Results Of Prospective Observational Study Research Articles

Abstract P5-15-19: Prophylaxis of chemotherapy-induced febrile neutropenia with biosimilar filgrastim: Description of patients, treatment patterns and outcomes in the MONITOR-GCSF study in the breast cancer cohort

Abstract Introduction: MONITOR-GCSF is a European prospective observational study of practice patterns and outcomes of patients treated with Sandoz' filgrastim (EP-2006) in the prophylaxis of chemotherapy-induced febrile neutropenia (CIN/FN). Objectives: To describe patients, treatment patterns of EP-2006, and outcomes in the breast cancer cohort of the MONITOR-GCSF study. Methods: Prospective observational study following 466 evaluable patients from 23 centers in Europe for up to 6 cycles within a single chemotherapy line including a total of 2714 cycles. Results: Median age was 56y (range 25-91); all but 3 patients were female. Table 1 presents chemotoxicity in terms of % FN risk and prophylaxis type. GCSF was correctly initiated as either primary or secondary prophylaxis per EORTC guideline recommendations (considering chemotherapy-related FN risk and patient-related factors) in 62% of patients. Eleven percent were undertreated, i.e., secondary prophylaxis when primary was indicated–either when CIN/FN risk >20% or when CIN/FN risk was 10-20% in combination with patient-related risk factors. Twenty-seven percent were overtreated, i.e., primary or secondary when not indicated–either primary prophylaxis in <10% risk of CIN/FN or in 10-20% risk of CIN/FN in the absence of risk factors, or secondary prophylaxis in <10% risk of CIN/FN in absence of prior CIN/FN. EP-2006 was started on average 2.8±2.6 days after chemotherapy was initiated and given for 4.9±2.1 days. Dosing was 45% at 30MIU/day, 55% at 48MIU/day. CIN (any grade) occurred in 12.0% of all cycles and 32.8% of patients had one or more episodes of CIN. 19.5% of patients had at least one episode of Grade 3 or 4 CIN of which 6.2% were febrile. CIN/FN-related hospitalizations were experienced by 5.2% of patients. CIN/FN-related chemotherapy disturbances (dose reduction, delay or cancellation) occurred in 9.4%. Table 1 n%Chemotherapy toxicity (risk of FN)>20%25053.8 10-20%17036.5 <10%459.7PhrophylaxisPrimary37279.8 Secondary9420.2Prophylaxis decision relative to guidelinesUndertreated5010.8 Correct28962.1 Overtreated12627.1 Conclusions: Variation in treatment with biosimilar GCSF in breast cancer patients is evident in terms of decision to treat with primary prophylaxis relative to guideline recommendations as well as day of initiation, duration and dose, yet incidence of CIN/FN and related events is low. Forthcoming analyses will determine whether variability in treatment is associated with differential outcomes. Citation Format: Pere Gascón, Matti Aapro, Heinz Ludwig, Mario Boccadoro, Carsten Bokemeyer, Matthew Turner, Michael Muenzberg, Ivo Abraham, Kris Denhaerynck, Karen MacDonald. Prophylaxis of chemotherapy-induced febrile neutropenia with biosimilar filgrastim: Description of patients, treatment patterns and outcomes in the MONITOR-GCSF study in the breast cancer cohort [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-15-19.

Measuring patient-perceived continuity of care for patients with long-term conditions in primary care.

