Challenges and best practices for recruiting families of children with intellectual disabilities for health research.

Research focused on children with intellectual disabilities has been of increasing interest over the last two decades. However, a considerable lag in the amount of research that is representative and generalizable to this population in comparison to neurotypical children remains, largely attributed to issues with participant engagement and recruitment. Challenges and barriers associated with engaging and recruiting this population include lack of research to provide a sound foundation of knowledge, ethical considerations, parental attitudes, family commitments, and organizational gatekeeping. Researchers can engage children and their families using participatory research methods, honouring the child's right to assent, and collaborating with parents. Recruitment strategies include partnering with organizations, working with parent and patient partners, and using remote methods. Employing evidence-informed engagement and recruitment strategies may provide substantial social and scientific value to the research field by ensuring that this underrepresented population benefits equitably from research findings.

Assessment and Management of Procedural Pain During the Entire Neonatal Intensive Care Unit Hospitalization.

BACKGROUND: Despite strong evidence that repeated pain exposure in neonates is associated with adverse outcomes, pain assessment and management continues to be less than optimal in most neonatal intensive care units (NICUs). AIMS: To evaluate current pain assessment and management practices, and identify factors associated with optimal treatment throughout a cohort of preterm neonates over the entire hospital stay. DESIGN: A secondary analysis of study data collected from 2012 to 2016 as part of a larger clinical trial and supplemental chart review. SETTINGS: Tertiary level neonatal intensive care unit. PARTICIPANTS/SUBJECTS: 242 stable preterm neonates born at less than 37 weeks gestational age. METHODS: Data were analyzed quantitatively using R for statistics. RESULTS: The 242 neonates underwent a total of 10,469 painful procedures (4,801 tissue breaking and 5,667 non-tissue breaking, with only 56.6% and 12.2% having a documented pain score using the Premature Infant Pain Profile, respectively). Average pain exposure was 43 with a median of 32(10-576) per entire hospital stay. Documented pain score and greater postnatal age were associated with higher use of a pain reducing intervention and lower gestational age, first day, first week, higher illness severity, non tissue breaking and night time procedures were associated with lower. Use of a pain relieving intervention was documented in 58.5% of procedures. Sucrose was most commonly used pharmacologic and non nutritive sucking the most common non pharmacologic interventions. CONCLUSIONS: Increased efforts are needed to promote consistent pain assessment and management to ensure optimal outcomes for vulnerable at risk neonates.

Are guidelines for measurement of quality of life contrary to patient-centred care?

AIMS: A discussion of how quality-adjusted life years are used to inform resource allocation decisions and highlight how assumptions underpinning the measurement of quality of life are contrary to the principles of patient-centred care. BACKGROUND: Cost-effectiveness analyses (CEAs) can provide influential guidance for health resource allocation, particularly in the context of a budget-constrained public health insurance plan. Most national economic guideline bodies recommend that quality-adjusted life year weights for CEA be elicited indirectly (public preferences). This has potentially important implications for healthcare provision and research, as it discounts the ability of a person experiencing an illness to describe how it affects their quality of life. DESIGN: Discussion paper. DATA SOURCES: Guidelines for the conduct of health economic evaluations, influential methodological and theoretical texts, and a review of PubMed conducted in April 2017. IMPLICATIONS FOR NURSING: Nurses are increasingly interested in leveraging methods from health economics to aid in decision-making and advocacy. In this analysis, we highlight how taken-for-granted approaches to the measurement of quality of life may discount the experience of patients and lead to decisions that are contrary to the principles of patient-centred care. Nurses conducting or reading research using these methods should consider whether the approach used to measure the quality of life are appropriate for the population under consideration. CONCLUSION: Since patient and public health preferences can differ in both magnitude and direction, guideline bodies should re-evaluate their partiality for public preferences in the reference case.

Skin-to-skin care for procedural pain in neonates.

