Web-based follow-up tool (ePIPARI) of preterm infants-study protocol for feasibility and performance.

BACKGROUND: Preterm infants have a risk of health and developmental problems emerging after discharge. This indicates the need for a comprehensive follow-up to enable early identification of these problems. In this paper, we introduce a follow-up tool "ePIPARI - web-based follow-up for preterm infants". Our future aim is to investigate whether ePIPARI is a feasible tool in the follow-up of preterm infants and whether it can identify children and parents in need of clinical interventions. METHODS: ePIPARI includes eight assessment points (at term age and at 1, 2, 4, 8, 12, 18, and 24 months of corrected age) when the child´s health and growth, eating and feeding, neurodevelopment, and parental well-being are evaluated. ePIPARI consists of several widely used, standardized questionnaires, in addition to questions typically presented to parents in clinical follow-up visits. It also provides video guidance and written information about age-appropriate neurodevelopment for the parents. Parents of children born before 34 weeks of gestation during years 2019-2022 are being invited to participate in the ePIPARI study, in which web-based follow-up with ePIPARI is compared to clinical follow-up. In addition, the parents of children born before 32 weeks of gestation, who reached the corrected age of two years during 2019-2021 were invited to participate for the assessment point of 24 months of ePIPARI. The parents are asked to fill in the online questionnaires two weeks prior to each clinical follow-up visit. DISCUSSION: The web-based tool, ePIPARI, was developed to acquire a sensitive and specific tool to detect infants and parents in need of further support and clinical interventions. This tool could allow individualized adjustments of the frequency and content of the clinical visits. TRIAL REGISTRATION: ClinicalTrials.cov, NCT05238168 . Registered 11 April 2022 - Retrospectively registered.

Pre-notifications increase retention in a 17-year follow-up of adolescents born very preterm.

OBJECTIVE: Retention is essential in follow-up studies to reduce missing data, which can cause bias and limit the generalizability of the results. We investigated whether pre-notification letters would increase the response rates of approval forms and questionnaires and reduce the need for post-notifications in a prospective follow-up study of 17-year-old adolescents. STUDY DESIGN: and settings This long-term follow-up study included 269 adolescents were randomized (1:1) into a pre-notification group (n = 132) and a no pre-notification group (n = 137). The pre-notification letter was sent prior to the approval form and questionnaires. The outcome measures were the response rates to the approval forms and questionnaires and the rate of post-notifications required. RESULTS: The adolescents who received the pre-notifications were more likely to return approval forms (n = 88/132, 67%) than the adolescents who did not receive the pre-notifications (n = 79/137, 58%) (OR 1.5, 95% CI 0.9-2.4). The rates of returned questionnaires were higher in the pre-notification group (n = 82/88, 93%) than in the no pre-notification group (n = 68/79, 86%) (OR 2.2, 95% CI 0.8-6.3). The adolescents who did not receive the pre-notifications were more likely to need the post-notifications than the adolescents who received the pre-notifications (OR 3.0, 95% CI 1.4 to 6.5). CONCLUSIONS: Pre-notifications decreased the need for post-notifications and may increase retention in 17-year-old adolescents. Based on our findings, pre-notification letters are recommended in future follow-up studies in adolescents. TRIAL REGISTRATION: The Ethics Review Committee of the Hospital District of South-West Finland approved the 17-year PIPARI Study protocol in January 2018 (23.1.2018; 2/180/2012). The study has been registered to the SWAT repository as SWAT 179. Filetoupload,1457904,en.pdf (qub.ac.uk).

Factors Influencing the Adoption of Magnetic Resonance-Guided High-Intensity Focused Ultrasound for Painful Bone Metastases in Europe, A Group Concept Mapping Study.

Magnetic resonance imaging-guided high-intensity focused ultrasound (MR-HIFU) is an innovative treatment for patients with painful bone metastases. The adoption of MR-HIFU will be influenced by several factors beyond its effectiveness. To identify contextual factors affecting the adoption of MR-HIFU, we conducted a group concept mapping (GCM) study in four European countries. The GCM was conducted in two phases. First, the participants brainstormed statements guided by the focus prompt "One factor that may influence the uptake of MR-HIFU in clinical practice is...". Second, the participants sorted statements into categories and rated the statements according to their importance and changeability. To generate a concept map, multidimensional scaling and cluster analysis were conducted, and average ratings for each (cluster of) factors were calculated. Forty-five participants contributed to phase I and/or II (56% overall participation rate). The resulting concept map comprises 49 factors, organized in 12 clusters: "competitive treatments", "physicians' attitudes", "alignment of resources", "logistics and workflow", "technical disadvantages", "radiotherapy as first-line therapy", "aggregating knowledge and improving awareness", "clinical effectiveness", "patients' preferences", "reimbursement", "cost-effectiveness" and "hospital costs". The factors identified echo those from the literature, but their relevance and interrelationship are case-specific. Besides evidence on clinical effectiveness, contextual factors from 10 other clusters should be addressed to support adoption of MR-HIFU.

