Geographical migration and fitness dynamics of Streptococcus pneumoniae.

Streptococcus pneumoniae is a leading cause of pneumonia and meningitis worldwide. Many different serotypes co-circulate endemically in any one location1,2. The extent and mechanisms of spread and vaccine-driven changes in fitness and antimicrobial resistance remain largely unquantified. Here using geolocated genome sequences from South Africa (n = 6,910, collected from 2000 to 2014), we developed models to reconstruct spread, pairing detailed human mobility data and genomic data. Separately, we estimated the population-level changes in fitness of strains that are included (vaccine type (VT)) and not included (non-vaccine type (NVT)) in pneumococcal conjugate vaccines, first implemented in South Africa in 2009. Differences in strain fitness between those that are and are not resistant to penicillin were also evaluated. We found that pneumococci only become homogenously mixed across South Africa after 50 years of transmission, with the slow spread driven by the focal nature of human mobility. Furthermore, in the years following vaccine implementation, the relative fitness of NVT compared with VT strains increased (relative risk of 1.68; 95% confidence interval of 1.59-1.77), with an increasing proportion of these NVT strains becoming resistant to penicillin. Our findings point to highly entrenched, slow transmission and indicate that initial vaccine-linked decreases in antimicrobial resistance may be transient.

Bacterial nasopharyngeal colonisation in children in South Africa before and during the COVID-19 pandemic: an observational study.

BACKGROUND: Deployment of non-pharmaceutical interventions such as face masking and physical distancing during the COVID-19 pandemic could have altered the transmission dynamics and carriage of respiratory organisms. We evaluated colonisation with Streptococcus pneumoniae and other upper respiratory tract bacterial colonisers before and during the COVID-19 pandemic. METHODS: We did two cross-sectional surveys in Soweto, South Africa from July 3 to Dec 13, 2018 (pre-COVID-19 period) and from Aug 4, 2021, to March 31, 2022 (COVID-19 period) in healthy children (aged ≤60 months) who had recorded HIV status and had not received antibiotics in the 21 days before enrolment. At enrolment, we collected nasopharyngeal swab samples from child participants. Following nucleic acid extraction, nanofluidic quantitative PCR was used to screen all samples for 92 S pneumoniae serotypes and 14 other bacteria. The primary objective was to compare the prevalence and density of pneumococcal nasopharyngeal colonisation, overall and stratified by 13-valent pneumococcal conjugate vaccine (PCV13) serotypes and non-vaccine serotypes. Secondary study objectives included a comparison of serotype-specific pneumococcal colonisation and density, as well as colonisation by the 14 other bacteria in the COVID-19 versus pre-COVID-19 period. We used an adjusted multiple logistic and linear regression model to compare the colonisation prevalence and density between study periods. FINDINGS: We analysed nasopharyngeal swabs from 1107 children (n=571 in the pre-COVID-19 period; n=536 in the COVID-19 period). We observed no change in overall pneumococcal colonisation between periods (274 [51%] of 536 in the COVID-19 period vs 282 [49%] of 571 in the pre-COVID-19 period; adjusted odds ratio [aOR] 1·03 [95% CI 0·95-1·12]). The prevalence of PCV13 serotypes was lower in the COVID-19 than in the pre-COVID-19 period (72 [13%] vs 106 [19%]; 0·87 [0·78-0·97]), whereas the prevalence of non-typeable S pneumoniae was higher (34 [6%] vs 63 [12%]; 1·30 [1·12-1·50]). The mean log10 density for overall pneumococcal colonisation was lower in the COVID-19 period than in the pre-COVID-19 period (3·96 [95% CI 3·85-4·07] vs 4·72 [4·63-4·80] log10 genome equivalents per mL; p<0·0001). A lower density of non-vaccine serotypes (3·63 [3·51-3·74] vs 4·08 [3·95-4·22] log10 genome equivalents per mL; p<0·0001) and non-typeable S pneumoniae (3·11 [2·94-3·29] vs 4·41 [4·06-4·75] log10 genome equivalents per mL; p<0·00001) was also observed in the COVID-19 period. There was no difference in the density of PCV13 serotypes between the periods. The prevalence of colonisation during the COVID-19 versus pre-COVID-19 period was lower for non-typeable Haemophilus influenzae (280 [49%] vs 165 [31%]; aOR 0·77 [95% CI 0·71-0·84]), Moraxella catarrhalis (328 [57%] vs 242 [45%]; 0·85 [0·79-0·92]), and Neisseria lactamica (51 [9%] vs 13 [2%]; 0·64 [0·52-0·78]), but higher for Acinetobacter baumannii (34 [6%] vs 102 [19%]; 1·55 [1·35-1·77]) and Staphylococcus aureus (29 [5%] vs 52 [10%]; 1·28 [1·10-1·50]). INTERPRETATION: There were variable effects on the colonisation prevalence and density of bacterial organisms during the COVID-19 compared with the pre-COVID-19 period. The lower prevalence of PCV13 serotype together with other respiratory organisms including non-typeable H influenzae and M catarrhalis could have in part contributed to a decrease in all-cause lower respiratory tract infections observed in South Africa during the initial stage of the COVID-19 pandemic. The pathophysiological mechanism for the increase in A baumannii and S aureus colonisation warrants further investigation, as does the clinical relevance of these findings. FUNDING: The Bill & Melinda Gates Foundation.