BACKGROUND: Skin-to-skin care (SSC), often referred to as 'kangaroo care' (KC) due to its similarity with marsupial behaviour of ventral maternal-infant contact, is one non-pharmacological intervention for pain control in infants. OBJECTIVES: The primary objectives were to determine the effect of SSC alone on pain from medical or nursing procedures in neonates compared to no intervention, sucrose or other analgesics, or additions to simple SSC such as rocking; and to determine the effects of the amount of SSC (duration in minutes), method of administration (e.g. who provided the SSC) of SSC in reducing pain from medical or nursing procedures in neonatesThe secondary objectives were to determine the safety of SSC care for relieving procedural pain in infants; and to compare the SSC effect in different postmenstrual age subgroups of infants. SEARCH METHODS: For this update, we used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 1); MEDLINE via PubMed (1966 to 25 February 2016); Embase (1980 to 25 February 2016); and CINAHL (1982 to 25 February 2016). We also searched clinical trials' databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials. SELECTION CRITERIA: Studies with randomisation or quasi-randomisation, double- or single-blinded, involving term infants (≥ 37 completed weeks' postmenstrual age (PMA) to a maximum of 44 weeks' PMA and preterm infants (< 37 completed weeks PMA) receiving SSC for painful procedures conducted by healthcare professionals. DATA COLLECTION AND ANALYSIS: The main outcome measures were physiological or behavioural pain indicators and composite pain scores. A mean difference (MD) with 95% confidence interval (CI) using a fixed-effect model was reported for continuous outcome measures. We included variations on type of tissue-damaging procedure, provider of care, and duration of SSC. MAIN RESULTS: Twenty-five studies (n = 2001 infants) were included. Nineteen studies (n = 1065) used heel lance as the painful procedure, one study combined venepuncture and heel stick (n = 50), three used intramuscular injection (n = 776), one used 'vaccination' (n = 60), and one used tape removal (n = 50). The studies were generally strong and had low or uncertain risk of bias. Blinding of the intervention was not possible, making them subject to high risk, depending on the method of scoring outcomes.Seventeen studies (n = 810) compared SSC to a no-treatment control. Although 15 studies measured heart rate during painful procedures, data from only five studies (n = 161) could be combined for a mean difference (MD) of -10.78 beats per minute (95% CI -13.63 to -7.93) favouring SSC. Meta-analysis of four studies (n = 120) showed no difference in heart rate following the painful procedure (MD 0.08, 95% CI -4.39 to 4.55). Two studies (n = 38) reported heart rate variability with no significant differences. Two studies (n = 101) in a meta-analysis on oxygen saturation at 30 and 60 seconds following the painful procedure did not show a difference. Duration of crying meta-analysis was performed on four studies (n = 133): two (n = 33) investigated response to heel lance (MD = -34.16, 95% CI -42.86 to -25.45), and two (n = 100) following IM injection (MD = -8.83, 95% CI -14.63 to -3.02), favouring SSC. Five studies, one consisting of two substudies (n = 267), used the Premature Infant Pain Profile (PIPP) as a primary outcome, which favoured SCC at 30 seconds (MD -3.21, 95% CI -3.94 to -2.47), at 60 seconds (3 studies; n = 156) (MD -1.64, 95% CI -2.86 to -0.43), and at 90 seconds (n = 156) (MD -1.28, 95% CI -2.53 to -0.04); but at 120 seconds there was no difference (n = 156) (MD 0.07, 95% CI -1.11 to 1.25). No studies on return of heart rate to baseline level, cortisol levels, and facial actions could be combined for meta-analysis findings.Eight studies compared SSC to another intervention with or without a no-treatment control. Two cross-over studies (n = 80) compared mother versus other provider (father, another female) on PIPP scores at 30, 60, 90, and 120 seconds with no significant difference. When SSC was compared to other interventions, there were not enough similar studies to pool results in an analysis. One study compared SSC (n = 640) with and without dextrose and found that the combination was most effective and that SSC alone was more effective than dextrose alone. Similarly, in another study SSC was more effective than oral glucose for heart rate (n = 95). SSC either in combination with breastfeeding or alone was favoured over a no-treatment control, but not different to breastfeeding. One study compared SSC alone and in combination with both sucrose and breastfeeding on heart rate (HR), NIPS scores, and crying time (n = 127). The combinations were more effective than SSC alone for NIPS and crying. Expressed breast milk was compared to SSC in one study (n = 50) and found both equally effective on PIPP scores. There were not enough participants with similar outcomes and painful procedures to compare age groups or duration of SSC. No adverse events were reported in any of the studies. AUTHORS' CONCLUSIONS: SSC appears to be effective as measured by composite pain indicators with both physiological and behavioural indicators and, independently, using heart rate and crying time; and safe for a single painful procedure. Purely behavioural indicators tended to favour SSC but with facial actions there is greater possibility of observers not being blinded. Physiological indicators were mixed although the common measure of heart rate favoured SSC. Two studies compared mother-providers to others, with non-significant results. There was more heterogeneity in the studies with behavioural or composite outcomes. There is a need for replication studies that use similar, clearly defined outcomes. Studies examining optimal duration of SSC, gestational age groups, repeated use, and long-term effects of SSC are needed. Of interest would be to study synergistic effects of SSC with other interventions.

