene variants.

The genetic background of primary Sjögren's syndrome (pSS) is partly shared with systemic lupus erythematosus (SLE). Immunoglobulin G Fc receptors are important for clearance of immune complexes. Fcγ receptor variants and gene deletion have been found to confer SLE risk. In this study, four Fcγ receptor single-nucleotide polymorphisms (SNPs) and one copy number variation (CNV) were studied. Swedish and Norwegian pSS patients (N=527) and controls (N=528) were genotyped for the Fcγ receptor gene variant FCGR2A H131R (rs1801274) by the Illumina GoldenGate assay. FCGR3A F158V (rs396991) was analysed in 488 patients and 485 controls, FCGR3B rs447536 was analysed in 471 patients and 467 controls, and FCGR3B rs448740 was analysed in 478 cases and 455 controls, using TaqMan SNP genotyping assays. FCGR3B CNV was analysed in 124 patients and 139 controls using a TaqMan copy number assay. None of the SNPs showed any association with pSS. Also, no FCGR3B CNV association was detected. The lack of association of pSS with Fcγ receptor gene variants indicates that defective immune complex clearance may not be as important in pSS pathogenesis as in SLE, and may point to important differences between SLE and pSS.

Association of EBF1, FAM167A(C8orf13)-BLK and TNFSF4 gene variants with primary Sjögren's syndrome.

We performed a candidate gene association study in 540 patients with primary Sjögren's Syndrome (SS) from Sweden (n=344) and Norway (n=196) and 532 controls (n=319 Swedish, n=213 Norwegian). A total of 1139 single-nucleotide polymorphisms (SNPs) in 84 genes were analyzed. In the meta-analysis of the Swedish and Norwegian cohorts, we found high signals for association between primary SS and SNPs in three gene loci, not previously associated with primary SS. These are the early B-cell factor 1 (EBF1) gene, P=9.9 × 10(-5), OR 1.68, the family with sequence similarity 167 member A-B-lymphoid tyrosine kinase (FAM167A-BLK) locus, P=4.7 × 10(-4), OR 1.37 and the tumor necrosis factor superfamily (TNFSF4=Ox40L) gene, P=7.4 × 10(-4), OR 1.34. We also confirmed the association between primary SS and the IRF5/TNPO3 locus and the STAT4 gene. We found no association between the SNPs in these five genes and the presence of anti-SSA/anti-SSB antibodies. EBF1, BLK and TNFSF4 are all involved in B-cell differentiation and activation, and we conclude that polymorphisms in several susceptibility genes in the immune system contribute to the pathogenesis of primary SS.

Additive effects of the major risk alleles of IRF5 and STAT4 in primary Sjögren's syndrome.

Primary Sjögren's syndrome (SS) shares many features with systemic lupus erythematosus (SLE). Here we investigated the association of the three major polymorphisms in IRF5 and STAT4 found to be associated with SLE, in patients from Sweden and Norway with primary SS. These polymorphisms are a 5-bp CGGGG indel in the promoter of IRF5, the single nucleotide polymorphism (SNP) rs10488631 downstream of IRF5 and the STAT4 SNP rs7582694, which tags the major risk haplotype of STAT4. We observed strong signals for association between all three polymorphisms and primary SS, with odds ratios (ORs) >1.4 and P-values <0.01. We also found a strong additive effect of the three risk alleles of IRF5 and STAT4 with an overall significance between the number of risk alleles and primary SS of P=2.5 x 10(-9). The OR for primary SS increased in an additive manner, with an average increase in OR of 1.78. For carriers of two risk alleles, the OR for primary SS is 1.43, whereas carriers of five risk alleles have an OR of 6.78. IRF5 and STAT4 are components of the type I IFN system, and our findings emphasize the importance of this system in the etiopathogenesis of primary SS.

Interferon regulatory factor 5 (IRF5) gene variants are associated with multiple sclerosis in three distinct populations.

