dmariko/init_data · Datasets at Hugging Face

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Availability of data and materials			The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.	PMC10460736
Declarations				PMC10460736
Conflict of interest			The authors declare that they have no competing interests.	PMC10460736
Ethics approval and consent to participate			Ethical approval was obtained from the Regional Ethical Review Committee in Stockholm (Dnr: 2019–04020). All participants signed an informed consent before being enrolled in the study.	PMC10460736
Consent for publication			There are no photographs of persons in this manuscript that require consent for publication.	PMC10460736
References				PMC10460736
Background			Previous studies have investigated the various effects of parenting on infant developmental outcomes. In particular, parental stress and social support have been found to significantly affect the growth of the newborn. Although many parents today use mobile apps to obtain more support in parenting and perinatal care, few studies have examined how these apps could affect infant development.	PMC9996416
Objective			This study aimed to examine the effectiveness of the Supportive Parenting App (SPA) in improving infant developmental outcomes during the perinatal period.	PMC9996416
Methods		REGRESSIONS	This study adopted a 2-group parallel prospective longitudinal design and recruited 200 infants and their parents (N=400 mothers and fathers). The parents were recruited at 24 weeks of gestation for a randomized controlled trial conducted from February 2020 to July 2022. They were randomly allocated to either the intervention or control group. The infant outcome measures included cognition, language, motor skills, and social-emotional development. Data were collected from the infants when they were aged 2, 4, 6, 9, and 12 months. Linear and modified Poisson regressions were used to analyze the data to examine between- and within-group changes.	PMC9996416
Results			At 9 and 12 months post partum, the infants in the intervention group were found to have better communication and language skills than those in the control group. An analysis of motor development revealed that a larger proportion of the infants in the control group fell under the at-risk category, where they scored approximately 2 SDs below the normative scores. The control group infants scored higher on the problem solving domain at 6 months post partum. However, at 12 months postpartum, the infants in the intervention group performed better on cognitive tasks than those in the control group. Despite not being statistically significant, the intervention group infants were found to have consistently scored better on the social components of the questionnaires than the control group infants.	PMC9996416
Conclusions			Overall, the infants whose parents had received the SPA intervention tended to fare better in most developmental outcome measures than those whose parents had received standard care only. The findings of this study suggest that the SPA intervention exerted positive effects on the communication, cognition, motor, and socioemotional development of the infants. Further research is needed to improve the content and support provided by the intervention to maximize the benefits gained by infants and their parents.	PMC9996416
Trial Registration			ClinicalTrials.gov NCT04706442; https://clinicaltrials.gov/ct2/show/NCT04706442	PMC9996416
Introduction				PMC9996416
Background	depression		The effects of parenting on infant development are a widely investigated topic. Studies have found that parenting knowledge, parental stress, and parental perceived support have significant impacts on the growth of an infant [The lack of social support has been linked to various parental outcomes, such as postnatal depression [According to Milgrom et al [The SPA is a theory- and evidence-based psychoeducational app developed using different theoretical frameworks, such as Singh et al’s [	PMC9996416
Aims and Hypotheses			This study aimed to examine whether the SPA intervention had any indirect effects on the developmental outcomes of the app users’ infants from birth to 12 months of age. The direct effects on parenting outcomes have been reported separately [	PMC9996416
Methods				PMC9996416
Study Design	depression, anxiety		A 2-group parallel prospective longitudinal design was adopted for this study, which was conducted from February 2020 to July 2022. Expecting parents were recruited from 2 public health care institutions in Singapore. The study was part of a randomized controlled trial (RCT) investigating the effectiveness of SPA in improving perinatal parental outcomes such as postnatal depression and anxiety [	PMC9996416
Eligibility Criteria		PREGNANCY-INDUCED HYPERTENSION, HIGH-RISK PREGNANCIES, PLACENTA PREVIA, PREECLAMPSIA	Parents were considered eligible for the study if they met the following criteria: (1) both parents were aged ≥21 years; (2) both parents were able to read and speak English; (3) the pregnancy was at low risk with >24 weeks of gestation (age of viability in Singapore); and (4) both parents owned a smartphone with internet access. Parents were excluded from the study if they had high-risk pregnancies (eg, pregnancy-induced hypertension, preeclampsia, and placenta previa major). Infants who were born via a complicated assisted delivery where the mother required prolonged hospitalization and admitted to the neonatal intensive care unit and infants with congenital issues were excluded from the study to minimize confounding influences on the outcome variables.	PMC9996416
Sample Size Calculation			As this study was part of an RCT investigating the effectiveness of the SPA intervention on parental outcomes, the parents enrolled in the RCT and their infants were recruited for this study. Considering the medium-sized effect of SPA, a Cohen	PMC9996416
Intervention	depression	RECRUITMENT	The control group parents received the standard perinatal care offered by the hospitals they were recruited from, which consisted of antenatal checkups, optional antenatal classes, care during their stay in the ward, and a postnatal review scheduled 6 weeks post partum. Perinatal care was provided to the parents by obstetricians, nurses, neonatologists, and lactation consultants. The intervention group parents received the standard perinatal care as well, but they were also granted access to the mHealth intervention SPA upon recruitment into the study. In addition, they were matched with trained peer volunteers, who were experienced mothers trained by the research team to provide peer support for the parents in the RCT.SPA included a variety of pregnancy-, childbirth-, postpartum-, and infant care–related information. This included articles, audio files, and videos about birth preparation, bonding and attachment across the perinatal period, breastfeeding, baby care–related tasks (from bathing to safe sleep habits), and involvement of both fathers and mothers in baby care tasks. The information was curated by the health care professionals involved in the study so that parents could conveniently access reliable and accurate information. Expert advice, discussion forums, and frequently asked questions were also features of the mobile app that aimed to resolve any pregnancy- or childcare-related queries that the parents might have. The parents were encouraged to interact with the peer volunteer with whom they were matched if they needed emotional or informational support from experienced mothers who had previously had and recovered from postnatal depression. Detailed features of the SPA mobile app and peer volunteer intervention can be found in the published development study [	PMC9996416
Procedure			Couples were recruited by a research assistant during their scheduled antenatal checkups at 2 tertiary hospitals in Singapore. They were provided with an explanation of the study, and interested couples were screened for eligibility before giving them an informed consent form where they could indicate their willingness to participate in the study. Subsequently, the couples were randomly allocated to the intervention or control group. The estimated due date of the couples was recorded, and the couples were then contacted shortly after their due date to gather information regarding their childbirth (eg, gender of the baby and whether they attended prenatal classes). The parents also entered this information into SPA so that the app could send them information that is specific and relevant to the infant’s age and respective postpartum time points.The parents were contacted via SMS text messages to complete the follow-up questionnaires at 1, 2, 4, 6, 9, and 12 months post partum. Mothers tended to be the ones who completed the infant-related questionnaires. A house visit was also scheduled at 6 and 12 months, during which a trained research assistant visited the participants’ homes to assess the infant using the Bayley-4.	PMC9996416
Outcome Measures			Conducting research with very young children involves various challenges regarding the accuracy of the data collected, as infants are not verbal, and thus it is difficult to obtain information directly from them. Therefore, the following instruments were used to measure the constructs examined in this study to provide an accurate representation of the infants’ developmental progress.	PMC9996416
Bayley Scales of Infant and Toddler Development—Fourth Edition			The Bayley-4 consists of 5 scales: cognitive, language, motor, social-emotional, and adaptive behavior (ADBE) [	PMC9996416
Brief Infant Toddler Social Emotional Assessment			The 42-item parent-reported Brief Infant Toddler Social Emotional Assessment (BITSEA) was divided into 2 scales: the problem scale (31 items) and the competence scale (11 items) [	PMC9996416
Data Analysis			Data analyses were conducted using SPSS (version 27.0; IBM Corp) [	PMC9996416
Ethics Approval			Before the commencement of the study, ethics approval was obtained from the National Health Group Domain Specific Review Board (NHG DSRB:2019/00875). The parents of the infants involved in this study were provided with information on the study and its procedures before they provided their written consent. It was communicated to the parents that participation was voluntary and that they had the right to withdraw anytime without incurring any consequences.	PMC9996416
Results				PMC9996416
Motor Skills		REGRESSION	The infants from the control group were significantly more likely to score below the cutoff score of the ASQ gross motor domain at 2 months post partum (risk ratio [RR]=0.417, 95% CI 0.20-0.85; The intervention group infants were found to have better fine motor skills than the control group infants at 6 months post partum, based on the results of the logistic regression model analysis. The infants from the control group were more likely to score below the cutoff score on the ASQ fine motor domain than those from the intervention group (RR=0.25, 95% CI 0.08-0.76; Similar to the trend graph of the ASQ communication domain, the ASQ gross motor graph showed that the intervention group scored better than the control group on the gross motor items (	PMC9996416
Cognition			At 6 months post partum, the infants from the control group had a higher chance of being in the at-risk group for the problem solving domain of the ASQ than those from the intervention group (RR=0.34, 95% CI 0.12-0.91; According to	PMC9996416
Behavioral Outcomes	−10.44, maladaptive behaviors		The ADBE scale of the Bayley-4 and the problem scale of the BITSEA assessed the behavioral outcomes of the infants. The BITSEA problem scale covered externalizing behaviors, dysregulating behaviors, and maladaptive behaviors. The infants from the control group were found to have significantly higher scores on the BITSEA problem scale than those from the intervention group (effect size=−5.87, 95% CI −10.44 to −1.70;	PMC9996416
Analysis of Covariates	’ motor skills	SECONDARY	Parents attending prenatal courses was found to significantly influence whether their infants’ ASQ scores on the communication (RR=0.13, 95% CI 0.02-0.75; The education level of the parents was also a predictor of the infants’ motor skills. The infants of parents with secondary educational qualifications had a higher chance of being in the at-risk group at 6 months post partum than those of parents who graduated from universities (RR=13.41, 95% CI 2.27-79.09; In this study, monthly household income was found to significantly affect the cognition and motor skills of the infants. The infants from households with a monthly income between SGD $3000 (US $2285.64) and SGD $5000 (US $3809.39) were more likely to belong to the at-risk group of the cognition domain of the Bayley-4 assessment than those from households earning >SGD $5000 (US $3809.39) monthly (RR=14.79, 95% CI 4.96-44.15;	PMC9996416
