Background: Despite the many harms and limited efficacy of opioids in managing chronic noncancer pain (CNCP), they are commonly prescribed for these patients in North America. One of the harms associated with prolonged opioid use is opioid use disorder (OUD); however, the risk of addiction is uncertain. We systematically reviewed observational studies to establish the prevalence of (OUD), and to explore factors associated with OUD in patients with CNCP. Methods: We searched MEDLINE, EMBASE, CINAHL, Cochrane Library, and PsycINFO from inception to December 2018 to identify studies that explored the prevalence of OUD or risk factors for OUD in patients with CNCP. Two specialists in addiction medicine reviewed each potentially eligible study, blinded to results, to ensure their outcome met DSM-5 criteria for OUD. We pooled estimates of OUD across eligible studies using random-effects models. When possible, we pooled estimates of association with OUD for all independent variables reported by more than one study. Results: Twenty-two studies reported the prevalence of OUD, and six studies reported the association of 36 factors with OUD in patients with CNCP. The pooled prevalence of OUD was 20% (95% CI: 15% to 25%); however, we found evidence for small study effects (interaction p<0.001). When restricted to larger studies (≥900 patients), the pooled prevalence of OUD was 5.8% (95% CI: 2.8% to 9.5%; moderate certainty evidence). The prevalence of OUD was not associated with level of certainty of OUD criteria, under- or overestimation of instruments compared to DSM-5 criteria, severity of OUD, or risk of bias (interaction p values ranged from 0.34 to 0.92). Moderate certainty evidence demonstrated an association between OUD and male sex (OR 1.50 [95% CI: 1.05 to 2.14]; absolute risk increase (ARI) 2.7% [95% CI: 0.3% more to 5.8% more]), current smokers (OR 1.63; [95% CI: 1.25 to 2.12]; ARI 3.3% [1.3% more to 5.7% more]), and a history of mental health disorders (OR 1.49 [95% CI: 1.17 to 1.89]; ARI 2.6% [95% CI: 0.9% more to 4.6% more]). Low certainty evidence demonstrated an association between OUD and younger age (OR for every 10-year decrement, 1.60 [95% CI: 1.11 to 2.30]; ARI, 3.2% for every 10-year decrement [95% CI: 0.6% more to 6.6% more]). Moderate certainty evidence suggested no association between OUD and a history of alcohol abuse/dependence (OR 1.32 [95% CI: 0.84 to 2.07]; ARI 1.7% [95% CI: 0.9% less to 5.5% more]), and low certainty evidence suggested no association between OUD and a history of drug abuse (OR 1.51 [95% CI: 0.75 to 3.02]; ARI 2.7% [95% CI: 1.4% less to 9.9% more]). Conclusion: Moderate certainty evidence suggests that 6% of CNCP patients prescribed opioids will develop OUD. Younger men who smoke, with a history of mental health disorders, are at higher risk. Additional research is needed to establish the association between OUD and a history of drug or alcohol abuse. / Thesis / Master of Science (MSc) / Opioids are commonly prescribed for patients with chronic pain that is not due to cancer; however, long-term opioid use inevitably leads to physical dependence and may result in addiction. Prior studies have reported extremely variable rates of opioid use disorder (OUD) following prescription for chronic noncancer pain, ranging from less than 1% to more than 50%, which has led to considerable confusion. My systematic review found moderate certainty evidence that the prevalence of OUD following prescription for chronic pain is 5.8% (95% CI: 2.8% to 9.5%). Patients who were younger, current smokers, males, and had a history of mental health disorders, had a higher risk of developing OUD. These findings will help support shared care decision-making between patients with chronic pain considering opioid therapy and their healthcare providers.

