Single Observational Cohort Study Research Articles

Daily Enemas for Pediatric Bowel Management

Introduction Children born with anorectal malformations, Hirschsprung disease, spinal cord defects, and related conditions have problems with constipation and fecal incontinence. In a large pediatric healthcare center, a weeklong outpatient program is offered to families, teaching daily high-volume enema administration. The purpose of this study is to assess the rate of adherence with daily enemas for bowel management and assess problems among children with elimination abnormalities. Methods A single-cohort observational study was conducted. Subjects included children ages 3–18 years and their parents who had attended a bowel management training program from April 2012 to December 2017. Data were collected utilizing an anonymous REDCap survey. Survey questions addressed adherence with daily enemas, supports and challenges, and parent-reported satisfaction and child acceptance. Results Surveys were sent to 112 parents, and 32 parents had completed the surveys. Approximately half of the sample, with a mean age of 9.9 years (SD = 3.7), adhered to daily enemas for bowel management. Parents reported a variety of problems and barriers to adherence with daily enemas, including child resistance (31.3%), difficulty retaining enema fluid (37.5%), cramping during enema (62.5%), time constraints (40.6%), getting or replacing equipment (28.1%), and bathroom space issues (25.0%). Sixty percent of the sample reported that enema administration requires more than 1 hour. Discussion In general, parents reported child acceptance, satisfaction, and limited difficulty with enema management; however, adherence was not as desired, and the rate of reported problems was high. Insight into problems experienced by parents provides nursing opportunity for educational programs that may improve adherence.

Sensor based eating time variables of dairy cows in the transition period related to the time to first service

In dairy cattle, reproductive diseases and infertility are some of the most important reasons for culling, where postpartum negative energy balance (NEB) reduces reproductive performance. This single cohort observational study reports the association between eating time and the interval between calving and first service in 2036 dairy cows on 17 commercial farms in The Netherlands. Cows were equipped with a commercially available neck sensor (Nedap, Groenlo, The Netherlands), that measured the time cows spent eating, from 28 days (d) before until 28 d after parturition. Primiparous cows spent a mean of +45 minutes (min) eating time per day ante partum and +15 min eating time post partum more than multiparous cows. A Cox proportional hazard model was used to analyze eating time variables in relation to the interval between calving and first service. From 4 weeks before until 4 weeks after calving eating time variables per week were used. Weeks -4, -3 + 3 and +4 were used as weeks with stable eating time patterns and therefore the mean eating time per week and the standard deviation of the mean eating time per week were used. Weeks -2, -1, +1 and +2 were addressed as periods with unstable eating patterns and therefore the slope in eating time per week and the residual variance of the slope per week were modeled. Significant results were the mean eating time in week -4 and +3 where in both weeks higher eating time lead to a higher hazard for first service. Difference between primiparous and multiparous cows were also significant with a higher hazard for first service for primiparous cows. Week 4 post partum presented a significant difference between eating time of primiparous cows and multiparous cows. These results display how eating time variables in the transition period could be related to the interval between calving and first service, and that there is a relation between mean eating time in week -4, +3, +4 and the interval between calving and first insemination.