Skin-to-skin contact for procedural pain in neonates: acceptability of novel systematic review synthesis methods and GRADEing of the evidence.

AIMS: The aim of this study was to assess the acceptability of methods that increase trial inclusion in meta-analyses, and the level of evidence for skin-to-skin contact for procedural pain in infants. BACKGROUND: The current Cochrane review of skin-to-skin contact for pain in newborns found it to be an effective intervention, but identified several methodological limitations. DESIGN: Meta-re-analysis METHODS: Trial designs included randomized trials reporting a validated pain assessment tool as a primary outcome including term and pre-term infants undergoing a tissue-breaking painful procedure. The search in the original review was conducted to January 2013. Scores of validated tools were scaled to the premature infant pain profile in a fixed-effect meta-re-analysis. The GRADE was used to assess quality of meta-analysed evidence. RESULTS: New analysis vs. original found a mean difference: -3·11 in favour of skin-to-skin contact vs. -3·21 at 30 seconds; and -2·71 vs. -1·85 at 60 seconds for heel lance. Based on cut-off scores for the Neonatal Infant Pain Scale, infants receiving skin-to-skin contact during IM injection were more likely to display low pain after injection; and during recovery. CONCLUSION: Scaling scores to a single outcome can provide additional information in meta-analyses, simplifies interpretability of pooled scores, and can improve GRADE outcomes. Sensitivity analyses of scaled scores improve confidence in their validity. Risk of bias subgroups simplified the GRADE process, and confidence intervals for heterogeneity statistics assisted in interpretation of sensitivity analyses.

Striving for Optimum Noise-Decreasing Strategies in Critical Care: Initial Measurements and Observations.

To identify baseline sound levels, patterns of sound levels, and potential barriers and facilitators to sound level reduction. The study setting was neonatal and pediatric intensive care units in a tertiary care hospital. Participants were staff in both units and parents of currently hospitalized children or infants. One 24-hour sound measurements and one 4-hour sound measurement linked to observed sound events were conducted in each area of the center's neonatal intensive care unit. Two of each measurement type were conducted in the pediatric intensive care unit. Focus groups were conducted with parents and staff. Transcripts were analyzed with descriptive content analysis and themes were compared against results from quantitative measurements. Sound levels exceeded recommended standards at nearly every time point. The most common code was related to talking. Themes from focus groups included the critical care context and sound levels, effects of sound levels, and reducing sound levels-the way forward. Results are consistent with work conducted in other critical care environments. Staff and families realize that high sound levels can be a problem, but feel that the culture and context are not supportive of a quiet care space. High levels of ambient sound suggest that the largest changes in sound levels are likely to come from design and equipment purchase decisions. L10 and Lmax appear to be the best outcomes for measurement of behavioral interventions.

The Power of a Parent's Touch: Evaluation of Reach and Impact of a Targeted Evidence-Based YouTube Video.

Despite strong evidence that skin-to-skin contact and breast-feeding are effective pain-relieving interventions for infants undergoing painful procedures, they remain underutilized in clinical practice. Given the important contribution of parents, there is a need to find innovative ways to assist parents to become actively involved in their infant's care. We developed a YouTube video to disseminate evidence-based information on the effectiveness of skin-to-skin contact and breast-feeding for infant pain management. The 2-minute 39-second video launched on December 2, 2014, and was promoted through Web-based and in-person communication and YouTube advertisements. Data were collected using YouTube analytics and an online survey. Post-18 months from its launch, the video had a reach of 157 938 views from 154 countries, with most viewers watching an average of 73% of the video (1 minute 56 seconds). Parents (n = 32) and healthcare providers (n = 170) completed the survey. Overall, both reported that they liked the video, found it helpful, felt more confident, and were more likely to use skin-to-skin contact (16% and 12%) and breast-feeding (3% and 11%), respectively, during future painful procedures. Despite the high-viewing patterns, alternative methods should be considered to better evaluate the impact on practice change.