Focused Ultrasound and RadioTHERapy for non-invasive palliative pain treatment in patients with bone metastasis: a study protocol for the three armed randomized controlled FURTHER trial.

BACKGROUND: Cancer-induced bone pain (CIBP), caused by bone metastases, is a common complication of cancer and strongly impairs quality of life (QoL). External beam radiotherapy (EBRT) is the current standard of care for treatment of CIBP. However, approximately 45% of patients have no adequate pain response after EBRT. Magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) may improve pain palliation in this patient population. The main objective of this trial was to compare MR-HIFU, EBRT, and MR-HIFU + EBRT for the palliative treatment of bone metastases. METHODS/DESIGN: The FURTHER trial is an international multicenter, three-armed randomized controlled trial. A total of 216 patients with painful bone metastases will be randomized in a 1:1:1 ratio to receive EBRT only, MR-HIFU only, or combined treatment with EBRT followed by MR-HIFU. During a follow-up period of 6 months, patients will be contacted at eight time points to retrieve information about their level of pain, QoL, and the occurrence of (serious) adverse events. The primary outcome of the trial is pain response at 14 days after start of treatment. Secondary outcomes include pain response at 14 days after trial enrolment, pain scores (daily until the 21st day and at 4, 6, 12 and 24 weeks), toxicity, adverse events, QoL, and survival. Cost-effectiveness and cost-utility analysis will be conducted. DISCUSSION: The FURTHER trial aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU-alone or in combination with EBRT-compared to EBRT to relieve CIBP. The trial will be performed in six hospitals in four European countries, all of which are partners in the FURTHER consortium. TRIAL REGISTRATION: The FURTHER trial is registered under the Netherlands Trials Register number NL71303.041.19 and ClinicalTrials.gov registration number NCT04307914. Date of trial registration is 13-01-2020.

Fewer maternal depression symptoms after the Close Collaboration with Parents intervention: Two-year follow-up.

AIM: To test whether the implementation of the Close Collaboration with Parents intervention at a neonatal intensive care unit (NICU) decreases depression symptoms of mothers up to two years after the delivery of preterm infants. METHODS: We used a non-equivalent two-group design, comparing mothers of very low birthweight infants in the same NICU before (2001-2006) and after (2011-215) the intervention. The unit carried out the educational intervention (2009-2012) that was targeted at its healthcare team and aimed to improve their skills to collaborate with parents. Maternal depression symptoms were measured using the Edinburgh Postnatal Depression Scale (EPDS) six months and two years after the expected birth date of the infant. RESULTS: We found a median difference of 2.56 (95% CI from 1.64 to 3.48) in EPDS at the two-year follow-up between the pre-intervention and post-intervention groups, p < 0.001. Furthermore, we found no interaction between measurement time-points and group, implying that the intervention effect on maternal depression symptoms was similar at the six-month and two-year time-points. CONCLUSION: The intervention seems to have long-term preventive effects on maternal depressive symptoms. This effect is of clinical significance as prolonged maternal depression associates with adverse child outcomes.

Associations between Language at 2 Years and Literacy Skills at 7 Years in Preterm Children Born at Very Early Gestational Age and/or with Very Low Birth Weight.

Preterm children (born <37 gestational weeks) who are born at very early gestational age (<32 weeks, very preterm, VP) and/or with very low birth weight (≤1500 g, VLBW) are at increased risk for language and literacy deficits. The continuum between very early language development and literacy skills among these children is not clear. Our objective was to investigate the associations between language development at 2 years (corrected age) and literacy skills at 7 years in VP/VLBW children. Participants were 136 VP/VLBW children and 137 term controls (a 6-year regional population cohort, children living in Finnish-speaking families). At 2 years of corrected age, language (lexical development, utterance length) was assessed using the Finnish version of the MacArthur-Bates Communicative Development Inventory and the Expressive Language Scale from Bayley scales of Infant Development, second edition. At 7 years, children's literacy skills (pre-reading skills, reading, and writing) were evaluated. Statistically significant correlations were found in both groups between language development at 2 years and literacy skills at 7 years (r-values varied between 0.29 and 0.43, p < 0.01). In the VP/VLBW group, 33% to 74% of the children with early weak language development had weak literacy skills at 7 years relative to those with more advanced early language skills (11% to 44%, p < 0.001 to 0.047). Language development at 2 years explained 14% to 28% of the variance in literacy skills 5 years later. Language development at 2 years had fair predictive value for literacy skills at 7 years in the VP/VLBW group (area under the receiver operating characteristic (ROC) curve (AUC) values varied between 0.70 and 0.77, p < 0.001). Findings provide support for the continuum between very early language development and later language ability, in the domain of literacy skills in preterm children.