Evidenzbasierte Medizin (EbM) versteht sich als Disziplin, die zwischen der klinischen Forschung und der Gesundheitsversorgung eine Brücke schlägt. Die vorliegende Habilitationsschrift behandelt in 4 Einzelprojekten das Thema "Die klinische Epidemiologie in der ärztlichen Entscheidungsfindung". In dem ersten Projekt "Beobachtung oder Experiment" haben wir nachgewiesen, dass die Randomisierung für den Wirksamkeitsnachweis klinischer Interventionen unverzichtbar ist, um eine möglichst unverzerrte Effektmessung sicherzustellen. Die Studienpopulation waren systematische Übersichtsarbeiten, die randomisierte und nicht-randomisierte Studien zu einem breiten Spektrum an Interventionen aus dem Gesundheitsbereich einschlossen und mehr als 3000 Primärstudien umfassten. In der Auswertung konnten wir zeigen, dass - verglichen mit einer randomisierten Patientenzuordnung - bei einer nicht-randomisierten Patientenzuordnung in Studien der Effekt der Intervention häufig überschätzt wird, aber auch unterschätzt oder sogar invers geschätzt werden kann. Allerdings ist es auch möglich, dass vergleichbare Effekte beobachtet werden. Aufgrund der grossen Gefahr für Effektverzerrung in nicht vorhersagbarer Richtung ist die Randomisierung bei Interventionsstudien absolut erforderlich, um Gruppen mit vergleichbaren Ausgangskriterien zu generieren und damit eine möglichst biasfreie Effektschätzung sicherzustellen. In dem zweiten Projekt haben wir in einer Simulationsstudie demonstriert, wie es durch systematische Fehler in der Durchführung klinischer Studien zu klinischen Fehlentscheidungen kommen kann. Mit Hilfe klinischer Daten von Intensivpatienten, unterschiedlichen Annahmen über das Ausgangsrisiko für gastrointestinale Blutungen und der relativen Risikoreduktion für gastrointestinale Blutung durch H2-Blocker wurden typische Risikokonstellationen identifiziert: Klinische Situationen mit einem moderaten bis niedrigen Patienten-Grundrisiko und moderater bis geringer Wirksamkeit der medizinischen Maßnahme waren für Fehlentscheidungen infolge verzerrter Studienergebnisse besonders anfällig. Diese Konstellation kommt in der Patientenversorgung häufig vor, wodurch die Erkenntnisse unserer Studie einen ganz konkreten Praxisbezug erhalten. In dem dritten Projekt, einer klinischen Studie über die Wirksamkeit von ärztlichen Fortbildungen in evidenzbasierter Medizin ("Berliner EbM-Studie"), haben wir auf der Grundlage des Berliner Gegenstandskatalogs EbM ein Instrument (2 Fragebögen à 15 Fragen) entwickelt und validiert, mit dem man zuverlässig und reproduzierbar zwischen unterschiedlichen Kenntnissen und Fertigkeiten von EbM differenzieren kann. In einer dreijährigen Studie konnten wir nachweisen, dass durch kurze intensive Kurse in evidenzbasierter Medizin (wie z.B. den Berliner EbM-Kursen) bei den 203 Teilnehmern ein statistisch signifikanter und klinisch relevanter Wissenszuwachs erzielt werden kann (vor dem Kurs 6,3 + 2,9, nach dem Kurs 9,9 + 2,4 richtige Antworten; p< 0.001). Im vierten Projekt ging es um die Implementierung der evidenzbasierten Medizin in die tägliche Praxis von Hausärzten. In einer clusterrandomisierten Studie unter Hausärzten hatten wir untersucht, ob man durch kurze, evidenzbasierte Erläuterungen zu im Krankenhaus neu angesetzten Behandlungen, die im Entlassungsbrief beigefügt werden, Hausärzte motivieren kann, diese Behandlung fortzusetzen. 178 Praxen nahmen an der Studie teil. Dabei wurden 417 Entlassungsbriefe mit insgesamt 59 unterschiedlichen evidenzbasierten Medikamentenempfehlungen versandt und nach 3-4 Monaten 268 Interviews erfolgreich durchgeführt. Ärzte in der Interventionsgruppe hatten eine statistisch signifikant geringere Wahrscheinlichkeit, von den Krankenhausempfehlungen abzuweichen als Ärzte in der Kontrollgruppe, die nur den üblichen Entlassungsbrief enthielten (absolute Risikoreduktion 12,5%; p=0.039). Die Ärzte waren über die zusätzliche Information sehr zufrieden, auch wenn diese Information i.a. keine neuen Erkenntnisse lieferte, vielmehr den gegenwärtigen Kenntnisstand der Ärzte bestätigte. Kurze evidenzbasierte Medikamenteninformationen können das rationale Verschreibungsverhalten von Hausärzten positiv beeinflussen. / Evidence-based medicine (ebm) can be described as the discipline bridging research and health care. This thesis covers 4 individual projects on the role of clinical epidemiology / evidence-based medicine in rational clinical decision-making. The first study "Observation or Experiment" addressed the methodological issue of the impact of observational studies versus randomised allocation to any intervention on the estimated effect of the intervention. The study population were systematic reviews including randomised and non-randomised studies on a broad spectrum of interventions and comprising more than 3000 primary studies. In the empirical assessment, we could demonstrate that lack of randomisation tended to exaggerate the estimated effect of the intervention, but could also