Discussion				PMC9996416
Principal Findings			This study examined the effects of the SPA intervention on infants’ developmental outcomes during the first 12 months of life. The infants in the intervention group mostly scored better in domains assessing communication, cognition, and social-emotional development. More infants from the control group fell under the at-risk category for motor skills than those from the intervention group. Findings from the main RCT reported a high attrition rate of 28.5% [	PMC9996416
Communication			From 2 to 12 months post partum, the infants from the intervention group were found to exhibit better communication skills than their control group counterparts. According to Bortfeld and Gabouer [On the basis of the trend graphs, the difference in the communication scores between the 2 groups increased over time. Topping et al [	PMC9996416
Motor Skills			Similar to the communication trend graphs, the fluctuations in gross and fine motor skills indicated by the ASQ scores can be attributed to the differences in normative scores. Overall, the motor skills of the intervention group infants developed to a greater extent than those of the control group infants. This might have been because the parents in the intervention group had read the guide on how they could engage in play with their children on SPA. The guide included some toy recommendations that can help improve the motor skills of infants by allowing them to practice movements such as grasping and head turning. Semistructured interviews with some of the parents [	PMC9996416
Cognition			Results from the problem solving domain of the ASQ revealed that the control group infants generally fared better than the intervention group infants during the first 6 months of their lives. However, the results of the 12-month Bayley-4 assessment revealed that the intervention group infants did better on the cognition scale than the control group infants. This finding is contrary to the hypothesis of this study, which proposed that the intervention group infants would perform better on cognition tasks than the control group infants. A reason for this might be that SPA did not include much content on enhancing the cognition and problem-solving skills of infants. Most of the parenting information available was related to childcare tasks such as feeding and swaddling or was related to parent-child communication and motor skills. As reported in a published qualitative paper [	PMC9996416
Social-Emotional Skills			Although there were no statistically significant group differences in the personal-social domain of the ASQ and social-emotional scale of the Bayley-4 assessment, the intervention group generally demonstrated greater social-emotional development. This lack of significance could be attributed to the fact that SPA did not include much information regarding the development of social-emotional skills in infants. However, the encouragement provided to parents to engage in age-appropriate parent-child play and increase parent-child interactions might have contributed to the slightly higher social-emotional and personal-social scores [	PMC9996416
Behavioral Outcomes			The infants from the intervention group were found to engage in more ADBEs than those from the control group. On the basis of the parents’ responses to the BITSEA, the control group infants exhibited more problem behaviors as well. Maternal responsivity and sensitivity to infant distress are important factors in predicting ADBE in infants. Higher maternal responsivity is associated with greater emotional regulation and fewer behavioral issues [	PMC9996416
Prenatal Courses, Education, and Household Income			This study found that prenatal classes had a positive impact on communication, gross motor, and personal-social scores at 2 months post partum. Prior research [The infants from families with higher household incomes were found to have more developed cognition. This is supported by previous literature, where it was found that children from families with low socioeconomic status (SES) had lower cognitive flexibility [Both higher parental education and higher monthly household income were significantly associated with stronger motor skills. Freitas et al [	PMC9996416
Strengths and Limitations		VIRUS	Given that social support has been proven to improve parental well-being and, in turn, promote infant growth in various areas, the SPA intervention was developed. The intervention aimed to meet the support needs of Singaporean parents during the perinatal period, thus helping them adjust to parenting roles and infant-care tasks. This study found that technology-based parenting interventions such as SPA can lead to benefits beyond enhancing parental well-being. The findings of this study are crucial for the future development of not only mobile apps for parents in Singapore but also those for parents in other countries. Providing parenting education and emotional support can indirectly improve infant developmental outcomes. However, it is important to recognize and consider the cultural beliefs, practices, and support needs of parents from other countries. This would allow app developers to provide a knowledge base and appraisal support that would be respectful of and helpful in meeting their individualized needs.Another strength of this study is that it used questionnaires that were completed by both parents and trained personnel. Parent-completed measures are advantageous in that parents spend the most time with their infants and are the most knowledgeable about them. However, existing literature [This study has some limitations. One of its limitations is its high attrition rate. Because of the COVID-19 pandemic, parents were more cautious of physical interactions, as they did not want themselves, their infants, or other family members to contract the virus. Therefore, many parents declined home visits for the Bayley-4 assessment. This may have affected the accuracy of the findings in representing the sample recruited for this study. Moreover, the longitudinal nature of the study might have also contributed to the high attrition rate. Parents tend to become busier post partum owing to the need for them to adjust to parenting responsibilities; in the case of this study, the need to take extra precautions to prevent contracting the COVID-19 virus added to these responsibilities. Therefore, it is paramount to devise strategies to keep parents interested in and willing to participate in the study. For example, research team members can frequently contact parents to build stronger rapport and remind them to access SPA if they have parenting-related concerns. Although the research team originally intended to do so, some technical issues led to the absence of chat notifications, affecting the communication between the team and parents. Furthermore, many of the research team members were also frontline health care workers; therefore, they were unable to meet often and resolve these issues in a timely manner.Another limitation of this study is the lack of information regarding whether the parents were experienced or new. This is an important limitation, as the struggles and support needs that new and experienced parents encounter may differ widely. Hence, future studies should take note to collect such information from parents to provide deeper perspectives regarding the effectiveness of parenting interventions in new and experienced mothers and fathers. Subsequent research may also investigate parental sensitivity and responsivity to provide further insight into how they may affect infant behavioral outcomes.	PMC9996416
Conclusions			This study examined the effects of the SPA intervention on infant developmental outcomes. The results showed that the infants from the intervention group generally developed better in terms of communication, motor skills, cognition, and social-emotional skills than those from the control group. The peer support and informational support that the SPA intervention offered to the intervention group parents were thus helpful in indirectly influencing the development of infants. More research is needed to obtain an in-depth understanding of what functions of the intervention influenced the infant outcomes and what information the current generation of parents hopes to see in parenting mobile apps. This would facilitate the creation of more effective mHealth app–based support for parents. In the future, interventions targeting infant growth and development should be created to measure the direct effects of educational interventions. In addition, future parenting interventions should focus on providing more support to families with lower SES to help promote the development of infants and support parents from these families.The authors would like to thank the Ministry of Health for funding this project through the Health Services Research Grant (HSRGHP18may-0001). They also extend their thanks to all the study participants for sharing their insights despite being new parents during the pandemic.Conflicts of Interest: None declared.	PMC9996416
Abbreviations			adaptive behaviorAges and Stages QuestionnaireBrief Infant Toddler Social Emotional Assessmentmobile healthrandomized controlled trialrisk ratiosocioeconomic statusSupportive Parenting App	PMC9996416
Purpose	FEP, First-episode psychosis		First-episode psychosis (FEP) is characterised by wide heterogeneity in terms of symptom presentation and illness course. However, the heterogeneity of quality of life (QoL) in FEP is not well understood. We investigated whether subgroups can be identified using participants' responses on four QoL domains (physical health, psychological, social relationships, and environmental) 18-months into the recovery phase of FEP. We then examined the discriminant validity of these subgroups with respect to clinical, cognitive, and functioning features of FEP.	PMC9992035
Method		REGRESSIONS	Demographic and clinical characteristics, QoL, cognition, and functioning were assessed in 100 people with FEP at the 18-month follow-up of a randomised controlled trial of Individual Placement Support, which aims to facilitate vocational recovery. QoL was measured using the World Health Organisation’s QoL-BRIEF. A two-stage clustering approach using Ward’s method and Squared Euclidean Distance with a k-means confirmation was conducted. Multinomial logistic regressions were used to establish external validity.	PMC9992035
Results	social/occupational functioning, depressive symptoms	SENSITIVITY	Three QoL subgroups emerged: a ‘good’ subgroup with relatively high QoL across all domains (31%), an ‘intermediate’ subgroup with relatively low psychological QoL (48%) and a ‘poor’ subgroup with markedly low social relationship QoL (21%). Negative symptoms, depressive symptoms, social/occupational functioning, and social inclusion at follow-up predicted subgroup membership. Sensitivity analysis found similar results.	PMC9992035
Conclusion	mental ill		Although some individuals with FEP have QoL comparable to individuals without mental ill health, QoL can remain concerningly low despite treatment efforts. Future research on interventions that target factors associated with poor QoL, such as low social inclusion, is required to counteract prolonged poor QoL in FEP.	PMC9992035
Supplementary Information			The online version contains supplementary material available at 10.1007/s11136-022-03277-x.	PMC9992035
Keywords			Open Access funding enabled and organized by CAUL and its Member Institutions	PMC9992035
Plain English summary	first-episode psychosis, depressive symptoms		Quality of life has emerged as a valuable outcome in first-episode psychosis (FEP) research. Young people with FEP also consider good quality of life to be more important than symptom management. Until recently, previous research into FEP has sought to identify which clinical, cognitive, and functioning factors are associated with low quality of life in FEP. However, these studies often ignore individual differences in quality of life. In this study we aimed to understand whether young people with FEP, who are in the later stages of their recovery, can be grouped into clinically meaningful subgroups based on their responses on four quality of life domains (i.e., physical health, psychological, social relationships, and environmental). This study indicates that young people with FEP experience either ‘good’, ‘intermediate’, or ‘poor’ quality of life at the later stages of recovery, and that depressive symptoms and social inclusion strongly predict membership to these quality of life subgroups. Findings from this study highlight the possibility of having good quality of life despite the challenges associated with FEP, whilst also demonstrating that poor quality of life can persist despite interventional effort. Future research should focus on developing interventions that address factors associated with poor quality of life, such as low social inclusion.	PMC9992035