Tracking Obstetrical and Gynecological Experiences Using Mobile Devices [19P

INTRODUCTION: Tracking clinical experiences is important toward progression of entrustable professional activities required by medical schools. The purpose of this study was to determine the effectiveness of using an innovative real-time mobile device tracker for medical student clinical experiences compared with the traditional tracking using a passport log. METHODS: A prospective single cohort observational study was performed using third year medical students in obstetrics and gynecology rotations. Participants downloaded the obstetrics and gynecology (OBG) tracker and recorded their clinical experiences; procedures, number, and degree of involvement. Results were compared with data from the passport log. Outcomes included data comparison from both tracking methods and end of clerkship student surveys. Internal review board exemption was obtained. Paired t-tests were used for data analysis. RESULTS: Thirty-six students participated in the study over 6 months. The OBG tracker recorded 269 entries, the passport recorded 187. The OBG tracker recorded higher numbers of procedures compared to the passport (procedure type, 56 OBG tracker, 8 passport, p<0.001; degree of involvement, 30 OBG tracker, 0 passport, p<0.001). OBG tracker also tabulated student involvement in cases; 40.2% vaginal deliveries, 41.2% delivered placentas, 62.0% coached patients, 50.9% inserted catheters, 35.8% sutured, 33.3% pelvic exam, 23.3% breast exams. Student surveys rated OBG tracker more useful than the passport (OBG tracker 1.29, passport 4.06, p<0.001). CONCLUSION: The use of a mobile device tracker for clinical experiences allowed for more meaningful real-time data of learners than the traditional passport logs. Tracking detailed experiences and degree of involvement is important to entrustment decisions in medical education.

Are we getting any better? A study on repair integrity in 1600 consecutive arthroscopic rotator cuff repairs

BackgroundPostoperative retear is the most common surgical complication after rotator cuff repair. This study aimed to determine whether there had been any improvements in rotator cuff repair integrity in our center and to identify any changes in the management of rotator cuff tears that may have impacted postoperative retear rate.MethodsThis retrospective observational single cohort study used running average analysis to examine 1600 consecutive patients over 8 years, who underwent primary arthroscopic rotator cuff repair by a single surgeon, and had cuff integrity assessed by ultrasound 6 months after operation.ResultsRetear rates ranged from 3% to 34%, with a mean of 15%. Over our study retear rates decreased from 18% to 5%. Reductions in retear rates were associated with less aggressive rehabilitation, postoperative abduction sling use, and increased surgical experience. Increases in retear rates were associated with increased false positives with a more sensitive ultrasound machine and learning curves with new equipment for a surgeon and sonographer.ConclusionA decrease in retear rate after arthroscopic rotator cuff repair occurred during our study. Although the study design prevents us from directly attributing changes in retear rate to changes in management, our results suggest that rehabilitation optimization and increased surgeon experience decrease postoperative retear.

Transitioning from club to national teams: Training and match load profiles of international footballers

ObjectivesTo quantify and profile the training and match loads of international footballers as they transition from club-to-camp-to-tournament contexts during multiple international tournaments. DesignRetrospective single-cohort observational study. MethodsExternal (session duration and count) and internal (session Rating of Perceived Exertion [s-RPE]) load data of all outfield players from the same national team were compared between club, pre-tournament camp and initial tournament phases of 3 recent international competitions. Further, load profiles were compared between each phase based on the acute:chronic (A/C) ratio using a 7 to 21-day ratio. ResultsModerate-to-large effect sizes existed for increased number of sessions (ES=1.92; 90% CI: 1.56, 2.27) and s-RPE training load (ES=1.16; 0.84, 1.48) from club to camp. Conversely, transitioning from camp-to-tournament showed very large effects for decreased number of training sessions (ES=−3.17; −3.47, −2.86) and s-RPE training load (ES=−2.05; −2.35, −1.75), alongside increased number of matches (ES=1.87; 1.55, 2.18) and s-RPE match load (ES=1.57; 1.25, 1.89). Consequently, a moderate effect was evident for increased A/C ratio during the club-to-camp transition (ES=1.02; 0.70, 1.33), while a moderate decrease in the A/C ratio occurred during the tournament (ES=−0.76; −1.06, −0.46). ConclusionsInternational footballers showed expected increased training load when entering into pre-tournament camps, predominately via increased number of training sessions. Subsequent reductions in training volume coincide with increased match volume, though total load decreases. Such profiles provide insight into load accumulation transitioning from club to national teams in international footballers.

Assessment of health care resource utilization (HRU) in patients with castration-resistant prostate cancer (CRPC).

