Exposure-based Interventions for the management of individuals with high levels of needle fear across the lifespan: a clinical practice guideline and call for further research.

Needle fear typically begins in childhood and represents an important health-related issue across the lifespan. Individuals who are highly fearful of needles frequently avoid health care. Although guidance exists for managing needle pain and fear during procedures, the most highly fearful may refuse or abstain from such procedures. The purpose of a clinical practice guideline (CPG) is to provide actionable instruction on the management of a particular health concern; this guidance emerges from a systematic process. Using evidence from a rigorous systematic review interpreted by an expert panel, this CPG provides recommendations on exposure-based interventions for high levels of needle fear in children and adults. The AGREE-II, GRADE, and Cochrane methodologies were used. Exposure-based interventions were included. The included evidence was very low quality on average. Strong recommendations include the following. In vivo (live/in person) exposure-based therapy is recommended (vs. no treatment) for children seven years and older and adults with high levels of needle fear. Non-in vivo (imaginal, computer-based) exposure (vs. no treatment) is recommended for individuals (over seven years of age) who are unwilling to undergo in vivo exposure. Although there were no included trials which examined children < 7 years, exposure-based interventions are discussed as good clinical practice. Implementation considerations are discussed and clinical tools are provided. Utilization of these recommended practices may lead to improved health outcomes due to better health care compliance. Research on the understanding and treatment of high levels of needle fear is urgently needed; specific recommendations are provided.

Prenatal exposure to antidepressants and persistent pulmonary hypertension of the newborn: systematic review and meta-analysis.

OBJECTIVE: To examine the risk for persistent pulmonary hypertension of the newborn associated with antenatal exposure to antidepressants. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Embase, Medline, PsycINFO, and CINAHL from inception to 30 December 2012. ELIGIBILITY: English language studies reporting persistent pulmonary hypertension of the newborn associated with exposure to antidepressants. Two independent reviewers extracted data and assessed the quality of each article. RESULTS: Of the 3077 abstracts reviewed, 738 papers were retrieved and seven included. All seven studies were above our quality threshold. Quantitative analysis was only possible for selective serotonin reuptake inhibitors (SSRIs). Although exposure to SSRIs in early pregnancy was not associated with persistent pulmonary hypertension of the newborn (odds ratio 1.23, 95% confidence interval 0.58 to 2.60; P=0.58), exposure in late pregnancy was (2.50, 1.32 to 4.73; P=0.005). Effects were not significant for any of the moderator variables examined, including study design, congenital malformations, and meconium aspiration. It was not possible to assess for the effect of caesarean section, body mass index, or preterm delivery. The absolute risk difference for development of persistent pulmonary hypertension of the newborn after exposure to SSRIs in late pregnancy was 2.9 to 3.5 per 1000 infants; therefore an estimated 286 to 351 women would need to be treated with an SSRI in late pregnancy to result in an average of one additional case of persistent pulmonary hypertension of the newborn. CONCLUSIONS: The risk of persistent pulmonary hypertension of the newborn seems to be increased for infants exposed to SSRIs in late pregnancy, independent of the potential moderator variables examined. A significant relation for exposure to SSRIs in early pregnancy was not evident. Although the statistical association was significant, clinically the absolute risk of persistent pulmonary hypertension of the newborn remained low even in the context of late exposure to SSRIs.

Antidepressant exposure during pregnancy and congenital malformations: is there an association? A systematic review and meta-analysis of the best evidence.

OBJECTIVE: Depression is often not optimally treated during pregnancy, partially because of conflicting data regarding antidepressant medication risk. This meta-analysis was conducted to determine whether antenatal antidepressant exposure is associated with congenital malformations and to assess the effect of known methodological limitations. DATA SOURCES: EMBASE, CINAHL, PsycINFO, and MEDLINE were searched from their start dates to June 2010. Keywords of various combinations were used, including, but not limited to depressive/mood disorder, pregnancy, antidepressant drug/agent, congenital malformation, and cardiac malformation. STUDY SELECTION: English language studies reporting congenital malformations associated with antidepressants were included. Of 3,074 abstracts reviewed, 735 studies were retrieved and 27 studies were included. DATA EXTRACTION: Two reviewers working independently assessed article quality. Data on use of any antidepressant, including fluoxetine and paroxetine specifically, were extracted. Outcomes included congenital malformations, major congenital malformations, cardiovascular defects, septal heart defects (ventral septal defects and atrial septal defects), and ventral septal defects only. RESULTS: Nineteen studies were above quality threshold and make up the primary meta-analyses. Pooled relative risks (RRs) were derived by using random-effects methods. Antidepressant exposure was not associated with congenital malformations (RR = 0.93; 95% CI, 0.85-1.02; P = .113) or major malformations (RR = 1.07; 95% CI, 0.99-1.17; P = .095). However, increased risk for cardiovascular malformations (RR = 1.36; 95% CI, 1.08-1.71; P = .008) and septal heart defects (RR = 1.40; 95% CI, 1.10-1.77; P = .005) were found; the RR for ventral septal defects was similar to septal defects, although not significant (RR = 1.54; 95% CI, 0.71-3.33; P = .274). Pooled effects were significant for paroxetine and cardiovascular malformations (RR = 1.43; 95% CI, 1.08-1.88; P = .012). These results are contrasted with those addressing methodological limitations but are typically consistent. CONCLUSIONS: Overall, antidepressants do not appear to be associated with an increased risk of congenital malformations, but statistical significance was found for cardiovascular malformations. Results were robust in several sensitivity analyses. Given that the RRs are marginal, they may be the result of uncontrolled confounders. Although the RRs were statistically significant, none reached clinically significant levels.