Social workers roles in achieving health quality metrics in primary care: a quality improvement case study.

Value-based payment models may improve patient health by targeting quality of care over quantity of health services. Social workers in primary care settings are well-positioned to improve the quality of health services for vulnerable patients by identifying and addressing patients' social determinants of health. This case study describes a Plan Do Study Act (PDSA) quality improvement approach implemented and refined by social workers to proactively address clinical quality gaps in one family medicine practice. The studied program - entitled Gap Closure Day - was led by a team of social workers to improve quality outcomes of patients. Findings highlight the important roles of social workers as members of health care teams to improve the quality of health services and address health equity.

Streptococcus pneumoniae and other bacterial nasopharyngeal colonization seven years post-introduction of 13-valent pneumococcal conjugate vaccine in South African children.

OBJECTIVES: Pneumococcal conjugate vaccines (PCVs) reduce pneumococcal-associated disease by reducing vaccine-serotype (VT) acquisition in vaccinated children, thereby interrupting VT transmission. The 7-valent-PCV was introduced in the South African immunization program in 2009 (13-valent-PCV since 2011) using a 2+1 schedule (at 6, 14, and 40 weeks of age). We aimed to evaluate temporal changes in VT and non-vaccine-serotype (NVT) colonization after 9 years of childhood PCV immunization in South Africa. METHODS: Nasopharyngeal swabs were collected from healthy children <60-month-old (n = 571) in 2018 (period-2) and compared with samples (n = 1135) collected during early PCV7-introduction (period-1, 2010-11) in an urban low-income setting (Soweto). Pneumococci were tested for using a multiplex quantitative-polymerase chain reaction serotyping reaction-set. RESULTS: Overall pneumococcal colonization in period-2 (49.4%; 282/571) was 27.5% lower than period-1 (68.1%; 773/1135; adjusted odds ratio [aOR]: 0.66; 95% confidence interval [CI]: 0.54-0.88). Colonization by VT was reduced by 54.5% in period-2 (18.6%; 106/571) compared with period-1 (40.9%; 465/1135; aOR: 0.41; 95% CI: 0.3-0.56). Nevertheless, serotype 19F carriage prevalence was higher (8.1%; 46/571) in period-2 compared with period-1 (6.6%; 75/1135; aOR: 2.0; 95% CI: 1.09-3.56). NVT colonization prevalence was similar in period-2 and period-1 (37.8%; 216/571 and 42.4%; 481/1135). CONCLUSION: There remains a high residual prevalence of VT, particularly 19F, colonization nine years post-introduction of PCV in the South African childhood immunization program.

Optimization of a high-throughput nanofluidic real-time PCR to detect and quantify of 15 bacterial species and 92 Streptococcus pneumoniae serotypes.