BACKGROUND: IRF5 is a transcription factor involved both in the type I interferon and the toll-like receptor signalling pathways. Previously, IRF5 has been found to be associated with systemic lupus erythematosus, rheumatoid arthritis and inflammatory bowel diseases. Here we investigated whether polymorphisms in the IRF5 gene would be associated with yet another disease with features of autoimmunity, multiple sclerosis (MS). METHODS: We genotyped nine single nucleotide polymorphisms and one insertion-deletion polymorphism in the IRF5 gene in a collection of 2337 patients with MS and 2813 controls from three populations: two case-control cohorts from Spain and Sweden, and a set of MS trio families from Finland. RESULTS: Two single nucleotide polymorphism (SNPs) (rs4728142, rs3807306), and a 5 bp insertion-deletion polymorphism located in the promoter and first intron of the IRF5 gene, showed association signals with values of p<0.001 when the data from all cohorts were combined. The predisposing alleles were present on the same common haplotype in all populations. Using electrophoretic mobility shift assays we observed allele specific differences in protein binding for the SNP rs4728142 and the 5 bp indel, and by a proximity ligation assay we demonstrated increased binding of the transcription factor SP1 to the risk allele of the 5 bp indel. CONCLUSION: These findings add IRF5 to the short list of genes shown to be associated with MS in more than one population. Our study adds to the evidence that there might be genes or pathways that are common in multiple autoimmune diseases, and that the type I interferon system is likely to be involved in the development of these diseases.

The sensitivity of the premature infant pain profile - PIPP to measure pain in hospitalized neonates.

AIM: The present study uses an Icelandic translation of the original version of the Premature Infant Pain Profile (PIPP) in order to assess its accuracy and sensitivity to the measure of pain in hospitalized neonates in Iceland. The PIPP is a composite tool developed to assess acute pain in preterm and term neonates. METHODS: A crossover design, with a sample of 24 neonates, was used on three, routinely occurring events in the neonatal intensive care unit, where neonates were their own controls. The three events were baseline, non-pain and pain event. Neonates were independently assessed for their pain, using the Icelandic translation of the PIPP, at the bedside. RESULTS: Repeated measures analysis yielded a statistically significant main effect for the three events (pain, non-pain and baseline), thus differentiating pain from non-pain and baseline events (F = 57.11; P < 0.0001). Pair-wise comparisons were subsequently carried out and the results show that PIPP scores at the pain event (11.72) were significantly lower (P < 0.0001) than that at the non-pain event (6.04) and that at the baseline event (3.54; P < 0.0001). The PIPP scores at the non-pain event were also significantly higher than that at the baseline event (P < 0.0001). These results suggest that the PIPP measure is sensitive to a painful event and differentiates between stress and pain in a clinical context across linguistic barriers. The findings also revealed almost a complete correlation between the PIPP scores of the two independent nurse raters at all events (P < 0.0001). CONCLUSION: Therefore the authors conclude that the Icelandic translation of the PIPP qualifies as a satisfying measure of pain responses in Icelandic neonates and can be recommended for use by clinicians and researchers. More research is, however, needed to further the accuracy and validity of the PIPP measure in general to assess pain in neonates in comparison to other pain measures.

Risk factors of back pain frequency in schoolchildren: a search for explanations to a public health problem.

UNLABELLED: This study examined physical, behavioral and social factors associated with schoolchildren's back pain. Factors associated with back pain were also identified using a stepwise regression method. The study was based on a self-administered questionnaire survey of a random national sample of 2173 Icelandic 11-12 and 15-16-y-old schoolchildren. It found that older subjects tended to report back pain more frequently than younger children. Back pain showed significant associations with different aspects of physical condition such as chronic health conditions, tiredness and physical fitness. A number of behavioral factors including participation in sports, television viewing, eating habits and smoking also had a relationship with back pain. Finally, children with lower social support were more likely to experience back pain. CONCLUSION: Overall, four major factors (age, morning tiredness, eating habits and parental support) emerged as factors associated with back pain in the study subjects. These results highlighted the roles of lifestyle and social factors in the experience of back pain in schoolchildren.

Sociodemographic differences in patterns of sedentary and physically active behavior in older children and adolescents.

UNLABELLED: Numerous studies have found that involvement in moderate-intensity and strenuous activity has positive effects on health. This study considered the prevalence of different aspects of physical activity and sedentary behavior in 11-16-y-olds based on a representative national survey of 3270 Icelandic primary schoolchildren (91% response rate). All-day sedentary behavior was extremely rare (< 1%), and the vast majority (91%) were physically active (> or = 3 times per week) during school or leisure time, thanks largely to school physical education. Only 39% were physically active (> or = 3 times per week) during leisure time, and only 29% engaged in regular (> or = 3 times per week) leisure time strenuous exercise. Girls were more sedentary, less leisure time physically active, and less involved in leisure time strenuous exercise. Sedentary behavior increased and physically active behavior decreased with age, especially after early adolescence. However, there were no age differences in strenuous leisure time exercise. Upper-class students were less sedentary and more physically active during leisure time than working-class students. Finally, rural students were more sedentary during leisure time, and less physically active than students from urban areas. An interaction was found between age and residence when predicting leisure time physical activity, indicating that the inverse age-activity relationship in urban areas is partly reversed in rural areas. CONCLUSION: Compulsory school physical education frequently failed to translate into voluntary physical involvement. Sociodemographic differences in physical activity were greater during leisure time, than during school and leisure time combined.

