Biological Mechanisms in Pregnant Women With Anxiety (Happy Mother-Healthy Baby Supplement Study): Protocol for a Longitudinal Mixed Methods Observational Study.

BACKGROUND: Anxiety and depression are common in the perinatal period and negatively affect the health of the mother and baby. Our group has developed "Happy Mother-Healthy Baby" (HMHB), a cognitive behavioral therapy-based psychosocial intervention to address risk factors specific to anxiety during pregnancy in low- and middle-income countries (LMICs). OBJECTIVE: The purpose of this study is to examine biological mechanisms that may be linked to perinatal anxiety in conjunction with a randomized controlled trial of HMHB in Pakistan. METHODS: We are recruiting 120 pregnant women from the Holy Family Hospital, a public facility in Rawalpindi, Pakistan. Participants are assessed for at least mild anxiety symptoms using the Hospital Anxiety and Depression Scale (ie, a score ≥8 on the anxiety scale is necessary for inclusion in the anxiety groups and <8 for inclusion in the healthy control group). Women who meet the criteria for an anxiety group are randomized into either the HMHB intervention group or an enhanced usual care (EUC) control group. Participants receive HMHB or EUC throughout pregnancy and undergo blood draws at 4 time points (baseline, second trimester, third trimester, and 6 weeks post partum). We will assess peripheral cytokine concentrations using a multiplex assay and hormone concentrations using gas chromatography and mass spectrometry. The statistical analysis will use generalized linear models and mixed effects models to assess the relationships across time among anxiety, immune dysregulation, and hormone levels, and to assess whether these biological factors mediate the relationship between anxiety and birth and child development outcomes. RESULTS: Recruitment started on October 20, 2020, and data collection was completed on August 31, 2022. The start date for recruitment for this biological supplement study was delayed by approximately half a year due to the COVID-19 pandemic. The trial was registered at ClinicalTrials.gov (NCT03880032) on September 22, 2020. The last blood samples were shipped to the United States on September 24, 2022, where they will be processed for analysis. CONCLUSIONS: This study is an important addition to the HMHB randomized controlled trial of an intervention for antenatal anxiety. The intervention itself makes use of nonspecialist providers and, if effective, will represent an important new tool for the treatment of antenatal anxiety in LMICs. Our biological substudy is one of the first attempts to link biological mechanisms to antenatal anxiety in an LMIC in the context of a psychosocial intervention, and our findings have the potential to significantly advance our knowledge of the biological pathways of perinatal mental illness and treatment efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT03880032; https://clinicaltrials.gov/ct2/show/NCT03880032. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43193.

Non-specialist-delivered psychosocial intervention for prenatal anxiety in a tertiary care setting in Pakistan: a qualitative process evaluation.

OBJECTIVES: A manualised cognitive-behavioural therapy-based psychosocial intervention for prenatal anxiety called Happy Mother Healthy Baby is being tested for its effectiveness through a randomised control trial in Pakistan. The aim of this study was to evaluate the intervention delivery process and the research process. DESIGN: Qualitative methods were used to explore in depth the intervention delivery and research process. SETTING: This process evaluation was embedded within a randomised control trial conducted in a tertiary care facility in Rawalpindi, Pakistan. PARTICIPANTS: Data were collected through in-depth interviews (n=35) with the trial participants and focus group discussions (n=3) with the research staff. Transcripts were analysed using a Framework Analysis. RESULTS: The evaluation of the intervention delivery process indicated that it can be effectively delivered by non-specialist providers trained and supervised by a specialist. The intervention was perceived to be culturally acceptable and appropriately addressing problems related to prenatal anxiety. Lack of awareness of 'talking' therapies and poor family support were potential barriers to participant engagement. The evaluation of the research process highlighted that culturally appropriate consent procedures facilitated recruitment of participants, while incentivisation and family involvement facilitated sustained engagement and retention. Lack of women's empowerment and mental health stigma were potential barriers to implementation of the programme. CONCLUSION: We conclude that non-specialists can feasibly deliver an evidence-based intervention integrated into routine antenatal care in a tertiary hospital. Non-specialist providers are likely to be more cost effective and less stigmatising. Inclusion of family is key for participant recruitment, retention and engagement with the intervention. TRIAL REGISTRATION NUMBER: NCT03880032.