Social functioning questionnaires of adolescents born preterm show average profiles and attenuated sex differences.

AIM: Prematurity has been shown to affect social competence in children and adults. Our aim was to evaluate profiles of self-reported social behaviours and loneliness in preterm- and term-born adolescents. METHODS: Preterm (≤1500 g and, or, <32 gestational weeks)- and term-born infants were recruited in Turku University Hospital from 2001 to 2006. The Multisource Assessment of Children's Social Competence Scale and the Peer Network and Dyadic Loneliness Scale were completed at the age of 11. Profiles of social competence and loneliness were labelled as low, average or high. RESULTS: A total of 172 preterm-born and 134 term-born adolescents returned the questionnaires. Most frequently, preterm adolescents reported a profile of average social competence and average levels of loneliness. Preterm-born boys reported a profile of low social functioning less often (preterm-born 36% vs. term-born 54%), and preterm-born girls reported a profile of high social functioning less frequently (preterm-born 26% vs. term-born 37%) than same-sex controls. Sex differences in social functioning profiles were smaller in preterm than term-born adolescents. CONCLUSION: The majority of young adolescents born preterm reported a high or average social functioning profile irrespective of sex. Prematurity seems to level out differences between the sexes.

Preterm children's developmental coordination disorder, cognition and quality of life: a prospective cohort study.

OBJECTIVE: To evaluate the rate of developmental coordination disorder (DCD) and its correlation to cognition and self-experienced health-related quality of life (HRQoL) in children born very preterm. DESIGN: Prospective follow-up study. SETTING: Regional population of children born very preterm in Turku University Hospital, Finland, in 2001-2006. PATIENTS: A total of 170 children born very preterm were followed up until 11 years of age. MAIN OUTCOME MEASURES: Motor and cognitive outcomes were evaluated using the Movement Assessment Battery for Children - Second Edition (Movement ABC-2) and the Wechsler Intelligence Scale for Children - Fourth Edition, respectively, and HRQoL using the 17-Dimensional Illustrated Questionnaire (17D). The Touwen neurological examination was performed to exclude other neurological conditions affecting the motor outcome. RESULTS: Eighteen children born very preterm (17 boys) (11.3%) had DCD, defined as Movement ABC-2 total test score ≤5th percentile. A positive correlation between motor and cognitive outcome (r=0.22, p=0.006) was found. Children born very preterm with DCD had lower cognitive scores than those without DCD (Full-Scale IQ mean 76.8 vs 91.6, p=0.001). Moreover, children born very preterm with DCD reported lower HRQoL than children born very preterm without motor impairment (17D mean 0.93 vs 0.96, p=0.03). However, HRQoL was higher in this group of children born very preterm compared with population-based normative test results (p<0.001). CONCLUSIONS: DCD was still common at 11 years of age in children born very preterm in 2000s. DCD associated with adverse cognitive development and lower self-experienced HRQoL. However, this group of children born very preterm reported better HRQoL in comparison with Finnish norms.

Health-related quality of life in very low birth weight children at nearly eight years of age.

AIM: This study examined the impact of prematurity-related morbidity on the health-related quality of life (HRQoL) of premature children at eight years of age, compared to term born controls of same age. METHODS: We focused on 155 premature, very low birth weight (VLBW) infants weighing up to 1500 g who were born from 2001 to 2006 in Turku University Hospital, Finland, and compared them with 129 full-term controls. Cognitive development and length was assessed at five years of age and the children self-reported 17 dimensions of HRQoL at eight years of age. The VLBW group was subdivided into healthy children and those with prematurity-related morbidities. RESULTS: Our findings showed that 64.5% of the VLBW children did not have prematurity-related morbidities. The HRQoL of the healthy preterm VLBW children was very good and did not differ significantly from the controls. However, the VLBW children with one or more morbidities had significantly lower scores in nine of the 17 HRQoL dimensions than the children in the control group. CONCLUSION: The majority of the VLBW children survived without prematurity-related morbidities, and their HRQoL was very good and similar to the control children. The main goal of neonatal care for preterm infants should be to prevent long-term morbidities.

Associations between parental psychological well-being and socio-emotional development in 5-year-old preterm children.