Helicobacter pylori antibodies and gastric cancer in Iceland - The decline in IgG antibody level is a risk factor.

H. pylori infection is considered a causal agent of duodenal ulcer and a significant risk factor for gastric cancer. Retrospective cohort studies have demonstrated a significant association between presence of antibody to H. pylori and gastric cancer when using samples obtained years before the diagnosis but not at the time of diagnosis. The present study investigates, in a population-based cohort, whether a decline occurs in H. pylori antibody levels before the diagnosis of stomach cancer. Repeat samples (2 to 5) were available from 23 persons with gastric cancer taken up to 20 years before the diagnosis and 128 control subjects matched for gender, age, time and number of repeat samples. The odds ratio of developing stomach cancer was 1.16 (95% CI 1.05-1.28) for those showing decline in antibody levels of 1 relative antibody activity unit per year versus those with constant or rising levels. We conclude that this decline in antibody levels in cases, and not in controls, supports an active role of H. pylori in the pathogenesis of gastric cancer by causing atrophic gastritis, and provides a better risk assessment for gastric cancer compared to single measurements.

Factors associated with suicide ideation in adults.

The study considers numerous factors potentially related to suicide ideation in adults, including life stress, stress perceptions, social support, personality, alcohol use, chronic conditions, distress symptoms and sociodemographic background. Using data from a health survey of 825 adult residents in the urban Reykjavik area of Iceland, the study finds that financial hardship, legal stress, family difficulties, stress perceptions and low material support are significantly related to thoughts of committing suicide. Multiple chronic conditions, frequent alcohol use and various forms of distress (e.g. depression, anxiety, hopelessness, pain) are also related to suicide ideation. Furthermore, low self-esteem and external locus of control (low sense of mastery) are both associated with suicidal thoughts. No significant relationships were found between sociodemographic background and suicide ideation. The meaning of the results, and their implications for continued theoretical and clinical work in this area, are discussed. Suicide research has primarily focused on completed suicides (e.g. Durkheim [1897] 1951; Fisher et al. 1993; Henry and Short 1954; Lester 1974; Pritchard 1996) or suicide attempts (e.g. Diekstra 1982; Maris 1981; Slap et al. 1989; Smith and Crawford 1986; Stack and Wasserman 1995). Relatively few studies have focused on thoughts of own death or suicide, or suicide planning. Nevertheless, there is a growing understanding that ideation and planning are important steps in a process of suicide, characterised by a stepwise hierarchy of actions with an underlying gradient of severity (Beck 1986; Bonner and Rich 1987; Diekstra 1993; Smith and Crawford 1986). Ideation precedes planning, which may result in an attempt leading to death. If nonfatal, the attempt may increase the likelihood of subsequent ideation, planning and attempt (see paths a-e in Fig. 1). It should therefore be of theoretical as well as clinical value to consider the risk factors associated with suicide ideation and planning.

Prevalence of pain combinations and overall pain: a study of headache, stomach pain and back pain among school-children.

The prevalence of pain combinations among school children is addressed in view of earlier findings of high pain prevalence in this population. The study considers the prevalence of combinations of three common pains headache, stomach pain and back pain-in a random national sample of 2173 Icelandic 11-12 and 15-16 year-old school children. According to the results from this study there is a 78.2% prevalence of monthly pain. One or more instances of weekly pain is experienced by 40.4% of the children, and 15.6% experience two or three pains weekly. Relevance of gender is greater when dealing with combinations of monthly than weekly pain. Combinations of weekly pains are more gender related than single weekly pains. Girls have significantly more frequent overall pain than boys. The distribution of pain combinations varies by age but not overall pain. The study yields important information about the extent of the overall problem of pain among school children and indicates the need to further study the correlates of different pain combinations in this age group.

Sociodemographic differences in the prevalence of self-reported stomach pain in school children.