'Those whom I have to talk to, I can't talk to': Perceived social isolation in the context of anxiety symptoms among pregnant women in Pakistan.

Anxiety during pregnancy is highly prevalent in low- and middle-income countries. The relative importance of different sources and types of perceived support in the Pakistani context is unknown. We explored social support during pregnancy and the role of social isolation in Pakistani women's experiences of antenatal anxiety. We conducted semi-structured interviews with 19 pregnant women with symptoms of anxiety and 10 female healthcare providers at a public urban hospital. We used inductive and deductive thematic coding to analyse the data. Many pregnant women reported feelings of physical and social isolation, even when living in joint families with larger social networks. Often fearing censure by their in-laws and peers for sharing or seeking help with pregnancy-related anxieties, women reported relying on husbands or natal family members. Normative expectations around pregnancy such as male gender preference, perceived immutability of wives' domestic responsibilities and expectations of accompanied travel by women may serve as sources of disconnectedness in the antenatal period. Providers viewed social isolation and deficits in social support during pregnancy as contributing to worse anxiety symptoms, reduced access to care and poorer health behaviours. One limitation is that the hospital setting for this study may have resulted in underreporting of abuse or neglect and limited inclusion of pregnant women who do not utilise facility-based antenatal care. In conclusion, husbands and natal families were key in reducing social isolation in pregnancy and mitigating anxiety, while in-laws did not always confer support. Targeted strategies should enhance existing support and strengthen in-law family relationships in pregnancy.

The Impact of the COVID-19 Pandemic on Pregnant Women with Perinatal Anxiety Symptoms in Pakistan: A Qualitative Study.

The impact of coronavirus disease 2019 (COVID-19) on people with existing mental health conditions is likely to be high. We explored the consequences of the pandemic on women of lower socioeconomic status with prenatal anxiety symptoms living in urban Rawalpindi, Pakistan. This qualitative study was embedded within an ongoing randomized controlled trial of psychosocial intervention for prenatal anxiety at a public hospital in Rawalpindi. The participants were women with symptoms of anxiety who had received or were receiving the intervention. In total, 27 interviews were conducted; 13 women were in their third trimester of pregnancy, and 14 were in their postnatal period. The data were collected through in-depth interviews and analyzed using framework analysis. Key findings were that during the pandemic, women experienced increased perinatal anxiety that was linked to greater financial problems, uncertainties over availability of appropriate obstetric healthcare, and a lack of trust in health professionals. Women experienced increased levels of fear for their own and their baby's health and safety, especially due to fear of infection. COVID-19 appears to have contributed to symptoms of anxiety in women already predisposed to anxiety in the prenatal period. Efforts to address women's heightened anxiety due to the pandemic are likely to have public health benefits.

Intersections between patient-provider communication and antenatal anxiety in a public healthcare setting in Pakistan.

This study explores pregnant women's and healthcare providers' perspectives on the role of patient-provider communication in experiences of antenatal anxiety within a low-resource setting. In 2017-18, we consecutively sampled pregnant women (n = 19) with at least mild anxiety and purposively sampled antenatal care providers (n = 10) from a public hospital in Punjab Province, Pakistan. We then conducted in-depth interviews and thematically coded them with a combination of inductive and deductive coding methodologies. We found that patients expressed a desire for warm, empathetic communication from providers who demonstrate respect, attentiveness, and a shared lived experience. Providers revealed an awareness that their heavy caseloads, high stress levels, and discourteous tones adversely influenced communication with pregnant women and may exacerbate their anxieties, but also reported that compassionately addressing women's concerns, providing financial problem-solving and/or assistance, and moderating conflicting healthcare desires between patients and their families could alleviate anxiety in pregnant women. Patients reported feelings of anxiety stemming from a belief that they received lower quality communication from antenatal providers at public hospitals than patients received from antenatal providers at private hospitals, an experience that they partially attributed to their low socioeconomic status. Meanwhile, some providers disclosed potentially stigmatizing views of women from particular sociocultural backgrounds or low socioeconomic status, including perceptions that appeared to shape communication with these patients in antenatal care encounters. Our findings provide preliminary evidence that communication between pregnant women and antenatal providers that is warm, normalizes patient fears, and integrates patients' interpersonal and financial considerations can mitigate pregnant women's experiences of anxiety and reduce barriers to accessing antenatal care in Pakistan's public healthcare facilities.