Introduction	psychotic symptoms, first-episode psychosis, mental ill	REMISSION	Compared to individuals without mental ill health, individuals with first-episode psychosis (FEP) report significantly lower levels of quality of life (QoL) [Understanding variability in QoL in FEP has important clinical implications. For instance, the disparity in QoL between individuals with FEP and the general population persists beyond symptomatic remission, suggesting that psychotic symptoms alone do not produce poor QoL [Liao et al. [However, the presence of QoL heterogeneity at a later stage of FEP recovery remains unclear; Liao et al.’s [Investigating whether heterogeneity in QoL persists into the later stages of the recovery phase is necessary as research suggests that whilst improvements in QoL may occur, it can remain poor or even deteriorate over time [Using the same sample and methodology as Liao et al. [	PMC9992035
Materials and methods				PMC9992035
Design	IPS	SECONDARY	The current study involved a secondary analysis of baseline and 18-month follow-up data of a single-blinded RCT (Australian and Clinical Trials Registry ACTRN12608000094370), which aimed to investigate the efficacy of Individual Placement and Supporting (IPS) in assisting young people with FEP to achieve vocational recovery [	PMC9992035
Participants	Psychosis	DISORDERS, RECRUITMENT	Young people with FEP who had expressed an interest in vocational recovery were approached to participate in the original RCT. Participant recruitment took place at the Early Psychosis Prevention and Intervention Centre (EPPIC), a clinic within the Orygen Specialist Programme in Melbourne, Australia, providing time-limited care. Participants were aged between 15 and 25 years and had experienced a FEP as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision [	PMC9992035
Measures				PMC9992035
QoL			QoL was measured using the WHOQoL-BREF [	PMC9992035
Demographics			The demographic characteristics assessed at baseline covered variables such as age, gender, and use of health services.	PMC9992035
Clinical characteristics	psychotic symptoms, DUP, psychosis	DUP	Duration of untreated psychosis (DUP) was defined as the time between onset of psychotic symptoms and registration at EPPIC [	PMC9992035
Cognition			Based on their association with QoL in FEP [	PMC9992035
Functioning			Social and occupational functioning was measured at follow-up using the single-item Social and Occupational Functioning Assessment Scale [	PMC9992035
Statistical analysis	depression	REGRESSION, DUP, REGRESSIONS	All analyses were completed using RStudio (Version 1.4.1717) and were chosen to mirror the methods of Liao et al. [The external validity of the QoL subgroups was evaluated using multinominal logistic regressions. A range of clinical, cognitive, and functional variables both at the baseline and follow-up were included in the models. These variables include baseline and follow-up clinical characteristics (DUP, treatment group, positive symptoms, negative symptoms, and depression), baseline cognition (IQ, ToM, and semantic verbal fluency), and follow-up functioning variables (social/occupational functioning, employment status, and social inclusion). A series of univariate multinomial logistic regression models were first conducted for individual variables. If a variable significantly predicted cluster group membership, it was henceforth included in the final multivariate model. For all models, the relative risk ratio (RRR), 95% confidence intervals of the RRR, and the Wald test were calculated to establish the level of association. The alpha (	PMC9992035
Sensitivity analysis	depression	APPENDIX, REGRESSIONS	Due to the high overlap between the psychological domain of the WHOQoL-BREF and depression symptoms (Appendix 1), sensitivity analyses were conducted with the psychological domain of the WHOQoL-BREF excluded from the k-means clustering analysis. Further external validation based on the clustering results not considering variations in the psychological domain was then conducted using multinominal logistic regressions.	PMC9992035
Results				PMC9992035
Sensitivity analysis		APPENDIX	The sensitivity analysis excluding the psychological domain showed very similar results. A k-means partitioning method also suggested a 3-cluster solution to be optimal and three clusters had distinct QoL characteristics (Appendix 10), namely a ‘poor’ cluster (	PMC9992035
Discussion			The current study aimed to extend the findings of Liao et al. [	PMC9992035
The heterogeneity of QoL in FEP	personality disorder, substance disorder, comorbid major depressive disorder		The finding of a ‘good’ QoL subgroup, with average QoL scores that mirror scores reported by healthy controls, contradicts the common finding that the QoL of FEP patients is significantly diminished and highlights the importance of approaching QoL in an individualistic manner [The ‘intermediate’ subgroup mirrors average QoL scores reported by young people in the recovery phase of FEP who do not have a comorbid major depressive disorder, substance disorder, or personality disorder [The ‘poor’ subgroup at follow-up demonstrates that low QoL is an enduring issue for a subset of young people recovering from FEP, despite months of treatment and time for symptomatic recovery. The participants in the ‘poor’ subgroup exhibited similar QoL scores reported by recovering FEP participants with comorbid major depressive disorder in previous studies [	PMC9992035
Factors associated with QoL in FEP	depressive, cognitive functioning, depressive symptoms		Consistent with previous research on QoL in FEP recovery [Although depressive symptoms emerged as the strongest predictor of the QoL subgroups, the relationship between depressive symptoms and QoL subgroups may be inflated due to measurement overlap [No cognitive measures were associated with the QoL subgroups at follow-up (before and after the psychological domain was removed), suggesting that cognitive functioning at baseline does not explain variation in QoL at a later stage of the recovery phase. Whilst speculative, early intervention may play a role in subduing the predictive ability of cognitive functioning at baseline. Amoretti et al. [In support of previous findings, social inclusion at follow-up predicted subgroup membership before and after the psychological items were removed [	PMC9992035
Strengths and limitations			The current study highlights the use of cluster analysis as an innovative approach to capturing heterogeneity in QoL in an FEP cohort. However, this study is limited by the aims and measures used in the original study, which did not specifically focus on QoL and its correlates [As a follow-up analysis, our study also allows comparisons with Liao et al.’s [	PMC9992035
Implications and future directions			We have demonstrated that heterogeneity of QoL in FEP exists at a later stage of FEP recovery. The results highlight that although individuals with FEP may exhibit good QoL, many report lower levels across all four QoL domains, despite months of treatment-as-usual. Currently, the central goal of FEP treatment is to encourage engagement and commence pharmacological and psychological interventions that target symptomatic recovery [	PMC9992035
Author contributions			EK, KA, and SC were involved in the design and data collection of the original study from which the current study is based on. KA, SC, EC, CG, and ZL contributed to the design of the current study. EC was responsible for data analysis and drafting of the manuscript. All authors revised and provided critical feedback for the manuscript. All authors agree to be accountable for all aspects of the work and ensure issues regarding the accuracy or integrity of the work is addressed and resolved.	PMC9992035
Funding			Open Access funding enabled and organized by CAUL and its Member Institutions. This work was supported by Australian Rotary Health; the Australian Research Council (LP0883273); Orygen, The National Centre of Excellence in Youth Mental Health; National Health and Medical Research Council Career Development Fellowships to KA (APP1141207) and to EK (APP1051891); National Health and Medical Research Council Senior Research Fellowship SC (APP1136344). The funding source had no role in the design and outcome of the study.	PMC9992035
Data availability			Data might be available on request and after appropriate institutional agreements and ethics approvals.	PMC9992035
Declarations				PMC9992035
Conflict of interest			None to declare.	PMC9992035
Ethical approval			Institutional ethics approval was given by Melbourne Health Human Research and Ethics Committee. All young people (and their guardians if under 18 years of age) provided written informed consent to participate in the study.	PMC9992035
References				PMC9992035
Method	MIH		A randomized controlled study design was used in the present study. The study was registered at clinicaltrials.gov with the identification number NCT03829995. Participants were randomized 1:4 (50:200) into a control- and intervention group. Participants in the control group were offered standard care and those in the intervention group were offered access to the MIH. A telephone interview performed 2–4 weeks after discharge assessed patient satisfaction with the helpline and patient’s feeling of safety in relation to medicine use (primary outcome). Data were analyzed using a Mann-Whitney U test. After case handling of each enquiry to the MIH, the cases were assessed with regard to medication-related problems (MRPs) and clinical impact of the MIH service was assessed (primary outcome).	PMC10602279
Results	MIH		A total of 250 participants were included in the study and 152 participated in the telephone interviews (33 control and 119 intervention). Thirty-seven questions were enquired by 26 participants to the MIH. Of these, 8 were requested before the telephone interviews and these patients all expressed a high satisfaction with the MIH (score 4.57 +/- 0.73 on a 5-point scale). Most patients offered access to the MIH expressed that it increased the sense of safety in relation to their medicines (79%). However, comparing the control- and intervention group with regard to patient concerns and feeling of safety in relation to medicine use no differences were found. Evaluation of the enquiries revealed at least one MRP per enquiry, and in most cases the advice given were assessed to have a high- or moderate clinical significance.	PMC10602279
Conclusion	MIH		The MIH was appreciated by the participants, indicating that the MIH could be a valuable service for discharged patients in improving the sense of safety in relation to medication and alleviating MRPs. Providing easy access for patients to medicine information may contribute to patient safe medicine use after discharge.	PMC10602279
Data Availability			All relevant data are within the paper and its	PMC10602279
Introduction	MIH	ADVERSE EVENTS, TRANSITION	Healthcare systems are becoming more and more complex, and patients must navigate between hospitals and the primary sector. Transition from hospitals to private homes is known to challenge patient safety [Importantly, it has been shown that patient education and counseling can reduce the risk of medicine related adverse events and rehospitalization, and patients have been identified as a key resource in improving medicines safety in cross-sector situations [Medicine Information Helplines (MIH) can play an important role in supporting patients in a safe medication after hospitalization [Up until 2018, discharged patients in Denmark had no access to a MIH. Patients may contact the general practitioners, community pharmacies or the respective hospital ward with medicine-related questions [	PMC10602279
Method				PMC10602279
Setting	MIH	EMERGENCY	The MIH was operated by experienced pharmacists and a pharmacy technician from the Medicine Information Centre (MIC) at the Hospital Pharmacy at Bispebjerg Hospital in the Capital Region of Denmark. Staff was trained in clinical pharmacy and drug information activities. The MIH team consists of 12 medicine information pharmacists and a pharmacy technician, who have been providing medicine information between 5–25 years in the MIC. The helpline is accessible on all weekdays from 8 am to 3.30 pm.An acute care setting and a non-acute inpatient setting were purposively chosen to obtain possible variations in the clinical impact related to the MIH, and the impact on patient satisfaction, concerns and perception of safety in relation to their medicine after discharge. Thus, the Emergency Department and the Department of Respiratory Medicine at Bispebjerg Hospital were selected. Bispebjerg Hospital is one of the hospitals in the Capital Region of Denmark. The hospital serves as a community hospital for approximately 400,000 citizens. The Emergency Department has around 40 beds while the Department of Respiratory Medicine has 38 beds [	PMC10602279