result in underestimation of the effect, in similar effect sizes or even in inverse effects. Therefore randomisation is mandatory in intervention studies to generate comparable baseline groups and thereby ensure an unbiased assessment of the underlying treatment effect. The second project was a simulation study investigating the impact of bias on clinical decision-making. Based on empirical data from ITU-patients, various assumptions on baseline risks of gastrointestinal bleeding and an estimate of the relative risk reduction for bleeding by H2-antagonists from a recent meta-analysis we investigated the potential for erroneous clinical decisions induced by systematic errors in the performance of clinical trials. We could demonstrate that certain clinical situations are particularly susceptible for errors in decision-making, in particular, if a patient’s baseline risk for an adverse event or the effectiveness of the intervention is only moderate or small. As low baseline risk and / or moderate treatment effects tend to occur frequently in physician-patient-encounters, physicians need to be aware of the increased risk for errors and pay meticulous attention on a reliable evidence base. The third project was a clinical trial on the effectiveness of teaching evidence-based medicine to physicians. The trial comprises two phases: Instrument development and performance of the trial. Starting from a comprehensive curriculum of evidence-based-medicine we identified relevant core items of ebm. Based on this curriculum we developed and validated a before-after instrument with 15 questions each that was able to distinguish varying degrees of knowledge and skills of ebm. Over a period of 3 years, the instrument was randomly administered to 203 participants in consecutive ebm-courses. Prior to the course, the participants scored a mean of 6,3 + 2,9, after the course the number of correct answers increased to 9,9 + 2,4 (p< 0.001). The scores of ebm-experts or ebm-naïve controls was significantly higher resp. lower. Thereby we could demonstrate that short intensive courses in evidence-based medicine (such as the Berlin courses) can lead to a significant and clinically meaningful increase in knowledge and skills. The forth project focussed on the implementation of evidence-based medicine in the day-to-day practice of family doctors. In a cluster-randomised study we investigated whether short evidence-based drug information in hospital discharge letters can influence the prescribing behaviour of general practitioners. 178 practices participated in the study, 417 discharge letters with 59 different evidence-based drug information were sent out and 268 interviews were successfully performed after an interval of 3 - 4 months. Physicians in the intervention group were statistically less likely to depart from the hospital recommendations than physicians in the control group who only received a regular discharge letter group (absolute risk reduction 12,5%; p=0.039). Furthermore, physicians were very satisfied with this additional piece of information, which tended to assure their own knowledge and reminded them to apply it in this individual patient (rather than providing new information). It was concluded that short evidence-based information in discharge letters could have a positive impact on a rational prescribing behaviour of physicians.

More than 1.2 million Americans are hospitalized annually with an acute coronary syndrome (ACS); many impaired quality of life after discharge with an ACS. This dissertation focuses on two novel aspects of patient health status (PHS) after ACS: how it can be predicted based on the socioeconomic status (SES) of the patient, and how it evolves over time. We used data from TRACE-CORE, a longitudinal prospective cohort of patients hospitalized with ACS. We measured PHS using both the SF-36 mental and physical component subscales (MCS and PCS) and the Seattle Angina Questionnaire (SAQ) health-related quality of life (HRQoL) and physical limitations subscales at the index hospitalization and at 1, 3, and 6-months post-discharge. Firstly, after adjusting for individual-level SES, we found that individuals living in the neighborhoods with the lowest neighborhood SES had significantly worse PHS. Secondly, we found that each of the components of PHS had subgroups with distinct patterns of evolution over time (trajectories). Both the PCS and the SAQ physical limitations subscale had two trajectories; one with average and one with impaired health status over time. For the HRQoL subscale of SAQ, we found three trajectories: Low, Average, and High scores. For MCS, we found four trajectories: High (consistently high scores), Low (consistently low scores), and two with average scores at baseline that either improved or worsened over time, referred to as Improving and Worsening, respectively. All PHS trajectories, except for MCS, predicted readmission and mortality during the 6 months to 1 year post-ACS discharge.