"A Woman Is a Puppet." Women's Disempowerment and Prenatal Anxiety in Pakistan: A Qualitative Study of Sources, Mitigators, and Coping Strategies for Anxiety in Pregnancy.

Common mental disorders are highly prevalent among pregnant women in low- and middle-income countries, yet prenatal anxiety remains poorly understood, particularly in the sociocultural context of South Asia. Our study explored sources, mitigators, and coping strategies for anxiety among symptomatic pregnant women in Pakistan, particularly in relation to autonomy in decision-making and social support. We interviewed 19 pregnant married women aged 18-37 years recruited from 2017-2018 at a public hospital in Rawalpindi who screened positive for anxiety. Thematic analysis was based on both inductive emergent codes and deductive a priori constructs of pregnancy-related empowerment. Gender norms emerged as an important dimension of Pakistani women's social environment in both constraining pregnancy-related agency and contributing to prenatal anxiety. Women's avenues of self-advocacy were largely limited to indirect means such as appeals to the husband for intercession or return to her natal home. The levels of autonomy during pregnancy depended on the area of decision-making, and peer/family support was a critical protective factor and enabling resource for maternal mental health. Women's disempowerment is a key contextual factor in the sociocultural experience of prenatal maternal anxiety in South Asia, and further examination of the intersections between empowerment and perinatal mental illness might help inform the development of more context-specific preventive approaches.

Cognitive-behavioral therapy-based intervention to treat symptoms of anxiety in pregnancy in a prenatal clinic using non-specialist providers in Pakistan: design of a randomised trial.

INTRODUCTION: Prenatal anxiety is a prevalent condition that is harmful for women and a strong predictor of postpartum depression. This trial assesses an intervention initiated in early pregnancy to mid pregnancy among women with clinical or subclinical symptoms of anxiety in Pakistan. METHODS AND ANALYSIS: Happy Mother, Healthy Baby (HMHB) is a phase three, two-arm, single-blind, individual randomised clinical trial conducted in the outpatient department of Holy Family Hospital, a large public tertiary care facility affiliated with Rawalpindi Medical University (RMU). Pregnant women (enrolled at ≤22 weeks of gestation) receive six individual HMHB sessions based on cognitive-behavioral therapy (CBT) and relaxation techniques that are administered by non-specialist providers and tailored to address anxiety symptoms. Two to six booster sessions are given between the fifth consecutive weekly core session and the sixth core session that occurs in the third trimester. Apart from baseline data, data are collected in the third trimester, at birth and at 6-weeks postpartum. Primary outcomes include diagnoses of postpartum common mental disorders. Secondary outcomes include symptoms of anxiety and of depression, and birth outcomes including small-for-gestational age, low birth weight and preterm birth. An economic analysis will determine the cost effectiveness of the intervention. ETHICS: Ethics approval was obtained from the Johns Hopkins Bloomberg School of Health Institutional Review Board (Baltimore, USA), the Human Development Research Foundation Ethics Committee (Islamabad, Pakistan), the RMU Institutional Research Forum (Rawalpindi, Pakistan) and the National Institute of Mental Health-appointed Global Mental Health Data Safety and Monitoring Board. DISSEMINATION: Results from this trial will build evidence for the efficacy of a CBT-based intervention for pregnant women delivered by non-specialised providers. Identification of an evidence-based intervention for anxiety starting in early pregnancy to mid pregnancy may be transferable for use and scale-up in other low-income and middle-income countries. TRIAL REGISTRATION NUMBER: NCT03880032.