Enrollment of participants	terminally illness, aphasia, dementia	MAY	A total of 250 patients were enrolled in the study from July 2018 to May 2019. The patients were enrolled from the two selected hospital wards by the first three authors from the MIC. All admitted patients at the two wards were assessed and eligible participants were subsequently approached for enrollment. Eligible participants were 18 years or older, spoke and understood Danish, and were scheduled for discharge to their private homes within a few days after enrollment. Exclusion criteria included severe dementia diagnosis, terminally illness, isolation precautions, aphasia, suicidal or patients in custody. Length of stay and whether the patient used medicines or not were not exclusion criteria.Participation in the study was voluntary and all patients were given oral and written information about the study, publication plans and his or her right to withdraw from the study at any time without further consequences. All participants signed a consent form and patients’ participation was documented in their hospital files by the clinical pharmacists.	PMC10602279
Study design	MIH	ADVERSE EFFECTS, DRUG INTERACTIONS	A randomized controlled study design was used to explore the study objective [The control group (50 participants) received no intervention beyond standard care which does not include access to any information services post discharge. The intervention group (200 participants) were offered standard care and the opportunity to contact the MIH on all business days, should any medicine-related questions arise after hospital discharge. Upon enrollment, patients in the intervention group received a card with contact information for the MIH. All enquiries to the MIH were answered orally and/or in writing by either a pharmacist or a pharmacy technician from the MIC. All enquiries and the case handling were documented in the MIC’s database and categorized into predefined types of categories, such as adverse effects, choice of therapy, dosage/administration, drug interactions and product information.	PMC10602279
Telephone interviews	MIH		A primary outcome of the present study was to evaluate whether the offer to contact the MIH influenced patient’s concerns and perception of safety in relation to their medicines (An interview guide was developed to assess patient satisfaction with the medicine information obtained during hospitalization, at discharge and given by the MIH. In order to investigate patients concerns and perception of safety in relation to medicines use, already validated questions from the Beliefs About Medicine Questionnaire proposed by Horne et al. [The questions in the interview guide were pilottested by 12 patients and 5 healthcare professionals, and the wording of some of the questions was subsequently optimized accordingly. All eligible participants were interviewed by telephone within 2–4 weeks after discharge to ensure that the patients remembered details about their hospital stay. The telephone interviews were performed by author one, two and three.Participants were rated as non-responders if they declined to be interviewed or if they did not answer the phone within five attempts on five different days over a two-week period. In addition, participants were also rated as a non-responder if they showed cognitive or/and communicative problems during the interview, making it difficult to complete the interview, or if the patient was readmitted or deceased.	PMC10602279
Clinical impact assessment			Another primary outcome of the present study was the clinical impact of MIH on patient safety. To assess the clinical impact, all enquiries were analyzed and categorized for MRPs and pharmacy interventions according to the Westerlund System; see	PMC10602279
Clinical impact assessment of MRPs and the pharmacy intervention.				PMC10602279
Data analysis			No similar studies are available from which a sample size can be calculated.This study used a randomized controlled study design, and it was set to detect a 10% improvement on a 5-point scale measuring patient satisfaction with medicine information and patient concerns about medicine. From the literature, a mean score of 3.5 ± 0.5 is anticipated [Power was set by the authors to 90% and p-values less than 0.05 were considered statistically significant. Thus, a sample size of 43 patients was calculated [Quantitative data from the patient interviews were analyzed in Microsoft Excel (for Office 365 MSO) and IBM SPSS (Version 25) with descriptive statistics and simple parametric statistics. Mann-Whitney U test were used for analysis of ordinal variables (five-point scale) and Chi-Square test were used for nominal variables (gender, yes/no). Data are displayed as the mean of rating ± SD (Standard Deviation) unless otherwise specified. A confidence interval (CI) was calculated using the Clopper-Pearson method for the primary outcome data using nominal variables. An independent t-test was used to test for difference in age and number of medications by admission and discharge. Test for normality was done using Shapiro-Wilk test. If data did not show a normality distribution a Wilcoxon rank sum test was used to test for difference. Free text comments were not analyzed explicitly but were solely used to support the interpretation of the patient interview.	PMC10602279
Results				PMC10602279
Participants			A total of 946 patients were assessed for eligibility at the two hospital wards. Of these, 319 patients failed to meet the inclusion criteria and 377 patients either declined the invitation to participate, were asleep, discharged or transferred to another ward at the time of inclusion.Thus, 250 participants were included in the study and randomized into a control group (n = 50) and an intervention group (n = 200). In the follow-up period, 98 participants (17 in the control group and 81 in the intervention group) were considered as non-responders. Finally, 33 participants were interviewed in the control group and 119 participants in the intervention group; see	PMC10602279
Consort study diagram showing the flow of invited, included, excluded and dropout patients.		EMERGENCY	The participants were included equally from the Emergency Department and from the Department of Respiratory Medicine, and their characteristics are presented in	PMC10602279
Medicine information during hospitalization and after discharge			A total of 152 participants were interviewed by telephone and the interview guide in In the control group 55% of the participants (18/33) reported a change in their medication during hospitalization, see	PMC10602279
Patient satisfaction with medicine information provided during hospitalization and after discharge.			Patients scored satisfaction with medicine information provided during hospitalization and at discharge on a 5-point scale where score 1 = not at all and score 5 = to a very great extent. Results are shown as mean of rating ± SD. No significant difference was found between the control- and intervention group with regard to satisfaction with medicine information provided during hospitalization (Mann-Whitney U test, p = 0.337) or at discharge (Mann-Whitney U test, p = 0.580).Approximately half of the participants (48%, 73/141) preferred receiving their medicine information both written and orally at discharge, and 2/3 of these expressed that this combination gave them the opportunity to validate and repeat the obtained information when settled at home. Of the participants in the control and intervention group, 21% (7/33) and 29% (34/118) respectively did not recall that they received a medication-status-list at discharge. There was no significant difference between the groups (p = 0.377).Of all participants, 26% (39/150) responded that they had questions regarding their medication after discharge (18% (6/33) in the control group and 28% (33/117) in the intervention group). The percentage of patients that had a question regarding their medication were higher in both control- and intervention group when looking at patients who reported a change in their medication (22% and 39,7% respectively). Among all patients who reported they had a question regarding their medicine a total of 67% in both the control group (4/6) and intervention group (22/33) found an answer to their question by searching the internet or contacting their general practitioner, pharmacy, hospital, relatives or visiting nurses, see	PMC10602279
Patient satisfaction with MIH	MIH		One of the primary outcomes was patient satisfaction with MIH. Participants in the intervention group were asked if the opportunity to contact the MIH affected the feeling of safety in relation to their medication, which the majority of the participants acknowledged (72%, 79/110, CI [0.67–0.84[). Patients who contacted the MIH before the telephone interview (n = 8) reported a slightly lower score on the questions regarding feeling of safety with regard to their medication and they felt to a higher degree that their medicines were a mystery to them (see Only patients in contact with the MIH before the telephone interview were asked about their satisfaction with the service (n = 8). The participants contacted the MIH by phone and received an answer by phone. The participants found the answers provided by the MIH timely, easy to understand and relevant. Furthermore, they reported that the answers to a great extent affected their use of medicine in a positive manner, just as they were satisfied with the answers to a very great extent (4.71 ± 0.45 on a 5-point scale). Generally, the participants were satisfied with the service (4.57 ± 0.73 on a 5-point scale), they would use it again (100% answered yes, n = 8), and they believed the helpline should be a permanent service for discharged patients in the Capital Region of Denmark (93% answered yes, n = 126).	PMC10602279
Concerns and perception of safety in relation to medication			The other primary outcome focused on patients’ concerns and perception of safety in relation to their medication. Both the control- and the intervention group responded that they felt safe to a great extent regarding their medication after discharge, which equals to a rating 4 or more on a 5-point Likert scale. There was no significant difference between the groups (p = 0.59). Both groups expressed that their current health to some extent or to a great extent was dependent on medication (no group difference, p = 0.33). However, they did not worry about taking their medicine (no group difference, p = 0.969), nor did they experience their medication as a mystery (no group difference, p = 0.507), and they expressed that the medication only disrupted their lives to a small extent (no group difference, p = 0.844) (see	PMC10602279
Concerns and perception of safety about medicine.			Patients scored on a 5-point scale with 1 = not at all and 5 = to a very great extent. Results are shown as mean of rating ± SD. No significant difference was found between control- and intervention group for any of the questions (Mann-Whitney U test, p>0.05 for all questions).	PMC10602279
Enquiries to the MIH service	MIH		During the study period, the participants from the intervention group were offered the possibility to contact the MIH if they had any questions regarding their medication after discharge.In all, 26 participants raised a total of 37 enquiries to the MIH pre-, post- or during the telephone interviews (	PMC10602279
Categorization of enquiries to MIH from July 2018 through May 2019 (n = 37).	MIH		MIH: Medicines Information Helpline. “Other” include enquiries about patients’ control/treatment at the hospital and the need to speak with either a hospital- or general physician.	PMC10602279
Clinical impact of MIH on patient safety			MRPs and the clinical impact of the helpline responses were assessed by two clinical pharmacists working at the MIC. All enquiries were included in the assessment regardless of when the patient asked the question relatively to the telephone interview, i.e., pre-, post- or during the telephone interviews. From the 37 enquiries, a total of 43 MRPs were identified according to the Westerlund system (	PMC10602279
Categorization of MRPs related to the enquiry according to the Westerlund system [	MIH		The 43 MRPs extracted from the 37 enquiries to the MIH. Other MRPs included enquiries about vitamins and the need to speak with either a hospital- or general physician.The pharmacy interventions for each MRP were also identified using the Westerlund system. One MRP may trigger several pharmaceutical interventions, and a total of 77 were identified. Of these, the pharmaceutical intervention Clinical significance was assessed using the DOCUMENT system [	PMC10602279