Sensitive tools for detecting concurrent colonizing pneumococcal serotypes are needed for detailed evaluation of the direct and indirect impact of routine pneumococcal conjugate vaccine (PCV) immunization. A high-throughput quantitative nanofluidic real-time PCR (Standard BioTools 'Fluidigm') reaction-set was developed to detect and quantify 92 pneumococcal serotypes in archived clinical samples. Nasopharyngeal swabs collected in 2009-2011 from South African children ≤ 5 years-old, previously serotyped with standard culture-based methods were used for comparison. The reaction-set within the 'Fluidigm' effectively amplified all targets with high efficiency (90-110%), reproducibility (R2 ≥ 0.98), and at low limit-of-detection (< 102 CFU/ml). A blind analysis of 1 973 nasopharyngeal swab samples showed diagnostic sensitivity > 80% and specificity > 95% compared with the referent standard, culture based Quellung method. The qPCR method was able to serotype pneumococcal types with good discrimination compared with Quellung (ROC-AUC: > 0.73). The high-throughput nanofluidic real-time PCR method simultaneously detects 57 individual serotypes, and 35 serotypes within 16 serogroups in 96 samples (including controls), within a single qPCR run. This method can be used to evaluate the impact of current PCV formulations on vaccine-serotype and non-vaccine-serotype colonization, including detection of multiple concurrently colonizing serotypes. Our qPCR method can allow for monitoring of serotype-specific bacterial load, as well as emergence or ongoing transmission of minor or co-colonizing serotypes that may have invasive disease potential.

Single priming and booster dose of ten-valent and 13-valent pneumococcal conjugate vaccines and Streptococcus pneumoniae colonisation in children in South Africa: a single-centre, open-label, randomised trial.

BACKGROUND: Pneumococcal conjugate vaccine (PCV) immunisation has reduced vaccine-serotype colonisation and invasive pneumococcal disease in South Africa, providing the opportunity to consider transitioning from a two-dose (2 + 1) to one-dose (1 + 1) primary series and a booster dose. METHODS: In this single-centre, open-label, randomised trial done in South Africa, infants aged 35-49 days without HIV infection, without childhood immunisations except for BCG and polio, and with gestation age at delivery of at least 37 weeks of age, a birthweight of at least 2500 g, and weight of at least 3500 g at the time of enrolment were randomly assigned (1:1:1:1:1:1), through block randomisation (block size of 30), to receive a single priming dose of ten-valent PCV (PCV10) or 13-valent PCV (PCV13) at either 6 weeks (6-week 1 + 1 group) or 14 weeks (14-week 1 + 1 group), compared with two priming doses at 6 weeks and 14 weeks (2 + 1 group), followed by a booster dose at 9 months of age in all groups. The primary objective of the trial has been published previously. We report the secondary objective of the effect of alternative doses of PCV10 and PCV13 on serotype-specific Streptococcus pneumoniae colonisation at 9 months, 15 months, and 18 months of age and a further exploratory analysis in which we assessed non-inferiority of serotype-specific serum IgG geometric mean concentrations 1 month after the booster (10 months of age) and the percentage of participants with serotype-specific IgG titre above the putative thresholds associated with a risk reduction of serotype-specific colonisation between the 1 + 1 and 2 + 1 groups for both vaccines. Non-inferiority was established if the lower limit of the 95% CI for the difference between the proportion of participants (1 + 1 group vs 2 + 1 group) above the putative thresholds was greater than or equal to -10%. All analyses were done in the modified intention-to-treat population, which included all participants who received PCV10 or PCV13 according to assigned randomisation group and for whom laboratory results were available. The trial is registered with ClinicalTrials.gov, NCT02943902. FINDINGS: 1564 nasopharyngeal swabs were available for molecular serotyping from 600 infants who were enrolled (100 were randomly assigned to each of the six study groups) between Jan 9 and Sept 20, 2017. There was no significant difference in the prevalence of overall or non-vaccine serotype colonisation between all PCV13 or PCV10 groups. PCV13 serotype colonisation was lower at 15 months of age in the 14-week 1 + 1 group than in the 2 + 1 group (seven [8%] of 85 vs 17 [20%] of 87; odds ratio 0·61 [95% CI 0·38-0·97], p=0·037), but no difference was seen at 9 months (nine [11%] of 86 vs ten [11%] of 89; 0·92 [0·60-1·55], p=0·87) or 18 months (nine [11%] of 85 vs 11 [14%] of 87; 0·78 [0·45-1·22], p=0·61). Compared with the PCV13 2 + 1 group, both PCV13 1 + 1 groups did not meet the non-inferiority criteria for serotype-specific anti-capsular antibody concentrations above the putative thresholds purportedly associated with risk reduction for colonisation; however, the PCV10 14-week 1 + 1 group was non-inferior to the PCV10 2 + 1 group. INTERPRETATION: The serotype-specific colonisation data reported in this study together with the primary immunogenicity endpoints of the control trial support transitioning to a reduced 1 + 1 schedule in South Africa. Ongoing monitoring of colonisation should, however, be undertaken immediately before and after transitioning to a PCV 1 + 1 schedule to serve as an early indicator of whether PCV 1 + 1 could lead to an increase in vaccine-serotype disease. FUNDING: The Bill & Melinda Gates Foundation.