Development of a Psychological Intervention to Address Anxiety During Pregnancy in a Low-Income Country.

Background: One in five women suffer from anxiety during pregnancy. Untreated anxiety is a risk factor for postnatal depression and is associated with adverse birth outcomes. Despite the high prevalence of prenatal anxiety in low- and middle-income countries (LMICs), efforts to develop and evaluate context-specific interventions in these settings are lacking. We aimed to develop a culturally appropriate, feasible, and acceptable psychological intervention for perinatal anxiety in the context of a low-income population in Pakistan. Methods: We conducted this research in Rawalpindi District at the Obstetrics Department of the Holy Family Hospital, Rawalpindi Medical University a government facility catering to a mixture of low-income urban, peri-urban, and rural populations. We used a mixture of research methods to: a) investigate the clinical, cultural, and health-service delivery context of perinatal anxiety; b) select an evidence-based approach that suited the population and health-delivery system; c) develop an intervention with extensive reference documentation/manuals; and d) examine issues involved in its implementation. Qualitative data were collected through in-depth interviews and focus group discussions, and analyzed using framework analysis. Results: Informed by the qualitative findings and review of existing evidence-based practices, we developed the "Happy Mother, Healthy Baby" intervention, which was based on principles of cognitive behavior therapy. Its evidence-based elements included: developing an empathetic relationship, challenging thoughts, behavior activation, problem solving, and involving family. These elements were applied using a three-step approach: 1) learning to identify unhealthy or unhelpful thinking and behavior; 2) learning to replace unhealthy or unhelpful thinking and behavior with helpful thinking and behavior; and 3) practicing thinking and acting healthy. Delivered by non-specialist providers, the intervention used culturally appropriate illustrations and examples of healthy activities to set tasks in collaboration with the women to encourage engagement in helpful behaviors. Feedback from the non-specialist providers indicated that the intervention was acceptable, feasible, and perceived to be helpful by the women receiving it. Conclusion: This new psychosocial intervention for perinatal anxiety, based on principles of cognitive behavior therapy and delivered by non-specialists, has the potential to address this important but neglected condition in LMICs.

Impact of Hospital Population Case-Mix, Including Poverty, on Hospital All-Cause and Infection-Related 30-Day Readmission Rates.

BACKGROUND: Reducing hospital readmissions, including preventable healthcare-associated infections, is a national priority. The proportion of readmissions due to infections is not well-understood. Better understanding of hospital risk factors for readmissions and infection-related readmissions may help optimize interventions to prevent readmissions. METHODS: Retrospective cohort study of California acute care hospitals and their patient populations discharged between 2009 and 2011. Demographics, comorbidities, and socioeconomic status were entered into a hierarchical generalized linear mixed model predicting all-cause and infection-related readmissions. Crude verses adjusted hospital rankings were compared using Cohen's kappa. RESULTS: We assessed 30-day readmission rates from 323 hospitals, accounting for 213 879 194 post-discharge person-days of follow-up. Infection-related readmissions represented 28% of all readmissions and were associated with discharging a high proportion of patients to skilled nursing facilities. Hospitals serving populations with high proportions of males, comorbidities, prolonged length of stay, and populations living in a federal poverty area, had higher all-cause and infection-related readmission rates. Academic hospitals had higher all-cause and infection-related readmission rates (odds ratio 1.24 and 1.15, respectively). When comparing adjusted vs crude hospital rankings for infection-related readmission rates, adjustment revealed 31% of hospitals changed performance category for infection-related readmissions. CONCLUSIONS: Infection-related readmissions accounted for nearly 30% of all-cause readmissions. High hospital infection-related readmissions were associated with serving a high proportion of patients with comorbidities, long lengths of stay, discharge to skilled nursing facility, and those living in federal poverty areas. Preventability of these infections needs to be assessed.

Prevalence and Clinical Import of Thoracic Injury Identified by Chest Computed Tomography but Not Chest Radiography in Blunt Trauma: Multicenter Prospective Cohort Study.