89 Background: Although patients with CRPC frequently develop metastasis within 3 years following castration resistance, the impact of metastasis on HRU in these patients is not well understood. Methods: The Optum de-identified electronic health record database (1/1/2007 – 4/30/2016) was used in this single cohort observational study comparing HRU after metastasis with HRU before metastasis. The cohort included only non-metastatic CRPC (nmCRPC) patients who later developed metastasis. The pre-metastasis period spanned from nmCRPC identification to development of metastasis; the post-metastasis period spanned from metastasis until death or end of data availability. Per-patient per-month (PPPM) HRU was estimated during both pre- and post-metastasis periods by a generalized linear mixed model adjusted for log-transformed baseline PSA, age, testosterone levels, and Charlson Comorbidity Index. Results: With a mean time of 11 and 17 months of pre- and post-metastasis periods, respectively, 540 CRPC men were included, with a mean age at nmCRPC identification of 75 years. Higher HRU was seen across all service types during the post-metastasis period. There was a 2.5-fold increase in inpatient admissions and a 6.4-fold increase in inpatient length-of-stay in the post-metastasis period compared to the pre-metastasis period (p &lt; 0.01). For emergency department (ED) visits, there was a 2.0-fold increase from the pre- to post-metastasis periods (p &lt; 0.01). For observation unit visits, a 2.7-fold increase was seen in the post-metastasis period (p &lt; 0.01). Finally, patients were 40% more likely to have an office visit after developing metastasis (p &lt; 0.01). The PPPM use of intensive care unit, hospice or skilled nursing facility were too low for meaningful comparison between the pre- and post-metastasis periods. Conclusions: Shorter time to metastasis was observed in this cohort vs. other nmCRPC studies, likely due to delayed disease identification. CRPC patients incurred substantially higher HRU after developing metastasis, attributable to inpatient, ED, observation unit as well as office visits, suggesting that delaying metastasis may reduce or delay the increased HRU in patients with nmCRPC.

Leucocyte- and platelet-rich fibrin block for bone augmentation procedure: A proof-of-concept study.

The objective of this proof-of-concept study was to investigate the effects of a new guided bone regeneration technique with a tissue engineering approach. This single cohort observational study evaluated the outcome of the leucocyte- and platelet-rich fibrin (L-PRF) Block for horizontal bone augmentation in the maxilla. The L-PRF Block is prepared by mixing a particulated biomaterial with chopped L-PRF membranes at a 50:50 ratio and adding liquid fibrinogen to glue all together. Horizontal augmentation was assessed linearly and volumetrically immediately after surgery and 5-8months later by matching consecutive cone beam computed tomography (CBCTs). Ten patients (mean age of 50.7years [±17.2]) representing 15 sites with horizontal alveolar deficiencies were included. Superimposition of pre-operative and posthealing CBCT scans showed an average linear horizontal bone gain of 4.6mm (±2.3), 5.3mm (±1.2) and 4.4mm (±2.3), measured at 2, 6 and 10mm from the alveolar crest, respectively. The volumetric gain was 1.05cm3 (±0.7) on average. The resorption rate after 5-8months was 15.6% (±6.7) on average. L-PRF Block may be a suitable technique to augment deficient alveolar ridges.

Early prediction of hypocalcemia following thyroid surgery. A prospective randomized clinical trial.

The aim of this randomized-controlled trial was to validate the results of a previous prospective single-cohort observational study conducted in the same surgical unit regarding the use of concomitant intact parathyroid hormone (iPTH) and serum calcium measurement in predicting hypocalcemia after total thyroidectomy. From January 2014 to January 2015, 150 patients underwent total thyroidectomy in our department and were randomized into two groups. The experimental group was submitted to iPTH assay 6h after surgery while the control group was submitted to a daily assay of serum calcium and phosphorus. Sensitivity and specificity of different serum measurements have been calculated using the receiver-operator characteristics (ROC) curve. The prevalence of hypocalcemia was 14.25% in both groups. The assay of iPTH 6h after surgery combined with the serum calcium assay 24h after surgery yielded the highest diagnostic accuracy in predicting hypocalcemia using ROC curves, with 100% sensitivity and 100% specificity. According to our previous study, the combined measurement of iPTH 6h after surgery and of serum calcium 24h after surgery are highly predictive of early postoperative hypocalcemia. These results are important in selecting the patients eligible for early discharge and those who need calcium and vitamin D supplementation.