Formative Study on the Wearability and Usability of a Large-Volume Patch Injector.

BACKGROUND: The subcutaneous self-administration of biologics using a single large-volume bolus dose requires novel large-volume patch injectors. However, the usability and wearability of such on-body devices has rarely been investigated thus far. Therefore, this formative simulated use experiment studies the overall handling and acceptability in terms of the size and weight of a novel 10 mL large-volume patch injector device platform. METHODS: Twenty-three participants, including patients and healthcare professionals, simulated two injections with the large-volume patch injector, each lasting 17 min. During the injections, the patient participants performed predefined movements and activities with the on-body devices. Perceived usability and wearability were assessed through observation by the moderator and participant-reported feedback using five-point Likert scales and open-ended interviews. RESULTS: All participants successfully completed the simulated injections. Only non-serious usability issues were identified. Users rated the device acceptability in terms of wearability and usability with high ratings. CONCLUSION: The results suggest the safe and effective usage of a novel prefilled large-volume patch injector that enables the subcutaneous delivery of a single bolus dose of up to 10 mL with an injection duration of 15 min. The participants of the simulated use study successfully used the device regardless of the disease state, age, or body size and habitus.

Delivery room interventions to prevent bronchopulmonary dysplasia in preterm infants: a protocol for a systematic review and network meta-analysis.

INTRODUCTION: As gestational age decreases, incidence of bronchopulmonary dysplasia (BPD) and chronic lung disease increases. There are many interventions used in the delivery room to prevent acute lung injury and consequently BPD in these patients. The availability of different treatment options often poses a practical challenge to the practicing neonatologist when it comes to making an evidence-based choice as the multitude of pairwise systematic reviews including Cochrane reviews that are currently available only provide a narrow perspective through head-to-head comparisons. METHODS AND ANALYSIS: We will conduct a systematic review of all randomised controlled trials evaluating delivery room interventions within the first golden hour after birth for prevention of BPD. The primary outcome includes BPD. Secondary outcomes include death at 36 weeks of postmenstrual age or before discharge; severe intraventricular haemorrhage (grade 3 or 4 based on the Papile criteria); any air leak syndromes (including pneumothorax or pulmonary interstitial emphysema); retinopathy of prematurity (any stage) and neurodevelopmental impairment at 18-24 months. We will search from their inception to August 2018, the following databases: Medline, EMBASE and Cochrane Central Register of Controlled Trials as well as grey literature resources. Two reviewers will independently screen titles and abstracts, review full texts, extract information and assess the risk of bias and the confidence in the estimate (with Grading of Recommendations Assessment, Development and Evaluation approach). This review will use Bayesian network meta-analysis approach which allows the comparison of the multiple delivery room interventions for prevention of BPD. We will perform a Bayesian network meta-analysis to combine the pooled direct and indirect treatment effect estimates for each outcome, effectiveness and safety of delivery room interventions for prevention of BPD. ETHICS AND DISSEMINATION: The proposed protocol is a network meta-analysis, which has been registered on PROSPERO International prospective register of systematic reviews (CRD42018078648). The results will provide an evidence-based guide to choosing the right sequence of early postnatal interventions that will be associated with the least likelihood of inducing lung injury and BPD in preterm infants. Furthermore, we will identify knowledge gaps and will encourage further research for other therapeutic options. Therefore, its results will be disseminated through peer-reviewed publications and conference presentations. Due to the nature of the design, no ethics approval is necessary.

Pharmacological Treatments for Neonatal Abstinence Syndrome: A Systematic Review and Network Meta-analysis.