L’anorexie mentale est une pathologie affectant à la fois la santé mentale et la santé physique. Les formes les plus sévères alors qu’elles nécessitent des soins hospitaliers longs, ont un taux d’échappement aux soins très élevé (20% des adolescents et 60% des adultes) et sont celles présentant le plus mauvais pronostic. Or cet échappement aux soins (ou sortie prématurée) génère à la fois des rechutes et une chronicisation. Si le devenir à long terme de ces patients est documenté, les études centrées sur les formes les plus sévères sont peu nombreuses, et parmi elles, celles prenant en compte simultanément les aspects somatiques et psychiques de leur évolution sont quasi inexistantes. C’est pourquoi, après une mise au point sur les données épidémiologiques, concernant l’anorexie mentale, nous avons choisi de centrer notre travail de thèse sur d’une part la recherche de facteurs expliquant l’échappement aux soins, et pouvant devenir des cibles thérapeutiques, et d’autre part le devenir physique et psychique de ces sujets dix ans après une hospitalisation.La première étude portant sur 180 patients issus de dix centres français prenant en charge des patients anorexiques sévères, s’est appuyé sur une étude d’épidémiologie clinique prospective multicentrique appelée EVALHOSPITAM. Notre objectif était d’identifier des facteurs prédictifs de l’échappement prématuré aux soins lors d’une hospitalisation pour anorexie mentale. En effet, la prise en compte de tels facteurs dès l’admission permettrait peut-être de diminuer l’échappement prématuré aux soins en cours d’hospitalisation, et par là contribuerait à améliorer le pronostic de ces sujets. La seconde étude expose les résultats d’une étude de devenir de ces patients hospitalisés à l’adolescence neuf années en moyenne après une hospitalisation. Notre travail se centre sur le devenir somatique à long terme de patients ayant souffert d’anorexie mentale, son lien avec le devenir psychique et une comparaison avec un échantillon issu de la population générale de même âge et de même sexe. / Anorexia nervosa is a disease that affects both mental and physical health. The most severe forms as they require long hospital care, with a drop-out rate very high (20% of adolescents and 60% of adults) are those with the worst prognosis. But this drop-out (or early exit) generates both relapse and a chronicisation. If the long-term outcome of these patients is documented, studies focusing on the most severe forms are few, and among them, those taking into account both the somatic and psychic aspects of their outcome are almost nonexistent. That’s why, after focusing on epidemiological data on anorexia nervosa, we chose to focus our thesis on first the search for factors explaining the drop-out and may become therapeutic targets, and second the physical and psychological outcome of these subjects ten years after hospitalization.The first study of 180 patients from ten centers taking care of severe anorexic patients, relied on a prospective clinical multicenter epidemiological study called EVALHOSPITAM. Our objective was to identify predictors of drop-out during hospitalization for anorexia nervosa. Indeed, taking into account such factors upon admission might help reduce drop-out during hospitalization, and thus help to improve the prognosis of these subjects.The second study presents the results of an outcome study of patients hospitalized during adolescence on average nine years before. Our work focuses on the somatic outcome of long-term patients who suffered from anorexia nervosa, its link to psychiatric outcome and finally a comparison with a sample from the general population of the same age and sex.

Hospital-acquired infections (HAI) are not uncommon in healthcare facilities. They are usually prevented by sanitation techniques and by maintaining a high standard of care. Catheter-associated urinary tract infections (CAUTI) make up a large percentage of hospital-acquired infections and are often the most preventable type of HAI. Patterns in infection rate could provide new ideas on prevention techniques, which might further reduce infection rate, saving lives and cutting costs. CAUTI infection rate was measured from January KJIY to September KJIL and was differentiated based on hospital ward as well as month and season. Overall, ICU units tended to have a higher CAUTI infection rate than ward units, particularly in January, February, April, and May. The CAUTI infection rate was highest in the ICU units during spring and May, and lowest during fall and October. In the ward units, the CAUTI infection rate was highest during summer and March, and lowest during winter and February.