Waiting time to surgery is correlated with an increased risk of serious adverse events during hospital stay in patients with hip-fracture: A cohort study

BackgroundHip fractures are common in the elderly and are associated with a high adverse event and mortality rate. Time to surgery is one of the major modifiable risk factors influencing adverse outcomes in hip-fracture patients. National guidelines and recommendations have been introduced which advocate specific time frames in which surgery should be performed i.e. within 24–48h. These time constraints have been arbitrarily set without being modelled on the linear assumption i.e. that risk increases continually over time and not within specific cut-off times. ObjectivesTo investigate how waiting time to surgery influenced the risk of serious adverse events in hip-fracture patients during the hospital stay and to examine how the risk increased over time. DesignAn observational single cohort study Participants 576 patients (72.4% females, mean [SD] age 82 [10]) years, with a hip fracture were included in the cohort study. MethodsThe outcomes of the study were the occurrence of serious adverse events during hospital stay, length of stay and one-year mortality. A structured medical record review was carried out to identify outcomes and mortality data was obtained from the Swedish National Death Registry. Waiting time to surgery was used as the exposure variable and age, sex, type of fracture, comorbidities using the American Society of Anaesthesiologists classification score and the presence of cognitive dysfunction were identified as confounders. A logistic regression analysis was performed to identify risk factors influencing outcomes. ResultsA total of 119 patients (20.6%) suffered 397 (range 1–5) serious adverse events during hospital stay. Every 10h of waiting time to surgery increased the risk of serious adverse events by 12% (odds ratio 1.12 [95% confidence interval 1.02–1.23]). We found no optimal cut-off times for waiting time to surgery. For every 24h of waiting time, the length of stay from surgery was increased by 0.6days (95% CI 0.1–1.1). We found no correlation between waiting time to surgery and one-year mortality. ConclusionsA large proportion of patients suffered from at least one serious adverse event after hip-fracture surgery and there are no safe limits for waiting time to surgery for hip-fracture patients. As the risk increases with every hour of waiting time, patients with higher American Society of Anesthesiologists classification scores, males and those with subtrochanteric fractures should be prioritized for surgery.

Hemorrhagic, Hemostatic, and Thromboelastometric Disorders in 35 Dogs with a Clinical Diagnosis of Leptospirosis: A Prospective Study.

BackgroundLeptospirosis in dogs is occasionally associated with a hemorrhagic syndrome, the pathophysiology of which is not fully understood.Hypothesis/ObjectivesTo characterize hematologic, hemostatic, and thromboelastometric abnormalities in dogs with leptospirosis and to study their association with hemorrhagic diatheses and outcomes.AnimalsThirty‐five client‐owned dogs.MethodsA prospective observational single cohort study was conducted. Results from the CBC, coagulation tests (prothrombin, activated partial thromboplastin and thrombin times, fibrinogen, fibrin(ogen) degradation products, and D‐dimer concentrations), rotational thromboelastometry (TEM), signalment, hemorrhagic diatheses, occurrence of disseminated intravascular coagulation (DIC) at admission, and survival to discharge were recorded.ResultsThe most common hematologic and hemostatic abnormalities were anemia (30/35), thrombocytopenia (21/35), and hyperfibrinogenemia (15/35). Eight dogs were diagnosed with DIC. A normal TEM profile was found in 14 dogs, a hypercoagulable profile in 14 dogs, and a hypocoagulable profile in 7 dogs. The 8 dogs with hemorrhagic diatheses at admission had significantly decreased platelet counts (P = .037) and increased D‐dimer concentrations (P = .015) compared with other dogs. Dogs with a hypocoagulable profile exhibited more hemorrhagic diatheses compared with the dogs that had normal and hypercoagulable profiles (P = .049). The mortality rate was lower in dogs with a hypercoagulable profile than in those with a hypocoagulable profile (21% vs 57%; P = .043). Disseminated intravascular coagulation was not a significant prognostic factor.Conclusions and Clinical ImportanceThromboelastometric parameters were altered in dogs with both hypercoagulable and hypocoagulable profiles. A hypocoagulable profile was significantly correlated with hemorrhagic diathesis and higher mortality rate.