BackgroundContinuity of care is widely acknowledged as important for patients with multi-morbidity but simple, service-orientated indices cannot capture the full impact of continuity in complex care delivery systems. The patient’s perspective is important to assess outcomes fully and this is challenging because generic measures of patient-perceived continuity are lacking. We investigate the Chao Perception of Continuity (Chao PC) scale to determine its suitability as a measure of continuity of care for patients with a long-term condition (stroke), and co-morbidity, in a primary care setting.MethodsDesign and Setting: A questionnaire study embedded in a prospective observational cohort study of outcomes for patients following acute stroke.Participants: 168 community dwelling patients (58% male) mean age 68 years a minimum one year post-stroke. Functional status: Barthel Index mean =16.Intervention: A 23-item questionnaire, the Chao Perception of Continuity (Chao PC) scale, sent by post to their place of residence or administered face to face as part of the final cohort study assessment.Results310 patients were invited to participate; 168 (54%) completed a questionnaire.All 23 questionnaire items were entered into a Principal Component Analysis. Emergent factors from the exploratory analysis were (1) inter-personal trust (relational continuity); (2) interpersonal knowledge and information (informational and relational continuity) and (3) the process of care (managerial continuity). The strongest of these was inter-personal trust.ConclusionThe context-specific items in the Chao PC scale are difficult for respondents to interpret in a United Kingdom Primary Care setting resulting in missing data and low response rates. The Chao-PC therefore cannot be recommended for wider application as a general measure of continuity of care without significant modification.Our findings reflect the acknowledged dimensions of continuity and support the concept of continuity of care as a multi-dimensional construct. We demonstrate the overlapping boundaries across the dimensions in the factor structure derived. Trust and interpersonal knowledge are clearly identified as valuable components of any patient-perceived measure of continuity of care.Electronic supplementary materialThe online version of this article (doi:10.1186/s12875-014-0191-8) contains supplementary material, which is available to authorized users.

Prospective observational study of practice and outcome of emergency appendectomies in a single centre

Prospective observational study of practice and outcome of emergency appendectomies in a single centre

Functional Status and Mortality in Chronic Kidney Disease: Results from a Prospective Observational Study

Background/Aims: Measures of functional status are used in the general population to aid prognostication but their use has not been explored in pre-dialysis chronic kidney disease (CKD). This analysis considers the association between the Karnofsky performance score (KPS) and all-cause mortality in a CKD stage 3-5 cohort. Methods: Patients were selected from the Chronic Renal Insufficiency Standards Implementation Study (CRISIS), a prospective observational study of outcome in CKD. Risk for death was assessed using multivariate Cox regression, and differences in progression of biochemical parameters were considered in a mixed-effects model. Results: A total of 1,515 patients with a median follow-up time of 2.9 (1.5-4.8) years were considered. Baseline age was 60 ± 11 years and eGFR was 30 ± 12 ml/min/1.73 m². Patients with a reduced KPS had an increased risk for death. The hazard ratio (HR) for death was: KPS 90 group, HR 1.2 (95% CI 0.9-1.5), p = 0.1; KPS ≤80 group, HR 1.8 (95% CI 1.4-2.4), p < 0.001. In the mixed-effects model, the average annual loss of eGFR was greater in patients with a KPS ≤80 versus patients with a KPS >80 (5 vs. 3%, p = 0.008). Conclusion: A reduced KPS is independently associated with risk for mortality in patients with CKD stages 3-5. This may relate to a more rapid loss of eGFR.

Five year prognosis in patients with angiographically proven stable coronary heart disease: results of prospective observational study in russia.

Objectives: To investigate prognostic value of different risk factors, associated with stable coronary artery disease (CAD), identify the key prognostic features, evaluate the risk distribution and develop an easy-to-use risk prediction model guiding the clinical management of patients with stable angina (SA).

Air Travel and Pneumothorax

The number of medical emergencies onboard aircraft is increasing as commercial air traffic increases and the general population ages, becomes more mobile, and includes individuals with serious medical conditions. Travelers with respiratory diseases are at particular risk for in-flight events because exposure to lower atmospheric pressure in a pressurized cabin at cruising altitude may result in not only hypoxemia but also pneumothorax due to gas expansion within enclosed pulmonary parenchymal spaces based on Boyle's law. Risks of pneumothorax during air travel pertain particularly to those patients with cystic lung diseases, recent pneumothorax or thoracic surgery, and chronic pneumothorax. Currently available guidelines are admittedly based on sparse data and include recommendations to delay air travel for 1 to 3 weeks after thoracic surgery or resolution of the pneumothorax. One of these guidelines declares existing pneumothorax to be an absolute contraindication to air travel although there are reports of uneventful air travel for those with chronic stable pneumothorax. In this article, we review the available data regarding pneumothorax and air travel that consist mostly of case reports and retrospective surveys. There is clearly a need for additional data that will inform decisions regarding air travel for patients at risk for pneumothorax, including those with recent thoracic surgery and transthoracic needle biopsy.