Geographic migration and vaccine-induced fitness changes of Streptococcus pneumoniae.

Streptococcus pneumoniae is a leading cause of pneumonia and meningitis worldwide. Many different serotypes co-circulate endemically in any one location. The extent and mechanisms of spread, and vaccine-driven changes in fitness and antimicrobial resistance (AMR), remain largely unquantified. Using geolocated genome sequences from South Africa (N=6910, 2000-2014) we developed models to reconstruct spread, pairing detailed human mobility data and genomic data. Separately we estimated the population level changes in fitness of strains that are (vaccine type, VT) and are not (non-vaccine type, NVT) included in the vaccine, first implemented in 2009, as well as differences in strain fitness between those that are and are not resistant to penicillin. We estimated that pneumococci only become homogenously mixed across South Africa after about 50 years of transmission, with the slow spread driven by the focal nature of human mobility. Further, in the years following vaccine implementation the relative fitness of NVT compared to VT strains increased (RR: 1.29 [95% CI 1.20-1.37]) - with an increasing proportion of these NVT strains becoming penicillin resistant. Our findings point to highly entrenched, slow transmission and indicate that initial vaccine-linked decreases in AMR may be transient.

Maternal and neonatal outcomes of trial of labor compared with elective cesarean delivery according to predicted likelihood of vaginal delivery.

OBJECTIVE: The vaginal birth after cesarean (VBAC) calculator developed by the Maternal-Fetal Medicine Units Network (MFMU) helps to identify the likelihood of VBAC. We sought to compare adverse maternal and neonatal outcomes of trial of labor after cesarean (TOLAC) to those of elective cesarean delivery after stratifying by VBAC likelihood. STUDY DESIGN: This was a retrospective cohort study of all women whose primary low transverse segment cesarean delivery and subsequent singleton term delivery with vertex presentation occurred at an academic center from January 2009 to June 2018. Only data from the second pregnancy were analyzed. The final analysis included 835 women. The MFMU VBAC calculator was used to assess the likelihood of VBAC. The two primary outcomes were composite adverse maternal (death or severe maternal complications) and neonatal outcomes (perinatal death or severe neonatal complications). The analyses were stratified based on the VBAC likelihood (less than 60% and 60-100%). Multivariable logistic regression was used to calculate adjusted odds ratio (OR) and 95% confidence interval (CI), controlling for predefined covariates. RESULTS: Among women with VBAC likelihood less than 60%, TOLAC compared with elective cesarean was associated with increased odds of the primary adverse maternal outcome (16.4% vs. 4.2%; adjusted OR 4.60 [95%CI 1.48-14.35]) and the primary adverse neonatal outcome (17.8% vs. 6.3%; adjusted OR 3.93 [95%CI 1.31-11.75]). Among women with VBAC likelihood of 60-100%, TOLAC compared with elective cesarean was associated with decreased odds of the primary adverse maternal outcome (6.4% vs. 11%; adjusted OR 0.47 [95%CI 0.25-0.89]) and similar odds of the primary adverse neonatal outcome (6.7% vs. 8.3%; adjusted OR 0.98 [95%CI 0.52-1.84]). CONCLUSIONS: Among women with a history of a primary low transverse cesarean delivery, those who underwent TOLAC compared to those who had elective cesarean had increased odds of adverse maternal and neonatal outcomes when VBAC likelihood was less than 60%.

Evaluating a Prototype Clinical Decision Support Tool for Chronic Pain Treatment in Primary Care.