STUDY OBJECTIVE: Chest computed tomography (CT) diagnoses more injuries than chest radiography, so-called occult injuries. Wide availability of chest CT has driven substantial increase in emergency department use, although the incidence and clinical significance of chest CT findings have not been fully described. We determine the frequency, severity, and clinical import of occult injury, as determined by changes in management. These data will better inform clinical decisions, need for chest CT, and odds of intervention. METHODS: Our sample included prospective data (2009 to 2013) on 5,912 patients at 10 Level I trauma center EDs with both chest radiography and chest CT at physician discretion. These patients were 40.6% of 14,553 enrolled in the parent study who had either chest radiography or chest CT. Occult injuries were pneumothorax, hemothorax, sternal or greater than 2 rib fractures, pulmonary contusion, thoracic spine or scapula fracture, and diaphragm or great vessel injury found on chest CT but not on preceding chest radiography. A priori, we categorized thoracic injuries as major (having invasive procedures), minor (observation or inpatient pain control >24 hours), or of no clinical significance. Primary outcome was prevalence and proportion of occult injury with major interventions of chest tube, mechanical ventilation, or surgery. Secondary outcome was minor interventions of admission rate or observation hours because of occult injury. RESULTS: Two thousand forty-eight patients (34.6%) had chest injury on chest radiography or chest CT, whereas 1,454 of these patients (71.0%, 24.6% of all patients) had occult injury. Of these, in 954 patients (46.6% of injured, 16.1% of total), chest CT found injuries not observed on immediately preceding chest radiography. In 500 more patients (24.4% of injured patients, 8.5% of all patients), chest radiography found some injury, but chest CT found occult injury. Chest radiography found all injuries in only 29.0% of injured patients. Two hundred and two patients with occult injury (of 1,454, 13.9%) had major interventions, 343 of 1,454 (23.6%) had minor interventions, and 909 (62.5%) had no intervention. Patients with occult injury included 514 with pulmonary contusions (of 682 total, 75.4% occult), 405 with pneumothorax (of 597 total, 67.8% occult), 184 with hemothorax (of 230 total, 80.0% occult), those with greater than 2 rib fractures (n=672/1,120, 60.0% occult) or sternal fracture (n=269/281, 95.7% occult), 12 with great vessel injury (of 18 total, 66.7% occult), 5 with diaphragm injury (of 6, 83.3% occult), and 537 with multiple occult injuries. Interventions for patients with occult injury included mechanical ventilation for 31 of 514 patients with pulmonary contusion (6.0%), chest tube for 118 of 405 patients with pneumothorax (29.1%), and 75 of 184 patients with hemothorax (40.8%). Inpatient pain control or observation greater than 24 hours was conducted for 183 of 672 patients with rib fractures (27.2%) and 79 of 269 with sternal fractures (29.4%). Three of 12 (25%) patients with occult great vessel injuries had surgery. Repeated imaging was conducted for 50.6% of patients with occult injury (88.1% chest radiography, 11.9% chest CT, 7.5% both). For patients with occult injury, 90.9% (1,321/1,454) were admitted, with 9.1% observed in the ED for median 6.9 hours. Forty-four percent of observed patients were then admitted (4.0% of patients with occult injury). CONCLUSION: In a more seriously injured subset of patients with blunt trauma who had both chest radiography and chest CT, occult injuries were found by chest CT in 71% of those with thoracic injuries and one fourth of all those with blunt chest trauma. More than one third of occult injury had intervention (37.5%). Chest tubes composed 76.2% of occult injury major interventions, with observation or inpatient pain control greater than 24 hours in 32.4% of occult fractures. Only 1 in 20 patients with occult injury was discharged home from the ED. For these patients with blunt trauma, chest CT is useful to identify otherwise occult injuries.

Computer-Assisted Diabetes Risk Assessment and Education (CADRAE) for Medically Vulnerable Populations in the Middle East: a Novel and Practical Method for Prevention.