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

PMC10460736

Declarations

PMC10460736

Conflict of interest

The authors declare that they have no competing interests.

PMC10460736

Ethics approval and consent to participate

Ethical approval was obtained from the Regional Ethical Review Committee in Stockholm (Dnr: 2019–04020). All participants signed an informed consent before being enrolled in the study.

PMC10460736

Consent for publication

There are no photographs of persons in this manuscript that require consent for publication.

PMC10460736

References

PMC10460736

Background

Previous studies have investigated the various effects of parenting on infant developmental outcomes. In particular, parental stress and social support have been found to significantly affect the growth of the newborn. Although many parents today use mobile apps to obtain more support in parenting and perinatal care, few studies have examined how these apps could affect infant development.

PMC9996416

Objective

This study aimed to examine the effectiveness of the Supportive Parenting App (SPA) in improving infant developmental outcomes during the perinatal period.

PMC9996416

Methods

REGRESSIONS

This study adopted a 2-group parallel prospective longitudinal design and recruited 200 infants and their parents (N=400 mothers and fathers). The parents were recruited at 24 weeks of gestation for a randomized controlled trial conducted from February 2020 to July 2022. They were randomly allocated to either the intervention or control group. The infant outcome measures included cognition, language, motor skills, and social-emotional development. Data were collected from the infants when they were aged 2, 4, 6, 9, and 12 months. Linear and modified Poisson regressions were used to analyze the data to examine between- and within-group changes.

PMC9996416

Results

At 9 and 12 months post partum, the infants in the intervention group were found to have better communication and language skills than those in the control group. An analysis of motor development revealed that a larger proportion of the infants in the control group fell under the at-risk category, where they scored approximately 2 SDs below the normative scores. The control group infants scored higher on the problem solving domain at 6 months post partum. However, at 12 months postpartum, the infants in the intervention group performed better on cognitive tasks than those in the control group. Despite not being statistically significant, the intervention group infants were found to have consistently scored better on the social components of the questionnaires than the control group infants.

PMC9996416

Conclusions

Overall, the infants whose parents had received the SPA intervention tended to fare better in most developmental outcome measures than those whose parents had received standard care only. The findings of this study suggest that the SPA intervention exerted positive effects on the communication, cognition, motor, and socioemotional development of the infants. Further research is needed to improve the content and support provided by the intervention to maximize the benefits gained by infants and their parents.

PMC9996416

Trial Registration

ClinicalTrials.gov NCT04706442; https://clinicaltrials.gov/ct2/show/NCT04706442

PMC9996416

Introduction

PMC9996416

Background

depression

The effects of parenting on infant development are a widely investigated topic. Studies have found that parenting knowledge, parental stress, and parental perceived support have significant impacts on the growth of an infant [The lack of social support has been linked to various parental outcomes, such as postnatal depression [According to Milgrom et al [The SPA is a theory- and evidence-based psychoeducational app developed using different theoretical frameworks, such as Singh et al’s [

PMC9996416

Aims and Hypotheses

This study aimed to examine whether the SPA intervention had any indirect effects on the developmental outcomes of the app users’ infants from birth to 12 months of age. The direct effects on parenting outcomes have been reported separately [

PMC9996416

Methods

PMC9996416

Study Design

depression, anxiety

A 2-group parallel prospective longitudinal design was adopted for this study, which was conducted from February 2020 to July 2022. Expecting parents were recruited from 2 public health care institutions in Singapore. The study was part of a randomized controlled trial (RCT) investigating the effectiveness of SPA in improving perinatal parental outcomes such as postnatal depression and anxiety [

PMC9996416

Eligibility Criteria

PREGNANCY-INDUCED HYPERTENSION, HIGH-RISK PREGNANCIES, PLACENTA PREVIA, PREECLAMPSIA

Parents were considered eligible for the study if they met the following criteria: (1) both parents were aged ≥21 years; (2) both parents were able to read and speak English; (3) the pregnancy was at low risk with >24 weeks of gestation (age of viability in Singapore); and (4) both parents owned a smartphone with internet access. Parents were excluded from the study if they had high-risk pregnancies (eg, pregnancy-induced hypertension, preeclampsia, and placenta previa major). Infants who were born via a complicated assisted delivery where the mother required prolonged hospitalization and admitted to the neonatal intensive care unit and infants with congenital issues were excluded from the study to minimize confounding influences on the outcome variables.

PMC9996416

Sample Size Calculation

As this study was part of an RCT investigating the effectiveness of the SPA intervention on parental outcomes, the parents enrolled in the RCT and their infants were recruited for this study. Considering the medium-sized effect of SPA, a Cohen

PMC9996416

Intervention

depression

RECRUITMENT

The control group parents received the standard perinatal care offered by the hospitals they were recruited from, which consisted of antenatal checkups, optional antenatal classes, care during their stay in the ward, and a postnatal review scheduled 6 weeks post partum. Perinatal care was provided to the parents by obstetricians, nurses, neonatologists, and lactation consultants. The intervention group parents received the standard perinatal care as well, but they were also granted access to the mHealth intervention SPA upon recruitment into the study. In addition, they were matched with trained peer volunteers, who were experienced mothers trained by the research team to provide peer support for the parents in the RCT.SPA included a variety of pregnancy-, childbirth-, postpartum-, and infant care–related information. This included articles, audio files, and videos about birth preparation, bonding and attachment across the perinatal period, breastfeeding, baby care–related tasks (from bathing to safe sleep habits), and involvement of both fathers and mothers in baby care tasks. The information was curated by the health care professionals involved in the study so that parents could conveniently access reliable and accurate information. Expert advice, discussion forums, and frequently asked questions were also features of the mobile app that aimed to resolve any pregnancy- or childcare-related queries that the parents might have. The parents were encouraged to interact with the peer volunteer with whom they were matched if they needed emotional or informational support from experienced mothers who had previously had and recovered from postnatal depression. Detailed features of the SPA mobile app and peer volunteer intervention can be found in the published development study [

PMC9996416

Procedure

Couples were recruited by a research assistant during their scheduled antenatal checkups at 2 tertiary hospitals in Singapore. They were provided with an explanation of the study, and interested couples were screened for eligibility before giving them an informed consent form where they could indicate their willingness to participate in the study. Subsequently, the couples were randomly allocated to the intervention or control group. The estimated due date of the couples was recorded, and the couples were then contacted shortly after their due date to gather information regarding their childbirth (eg, gender of the baby and whether they attended prenatal classes). The parents also entered this information into SPA so that the app could send them information that is specific and relevant to the infant’s age and respective postpartum time points.The parents were contacted via SMS text messages to complete the follow-up questionnaires at 1, 2, 4, 6, 9, and 12 months post partum. Mothers tended to be the ones who completed the infant-related questionnaires. A house visit was also scheduled at 6 and 12 months, during which a trained research assistant visited the participants’ homes to assess the infant using the Bayley-4.

PMC9996416

Outcome Measures

Conducting research with very young children involves various challenges regarding the accuracy of the data collected, as infants are not verbal, and thus it is difficult to obtain information directly from them. Therefore, the following instruments were used to measure the constructs examined in this study to provide an accurate representation of the infants’ developmental progress.

PMC9996416

Bayley Scales of Infant and Toddler Development—Fourth Edition

The Bayley-4 consists of 5 scales: cognitive, language, motor, social-emotional, and adaptive behavior (ADBE) [

PMC9996416

Brief Infant Toddler Social Emotional Assessment

The 42-item parent-reported Brief Infant Toddler Social Emotional Assessment (BITSEA) was divided into 2 scales: the problem scale (31 items) and the competence scale (11 items) [

PMC9996416

Data Analysis

Data analyses were conducted using SPSS (version 27.0; IBM Corp) [

PMC9996416

Ethics Approval

Before the commencement of the study, ethics approval was obtained from the National Health Group Domain Specific Review Board (NHG DSRB:2019/00875). The parents of the infants involved in this study were provided with information on the study and its procedures before they provided their written consent. It was communicated to the parents that participation was voluntary and that they had the right to withdraw anytime without incurring any consequences.

PMC9996416

Results

PMC9996416

Motor Skills

REGRESSION

The infants from the control group were significantly more likely to score below the cutoff score of the ASQ gross motor domain at 2 months post partum (risk ratio [RR]=0.417, 95% CI 0.20-0.85; The intervention group infants were found to have better fine motor skills than the control group infants at 6 months post partum, based on the results of the logistic regression model analysis. The infants from the control group were more likely to score below the cutoff score on the ASQ fine motor domain than those from the intervention group (RR=0.25, 95% CI 0.08-0.76; Similar to the trend graph of the ASQ communication domain, the ASQ gross motor graph showed that the intervention group scored better than the control group on the gross motor items (

PMC9996416

Cognition

At 6 months post partum, the infants from the control group had a higher chance of being in the at-risk group for the problem solving domain of the ASQ than those from the intervention group (RR=0.34, 95% CI 0.12-0.91; According to

PMC9996416

Behavioral Outcomes

−10.44, maladaptive behaviors

The ADBE scale of the Bayley-4 and the problem scale of the BITSEA assessed the behavioral outcomes of the infants. The BITSEA problem scale covered externalizing behaviors, dysregulating behaviors, and maladaptive behaviors. The infants from the control group were found to have significantly higher scores on the BITSEA problem scale than those from the intervention group (effect size=−5.87, 95% CI −10.44 to −1.70;

PMC9996416

Analysis of Covariates

’ motor skills

SECONDARY

Parents attending prenatal courses was found to significantly influence whether their infants’ ASQ scores on the communication (RR=0.13, 95% CI 0.02-0.75; The education level of the parents was also a predictor of the infants’ motor skills. The infants of parents with secondary educational qualifications had a higher chance of being in the at-risk group at 6 months post partum than those of parents who graduated from universities (RR=13.41, 95% CI 2.27-79.09; In this study, monthly household income was found to significantly affect the cognition and motor skills of the infants. The infants from households with a monthly income between SGD $3000 (US $2285.64) and SGD $5000 (US $3809.39) were more likely to belong to the at-risk group of the cognition domain of the Bayley-4 assessment than those from households earning >SGD $5000 (US $3809.39) monthly (RR=14.79, 95% CI 4.96-44.15;