Therapy optimization in multiple sclerosis: a prospective observational study of therapy compliance and outcomes

BackgroundData sources for MS research are numerous but rarely provide an objective measure of drug therapy compliance coupled with patient-reported health outcomes. The objective of this paper is to describe the methods and baseline characteristics of the Therapy Optimization in MS (TOP MS) study designed to investigate the relationship between disease-modifying therapy compliance and health outcomes.MethodsTOP MS was designed as a prospective, observational, nationwide patient-focused study using an internet portal for data entry. The protocol was reviewed and approved by Sterling IRB. The study was registered with ClinicalTrials.gov. It captured structured survey data monthly from MS patients recruited by specialty pharmacies. Data collection included the clinical characteristics of MS such as MS relapses. Disability, quality of life and work productivity and activity impairment were assessed quarterly with well-validated scales. When events like severe fatigue or new or worsening depression were reported, feedback was provided to treating physicians. The therapy compliance measure was derived from pharmacy drug shipment records uploaded to the study database. The data presented in this paper use descriptive statistics.ResultsThe TOP MS Study enrolled 2966 participants receiving their disease-modifying therapy (DMT) from specialty pharmacies. The mean age of the sample was 49 years, 80.4% were female, 89.9% were Caucasian and 55.7% were employed full or part time. Mean time since first symptoms was 11.5 years; mean duration since diagnosis was 9.5 years. Patient-reported EDSS was 3.5; 72.2% had a relapsing-remitting disease course. The most commonly reported symptoms at the time of enrollment were fatigue (74.7%), impaired coordination or balance (61.8%) and numbness and tingling (61.2%). Half of the sample was using glatiramer acetate and half was using beta-interferons.ConclusionDemographic and clinical characteristics of the TOP MS sample at enrollment are consistent with other community-based MS samples, and the sample appears to be representative of DMT users in the US. TOP MS data can be used to explore the associations between disease-modifying therapy compliance and health outcomes.Trial registrationClinicalTrials.gov (NCT00819000)

Noise Exposure in the Neonatal Intensive Care Unit: A Prospective Study

Objectives: 1) Describe the sound pressure levels experienced by premature infants in a neonatal intensive care unit (NICU) over an entire admission, compared to neonatal standards for sound exposure by the American Academy of Pediatrics (AAP) and Journal of Perinatology (JP), as well as adult standards by the National Institute for Occupational Safety and Health. 2) Determine whether this population may be at higher risk for noise-induced hearing loss. Methods: Prospective observational outcomes study from August 2012- present. Condition Studied: noise-induced hearing loss. Subjects: Admissions to the NICU, &lt;37 weeks gestational age. Outcome Measurements: Sound pressure levels/cumulative sound exposure dosage. Independent Variables: bed type, location, number of patients per room, machine therapies. Preliminary Analyses: This dataset represents preliminary data from an ongoing study with a target enrollment of 150 over 12 months. Results: The average sound pressure level per admission ranged from 57.4 to 67.8 dBA. Neonates in enclosed beds experienced a trend toward higher decibel levels than those in open beds. Neonates on machines such as ventilators, continuous positive airway pressure (CPAP), or phototherapy were found to experience higher decibel levels. Conclusions: All infants received sound exposures that substantially exceeded AAP and JP guidelines of &lt;45 dBA and &lt;50 dBA for the NICU. Reducing NICU decibel levels should concentrate on bed design, individual alarm noise, and staff education regarding the sources and consequences of sound exposure. Newborn hearing screening protocols should consider additional testing to determine the risk of noise-induced hearing loss.