OBJECTIVES: The Chronic Pain Treatment Tracker (Tx Tracker) is a prototype decision support tool to aid primary care clinicians when caring for patients with chronic noncancer pain. This study evaluated clinicians' perceived utility of Tx Tracker in meeting information needs and identifying treatment options, and preferences for visual design. METHODS: We conducted 12 semi-structured interviews with primary care clinicians from four health systems in Indiana. The interviews were conducted in two waves, with prototype and interview guide revisions after the first six interviews. The interviews included exploration of Tx Tracker using a think-aloud approach and a clinical scenario. Clinicians were presented with a patient scenario and asked to use Tx Tracker to make a treatment recommendation. Last, participants answered several evaluation questions. Detailed field notes were collected, coded, and thematically analyzed by four analysts. RESULTS: We identified several themes: the need for clinicians to be presented with a comprehensive patient history, the usefulness of Tx Tracker in patient discussions about treatment planning, potential usefulness of Tx Tracker for patients with high uncertainty or risk, potential usefulness of Tx Tracker in aggregating scattered information, variability in expectations about workflows, skepticism about underlying electronic health record data quality, interest in using Tx Tracker to annotate or update information, interest in using Tx Tracker to translate information to clinical action, desire for interface with visual cues for risks, warnings, or treatment options, and desire for interactive functionality. CONCLUSION: Tools like Tx Tracker, by aggregating key information about past, current, and potential future treatments, may help clinicians collaborate with their patients in choosing the best pain treatments. Still, the use and usefulness of Tx Tracker likely relies on continued improvement of its functionality, accurate and complete underlying data, and tailored integration with varying workflows, care team roles, and user preferences.

Interpregnancy body mass index change and risk of hypertensive disorders in pregnancy.

BACKGROUND: Hypertensive disorders are a common cause of maternal mortality. Whether interpregnancy BMI (body mass index kg/m2) gain is associated with hypertensive disorders in a subsequent pregnancy is not unclear. OBJECTIVES: To examine the association between interpregnancy BMI and hypertensive disorders in women without a history of hypertensive disorders in pregnancy. STUDY DESIGN: This was a retrospective cohort study of all women who had more than one singleton pregnancy at 23 weeks' gestation or greater at a single academic institution. Only the second pregnancy in the dataset was analyzed. We excluded women who had any hypertensive disorder in the index pregnancy. Interpregnancy BMI change was calculated by the change of early pregnancy BMI (within 14 weeks' gestation) measured in the office between the index pregnancy compared to that of the subsequent pregnancy. Women were categorized according to interpregnancy BMI change (BMI loss greater than 2 kg/m2, BMI change ±2 kg/m2, and BMI gain greater than 2 kg/m2). The primary outcome was any hypertensive disorder (chronic hypertension and pregnancy-associated hypertension). Multivariable logistic regression was performed to calculate adjusted odds ratios (aOR) with 95% confidence interval (95%CI) after adjusting for predefined covariates. RESULTS: Of 3068 women who were analyzed, 342 (11%), 1698 (55%), and 1028 (34%) had interpregnancy BMI loss greater than 2 kg/m2, interpregnancy BMI change ±2 kg/m2, and interpregnancy BMI gain greater than 2 kg/m2, respectively. Interpregnancy BMI gain greater than 2 kg/m2 compared to interpregnancy BMI loss more than 2 kg/m2 was associated with increased odds of hypertensive disorders (8.3% vs. 4.0%; adjusted odds ratio 2.20 [95% confidence interval 1.55-3.13]) and pregnancy-associated hypertension (adjusted odds ratio 2.25 [95% confidence interval 1.54-3.27]). Interpregnancy BMI loss greater than 2 kg/m2 compared to interpregnancy BMI change ±2 kg/m2 was not associated with increased odds of any hypertensive disorders (5.3% vs. 4.0%; adjusted odds ratio 0.58 [95% confidence interval 0.32-1.05]). CONCLUSIONS: Compared to interpregnancy BMI change ±2 kg/m2, interpregnancy BMI gain greater than 2 kg/m2 was associated with increased odds of any hypertensive disorder. Weight control after pregnancy could be a potentially modifiable factor that may reduce the risk of hypertensive disorders.

How opioid prescribing policies influence primary care clinicians' treatment decisions and conversations with patients with chronic pain.

OBJECTIVE: The 2016 Centers for Disease Control and Prevention guideline for prescribing opioids for chronic pain aimed to assist primary care clinicians in safely and effectively prescribing opioids for chronic noncancer pain. Individual states, payers, and health systems issued similar policies imposing various regulations around opioid prescribing for patients with chronic pain. Experts argued that healthcare organizations and clinicians may be misapplying the federal guideline and subsequent opioid prescribing policies, leading to an inadequate pain management. The objective of this study was to understand how primary care clinicians involve opioid prescribing policies in their treatment decisions and in their conversations with patients with chronic pain. DESIGN: We conducted a secondary qualitative analysis of data from 64 unique primary care visits and 87 post-visit interviews across 20 clinicians from three healthcare systems in the Midwestern United States. Using a multistep process and thematic analysis, we systematically analyzed data excerpts addressing opioid prescribing policies. RESULTS: Opioid prescribing policies influenced clinicians' treatment decisions to not initiate opioids, prescribe fewer opioids overall (theme #1), and begin tapering and discontinuation of opioids (theme #2) for most patients with chronic pain. Clinical precautions, described in the opioid prescribing policies to monitor use, were directly invoked during visits for patients with chronic pain (theme #3). CONCLUSIONS: Opioid prescribing policies have multidimensional influence on clinician treatment decisions for patients with chronic pain. Our findings may inform future studies to explore mechanisms for aligning pressures around opioid prescribing, stemming from various opioid prescribing policies, with the need to deliver individualized pain care.