PMC9996416

Discussion

PMC9996416

Principal Findings

This study examined the effects of the SPA intervention on infants’ developmental outcomes during the first 12 months of life. The infants in the intervention group mostly scored better in domains assessing communication, cognition, and social-emotional development. More infants from the control group fell under the at-risk category for motor skills than those from the intervention group. Findings from the main RCT reported a high attrition rate of 28.5% [

PMC9996416

Communication

From 2 to 12 months post partum, the infants from the intervention group were found to exhibit better communication skills than their control group counterparts. According to Bortfeld and Gabouer [On the basis of the trend graphs, the difference in the communication scores between the 2 groups increased over time. Topping et al [

PMC9996416

Motor Skills

Similar to the communication trend graphs, the fluctuations in gross and fine motor skills indicated by the ASQ scores can be attributed to the differences in normative scores. Overall, the motor skills of the intervention group infants developed to a greater extent than those of the control group infants. This might have been because the parents in the intervention group had read the guide on how they could engage in play with their children on SPA. The guide included some toy recommendations that can help improve the motor skills of infants by allowing them to practice movements such as grasping and head turning. Semistructured interviews with some of the parents [

PMC9996416

Cognition

Results from the problem solving domain of the ASQ revealed that the control group infants generally fared better than the intervention group infants during the first 6 months of their lives. However, the results of the 12-month Bayley-4 assessment revealed that the intervention group infants did better on the cognition scale than the control group infants. This finding is contrary to the hypothesis of this study, which proposed that the intervention group infants would perform better on cognition tasks than the control group infants. A reason for this might be that SPA did not include much content on enhancing the cognition and problem-solving skills of infants. Most of the parenting information available was related to childcare tasks such as feeding and swaddling or was related to parent-child communication and motor skills. As reported in a published qualitative paper [

PMC9996416

Social-Emotional Skills

Although there were no statistically significant group differences in the personal-social domain of the ASQ and social-emotional scale of the Bayley-4 assessment, the intervention group generally demonstrated greater social-emotional development. This lack of significance could be attributed to the fact that SPA did not include much information regarding the development of social-emotional skills in infants. However, the encouragement provided to parents to engage in age-appropriate parent-child play and increase parent-child interactions might have contributed to the slightly higher social-emotional and personal-social scores [

PMC9996416

Behavioral Outcomes

The infants from the intervention group were found to engage in more ADBEs than those from the control group. On the basis of the parents’ responses to the BITSEA, the control group infants exhibited more problem behaviors as well. Maternal responsivity and sensitivity to infant distress are important factors in predicting ADBE in infants. Higher maternal responsivity is associated with greater emotional regulation and fewer behavioral issues [

PMC9996416

Prenatal Courses, Education, and Household Income

This study found that prenatal classes had a positive impact on communication, gross motor, and personal-social scores at 2 months post partum. Prior research [The infants from families with higher household incomes were found to have more developed cognition. This is supported by previous literature, where it was found that children from families with low socioeconomic status (SES) had lower cognitive flexibility [Both higher parental education and higher monthly household income were significantly associated with stronger motor skills. Freitas et al [

PMC9996416

Strengths and Limitations

VIRUS

Given that social support has been proven to improve parental well-being and, in turn, promote infant growth in various areas, the SPA intervention was developed. The intervention aimed to meet the support needs of Singaporean parents during the perinatal period, thus helping them adjust to parenting roles and infant-care tasks. This study found that technology-based parenting interventions such as SPA can lead to benefits beyond enhancing parental well-being. The findings of this study are crucial for the future development of not only mobile apps for parents in Singapore but also those for parents in other countries. Providing parenting education and emotional support can indirectly improve infant developmental outcomes. However, it is important to recognize and consider the cultural beliefs, practices, and support needs of parents from other countries. This would allow app developers to provide a knowledge base and appraisal support that would be respectful of and helpful in meeting their individualized needs.Another strength of this study is that it used questionnaires that were completed by both parents and trained personnel. Parent-completed measures are advantageous in that parents spend the most time with their infants and are the most knowledgeable about them. However, existing literature [This study has some limitations. One of its limitations is its high attrition rate. Because of the COVID-19 pandemic, parents were more cautious of physical interactions, as they did not want themselves, their infants, or other family members to contract the virus. Therefore, many parents declined home visits for the Bayley-4 assessment. This may have affected the accuracy of the findings in representing the sample recruited for this study. Moreover, the longitudinal nature of the study might have also contributed to the high attrition rate. Parents tend to become busier post partum owing to the need for them to adjust to parenting responsibilities; in the case of this study, the need to take extra precautions to prevent contracting the COVID-19 virus added to these responsibilities. Therefore, it is paramount to devise strategies to keep parents interested in and willing to participate in the study. For example, research team members can frequently contact parents to build stronger rapport and remind them to access SPA if they have parenting-related concerns. Although the research team originally intended to do so, some technical issues led to the absence of chat notifications, affecting the communication between the team and parents. Furthermore, many of the research team members were also frontline health care workers; therefore, they were unable to meet often and resolve these issues in a timely manner.Another limitation of this study is the lack of information regarding whether the parents were experienced or new. This is an important limitation, as the struggles and support needs that new and experienced parents encounter may differ widely. Hence, future studies should take note to collect such information from parents to provide deeper perspectives regarding the effectiveness of parenting interventions in new and experienced mothers and fathers. Subsequent research may also investigate parental sensitivity and responsivity to provide further insight into how they may affect infant behavioral outcomes.

PMC9996416

Conclusions

This study examined the effects of the SPA intervention on infant developmental outcomes. The results showed that the infants from the intervention group generally developed better in terms of communication, motor skills, cognition, and social-emotional skills than those from the control group. The peer support and informational support that the SPA intervention offered to the intervention group parents were thus helpful in indirectly influencing the development of infants. More research is needed to obtain an in-depth understanding of what functions of the intervention influenced the infant outcomes and what information the current generation of parents hopes to see in parenting mobile apps. This would facilitate the creation of more effective mHealth app–based support for parents. In the future, interventions targeting infant growth and development should be created to measure the direct effects of educational interventions. In addition, future parenting interventions should focus on providing more support to families with lower SES to help promote the development of infants and support parents from these families.The authors would like to thank the Ministry of Health for funding this project through the Health Services Research Grant (HSRGHP18may-0001). They also extend their thanks to all the study participants for sharing their insights despite being new parents during the pandemic.Conflicts of Interest: None declared.

PMC9996416

Abbreviations

adaptive behaviorAges and Stages QuestionnaireBrief Infant Toddler Social Emotional Assessmentmobile healthrandomized controlled trialrisk ratiosocioeconomic statusSupportive Parenting App

PMC9996416

Purpose

FEP, First-episode psychosis

First-episode psychosis (FEP) is characterised by wide heterogeneity in terms of symptom presentation and illness course. However, the heterogeneity of quality of life (QoL) in FEP is not well understood. We investigated whether subgroups can be identified using participants' responses on four QoL domains (physical health, psychological, social relationships, and environmental) 18-months into the recovery phase of FEP. We then examined the discriminant validity of these subgroups with respect to clinical, cognitive, and functioning features of FEP.

PMC9992035

Method

REGRESSIONS

Demographic and clinical characteristics, QoL, cognition, and functioning were assessed in 100 people with FEP at the 18-month follow-up of a randomised controlled trial of Individual Placement Support, which aims to facilitate vocational recovery. QoL was measured using the World Health Organisation’s QoL-BRIEF. A two-stage clustering approach using Ward’s method and Squared Euclidean Distance with a k-means confirmation was conducted. Multinomial logistic regressions were used to establish external validity.

PMC9992035

Results

social/occupational functioning, depressive symptoms

SENSITIVITY

Three QoL subgroups emerged: a ‘good’ subgroup with relatively high QoL across all domains (31%), an ‘intermediate’ subgroup with relatively low psychological QoL (48%) and a ‘poor’ subgroup with markedly low social relationship QoL (21%). Negative symptoms, depressive symptoms, social/occupational functioning, and social inclusion at follow-up predicted subgroup membership. Sensitivity analysis found similar results.

PMC9992035

Conclusion

mental ill

Although some individuals with FEP have QoL comparable to individuals without mental ill health, QoL can remain concerningly low despite treatment efforts. Future research on interventions that target factors associated with poor QoL, such as low social inclusion, is required to counteract prolonged poor QoL in FEP.

PMC9992035

Supplementary Information

The online version contains supplementary material available at 10.1007/s11136-022-03277-x.

PMC9992035

Keywords

Open Access funding enabled and organized by CAUL and its Member Institutions

PMC9992035

Plain English summary

first-episode psychosis, depressive symptoms

Quality of life has emerged as a valuable outcome in first-episode psychosis (FEP) research. Young people with FEP also consider good quality of life to be more important than symptom management. Until recently, previous research into FEP has sought to identify which clinical, cognitive, and functioning factors are associated with low quality of life in FEP. However, these studies often ignore individual differences in quality of life. In this study we aimed to understand whether young people with FEP, who are in the later stages of their recovery, can be grouped into clinically meaningful subgroups based on their responses on four quality of life domains (i.e., physical health, psychological, social relationships, and environmental). This study indicates that young people with FEP experience either ‘good’, ‘intermediate’, or ‘poor’ quality of life at the later stages of recovery, and that depressive symptoms and social inclusion strongly predict membership to these quality of life subgroups. Findings from this study highlight the possibility of having good quality of life despite the challenges associated with FEP, whilst also demonstrating that poor quality of life can persist despite interventional effort. Future research should focus on developing interventions that address factors associated with poor quality of life, such as low social inclusion.