The effect of prenatal antidepressant exposure on neonatal adaptation: a systematic review and meta-analysis.

OBJECTIVE: Conflicting reports on potential risks of antidepressant exposure during gestation for the infant have been reported in the literature. This systematic review and meta-analysis on immediate neonatal outcomes were conducted to clarify what, if any, risks are faced by infants exposed to antidepressants in utero. Subanalyses address known methodological limitations in the field. DATA SOURCES: MEDLINE, EMBASE, CINAHL, and PsycINFO were searched from their start dates to June 2010. Various combinations of keywords were utilized including, but not limited to, depressive/mood disorder, pregnancy/pregnancy trimesters, antidepressant drugs, and neonatal effects. STUDY SELECTION: English language and cohort and case-control studies reporting on a cluster of signs defined as poor neonatal adaptation syndrome (PNAS) or individual clinical signs (respiratory distress and tremors) associated with pharmacologic treatment were selected. Of 3,074 abstracts reviewed, 735 articles were retrieved and 12 were included in this analysis. DATA EXTRACTION: Two independent reviewers extracted data and assessed the quality of the articles. RESULTS: Twelve studies were retrieved that examined PNAS or the signs of respiratory distress and tremors in the infant. There was a significant association between exposure to antidepressants during pregnancy and overall occurrence of PNAS (odds ratio [OR] = 5.07; 95% CI, 3.25-7.90; P < .0001). Respiratory distress (OR = 2.20; 95% CI, 1.81-2.66; P < .0001) and tremors (OR = 7.89; 95% CI, 3.33-18.73; P < .0001) were also significantly associated with antidepressant exposure. For the respiratory outcome, studies using convenience samples had significantly higher ORs (Q1 = 5.4, P = .020). No differences were found in any other moderator analyses. CONCLUSIONS: An increased risk of PNAS exists in infants exposed to antidepressant medication during pregnancy; respiratory distress and tremors also show associations. Neonatologists need to be prepared and updated in their management, and clinicians must inform their patients of this risk.

The impact of maternal depression during pregnancy on perinatal outcomes: a systematic review and meta-analysis.

OBJECTIVE: Depression often remains undertreated during pregnancy and there is growing evidence that untoward perinatal outcomes can result. Our systematic review and meta-analysis was conducted to determine whether maternal depression during pregnancy is associated with adverse perinatal and infant outcomes. DATA SOURCES: MEDLINE, EMBASE, CINAHL, and PsycINFO were searched from their start dates to June 2010. Keywords utilized included depressive/mood disorder, postpartum/postnatal, pregnancy/pregnancy trimesters, prenatal or antenatal, infant/neonatal outcomes, premature delivery, gestational age, birth weight, NICU, preeclampsia, breastfeeding, and Apgar. STUDY SELECTION: English language studies reporting on perinatal or child outcomes associated with maternal depression were included, 3,074 abstracts were reviewed, 735 articles retrieved, and 30 studies included. DATA EXTRACTION: Two independent reviewers extracted data and assessed article quality. All studies were included in the primary analyses, and between-group differences for subanalyses are also reported. RESULTS: Thirty studies were eligible for inclusion. Premature delivery and decrease in breastfeeding initiation were significantly associated with maternal depression (odds ratio [OR] = 1.37; 95% CI, 1.04 to 1.81; P = .024; and OR = 0.68; 95% CI, 0.61 to 0.76; P < .0001, respectively). While birth weight (mean difference = -19.53 g; 95% CI, -64.27 to 25.20; P = .392), low birth weight (OR = 1.21; 95% CI, 0.91 to 1.60; P = .195), neonatal intensive care unit admissions (OR = 1.43; 95% CI, 0.83 to 2.47; P = .195), and preeclampsia (OR = 1.35; 95% CI, 0.95 to 1.92; P = .089) did not show significant associations in the main analyses, some subanalyses were significant. Gestational age (mean difference = -0.19 weeks; 95% CI, -0.53 to 0.14; P = .262) and Apgar scores at 1 (mean difference = -0.05; 95% CI, -0.28 to 0.17; P = .638) and 5 minutes (mean difference = 0.01; 95% CI, -0.08 to 0.11; P = .782) did not demonstrate any significant associations with depression. For premature delivery, a convenience sample study design was associated with higher ORs (OR = 2.43; 95% CI, 1.47 to 4.01; P = .001). CONCLUSIONS: Maternal depression during pregnancy is associated with increased odds for premature delivery and decreased breastfeeding initiation; however, the effects are modest. More research of higher methodological quality is needed.