The clinical application of "jetting suture" technique in annular repair under microendoscopic discectomy: A prospective single-cohort observational study.

To introduce a new designed suture technique in annular repair under the microendoscopic discectomy (MED) surgery and to evaluate the clinical application of the technique in annular repair under MED with at least 2-year follow-up period.A new method of annular repair was designed and named “jetting suture” technique. Thirty consecutive patients with lumbar disc herniation were enrolled in the prospective single-cohort observational study. Patients were followed up at intervals of preoperative, postoperative 1 week, 3 months, 6 months, 1 year, and last follow-up. The clinical outcomes were evaluated by using Japanese Orthopaedic Association (JOA) score, Oswestry Disability Index, and modified Mcnab criteria.The procedure was successfully performed in all cases. No case required conversion to an open procedure. The mean age of patients was 36.6 years. Average blood loss was 45.8 ± 10.2 mL. The preoperative symptoms were alleviated significantly after surgery. All the standardized measures improved significantly at the last follow-up, including JOA score (10.1 to 26.6; P < 0.05) and Oswestry Disability Index (75.3 to 9.6; P < 0.05). Improvement rate of JOA score was 86.4%. Approximately 83.4% of patients reported good or excellent outcomes based on modified Mcnab criteria. No postoperative complication and recurrence of disc herniation was reported.The designed “jetting suture” technique in annular repair under MED can be performed safely and effectively. It could be a viable alternative to annular repair under lumbar discectomy.

Are We Getting Any Better? A Study on Repair Integrity in 1600 Consecutive Arthroscopic Rotator Cuff Repairs

Objectives:Post-operative retear is the most common surgical complication following rotator cuff repair with reported rates ranging from 11% to 94%. There have been a number of advancements in the technology and management of rotator cuff repair which may have improved retear rates. The aim of this study was to determine if there has been any improvements in rotator cuff repair integrity in our centre and, to identify any changes in the management of rotator cuff tears that may have impacted post-operative re tear rate.Methods:This observational single cohort study used running average analysis to examine 1600 consecutive patients who underwent primary arthroscopic rotator cuff repair by a single surgeon, and had cuff integrity assessed by ultrasound six months post operation. Exclusion criteria included revision rotator cuff repairs, isolated subscapularis repairs, and irreparable tears.Results:Retear rates over the course of our study ranged from 3% to 34%, with the mean retear rate being 15%. The retear rate at the commencement of our study was 18% and decreased to 5% by the end. Reductions in retear were associated with; more passive rehabilitation, more attention to post-operative abduction sling use, increased surgical team experience. Increases in retear rates were associated with; increased false positives with a more sensitive ultrasound machine and, learning curves with new equipment for surgeon and sonographer.Conclusion:A significant decrease in retear rate following arthroscopic rotator cuff repair was observed over the course of our study with the re-tear rate at the end of the study being 5%. While the study design does not allow us to directly attribute changes in retear rate to changes in management, our results suggest that less aggressive rehabilitation, abduction sling use and increased surgeon experience decrease postoperative retear.

P329. Infliximab biosimilar in the treatment of inflammatory bowel disease: a Japanese single-cohort observational study

P329. Infliximab biosimilar in the treatment of inflammatory bowel disease: a Japanese single-cohort observational study

Determination of a cutoff value for pelvic floor distensibility using the Epi-no balloon to predict perineal integrity in vaginal delivery: ROC curve analysis. Prospective observational single cohort study.