Syphilis, a systemic sexually transmitted disease, is on the rise in the US, with infection rates the highest recorded since 1994 according to the CDC. Useful laboratory testing is an important diagnostic tool for determining individual syphilis infection and preventing community-wide disease spread. The purpose of this study was to determine the usefulness of a specific automated treponemal test method, the CaptiaTM Syphilis IgG EIA, and the syphilis reverse algorithm interpretation for detecting syphilis infection among patients seeking care in a public health clinic. The study employed a retrospective, nonexperimental descriptive correlational design with data collected between 2012-2013 from 4,077 public health clinic patients with 21% of the patients diagnosed with syphilis infection. There was a statistically significant difference between the CaptiaTM Syphilis IgG and the Fujirebio Serodia TP-PA test results; between the CaptiaTM Syphilis IgG Signal to Cutoff (S/CO) and the MacroVue RPR titer continuous variables; and between the reverse and traditional syphilis interpretation algorithms. The reverse algorithm using the CaptiaTM Syphilis IgG test method provided more useful performance measures with a sensitivity of 82%; specificity of 99%; accuracy of 95%; positive likelihood ratio of 63.06 and negative likelihood of 0.18 than the traditional algorithm using the MacroVue RPR test method. Statistical comparison of the area under the curve (AUC) for the continuous variables, CaptiaTM Syphilis IgG S/CO and RPR titer, concluded that the Syphilis IgG AUC (0.9500) was higher than the RPR titer (0.8155) indicating greater accuracy for detecting syphilis infection. This was the first study to determine that the CaptiaTM Syphilis IgG, the S/CO value, and reverse algorithm are useful diagnostic predictors of syphilis infection among public health clinic patients. The data from this study can be utilized by future researchers and scientists who are developing or improving syphilis detection methods.

Hospital readmissions are a major burden for patients with end stage renal disease (ESRD). On average, one in three hospital discharges among patients with ESRD are followed by a readmission within 30 days. Currently, dialysis facilities are held accountable for readmissions via the ESRD Quality Incentive Program standardized readmission ratio (SRR) clinical measure. However, little is known about facility-level factors associated with readmission. Additionally, unlike other standardized measures of quality in the dialysis setting, incident patients within their first 90-days of dialysis are included in the performance calculation. This study analyzed CMS Dialysis Facility Report data from 2013 to 2016 to examine dialysis facility and incident patient factors associated with SRR using multivariate mixed models. Among 5,419 dialysis facilities treating 104,768 incident patients, the mean SRR remained stable across all four study years at 0.99. Factors significantly associated with a lower SRR (p<0.0001) included Western geographic region and higher patient care technician ratios. Several incident patient pre-dialysis nephrology care characteristics were associated with lower SRRs including higher percentages of patients with a fistula present at first dialysis treatment, higher percentages of patients receiving 6-12 months or greater than 12 months of nephrology care prior to dialysis and higher facility average hemoglobin. Factors significantly associated with a higher SRR (p<0.0001) included Northeastern geographic region, higher registered nurse ratios, higher percentage of incident patients, and higher facility average GFR. Understanding facility-level and patient-level factors associated with higher SRRs may inform interventions to reduce 30-day hospital readmission among patients receiving dialysis.

The objective of this study was to determine the patterns of regulatory noncompliance, as identified by the U.S. Food and Drug Administration (FDA), and their effects on meta-analyses. In order to achieve these objective, three studies were undertaken: analysis of citations issued by FDA Investigators at the conclusion of an inspection; analysis of regulatory actions taken by the FDA towards clinical researchers based on the observations cited by FDA Investigators; and sensitivity analysis of meta-analyses based on the Agency’s determination of research misconduct, primarily the falsification of data. FDA Investigator citations were analyzed using Chi-Square analysis based on geographic location of the inspection, type of inspection, and type of violation. Temporal changes in the number of inspections and the violations cited were analyzed using bivariate Poisson regression models. Bonferroni correction was employed for temporal changes across the time period analyzed. Regulatory actions taken by the agency were analyzed via Chi-Square or Fisher’s exact test based on changes identified in previous publications, temporal changes, and differences between regulatory action types. Sensitivity analysis of meta-analyses identified through a systematic review were assessed both qualitatively and quantitatively for the effects of including publications of apixaban trials with significant FDA regulatory action, i.e. the comparison of odds ratio point estimate, upper and lower 95% confidence interval, both before and after consideration of falsified data. Under the FDA’s Bioresearch Monitoring program from 2007-2015, the number of inspections increased, but the rate of citation issuance per inspection decreased. One third of the violations were related to adherence to investigational procedures followed by informed consent violations and violations involving study records. During this same time period, 194 clinical researchers received a regulatory action based on FDA’s review of inspection results. Since 2007, rates of significant deviations had decreased. Lack of researcher supervision and submission of false information were cited more frequently for disqualification proceedings. A systematic review found 99 statistical analyses from 22 different meta-analyses available for sensitivity analyses. Nearly one-third resulted in a change in the conclusions reported in the originally published statistical analyses. In approximately the last decade, the number of violations cited during inspections under the Bioresearch Monitoring program has decreased; however, significant improvements can continue to be made regarding adherence to study procedures, the consenting of human subjects, and creation of adequate and accurate study documentation. Disqualification of clinical researchers is more likely to occur when researchers fail to supervise a clinical trial or false information is submitted to the FDA. Falsified data can make its way into the exploding field of meta-analyses, a study method that provides a concise and compelling method for the dissemination of medical intervention knowledge; however, this method can be highly unstable and can provide biased results. A robust sensitivity analysis that considers data quality from available sources can help ensure calculations of the best estimates.