Importance: Incidence of neonatal abstinence syndrome is rising rapidly, and optimal pharmacotherapy may meaningfully reduce length of treatment. Objective: To compare pharmacological therapies for neonatal abstinence syndrome. Data Sources: Systematic review and network meta-analysis of Medline (1946-June 2018), Embase (1974-June 2018), Cochrane CENTRAL (1966-June 2018), Web of Science (1900-June 2018), and ClinicalTrials.gov (June 2018). Study Selection: Randomized clinical trials of pharmacological treatments for neonatal abstinence syndrome alone or in combination with adjuvant treatments. Abstract, title, and full-text screening were conducted independently by 2 reviewers (T.D. and C.G.). Data Extraction and Synthesis: Data extraction was conducted independently by 2 reviewers (T.D. and C.G.) according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA)-Network Meta-Analyses guidelines. Quality was assessed with the Cochrane Risk of Bias tool and data were pooled with fixed-effect models as a result of the low number of trials that were included in the analysis. Main Outcomes and Measures: The primary outcome was the length of treatment. The length of stay, need for adjuvant therapy, and adverse events were considered as secondary outcomes. Results: Eighteen trials (N = 1072) were eligible for inclusion. The treatments that were included in the length of treatment analysis were buprenorphine, clonidine, diluted tincture of opium and clonidine, diluted tincture of opium, morphine, methadone, and phenobarbital. Sublingual buprenorphine was considered the optimal treatment for a reduction in the length of treatment (days: mean difference vs morphine, -12.75 [95% CI, -17.97 to -7.58]; median rank, 1 [3-1]) and length of stay (days: mean difference vs morphine, -11.43 [95% CI, -16.95 to -5.82]; median rank, 1 [3-1]) but not the need for adjuvant treatment (odds ratio vs morphine, 1.23 [95% CI, 0.46-3.44]; median rank, 3 [5-1]). The results were robust to bias but sensitive to imprecision. Conclusions and Relevance: The current evidence suggests that buprenorphine is the optimal treatment for neonatal abstinence treatment, but limitations are considerable and wide-scale adoption requires a large multisite trial. Morphine, which is considered standard of care in most hospitals, was the lowest-ranked opioid for length of treatment and length of stay.

Sustained efficacy of kangaroo care for repeated painful procedures over neonatal intensive care unit hospitalization: a single-blind randomized controlled trial.

Preterm neonates hospitalized in the neonatal intensive care unit undergo frequent painful procedures daily, often without pain treatment, with associated long-term adverse effects. Maternal-infant skin-to-skin contact, or kangaroo care (KC), and sweet-tasting solutions such as sucrose are effective strategies to reduce pain during a single procedure; however, evidence of sustained efficacy over repeated procedures is limited. We aimed to determine the relative sustained efficacy of maternal KC, administered alone or in combination with 24% sucrose, to reduce behavioral pain intensity associated with routine neonatal procedures, compared with 24% sucrose alone. Stable preterm infants (n = 242) were randomized to receive KC and water, KC and 24% sucrose, or 24% sucrose before all routine painful procedures throughout their neonatal intensive care unit stay. Pain intensity, determined using the Premature Infant Pain Profile, was measured during 3 medically indicated heel lances distributed across hospitalization. Maternal and neonatal baseline characteristics, Premature Infant Pain Profile scores at 30, 60, or 90 seconds after heel lance, the distribution of infants with pain scores suggesting mild, moderate, or severe pain, Neurobehavioral Assessment of the Preterm Infant scores, and incidence of adverse outcomes were not statistically significantly different between groups. Maternal KC, as a pain-relieving intervention, remained efficacious over time and repeated painful procedures without evidence of any harm or neurological impact. It seemed to be equally effective as 24% oral sucrose, and the combination of maternal KC and sucrose did not seem to provide additional benefit, challenging the existing recommendation of using sucrose as the primary standard of care.

Memories of Infant Pain in the Neonatal Intensive Care Unit Influence Posttraumatic Stress Symptoms in Mothers of Infants Born Preterm.