Several risk factors are involved in perineal lacerations during vaginal delivery. However, little is known about the influence of perineal distensibility as a protective factor. The aim here was to determine a cutoff value for pelvic floor distensibility measured using the Epi-no balloon, which could be used as a predictive factor for perineal integrity in vaginal delivery. Prospective observational single cohort study conducted in a maternity hospital. A convenience sample of 227 consecutive at-term parturients was used. All women had a single fetus in the vertex presentation, with up to 9.0 cm of dilation. The maximum dilation of the Epi-no balloon was measured using a tape measure after it had been inflated inside the vagina up to the parturients' maximum tolerance. The receiver operating characteristic (ROC) curve was used to obtain the Epi-no circumference measurement with best sensitivity and specificity. Among the 161 patients who were included in the study, 50.9% underwent episiotomy, 21.8% presented lacerations and 27.3% retained an intact perineum. Age > 25.9 years; number of pregnancies > 3.4; number of deliveries > 2.2 and circumference measured by Epi-no > 21.4 cm were all directly correlated with an intact perineum. Circumference measurements using the Epi-no balloon that were greater than 20.8 cm showed sensitivity and specificity of 70.5% and 66.7% (area under curve = 0.713), respectively, as a predictive factor for an intact perineum in vaginal delivery. Circumferences greater than 20.8 cm achieved using the Epi-no balloon are a predictive factor for perineal integrity in parturients.

Analysis of a pilot program to implement physical therapy for women with gynecologic fistula in the Democratic Republic of Congo

ObjectiveTo describe components of a physical therapy pilot program for women with gynecologic fistula, and to report prospective data from the first 2years of program implementation. MethodsA single-cohort observational study with repeated measures was conducted at HEAL Africa Hospital, Goma, Democratic Republic of Congo. Hospital staff received training in pelvic floor physical therapy. Guidelines for exercise, functional training, and reproductive health education were integrated into the existing program. Demographics, clinical findings, and functional outcomes were recorded. Key stakeholders were interviewed to understand the perceived strengths and limitations of the program. ResultsA total of 205 women were followed up; 161 participated in physical therapy, with an average of 9.45 sessions. Of 161 women examined postoperatively, 102 (63.4%) reported no incontinence; they remained continent at discharge. Of 21 who indicated a change in level of incontinence during postoperative physical therapy, 15 (71.4%) improved. The program was feasible and well received by staff and patients. ConclusionPelvic floor physical therapy could have significant results in women with gynecologic fistula, may be an important adjunctive treatment in comprehensive fistula care, and warrants further investigation.

Impact of adherence to treatment with fluticasone propionate/salmeterol in asthma patients

Objective:Low adherence with asthma treatment may be associated with suboptimal outcomes and hence create a treatment gap in the real-life setting. The objective of this study was to assess the long-term association between adherence to treatment with fixed-dose fluticasone propionate/salmeterol (FSC) and the risk of exacerbations and health care utilization in patients with asthma.Research design and methods:Observational single cohort study utilizing the Quebec Health Insurance databases. All patients (age >12 years) with a diagnosis of asthma (ICD9-CM 493.xx) between 2001 and 2010 were entered into the study cohort at the time of their first prescription for FSC at any dose. Follow-up continued to the last known claim or death. Adherence to treatment was ascertained as compliance (medication possession ratio ≥80%) and persistence (absence of treatment gap ≥30 days).Main outcome measures:Outcomes assessed were exacerbations defined as one of the following: use of oral corticosteroid (OCS), emergency room (ER) visit for asthma or hospitalization for asthma. Asthma related health care resource utilizations ascertained were number of prescription claims for rescue medications, ER visits, hospitalizations, intensive care unit (ICU) stay, intubations, and general practitioner (GP) and respirologist visits.Results:A total of 19,126 patients were included in the study. The proportion of compliant and persistent patients were 42.7% and 29.3% respectively. Multivariate logistic regression analyses showed a significantly reduced adjusted odds of exacerbations for compliant (OR = 0.48; 95% CI: 0.44–0.54) and persistent patients (OR = 0.42; 95% CI: 0.38–0.48). Similarly, significantly lower rates of health care utilization were observed for compliant and persistent patients.Conclusions:The results of this large population-based study have shown that increased adherence to treatment with FSC is associated with lower risk for exacerbations, lower rescue medication use and lower health care utilization in asthma patients. Despite the typical limitations of an administrative database study including validity of the diagnosis, the fact that compliance and persistence are calculated based on filled claims which does not guarantee that the patients actually took their medications, and the absence of clinical and laboratory data, the findings have implications for physician and patient awareness of the importance of adherence in the management of asthma.