PMC9992035

Introduction

psychotic symptoms, first-episode psychosis, mental ill

REMISSION

Compared to individuals without mental ill health, individuals with first-episode psychosis (FEP) report significantly lower levels of quality of life (QoL) [Understanding variability in QoL in FEP has important clinical implications. For instance, the disparity in QoL between individuals with FEP and the general population persists beyond symptomatic remission, suggesting that psychotic symptoms alone do not produce poor QoL [Liao et al. [However, the presence of QoL heterogeneity at a later stage of FEP recovery remains unclear; Liao et al.’s [Investigating whether heterogeneity in QoL persists into the later stages of the recovery phase is necessary as research suggests that whilst improvements in QoL may occur, it can remain poor or even deteriorate over time [Using the same sample and methodology as Liao et al. [

PMC9992035

Materials and methods

PMC9992035

Design

IPS

SECONDARY

The current study involved a secondary analysis of baseline and 18-month follow-up data of a single-blinded RCT (Australian and Clinical Trials Registry ACTRN12608000094370), which aimed to investigate the efficacy of Individual Placement and Supporting (IPS) in assisting young people with FEP to achieve vocational recovery [

PMC9992035

Participants

Psychosis

DISORDERS, RECRUITMENT

Young people with FEP who had expressed an interest in vocational recovery were approached to participate in the original RCT. Participant recruitment took place at the Early Psychosis Prevention and Intervention Centre (EPPIC), a clinic within the Orygen Specialist Programme in Melbourne, Australia, providing time-limited care. Participants were aged between 15 and 25 years and had experienced a FEP as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision [

PMC9992035

Measures

PMC9992035

QoL

QoL was measured using the WHOQoL-BREF [

PMC9992035

Demographics

The demographic characteristics assessed at baseline covered variables such as age, gender, and use of health services.

PMC9992035

Clinical characteristics

psychotic symptoms, DUP, psychosis

DUP

Duration of untreated psychosis (DUP) was defined as the time between onset of psychotic symptoms and registration at EPPIC [

PMC9992035

Cognition

Based on their association with QoL in FEP [

PMC9992035

Functioning

Social and occupational functioning was measured at follow-up using the single-item Social and Occupational Functioning Assessment Scale [

PMC9992035

Statistical analysis

depression

REGRESSION, DUP, REGRESSIONS

All analyses were completed using RStudio (Version 1.4.1717) and were chosen to mirror the methods of Liao et al. [The external validity of the QoL subgroups was evaluated using multinominal logistic regressions. A range of clinical, cognitive, and functional variables both at the baseline and follow-up were included in the models. These variables include baseline and follow-up clinical characteristics (DUP, treatment group, positive symptoms, negative symptoms, and depression), baseline cognition (IQ, ToM, and semantic verbal fluency), and follow-up functioning variables (social/occupational functioning, employment status, and social inclusion). A series of univariate multinomial logistic regression models were first conducted for individual variables. If a variable significantly predicted cluster group membership, it was henceforth included in the final multivariate model. For all models, the relative risk ratio (RRR), 95% confidence intervals of the RRR, and the Wald test were calculated to establish the level of association. The alpha (

PMC9992035

Sensitivity analysis

depression

APPENDIX, REGRESSIONS

Due to the high overlap between the psychological domain of the WHOQoL-BREF and depression symptoms (Appendix 1), sensitivity analyses were conducted with the psychological domain of the WHOQoL-BREF excluded from the k-means clustering analysis. Further external validation based on the clustering results not considering variations in the psychological domain was then conducted using multinominal logistic regressions.

PMC9992035

Results

PMC9992035

Sensitivity analysis

APPENDIX

The sensitivity analysis excluding the psychological domain showed very similar results. A k-means partitioning method also suggested a 3-cluster solution to be optimal and three clusters had distinct QoL characteristics (Appendix 10), namely a ‘poor’ cluster (

PMC9992035

Discussion

The current study aimed to extend the findings of Liao et al. [

PMC9992035

The heterogeneity of QoL in FEP

personality disorder, substance disorder, comorbid major depressive disorder

The finding of a ‘good’ QoL subgroup, with average QoL scores that mirror scores reported by healthy controls, contradicts the common finding that the QoL of FEP patients is significantly diminished and highlights the importance of approaching QoL in an individualistic manner [The ‘intermediate’ subgroup mirrors average QoL scores reported by young people in the recovery phase of FEP who do not have a comorbid major depressive disorder, substance disorder, or personality disorder [The ‘poor’ subgroup at follow-up demonstrates that low QoL is an enduring issue for a subset of young people recovering from FEP, despite months of treatment and time for symptomatic recovery. The participants in the ‘poor’ subgroup exhibited similar QoL scores reported by recovering FEP participants with comorbid major depressive disorder in previous studies [

PMC9992035

Factors associated with QoL in FEP

depressive, cognitive functioning, depressive symptoms

Consistent with previous research on QoL in FEP recovery [Although depressive symptoms emerged as the strongest predictor of the QoL subgroups, the relationship between depressive symptoms and QoL subgroups may be inflated due to measurement overlap [No cognitive measures were associated with the QoL subgroups at follow-up (before and after the psychological domain was removed), suggesting that cognitive functioning at baseline does not explain variation in QoL at a later stage of the recovery phase. Whilst speculative, early intervention may play a role in subduing the predictive ability of cognitive functioning at baseline. Amoretti et al. [In support of previous findings, social inclusion at follow-up predicted subgroup membership before and after the psychological items were removed [

PMC9992035

Strengths and limitations

The current study highlights the use of cluster analysis as an innovative approach to capturing heterogeneity in QoL in an FEP cohort. However, this study is limited by the aims and measures used in the original study, which did not specifically focus on QoL and its correlates [As a follow-up analysis, our study also allows comparisons with Liao et al.’s [

PMC9992035

Implications and future directions

We have demonstrated that heterogeneity of QoL in FEP exists at a later stage of FEP recovery. The results highlight that although individuals with FEP may exhibit good QoL, many report lower levels across all four QoL domains, despite months of treatment-as-usual. Currently, the central goal of FEP treatment is to encourage engagement and commence pharmacological and psychological interventions that target symptomatic recovery [

PMC9992035

Author contributions

EK, KA, and SC were involved in the design and data collection of the original study from which the current study is based on. KA, SC, EC, CG, and ZL contributed to the design of the current study. EC was responsible for data analysis and drafting of the manuscript. All authors revised and provided critical feedback for the manuscript. All authors agree to be accountable for all aspects of the work and ensure issues regarding the accuracy or integrity of the work is addressed and resolved.

PMC9992035

Funding

Open Access funding enabled and organized by CAUL and its Member Institutions. This work was supported by Australian Rotary Health; the Australian Research Council (LP0883273); Orygen, The National Centre of Excellence in Youth Mental Health; National Health and Medical Research Council Career Development Fellowships to KA (APP1141207) and to EK (APP1051891); National Health and Medical Research Council Senior Research Fellowship SC (APP1136344). The funding source had no role in the design and outcome of the study.

PMC9992035

Data availability

Data might be available on request and after appropriate institutional agreements and ethics approvals.

PMC9992035

Declarations

PMC9992035

Conflict of interest

None to declare.

PMC9992035

Ethical approval

Institutional ethics approval was given by Melbourne Health Human Research and Ethics Committee. All young people (and their guardians if under 18 years of age) provided written informed consent to participate in the study.

PMC9992035

References

PMC9992035

Method

MIH

A randomized controlled study design was used in the present study. The study was registered at clinicaltrials.gov with the identification number NCT03829995. Participants were randomized 1:4 (50:200) into a control- and intervention group. Participants in the control group were offered standard care and those in the intervention group were offered access to the MIH. A telephone interview performed 2–4 weeks after discharge assessed patient satisfaction with the helpline and patient’s feeling of safety in relation to medicine use (primary outcome). Data were analyzed using a Mann-Whitney U test. After case handling of each enquiry to the MIH, the cases were assessed with regard to medication-related problems (MRPs) and clinical impact of the MIH service was assessed (primary outcome).

PMC10602279

Results

MIH

A total of 250 participants were included in the study and 152 participated in the telephone interviews (33 control and 119 intervention). Thirty-seven questions were enquired by 26 participants to the MIH. Of these, 8 were requested before the telephone interviews and these patients all expressed a high satisfaction with the MIH (score 4.57 +/- 0.73 on a 5-point scale). Most patients offered access to the MIH expressed that it increased the sense of safety in relation to their medicines (79%). However, comparing the control- and intervention group with regard to patient concerns and feeling of safety in relation to medicine use no differences were found. Evaluation of the enquiries revealed at least one MRP per enquiry, and in most cases the advice given were assessed to have a high- or moderate clinical significance.

PMC10602279

Conclusion

MIH

The MIH was appreciated by the participants, indicating that the MIH could be a valuable service for discharged patients in improving the sense of safety in relation to medication and alleviating MRPs. Providing easy access for patients to medicine information may contribute to patient safe medicine use after discharge.

PMC10602279

Data Availability

All relevant data are within the paper and its

PMC10602279

Introduction

MIH

ADVERSE EVENTS, TRANSITION

Healthcare systems are becoming more and more complex, and patients must navigate between hospitals and the primary sector. Transition from hospitals to private homes is known to challenge patient safety [Importantly, it has been shown that patient education and counseling can reduce the risk of medicine related adverse events and rehospitalization, and patients have been identified as a key resource in improving medicines safety in cross-sector situations [Medicine Information Helplines (MIH) can play an important role in supporting patients in a safe medication after hospitalization [Up until 2018, discharged patients in Denmark had no access to a MIH. Patients may contact the general practitioners, community pharmacies or the respective hospital ward with medicine-related questions [

PMC10602279

Method

PMC10602279

Setting

MIH

EMERGENCY

The MIH was operated by experienced pharmacists and a pharmacy technician from the Medicine Information Centre (MIC) at the Hospital Pharmacy at Bispebjerg Hospital in the Capital Region of Denmark. Staff was trained in clinical pharmacy and drug information activities. The MIH team consists of 12 medicine information pharmacists and a pharmacy technician, who have been providing medicine information between 5–25 years in the MIC. The helpline is accessible on all weekdays from 8 am to 3.30 pm.An acute care setting and a non-acute inpatient setting were purposively chosen to obtain possible variations in the clinical impact related to the MIH, and the impact on patient satisfaction, concerns and perception of safety in relation to their medicine after discharge. Thus, the Emergency Department and the Department of Respiratory Medicine at Bispebjerg Hospital were selected. Bispebjerg Hospital is one of the hospitals in the Capital Region of Denmark. The hospital serves as a community hospital for approximately 400,000 citizens. The Emergency Department has around 40 beds while the Department of Respiratory Medicine has 38 beds [

PMC10602279

Enrollment of participants

terminally illness, aphasia, dementia

MAY

A total of 250 patients were enrolled in the study from July 2018 to May 2019. The patients were enrolled from the two selected hospital wards by the first three authors from the MIC. All admitted patients at the two wards were assessed and eligible participants were subsequently approached for enrollment. Eligible participants were 18 years or older, spoke and understood Danish, and were scheduled for discharge to their private homes within a few days after enrollment. Exclusion criteria included severe dementia diagnosis, terminally illness, isolation precautions, aphasia, suicidal or patients in custody. Length of stay and whether the patient used medicines or not were not exclusion criteria.Participation in the study was voluntary and all patients were given oral and written information about the study, publication plans and his or her right to withdraw from the study at any time without further consequences. All participants signed a consent form and patients’ participation was documented in their hospital files by the clinical pharmacists.