Differences in DPOAE and AABR in Noise‐Exposed Infants in the Neonatal Intensive Care Unit

Objectives: 1) Describe the differences in distortion product otoacoustic emissions (DPOAE) and automated auditory brainstem response (AABR) results in premature infants in the neonatal intensive care unit (NICU) with noise exposure. 2) Discuss optimal newborn hearing screen protocols for capturing at-risk NICU graduates. Methods: Prospective observational outcomes study from August to the present. Subjects: Admissions to the NICU, &lt;37 weeks gestational age. Setting: NICU. Outcome Measurements: DPOAE, AABR, and follow-up audiometry collected by the Oregon Early Hearing Detection and Intervention (EHDI) program. Independent variables: Sound pressure levels and cumulative sound dosage. Preliminary analyses: This dataset represents preliminary data from an ongoing study with a target enrollment of 150 over 12 months. Results: The average sound pressure level per individual admission ranged from 57.4 to 67.8 dBA. DPOAE demonstrated a greater rate of abnormalities in the high frequency range of 4000-10000 Hz (40-45%) compared to lower frequencies (10-15%). AABR generated only a 5% rate of referrals; however, 50% of DPOAEs obtained showed abnormal results in at least 2/3 of the high frequencies tested. Conclusions: All infants received sound exposures that substantially exceeded AAP guidelines. More abnormalities were found on DPOAE than AABR, with a significantly higher rate in the high frequencies compared to lower frequencies, consistent with possible noise-induced cochlear dysfunction. Neonatal intensive care units should consider adding DPOAE to their hearing screen protocols so that infants at risk for noise-induced hearing loss are not missed.

Prospective Observational Study of Breast Cancer Treatment Outcomes for UK Women Aged 18–40 Years at Diagnosis: The POSH Study

Breast cancer at a young age is associated with poor prognosis. The Prospective Study of Outcomes in Sporadic and Hereditary Breast Cancer (POSH) was designed to investigate factors affecting prognosis in this patient group. Between 2000 and 2008, 2956 patients aged 40 years or younger were recruited to a UK multicenter prospective observational cohort study (POSH). Details of tumor pathology, disease stage, treatment received, and outcome were recorded. Overall survival (OS) and distant disease-free interval (DDFI) were assessed using Kaplan-Meier curves. All statistical tests were two-sided. Median age of patients was 36 years. Median tumor diameter was 22 mm, and 50% of patients had positive lymph nodes; 59% of tumors were grade 3, 33.7% were estrogen receptor (ER) negative, and 24% were human epidermal growth factor receptor 2 (HER2) positive. Five-year OS was higher for patients with ER-positive than ER-negative tumors (85.0%, 95% confidence interval [CI] = 83.2% to 86.7% vs 75.7%, 95% CI = 72.8% to 78.4%; P < .001), but by eight years, survival was almost equal. The eight-year OS of patients with ER-positive tumors was similar to that of patients with ER-negative tumors in both HER2-positive and HER2-negative subgroups. The flexible parametric survival model for OS shows that the risk of death increases steadily over time for patients with ER-positive tumors in contrast to patients with ER-negative tumors, where risk of death peaked at two years. These results confirm the increased frequency of ER-negative tumors and early relapse in young patients and also demonstrate the equally poor longer-term outlook of young patients who have ER-positive tumors with HER2-negative or -positive disease.

Malnutrition and Associated Clinical Outcomes in Hospitalized Patients Aged 60 and Older: An Observational Study in Rural Wales

This is a prospective observational study of malnutrition and six-week clinical outcomes on a previously unstudied population of older hospital inpatients in rural Wales. One hundred and twenty-six of 152 patients older than 60 years identified on the wards surveyed were included. Patients unable to give informed consent and those too ill to participate were excluded. The main findings were that 55 (44%) were malnourished at the first assessment, that nutrition risk predicted mortality (P = 0.019), length of hospital stay (P = 0.026), and discharge destination (P = 0.005), that only 17 patients had received nutritional support, and that many of those who received support nevertheless had lost weight at the 6-week follow-up. This confirms previous research which suggests that, while malnutrition is associated with poorer clinical outcomes, nutrition support for older patients in hospital nevertheless is often insufficient.