Impact of adherence to treatment with tiotropium and fluticasone propionate/salmeterol in chronic obstructive pulmonary diseases patients

Objective:Poor adherence to treatment may contribute to the treatment gap in chronic obstructive pulmonary diseases (COPD). The aim of the current study was to describe the association between adherence to treatment and the risk of COPD moderate (ME) and severe (SE) exacerbations, and health care utilization.Research design and methods:Observational single cohort study utilizing the Quebec Provincial Health Insurance databases. All patients older than 40 years with a diagnosis of COPD between 2001 and 2010 were entered in the study cohort at the time of their first prescription for tiotropium (TIO) alone or co-administered with fluticasone propionate/salmeterol (TIO + FSC). Follow-up continued to the last known claim or death. Adherence was measured by the medication possession ratio (MPR) ≥80% and persistence defined as no treatment gap ≥30 days.Main outcome measures:ME was defined as use of an oral corticosteroid or antibiotic, SE as COPD related hospitalization or an emergency room (ER) visit. COPD related health care resource utilization ascertained was prescription of rescue medications, ER visits, hospitalizations, intensive care unit (ICU) admissions, intubations, and general practitioner (GP) and respirologist visits.Results:There were 23,707 patients included in this study. Compliance and persistence with TIO for monotherapy patients were 61.1% and 47.6% respectively. For patients treated with TIO + FSC, compliance and persistence for TIO were 62.9% and 45.3% respectively, and for FSC they were 35.4% and 33.0%. Multivariate analyses showed a significant (P < 0.001) adjusted odds ratios for ME (ORME) and SE (ORSE) for TIO compliant vs. non-compliant patients (TIO: ORME = 0.543, ORSE = 0.712; TIO + FSC: ORME = 0.436, ORSE = 0.570). Similarly for FSC compliance: ORME = 0.546; ORSE = 0.749. Similar results were observed for persistence. Compliance and persistence with TIO and FSC were associated with significantly reduced rates of health care utilization.Conclusions:Despite the typical limitations of an administrative database study, the results of this large population-based study have shown that reduced adherence to treatment with TIO and FSC is associated with increased risk for exacerbations and higher health care utilization in COPD patients.

Coeliotomy‐assisted intrauterine insemination in dogs: a study of 238 inseminations

(1) To report whelping rates and litter sizes following coeliotomy-assisted intrauterine inseminations (CAII) performed commercially and (2) to identify factors that may influence these outcomes. Retrospective single cohort observational study. All oestrous cycles in bitches that presented to the study hospital for CAII between 1 January 2005 and 31 December 2010 were included. One insemination was performed per oestrus. Whelping and litter size following CAII were recorded. Potential determinants of these outcomes were assessed. Of 238 inseminations performed, 174 (73.1%) resulted in whelping. The known litter size ranged from 1 to 16 pups (mean ± SD 6.12 ± 3.12 pups). From univariable analyses, progressive motility percentage was the only variable significantly associated with odds of whelping (P = 0.020); bitch parity and weight were associated with litter size when adjusted for each other (P = 0.035 and 0.003, respectively). Inseminations performed with >200 × 10(6) progressively motile sperm were more likely to result in whelping relative to inseminations with >100-200 × 10(6) progressively motile sperm (odds ratio 3.61, 95% confidence interval 0.84-15.5, P = 0.084), and, in a separate model, relative to >75-125 × 10(6) progressively motile sperm (odds ratio 6.09, 95% confidence interval 1.41-26.36, P = 0.016). Whelping rates and litter sizes were similar to other case studies and the experimental reports of CAII. Progressive motility percentage affects the odds of whelping, and litter size is affected by both the weight and parity of the bitch. Importantly, these findings provide some evidence that whelping rates with CAII are not maximised unless more than 200 × 10(6) progressively motile sperm are inseminated.