PMC10602279

Study design

MIH

ADVERSE EFFECTS, DRUG INTERACTIONS

A randomized controlled study design was used to explore the study objective [The control group (50 participants) received no intervention beyond standard care which does not include access to any information services post discharge. The intervention group (200 participants) were offered standard care and the opportunity to contact the MIH on all business days, should any medicine-related questions arise after hospital discharge. Upon enrollment, patients in the intervention group received a card with contact information for the MIH. All enquiries to the MIH were answered orally and/or in writing by either a pharmacist or a pharmacy technician from the MIC. All enquiries and the case handling were documented in the MIC’s database and categorized into predefined types of categories, such as adverse effects, choice of therapy, dosage/administration, drug interactions and product information.

PMC10602279

Telephone interviews

MIH

A primary outcome of the present study was to evaluate whether the offer to contact the MIH influenced patient’s concerns and perception of safety in relation to their medicines (An interview guide was developed to assess patient satisfaction with the medicine information obtained during hospitalization, at discharge and given by the MIH. In order to investigate patients concerns and perception of safety in relation to medicines use, already validated questions from the Beliefs About Medicine Questionnaire proposed by Horne et al. [The questions in the interview guide were pilottested by 12 patients and 5 healthcare professionals, and the wording of some of the questions was subsequently optimized accordingly. All eligible participants were interviewed by telephone within 2–4 weeks after discharge to ensure that the patients remembered details about their hospital stay. The telephone interviews were performed by author one, two and three.Participants were rated as non-responders if they declined to be interviewed or if they did not answer the phone within five attempts on five different days over a two-week period. In addition, participants were also rated as a non-responder if they showed cognitive or/and communicative problems during the interview, making it difficult to complete the interview, or if the patient was readmitted or deceased.

PMC10602279

Clinical impact assessment

Another primary outcome of the present study was the clinical impact of MIH on patient safety. To assess the clinical impact, all enquiries were analyzed and categorized for MRPs and pharmacy interventions according to the Westerlund System; see

PMC10602279

Clinical impact assessment of MRPs and the pharmacy intervention.

PMC10602279

Data analysis

No similar studies are available from which a sample size can be calculated.This study used a randomized controlled study design, and it was set to detect a 10% improvement on a 5-point scale measuring patient satisfaction with medicine information and patient concerns about medicine. From the literature, a mean score of 3.5 ± 0.5 is anticipated [Power was set by the authors to 90% and p-values less than 0.05 were considered statistically significant. Thus, a sample size of 43 patients was calculated [Quantitative data from the patient interviews were analyzed in Microsoft Excel (for Office 365 MSO) and IBM SPSS (Version 25) with descriptive statistics and simple parametric statistics. Mann-Whitney U test were used for analysis of ordinal variables (five-point scale) and Chi-Square test were used for nominal variables (gender, yes/no). Data are displayed as the mean of rating ± SD (Standard Deviation) unless otherwise specified. A confidence interval (CI) was calculated using the Clopper-Pearson method for the primary outcome data using nominal variables. An independent t-test was used to test for difference in age and number of medications by admission and discharge. Test for normality was done using Shapiro-Wilk test. If data did not show a normality distribution a Wilcoxon rank sum test was used to test for difference. Free text comments were not analyzed explicitly but were solely used to support the interpretation of the patient interview.

PMC10602279

Results

PMC10602279

Participants

A total of 946 patients were assessed for eligibility at the two hospital wards. Of these, 319 patients failed to meet the inclusion criteria and 377 patients either declined the invitation to participate, were asleep, discharged or transferred to another ward at the time of inclusion.Thus, 250 participants were included in the study and randomized into a control group (n = 50) and an intervention group (n = 200). In the follow-up period, 98 participants (17 in the control group and 81 in the intervention group) were considered as non-responders. Finally, 33 participants were interviewed in the control group and 119 participants in the intervention group; see

PMC10602279

Consort study diagram showing the flow of invited, included, excluded and dropout patients.

EMERGENCY

The participants were included equally from the Emergency Department and from the Department of Respiratory Medicine, and their characteristics are presented in

PMC10602279

Medicine information during hospitalization and after discharge

A total of 152 participants were interviewed by telephone and the interview guide in In the control group 55% of the participants (18/33) reported a change in their medication during hospitalization, see

PMC10602279

Patient satisfaction with medicine information provided during hospitalization and after discharge.

Patients scored satisfaction with medicine information provided during hospitalization and at discharge on a 5-point scale where score 1 = not at all and score 5 = to a very great extent. Results are shown as mean of rating ± SD. No significant difference was found between the control- and intervention group with regard to satisfaction with medicine information provided during hospitalization (Mann-Whitney U test, p = 0.337) or at discharge (Mann-Whitney U test, p = 0.580).Approximately half of the participants (48%, 73/141) preferred receiving their medicine information both written and orally at discharge, and 2/3 of these expressed that this combination gave them the opportunity to validate and repeat the obtained information when settled at home. Of the participants in the control and intervention group, 21% (7/33) and 29% (34/118) respectively did not recall that they received a medication-status-list at discharge. There was no significant difference between the groups (p = 0.377).Of all participants, 26% (39/150) responded that they had questions regarding their medication after discharge (18% (6/33) in the control group and 28% (33/117) in the intervention group). The percentage of patients that had a question regarding their medication were higher in both control- and intervention group when looking at patients who reported a change in their medication (22% and 39,7% respectively). Among all patients who reported they had a question regarding their medicine a total of 67% in both the control group (4/6) and intervention group (22/33) found an answer to their question by searching the internet or contacting their general practitioner, pharmacy, hospital, relatives or visiting nurses, see

PMC10602279

Patient satisfaction with MIH

MIH

One of the primary outcomes was patient satisfaction with MIH. Participants in the intervention group were asked if the opportunity to contact the MIH affected the feeling of safety in relation to their medication, which the majority of the participants acknowledged (72%, 79/110, CI [0.67–0.84[). Patients who contacted the MIH before the telephone interview (n = 8) reported a slightly lower score on the questions regarding feeling of safety with regard to their medication and they felt to a higher degree that their medicines were a mystery to them (see Only patients in contact with the MIH before the telephone interview were asked about their satisfaction with the service (n = 8). The participants contacted the MIH by phone and received an answer by phone. The participants found the answers provided by the MIH timely, easy to understand and relevant. Furthermore, they reported that the answers to a great extent affected their use of medicine in a positive manner, just as they were satisfied with the answers to a very great extent (4.71 ± 0.45 on a 5-point scale). Generally, the participants were satisfied with the service (4.57 ± 0.73 on a 5-point scale), they would use it again (100% answered yes, n = 8), and they believed the helpline should be a permanent service for discharged patients in the Capital Region of Denmark (93% answered yes, n = 126).

PMC10602279

Concerns and perception of safety in relation to medication

The other primary outcome focused on patients’ concerns and perception of safety in relation to their medication. Both the control- and the intervention group responded that they felt safe to a great extent regarding their medication after discharge, which equals to a rating 4 or more on a 5-point Likert scale. There was no significant difference between the groups (p = 0.59). Both groups expressed that their current health to some extent or to a great extent was dependent on medication (no group difference, p = 0.33). However, they did not worry about taking their medicine (no group difference, p = 0.969), nor did they experience their medication as a mystery (no group difference, p = 0.507), and they expressed that the medication only disrupted their lives to a small extent (no group difference, p = 0.844) (see

PMC10602279

Concerns and perception of safety about medicine.

Patients scored on a 5-point scale with 1 = not at all and 5 = to a very great extent. Results are shown as mean of rating ± SD. No significant difference was found between control- and intervention group for any of the questions (Mann-Whitney U test, p>0.05 for all questions).

PMC10602279

Enquiries to the MIH service

MIH

During the study period, the participants from the intervention group were offered the possibility to contact the MIH if they had any questions regarding their medication after discharge.In all, 26 participants raised a total of 37 enquiries to the MIH pre-, post- or during the telephone interviews (

PMC10602279

Categorization of enquiries to MIH from July 2018 through May 2019 (n = 37).

MIH

MIH: Medicines Information Helpline. “Other” include enquiries about patients’ control/treatment at the hospital and the need to speak with either a hospital- or general physician.

PMC10602279

Clinical impact of MIH on patient safety

MRPs and the clinical impact of the helpline responses were assessed by two clinical pharmacists working at the MIC. All enquiries were included in the assessment regardless of when the patient asked the question relatively to the telephone interview, i.e., pre-, post- or during the telephone interviews. From the 37 enquiries, a total of 43 MRPs were identified according to the Westerlund system (

PMC10602279

Categorization of MRPs related to the enquiry according to the Westerlund system [

MIH

The 43 MRPs extracted from the 37 enquiries to the MIH. Other MRPs included enquiries about vitamins and the need to speak with either a hospital- or general physician.The pharmacy interventions for each MRP were also identified using the Westerlund system. One MRP may trigger several pharmaceutical interventions, and a total of 77 were identified. Of these, the pharmaceutical intervention Clinical significance was assessed using the DOCUMENT system [

PMC10602279