OBJECTIVES: The birth of a preterm infant and witnessing ones' infant in pain is remembered by parents as being one of the most stressful aspects of the neonatal intensive care unit (NICU). Elevated posttraumatic stress symptoms (PTSS) are highly prevalent among mothers of preterm infants, however, little is known about mothers' memories of invasive procedures in the NICU and how these memories may contribute to the development of PTSS. We examined the relationships between number of invasive procedures, mothers' memories of these procedures, and their PTSS at discharge from the NICU. MATERIALS AND METHODS: Participants included 36 mothers of infants born below 37 weeks gestational age recruited from a tertiary-level NICU. Medical chart review was performed between birth and discharge from the NICU. At discharge, a research nurse conducted a structured memory interview with the mothers to assess their memories of their infants' invasive procedures. Mothers also completed a self-report measure of PTSS (Posttraumatic Stress Disorder Checklist for the DSM-5). RESULTS: Mothers of infants exposed to greater numbers of invasive procedures had more elevated PTSS at discharge (R=0.37). Moreover, mothers who recalled having greater anxiety about their infant's invasive procedures had greater symptoms of reexperiencing (R=0.34) and avoidance (R=0.28) at discharge from the NICU. DISCUSSION: Greater neonatal exposure to invasive procedures and mothers' recall of these procedures were related to mothers' posttraumatic stress symptomatology at discharge. Invasive procedures in the NICU represent an important target area for neonatal intervention to reduce maternal distress and improve outcomes.

Pain-Relieving Interventions for Retinopathy of Prematurity: A Meta-analysis.

CONTEXT: Retinopathy of prematurity eye examinations conducted in the neonatal intensive care. OBJECTIVE: To combine randomized trials of pain-relieving interventions for retinopathy of prematurity examinations using network meta-analysis. DATA SOURCES: Systematic review and network meta-analysis of Medline, Embase, Cochrane Central Register of Controlled Trials, Web of Science, and the World Health Organization International Clinical Trials Registry Platform. All databases were searched from inception to February 2017. STUDY SELECTION: Abstract and title screen and full-text screening were conducted independently by 2 reviewers. DATA EXTRACTION: Data were extracted by 2 reviewers and pooled with random effect models if the number of trials within a comparison was sufficient. The primary outcome was pain during the examination period; secondary outcomes were pain after the examination, physiologic response, and adverse events. RESULTS: Twenty-nine studies (N = 1487) were included. Topical anesthetic (TA) combined with sweet taste and an adjunct intervention (eg, nonnutritive sucking) had the highest probability of being the optimal treatment (mean difference [95% credible interval] versus TA alone = -3.67 [-5.86 to -1.47]; surface under the cumulative ranking curve = 0.86). Secondary outcomes were sparsely reported (2-4 studies, N = 90-248) but supported sweet-tasting solutions with or without adjunct interventions as optimal. LIMITATIONS: Limitations included moderate heterogeneity in pain assessment reactivity phase and severe heterogeneity in the regulation phase. CONCLUSIONS: Multisensory interventions including sweet taste is likely the optimal treatment for reducing pain resulting from eye examinations in preterm infants. No interventions were effective in absolute terms.

Single room versus open-bay design in neonatal intensive care units for improvement in infant outcomes: a systematic review protocol.

REVIEW QUESTION/OBJECTIVE: The objective of this review is to identify the impact of single room neonatal intensive care unit (NICU) design on infant outcomes compared to alternative design.The specific question is: what is the impact of single room design on outcomes of infants cared for in intensive care units compared to those in alternative designs?

Understanding kangaroo care and its benefits to preterm infants.

The holding of an infant with ventral skin-to-skin contact typically in an upright position with the swaddled infant on the chest of the parent, is commonly referred to as kangaroo care (KC), due to its simulation of marsupial care. It is recommended that KC, as a feasible, natural, and cost-effective intervention, should be standard of care in the delivery of quality health care for all infants, regardless of geographic location or economic status. Numerous benefits of its use have been reported related to mortality, physiological (thermoregulation, cardiorespiratory stability), behavioral (sleep, breastfeeding duration, and degree of exclusivity) domains, as an effective therapy to relieve procedural pain, and improved neurodevelopment. Yet despite these recommendations and a lack of negative research findings, adoption of KC as a routine clinical practice remains variable and underutilized. Furthermore, uncertainty remains as to whether continuous KC should be recommended in all settings or if there is a critical period of initiation, dose, or duration that is optimal. This review synthesizes current knowledge about the benefits of KC for infants born preterm, highlighting differences and similarities across low and higher resource countries and in a non-pain and pain context. Additionally, implementation considerations and unanswered questions for future research are addressed.