Maternal characteristics during pregnancy and risk factors for positive HIV RNA at delivery: a single-cohort observational study (Brescia, Northern Italy)

BackgroundDetectable HIV RNA in mothers at delivery is an important risk factor for HIV transmission to newborns. Our hypothesis was that, in migrant women, the risk of detectable HIV RNA at delivery is greater owing to late HIV diagnosis. Therefore, we examined pregnant women by regional provenance and measured variables that could be associated with detectable HIV RNA at delivery.MethodsA observational retrospective study was conducted from January 1999 to May 2008. Univariate and multivariable regression analyses (generalized linear models) were used, with detectable HIV RNA at delivery as dependent variable.ResultsThe overall population comprised 154 women (46.8% migrants). Presentation was later in migrant women than Italians, as assessed by CD4-T-cell count at first contact (mean 417/mm3 versus 545/mm3, respectively; p = 0.003). Likewise, HIV diagnosis was made before pregnancy and HAART was already prescribed at the time of pregnancy in more Italians (91% and 75%, respectively) than migrants (61% and 42.8%, respectively). A subgroup of women with available HIV RNA close to term (i.e., ≤30 days before labour) was studied for risk factors of detectable HIV RNA (≥50 copies/ml) at delivery. Among 93 women, 25 (26.9%) had detectable HIV RNA. A trend toward an association between non-Italian nationality and detectable HIV RNA at delivery was demonstrated by univariate analysis (relative risk, RR = 1.86; p = 0.099). However, by multivariable regression analysis, the following factors appeared to be more important: lack of stable (i.e., ≥14 days) antiretroviral therapy at the time of HIV RNA testing (RR = 4.3; p < 0.0001), and higher CD4+ T-cell count at pregnancy (per 50/mm3, RR = 0.94; p = 0.038).ConclusionsThese results reinforce the importance of extensive screening for HIV infection, earlier initiation of antiretroviral therapy and stricter monitoring of pregnant women to reduce the risk of detectable HIV RNA at delivery. Public health interventions should be particularly targeted to migrant women who are frequently unaware of their HIV status at the time of pregnancy.

Assessment of Changes in Utilization of Health-Care Services after Implementation of a Prior Authorization Policy for Atypical Antipsychotic Agents

In 2004, the Georgia Medicaid program implemented a prior authorization (PA) policy for certain atypical antipsychotic agents, resulting in an average savings of $2.7 million per year. To determine whether implementation of a PA policy for atypical antipsychotic drugs increased health-care utilization in the Georgia Medicaid program from July 2003 to April 2006. A single cohort observational study employing segmented regression and time series analysis was conducted to determine health-care services utilization, including emergency department (ED) visits, outpatient office visits, hospital admissions, and length of stay (LOS). Study subjects included continuously eligible adult Georgia Medicaid recipients with a schizophrenia-related diagnosis and documented use of an atypical antipsychotic medication (N = 12,120). Where applicable, analysis of a noncontinuously eligible population was also performed to investigate disenrollment bias in study results. A significant decline in post-policy trend for the average number of ED visits (absolute difference -0.042 per member per month (PMPM); relative difference -20.92%) and average number of hospital admissions PMPM (absolute difference -0.010 PMPM; relative difference -22.27%) was observed at the end of the study period. Baseline and pre-policy trends were found to be significant predictors for both endpoints. Significant models were not identified for average outpatient office visits PMPM or average LOS per admission. In contrast to other published studies on PA for atypical antipsychotics, patient outcomes improved after the initiation of the policy. To the extent that medical utilization reflects patient health outcomes and health status, the results of this study indicate that the PA program has potentially improved the health of schizophrenic patients in Georgia and lowered program costs.