UNLABELLED: The study considered the prevalence of experienced stomach pain in a nationwide random sample of 2161 Icelandic 11-12 and 15-16-year-old school children. It found an 18.4% prevalence of "at least weekly" stomach pain and a 53.4% overall prevalence. The prevalence of stomach pain was significantly higher among younger children (P < or = 0.001). Higher prevalence (P < or = 0.001) of stomach pain was seen in girls in the overall sample and the gender difference was significant in both age groups. No overall class or residential differences were detected. However, the findings suggest some age-related links between social status and the experience of stomach pain. The frequency of stomach pain was moderately and significantly associated with medication use. The theoretical and clinical implications of the results are briefly discussed. CONCLUSION: The high prevalence of frequent stomach pain found in this study calls for future research documenting further the epidemiology of stomach pain and various bio-psycho-social factors related to the experience and extent of this pain in school children.

Prevalence of self-reported back pain in school children: a study of sociodemographic differences.

UNLABELLED: The study considers the prevalence of back pain experienced in a nationwide random sample of 2173 Icelandic school children aged 11-12 and 15-16. The study found a 20.6% prevalence of "at least weekly" back pain. The prevalence of back pain was significantly more frequent among the older children. No gender or class difference was found in the overall sample. Older children from rural areas have significantly more back pain than those living in the city. The need for a thorough epidemiological investigation of the association of back pain in children is emphasized. CONCLUSION: The high prevalence of frequent back pain found in this study should be of great concern to health care professionals. An important step in future research is to broadly document the prevalences of various combinations of pains and various bio-psycho-social factors that are related to pain experiences and pain frequency in this age group.

Perceived importance of needs expressed by parents of hospitalized two- to six-year-olds.

The study describes the needs of 34 parents, 12 fathers and 22 mothers, of hospitalized 2-6 year-olds in a Pediatric Hospital in Iceland. Subjects responded to 43 statements of possible needs during a child's hospitalization on a Likert-type scale based on their perception of the importance of items. The reliability coefficient was over 0.91 for all three parts of the instrument. Parents' perception of importance was significantly and positively correlated with their perception of how their needs were being met and with their request for help from the hospital to fulfil them. None of the statements were perceived to be unimportant. Items related to parents' need to trust nurses and doctors were consistently rated as very important. Items related to the need for information and needs related to other family members were consistently rated as lying between important and very important. Needs related to human and physical resources, and the need for support and guidance were in general rated lowest. Items related to the need to be trusted had a mean importance significantly (p < 0.01) lower for fathers. Although not exhaustive, the statements presented were found to be representative of the needs and concerns of parents during the hospitalization of their children.

Sociodemographic differences in the prevalence of self-reported headache in Icelandic school-children.

The study considers the prevalence of headache experiences in a random national sample of 2140 Icelandic 11-12 and 15-16 year-old school-children. The study finds an overall 21.9% prevalence of "at least weekly" headache. The prevalence is significantly higher among younger children and among girls. The gender difference is found to be related to the fact that older boys have a markedly lower prevalence than younger boys. No gender difference is observed in the younger group. Social class interacts with gender, with the gender difference leveling out in the upper class. The frequency of headache experiences correlates with last months use of medication to relieve headache. The high overall prevalence of headache found in this study agrees with earlier findings, and is a matter of concern since little is being done to counter this problem of discomfort among school-children.

A study of the needs of parents of hospitalized 2- to 6-year-old children.

The present study uses a qualitative approach to explore and identify areas of needs among parents of 2- to 6-year-old children who are hospitalized. An extensive literature review and informal in-depth interviews with five parents and six pediatric health care professionals were analyzed by content to develop a representative list of statements about needs. Six groups of needs were recognized: (a) the need to be able to trust doctors and nurses, (b) the need for information, (c) needs related to other family members, (d) a need to feel that they are trusted, (e) needs related to human and physical resources, and (e) the need for support and guidance. A congruency is found between statements about needs of parents of hospitalized 2- to 6-year-olds in the literature on the one hand and the needs of parents expressed by parents themselves and pediatric health care professionals on the other hand.

The importance of an introduction to scientific methodology and research evaluation in the nursing curriculum: an Icelandic experience.

This article briefly presents a total academic program for preparing professional nurses at the University of Iceland and discusses the reasons for teaching an introductory course in scientific methodology and research evaluation in its curriculum. It is argued that scientific methodology and research evaluation adds a necessary component to the qualification of the nursing graduate and an ability to participate in clinical research and advancement of research-based practice.