The prevalence of diabetes in the Middle East is increasing rapidly due to urbanization, reduced levels of physical activity, and a nutritional transition toward increased consumption of fats and refined carbohydrates. Preventive strategies are of paramount importance to stemming the tide. Portable touch-screen computer technology may hold an answer for alleviating the burdens of cost, time, and training that limit the implementation of diabetes risk screening and intervention, especially among refugees and other vulnerable populations. The Computer-Assisted Diabetes Risk Assessment and Education (CADRAE) Arabic-language intervention program is proposed as a model method for practicing proactive type 2 diabetes prevention in resource-limited settings of the Middle East that combines the efficiency of risk-score screening methods, the advantages of portable computer interface, and the spirit of brief motivational interviewing. This paper aims to describe the theory and novel design of CADRAE-introduced at the Noor Al Hussein Foundation's Institute of Family Health in January 2014-as well as discuss opportunities and challenges for its implementation and evaluation in primary or emergency care settings. Features of CADRAE are elucidated in detail, including development, translation, conceptual framework, theoretical basis, method of risk assessment, brief intervention style, definition of outcomes, requirements for implementation, and potential means of evaluation and quality improvement. CADRAE offers the first example of portable computer technology integrating diabetes risk screening with behavior change counseling tailored for an Arabic-speaking population of mostly refugees and could offer a valuable model for researchers and policy makers of the Middle East as well as other resource-limited settings.

Yield and clinical predictors of thoracic spine injury from chest computed tomography for blunt trauma.

INTRODUCTION: Cost and radiation risk have prompted intense examination of trauma patient imaging. A proposed decision instrument (DI) for the use of chest computed tomography (CT), (CCT) in blunt trauma patients includes thoracic spine (TS) tenderness, altered mental status (AMS) and distracting painful injury (DPI) as potential predictor variables. TS CT is a separate, costly study whose value is currently ill-defined. The objective of this study is to determine test characteristics of these predictor variables alone, and in combination, to derive a TS injury DI. METHODS: Prospective cohort study of blunt trauma patients age > 14 in a Level I Trauma Center who had either CCT or TS CT. RESULTS: Of 1,798 blunt trauma patients, 1,174 (65.3%) had CCT, and 46 (2.6%) had a TS CT at physician discretion. CCT identified 58 TS injuries in 1,220 patients (4.8%). For 1,032 patients without AMS, 18/35 had TS tenderness, for sensitivity of 51.4%, specificity 84.7%, positive (PPV) and negative predictive values (NPV) of 10.5% and 98.0%. Positive likelihood ratio (+LR) was 3.35, with negative (-LR) 0.57. Among the 58 TS injuries, 23 had AMS for sensitivity of 39.7%, with other test characteristics of 85.8%, 12.2%, 96.6%, with +LR 2.79 and -LR 0.70. Thirty-eight of 58 had DPI, for sensitivity 65.5%, with other test characteristics 65.7%, 8.7%, and 97.4%, with +LR 1.91 and -LR 0.52. Combining 3 predictor variables into a proposed DI found 56/58 injuries for test characteristics of 96.6% (95% CI 88.1-99.6%), 49.1% (46.1-52.0%), 8.6% (6.6-11.1%) and 99.7% (CI 98.7-100%), with +LR 1.90 (1.76-2.04) and -LR 0.07 (0.02-0.28). If validated, the DI would exclude 572/1,220 CCT patients from separate TS CT (46.9%, CI 44.1-49.7%), and 141/511 (27.6%, CI 23.8-31.7%) patients who actually had TS CT in our cohort. Medicare payment at our center for sagittal reconstructions of TS CT is $280 for professional plus technical charges ($3,312 per study). The DI, if validated, would save $39,000-$160,000 in TS imaging payments. CONCLUSION: TS CT is low yield and costly. Patients who are alert, have no TS tenderness and no DPI have a very low likelihood of TS injury (NPV 99.7% 95% CI lower limit 98.7%) with -LR=0.07, 95% CI upper limit 0.28). Avoiding TS CT may save considerable charges and payments.