Giant primary vaginal tubulovillous adenoma: A case report and review of literature.

Primary adenomas are common in the gastrointestinal tract but exceedingly rare on the periurethral surface and vagina. The pathogenesis remains unknown but vaginal adenomas are hypothesized to arise from vaginal adenosis or embryonic cloacal remnants and possess malignant potential. We present a case of a large primary vaginal tubulovillous adenoma in an eighty-one-year-old, likely diethylstilbestrol naïve patient. To the best of our knowledge the patient's 7.4 x 4.5 × 1.4 cm primary vaginal tubulovillous adenoma is the largest ever reported in literature.

Primary Care Clinicians' Beliefs and Strategies for Managing Chronic Pain in an Era of a National Opioid Epidemic.

BACKGROUND: Little is known about how primary care clinicians (PCCs) approach chronic pain management in the current climate of rapidly changing guidelines and the growing body of research about risks and benefits of opioid therapy. OBJECTIVE: To better understand PCCs' approaches to managing patients with chronic pain and explore implications for technological and administrative interventions. DESIGN: We conducted adapted critical decision method interviews with 20 PCCs. Each PCC participated in 1-5 interviews. PARTICIPANTS: PCCs interviewed had a mean of 14 years of experience. They were sampled from 13 different clinics in rural, suburban, and urban health settings across the state of Indiana. APPROACH: Interviews included discussion of participants' general approach to managing chronic pain, as well as in-depth discussion of specific patients with chronic pain. Interviews were audio recorded. Transcripts were analyzed thematically. KEY RESULTS: PCCs reflected on strategies they use to encourage and motivate patients. We identified four associated strategic themes: (1) developing trust, (2) eliciting information from the patient, (3) diverting attention from pain to function, and (4) articulating realistic goals for the patient. In discussion of chronic pain management, PCCs often explained their beliefs about opioid therapy. Three themes emerged: (1) Opioid use tends to reduce function, (2) Opioids are often not effective for long-term pain treatment, and (3) Response to pain and opioids is highly variable. CONCLUSIONS: PCC beliefs about opioid therapy generally align with the clinical evidence, but may have some important gaps. These findings suggest the potential value of interventions that include improved access to research findings; organizational changes to support PCCs in spending time with patients to develop rapport and trust, elicit information about pain, and manage patient expectations; and the need for innovative clinical cognitive support.

Factors That Influence Changes to Existing Chronic Pain Management Plans.

BACKGROUND: The objective of this qualitative study is to better understand primary care clinician decision making for managing chronic pain. Specifically, we focus on the factors that influence changes to existing chronic pain management plans. Limitations in guidelines and training leave clinicians to use their own judgment and experience in managing the complexities associated with treating patients with chronic pain. This study provides insight into those judgments based on clinicians' first-person accounts. Insights gleaned from this study could inspire innovations aimed at supporting primary care clinicians (PCCs) in managing chronic pain. METHODS: We conducted 89 interviews with PCCs to obtain their first-person perspective of the factors that influenced changes in treatment plans for their patients. Interview transcripts were analyzed thematically by a multidisciplinary team of clinicians, cognitive scientists, and public health researchers. RESULTS: Seven themes emerged through our analysis of factors that influenced a change in chronic pain management: 1) change in patient condition; 2) outcomes related to treatment; 3) nonadherent patient behavior; 4) insurance constraints; 5) change in guidelines, laws, or policies; 6) approaches to new patients; and 7) specialist recommendations. CONCLUSIONS: Our analysis sheds light on the factors that lead PCCs to change treatment plans for patients with chronic pain. An understanding of these factors can inform the types of innovations needed to support PCCs in providing chronic pain care. We highlight key insights from our analysis and offer ideas for potential practice innovations.