Background: Coronary artery disease is a common cause of morbidity and mortality in the UK. Interventional revascularisation procedures for addressing the disease include percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), which respectively seek to open up or bypass blocked arteries to restore blood flow to heart muscle. Rates at which these procedures are carried out have changed in recent years, as have clinical indications for referral. PCI is delivered by interventional cardiologists, while CABG is carried out by cardiothoracic surgeons, necessitating multi-disciplinary decision making. There is both within- and cross-speciality debate as to the optimal treatment strategy in some case types. Evaluation of the care provided is of clinical and political importance, and requires information about how post-procedure event rates per operator and hospital compare with those expected given the composition of patient populations. Methods: Two UK-wide audit databases of PCI and CABG procedures were used to explore a range of clinical outcome questions. The patient populations contained within each database were compared to see how they differed, and also how each had changed in recent years. In CABG patients, comparative effectiveness of two different surgical techniques (single vs bilateral mammary artery grafting) was assessed with respect to both short-term and long-term mortality outcomes. In PCI patients, a risk model to predict 30-day mortality was developed for use in clinical appraisal. Results: In both patient populations there had been changes to the relative frequencies of many characteristics over time. In the CABG population, multivariable analysis showed that patients undergoing single mammary artery grafting had lower odds of all-cause mortality within 30 days of procedure than those receiving bilateral mammary artery grafting, but had worse overall survival in the long term. In the PCI population, the developed risk model demonstrated good calibration and discrimination at predicting 30-day all-cause mortality. Discussion: The studies described above demonstrate that large-scale routinely collected data can be used to gain insights into clinical care quality and delivery. These resources are under-utilised at present; correcting this requires an understanding of the limitations of the data and how the information contained therein relates to actual clinical care.

Introduction: ReadNPlay for a Bright Future is an initiative developed by the East Tennessee State University (ETSU) pediatricians and partners, to promote healthy active living among families with young children. The project includes giving families a packet with a baby book and a tips booklet when they bring their young children to the pediatrician's office for the newborn visit. My Baby Book is based on Bright Futures guidelines and contains age-appropriate advice on keeping babies healthy, sharing books, eating healthy, preventing injury, and being active as a family, as well as space to record special memories and milestones. The vision of this project is to encourage families in the region to Play More, Play Together, Play Safely, and have Fuel to Play. Methodology: In January 2013, anonymous surveys in English or Spanish were administered to a sample of 80 mothers of infants under 24 months of age during well child visits at the ETSU Pediatric Clinic. This served as the pre-intervention survey to assess baseline self-reported behaviors of mothers and infants before the intervention (My Baby Book) was implemented. 3 follow up surveys were carried out in July 2013, April 2014 and July 2015 respectively to collect post-intervention data. Questions centered around screen time, physical activity, injury prevention, and healthy eating. Pre-intervention data was compared to post-intervention data consisting of the 3 follow up surveys combined together to determine the effectiveness of the ReadNPlay project. Data was collected using Epi Info and Excel and analyzed with SPSS. Results: The total sample size was 80 at each time point. Majority of the mothers are beneficiaries of the Women, Infants and Children (WIC) program. Preliminary results include that there was a 5.28% decrease in the number of mothers who reported spending more than 20 hours/week watching TV or videos; 4.22% increase in the number of mothers who spent at least 3 hours/week being engaged in light/moderate recreational activities; 14.35% increase in the number of mothers who spent at least 2 hours engaged in vigorous recreational activities or sports; 3% increase in the number of mothers who spent at least 3 hours/week walking for fun/exercise, and a 3.3% increase in the number of mothers who breastfed their children for at least 6 months. Among infants, a 6.39% decrease in hospital visits for injuries was reported as well as 8.23% increase in the number of infants who had no screen time. Conclusion: Limitations of this study include lack of a control group, potential for cohort effect, and the self-reported nature of the data collection. ReadNPlay for a Bright has subsequently been expanded to include distribution of a ReadNPlay children’s book series, development of a mobile application based on My Baby Book, and development of regular healthy active living community events and support groups to link families to in the region. A longitudinal evaluation of the program including several different clinics in the region is underway.