Selected pregnancy and delivery outcomes after exposure to antidepressant medication: a systematic review and meta-analysis.

IMPORTANCE: Untreated depression during pregnancy has been associated with increased morbidity and mortality for both mother and child and, as such, optimal treatment strategies are required for this population. CONTEXT: There are conflicting data regarding potential risks of prenatal antidepressant treatment. OBJECTIVE: To determine whether prenatal antidepressant exposure is associated with risk for selected adverse pregnancy or delivery outcomes. DATA SOURCES MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, and the Cochrane Library were searched from their start dates to June 30, 2010. STUDY SELECTION English-language studies reporting outcomes associated with pharmacologic treatment during pregnancy were included. We reviewed 3074 abstracts, retrieved 735 articles, and included 23 studies in this meta-analysis. DATA EXTRACTION: Study design, antidepressant exposure, adjustment for confounders, and study quality were extracted by 2 independent reviewers. RESULTS: There was no significant association between antidepressant medication exposure and spontaneous abortion (odds ratio [OR], 1.47; 95% CI, 0.99 to 2.17; P = .055). Gestational age and preterm delivery were statistically significantly associated with antidepressant exposure (mean difference [MD] [weeks], -0.45; 95% CI, -0.64 to -0.25; P < .001; and OR, 1.55; 95% CI, 1.38 to 1.74; P < .001, respectively), regardless of whether the comparison group consisted of all unexposed mothers or only depressed mothers without antidepressant exposure. Antidepressant exposure during pregnancy was significantly associated with lower birth weight (MD [grams], -74; 95% CI, -117 to -31; P = .001); when this comparison group was limited to depressed mothers without antidepressant exposure, there was no longer a significant association. Antidepressant exposure was significantly associated with lower Apgar scores at 1 and 5 minutes, regardless of whether the comparison group was all mothers or only those who were depressed during pregnancy but not exposed to antidepressants. CONCLUSIONS AND RELEVANCE: Although statistically significant associations between antidepressant exposure and pregnancy and delivery outcomes were identified, group differences were small and scores in the exposed group were typically within the normal ranges, indicating the importance of considering clinical significance. Treatment decisions must weigh the effect of untreated maternal depression against the potential adverse effects of antidepressant exposure.

Screening and recording of alcohol use among women of child-bearing age and pregnant women.

A woman's alcohol use during pregnancy is one of the top preventable causes of birth defects and developmental disabilities that are known as fetal alcohol spectrum disorders (FASD). The social and economic burden of FASD is substantial. Lifetime direct tangible costs per individual related to health care, education and social services in Canada have been estimated to be $1.4 million. Screening women of child-bearing age and pregnant women and recording their alcohol consumption is a practical process to identify and evaluate women at-risk and to identify potentially exposed infants. The FASD Advisory Workgroup proposes the following three levels of screenings which should be done on consenting women: Level I screening involves practice-based approaches that can be used by health care providers when talking to women about alcohol use, such as motivational interviewing and supportive dialogue. Level II screening includes a number of structured questionnaires that can be used with direct questioning (TLFB) or indirect /masked screening (AUDIT, BMAST / SMAST, CAGE, CRAFFT, T-ACE, TWEAK). Level III screening includes laboratory-based tools that can be used to confirm the presence of a drug, its level of exposure and determine the presence of multiple drugs. There are challenges and limitations in the use of the screening and assessment tools outlined. For example, the single question about alcohol use and the various questionnaires rely on a woman to provide details about her alcohol use. There is no consensus on the appropriate screening to use across Canada as each provincial / territorial jurisdiction, health care organization and healthcare provider uses a variety of formal and informal screening tool. In addition, there are inconsistent processes across Canada for the recording of the alcohol use in a woman's chart and the transfer of the information to the infant and the child's health records. The FASD Advisory Workgroup proposes eleven recommendations to improve the screening and recording processes for alcohol use in women of child-bearing age and pregnant women.

The 18-month well-child visit in primary care: Clinical strategies for early intervention.

Family physicians, paediatricians, nurse practitioners and all primary health care providers are well-positioned in the health care system to provide identification and intervention for developmental delay in early childhood. This can be accomplished through the promotion of healthy child development by supporting children and their parents, paying special attention to issues of attachment and parent-child interactions. Early recognition and intervention is critical for addressing all developmental, social and behavioural problems in young children. A familiarity with local community resources and services is crucial; it will assist primary health care providers in supporting families by providing extra assistance and assessment for families at risk. The present article reports on the evidence-based interventions at the 18-month visit including screening tools, resources and a case example. The importance of interdisciplinary coordination to provide a comprehensive approach to screening, assessment and intervention for developmental delays in infants and young children is highlighted.