An Analysis of Primary Care Clinician Communication About Risk, Benefits, and Goals Related to Chronic Opioid Therapy.

Background. Safe opioid prescribing and effective pain care are particularly important issues in the United States, where decades of widespread opioid prescribing have contributed to high rates of opioid use disorder. Because of the importance of clinician-patient communication in effective pain care and recent initiatives to curb rising opioid overdose deaths, this study sought to understand how clinicians and patients communicate about the risks, benefits, and goals of opioid therapy during primary care visits. Methods. We recruited clinicians and patients from six primary care clinics across three health systems in the Midwest United States. We audio-recorded 30 unique patients currently receiving opioids for chronic noncancer pain from 12 clinicians. We systematically analyzed transcribed, clinic visits to identify emergent themes. Results. Twenty of the 30 patient participants were females. Several patients had multiple pain diagnoses, with the most common diagnoses being osteoarthritis (n = 10), spondylosis (n = 6), and low back pain (n = 5). We identified five themes: 1) communication about individual-level and population-level risks, 2) communication about policies or clinical guidelines related to opioids, 3) communication about the limited effectiveness of opioids for chronic pain conditions, 4) communication about nonopioid therapies for chronic pain, and 5) communication about the goal of the opioid tapering. Conclusions. Clinicians discuss opioid-related risks in varying ways during patient visits, which may differentially affect patient experiences. Our findings may inform the development and use of more standardized approaches to discussing opioids during primary care visits.

Decision-Centered Design of Patient Information Visualizations to Support Chronic Pain Care.

BACKGROUND: For complex patients with chronic conditions, electronic health records (EHRs) contain large amounts of relevant historical patient data. To use this information effectively, clinicians may benefit from visual information displays that organize and help them make sense of information on past and current treatments, outcomes, and new treatment options. Unfortunately, few clinical decision support tools are designed to support clinical sensemaking. OBJECTIVE: The objective of this study was to describe a decision-centered design process, and resultant interactive patient information displays, to support key clinical decision requirements in chronic noncancer pain care. METHODS: To identify key clinical decision requirements, we conducted critical decision method interviews with 10 adult primary care clinicians. Next, to identify key information needs and decision support design seeds, we conducted a half-day multidisciplinary design workshop. Finally, we designed an interactive prototype to support the key clinical decision requirements and information needs uncovered during the previous research activities. RESULTS: The resulting Chronic Pain Treatment Tracker prototype summarizes the current treatment plan, past treatment history, potential future treatments, and treatment options to be cautious about. Clinicians can access additional details about each treatment, current or past, through modal views. Additional decision support for potential future treatments and treatments to be cautious about is also provided through modal views. CONCLUSION: This study designed the Chronic Pain Treatment Tracker, a novel approach to decision support that presents clinicians with the information they need in a structure that promotes quick uptake, understanding, and action.

Burden of Respiratory Syncytial Virus Infection in South African Human Immunodeficiency Virus (HIV)-Infected and HIV-Uninfected Pregnant and Postpartum Women: A Longitudinal Cohort Study.

Background: Limited data exist on the burden of respiratory syncytial virus (RSV) illness among pregnant women, to determine their potential benefit from RSV vaccination. We evaluated the incidence of RSV illness from midpregnancy until 24 weeks postpartum in human immunodeficiency virus (HIV)-uninfected and HIV-infected women and their infants. Methods: Mother-infant dyads were enrolled in maternal influenza vaccine efficacy trials. These included 1060 and 1056 HIV-uninfected pregnant women in 2011 and 2012, respectively, 194 HIV-infected pregnant women in 2011, and their infants. Upper respiratory tract samples obtained at illness visits were tested for RSV. Results: The incidence (per 1000 person-months) of RSV illness (n = 43 overall) among HIV-uninfected women was lower in 2011 (1.2; 95% confidence interval [CI], .6-2.2) than in 2012 (4.0; 95% CI, 2.8-5.6). The incidence of RSV illness (n = 5) in HIV-infected women was 3.4 (95% CI, 1.4-8.1). Maternal RSV infection was associated with respiratory symptoms including cough (72.1%), rhinorrhea (39.5%), sore throat (37.2%), and headache (42%), but fever was absent. RSV infection during pregnancy was not associated with adverse pregnancy outcomes. Postpartum, RSV infection in mothers (n = 27) was associated with concurrent infection among 51.9% of their infants and, conversely, 29.8% of mothers investigated within 7 days of their infants having an RSV illness also tested positive for RSV. Conclusions: RSV infection is associated with respiratory illness during pregnancy and postpartum. Vaccination of pregnant women against RSV could benefit the mother, albeit primarily against nonfebrile illness, and her infant. Clinical Trial Registration: NCT01306669 and NCT01306682.