BACKGROUND: Preterm children are at risk for developing behavioral and emotional problems, as well as being less socially competent. Premature birth causes chronic distress in the parents. AIMS: The aim of the paper is to discover whether parental psychological well-being is associated with the social, behavioral, and functional development of very low birth weight (VLBW, ≤1500g) children at 5years of age. STUDY DESIGN: A longitudinal prospective cohort study. SUBJECTS: A cohort of 201 VLBW infants (≤1500g, <37weeks of gestation) born during 2001-2006 in Turku University Hospital, Finland was studied. OUTCOME MEASURES: At 4-year chronological age of their child, parents independently completed validated questionnaires (Beck Depression Inventory, Parenting Stress Index and Sense of Coherence Scale). At 5years, parents and day-care providers evaluated the development of the child by completing the Five to Fifteen questionnaire. RESULTS: The parents of VLBW children reported significantly more problems in child development compared to the Finnish normative data. Depressive symptoms and weaker sense of coherence in mothers, but not in fathers, were associated with more problems in child development. Parenting stress, for both mothers and fathers, was associated with developmental problems in their child at 5years of age. CONCLUSIONS: Maternal depressive symptoms and parenting stress of both parents may be risk factors for the social, behavioral, and functional development of 5-year-old preterm children. On the other hand, stronger maternal sense of coherence may be a protective factor.

Preterm infant's early crying associated with child's behavioral problems and parents' stress.

OBJECTIVE: To study how the early crying behavior of preterm infants at term, 6 weeks, and 5 months of corrected age is related to later behavioral problems at age 3 and 4 years and parenting stress at 2 and 4 years. METHODS: The study group included 202 live-born, low birth weight infants (birth weight ≤1500 g) born from January 2001 through December 2006 at the Turku University Hospital, Finland. A Baby Day Diary was used to assess the preterm infants' crying behavior at term, 6 weeks, and 5 months of corrected age. The children's behavior was assessed using the Child Behavior Check List at 3 and 4 years old, and parenting stress was assessed by using the Parenting Stress Index when the child was 2 and 4 years old. RESULTS: The duration and frequency of crying bouts in infancy was associated with Child Behavior Check List scores at 4 years old and to both mothers' and fathers' stress when the child was 2 and 4 years old. CONCLUSIONS: Early excessive crying, especially if lasting up to 5 months of corrected age, is a clinically relevant signal in preterm infants because it may reflect infants' regulatory problems and/or parenting stress. The crying behavior of preterm infants should be systematically inquired about at well-baby clinics.

Parental psychological well-being and behavioral outcome of very low birth weight infants at 3 years.

OBJECTIVE: The purpose was to explore whether poor parental psychological well-being is associated with behavioral problems of very low birth weight (VLBW, ≤1500 g) infants at 3 years of age. METHODS: In this prospective cohort study, 189 VLBW preterm infants born between January 2001 and December 2006 at the Turku University Hospital, Finland, were followed. Validated questionnaires (Beck Depression Inventory, Parenting Stress Index, and Sense of Coherence Scale) were mailed to the parents when their children were 2 years corrected age. A total of 140 parents evaluated the behavior of the child at 3 years by filling out the Child Behavior Checklist. RESULTS: There were significant associations between most of the measures of parental symptoms of depression, parenting stress, and sense of coherence and the behavioral outcome of the VLBW infants. The concomitant symptoms of both parents were associated with more problematic child behavior. CONCLUSIONS: Parents report more behavioral and emotional problems in VLBW children at age 3 if they themselves have had symptoms of depression, parenting stress, or weak sense of coherence 1 year earlier. The new finding of this study was to show the significance of the father's psychological well-being on the behavioral development of a preterm child.

Parental psychological well-being and cognitive development of very low birth weight infants at 2 years.

AIM: To assess the associations between cognitive development of very low birth weight (VLBW) infants and measures of parental psychological well-being. METHODS: In this prospective cohort study, 182 VLBW infants born 1/2001-12/2006 at the Turku University Hospital, Finland, were followed up. At 2 years corrected age, cognitive development of the child was assessed using the Mental Development Index of Bayley Scales, and both parents filled in validated questionnaires defining parental psychological well-being (Beck Depression Inventory, Parenting Stress Index and Sense of Coherence Scale). RESULTS: The cognitive delay of the infant was associated with paternal symptoms of depression (p = 0.007) and parenting stress (p = 0.03). Mothers of the infants with cognitive delay reported increased parenting stress related to the difficulty to accept the child (p = 0.001). Weak sense of coherence predicted depressive symptoms in both parents (p < 0.0001). CONCLUSION: Even if the fathers of VLBW infants experienced depressive symptoms less often than the mothers, the ability of the fathers to cope was significantly associated with the cognitive development of the infant. In addition, the fathers reported more parenting stress if the infant had a cognitive delay. The mothers reported more parenting stress related to accepting the VLBW infant with cognitive delay.