Information Needs and Requirements for Decision Support in Primary Care: An Analysis of Chronic Pain Care.

Decision support system designs often do not align with the information environments in which clinicians work. These work environments may increase Clinicians' cognitive workload and harm their decision making. The objective of this study was to identify information needs and decision support requirements for assessing, diagnosing, and treating chronic noncancer pain in primary care. We conducted a qualitative study involving 30 interviews with 10 primary care clinicians and a subsequent multidisciplinary systems design workshop. Our analysis identified four key decision requirements, eight clinical information needs, and four decision support design seeds. Our findings indicate that clinicians caring for chronic pain need decision support that aggregates many disparate information elements and helps them navigate and contextualize that information. By attending to the needs identified in this study, decision support designers may improve Clinicians' efficiency, reduce mental workload, and positively affect patient care quality and outcomes.

UNDERSTANDING HOW PRIMARY CARE CLINICIANS MAKE SENSE OF CHRONIC PAIN.

Chronic pain leads to reduced quality of life for patients, and strains health systems worldwide. In the U.S. and some other countries, the complexities of caring for chronic pain are exacerbated by individual and public health risks associated with commonly used opioid analgesics. To help understand and improve pain care, this article uses the data-frame theory of sensemaking to explore how primary care clinicians in the U.S. manage their patients with chronic noncancer pain. We conducted Critical Decision Method interviews with 10 primary care clinicians about 30 individual patients with chronic pain. In these interviews, we identified several patient, social/environmental, and clinician factors that influence the frames clinicians use to assess their patients and determine a pain management plan. Findings suggest significant ambiguity and uncertainty in clinical pain management decision making. Therefore, interventions to improve pain care might focus on supporting sensemaking in the context of clinical evidence rather than attempting to provide clinicians with decontextualized and/or algorithm-based decision rules. Interventions might focus on delivering convenient and easily interpreted patient and social/environmental information in the context of clinical practice guidelines.

Efficacy of Maternal Influenza Vaccination Against All-Cause Lower Respiratory Tract Infection Hospitalizations in Young Infants: Results From a Randomized Controlled Trial.

Background: Influenza immunization of pregnant women protects their young infants against laboratory-confirmed influenza infection. Influenza infection might predispose to subsequent bacterial infections that cause severe pneumonia. In a secondary analysis of a randomized clinical trial (RCT), we evaluated the effect of maternal vaccination on infant hospitalizations for all-cause acute lower respiratory tract infection (ALRI). Methods: Infants born to women who participated in a double-blind placebo-controlled RCT in 2011 and 2012 on the efficacy of trivalent inactivated influenza vaccine (IIV) during pregnancy were followed during the first 6 months of life. Results: The study included 1026 infants born to IIV recipients and 1023 born to placebo recipients. There were 52 ALRI hospitalizations (median age, 72 days). The incidence (per 1000 infant-months) of ALRI hospitalizations was lower in infants born to IIV recipients (3.4 [95% confidence interval {CI}, 2.2-5.4]; 19 cases) compared with placebo recipients (6.0 [95% CI, 4.3-8.5]; 33 cases) with a vaccine efficacy of 43.1% (P = .050). Thirty of the ALRI hospitalizations occurred during the first 90 days of life, 9 in the IIV group (3.0 [95% CI, 1.6-5.9]) and 21 in the placebo group (7.2 [95% CI, 4.7-11.0]) (incidence rate ratio, 0.43 [95% CI, .19-.93]) for a vaccine efficacy of 57.5% (P = .032). The incidence of ALRI hospitalizations was similar in the IIV and placebo group for infants >3 months of age. Forty-four of the hospitalized infants were tested for influenza virus infection and 1 tested positive. Conclusions: Using an RCT as a vaccine probe, influenza vaccination during pregnancy decreased all-cause ALRI hospitalization during the first 3 months of life, suggesting possible protection against subsequent bacterial infections that influenza infection might predispose to. Clinical Trial Registration: NCT01306669.