Pulmonary resections in a tertiary care center—a prospective observational study of outcome

Introduction In order to assess short term outcomes of pulmonary resections in one year, a prospective observational study was made. To assess the predictive factors for postoperative complications.

1555P - Biosimilar Filgrastim Initiation in Patients Enrolled in the Monitor G-CSF Observational Study Relative to EORTC Guidelines

ABSTRACT Introduction MONITOR G-CSF is a prospective observational study of practice patterns and outcomes for prophylaxis of chemotherapy-induced febrile neutropenia (FN) with biosimilar filgrastim (Zarzio®, Sandoz Biopharmaceuticals). Methods This analysis describes treatment initiation with biosimilar filgrastim in the 788 patients enrolled to date (target 1500) in the MONITOR G-CSF study relative to the 2010 EORTC G-CSF guidelines. Patients were enrolled at 134 centres (199 open) across 12 European countries. Results In this mainly female (62%) and older (61.6 ± 11.9 years) cohort with predominately solid tumours (79%), FN risk based on chemotherapy (CT) regimen was 20% in 39% of patients. All patients with Table 1 . All patients Prophylaxis (%) Initiation (%) Duration (%) Primary Secondary 24-72 h Days 5-8 3 days 5 days Tumour type: Oncology Haematology 70 70 30 30 56 24 30 56 16 11 42 47 CT toxicity: > 20% 10-20% 76 74 56 24 26 44 53 49 54 29 32 25 13 13 15 44 39 41 Table 2 . FN risk 10-20% Prophylaxis (%) Patient-related risk factors Primary Secondary Age >65 years 79 21 Advanced disease (Stage IV) 74 26 History of prior FN 29 71 No antibiotic prophylaxis 73 24 Poor performance (ECOG >2) 83 17 Female 76 24 Hb 70 30 Liver, renal or CV disease 72 28 One or more risks 74 26 Conclusions Variability exists in biosimilar filgrastim initiation by tumour type (day of initiation), CT toxicity and patient-related risk. About a quarter of patients with FN risk >20% or 10-20% in combination with other risk factors did not receive primary prophylaxis as recommended. The trend to initiate filgrastim in regimens with Disclosure M.S. Aapro: Member of the steering committee for Sandoz Biopharmaceuticals supported study. P. Gascon: Member of the steering committee for Sandoz Biopharmaceuticals supported study. H. Ludwig: Member of the steering committee for Sandoz Biopharmaceuticals supported study. On Speakers Bureau and advisory board for Amgen. C. Bokemeyer: Member of the steering committee for Sandoz Biopharmaceuticals supported study. M. Boccadoro: Member of the steering committee for Sandoz Biopharmaceuticals supported study. M. Turner: Employee of Sandoz Biopharmaceuticals. M. Muenzberg: Employee of Sandoz Biopharmaceuticals. K. Denhaerynck: Employee of Matrix 45. I. Abraham: Employee of Matrix 45. K. Macdonald: Employee of Matrix 45.

Clinical Outcomes Analysis of Conservative and Surgical Treatment of Patients With Clinical Indications of Prearthritic, Intra-articular Hip Disorders

To describe outcomes of the conservative treatment of patients who had the clinical presentation of a prearthritic, intra-articular hip disorder, including acetabular labral tears, developmental hip dysplasia, and femoroacetabular impingement. Prospective observational clinical outcomes study. Outpatient orthopedic clinic at a tertiary university hospital. Patients presenting with prearthritic, intra-articular hip disorders were recruited. Fifty-eight consecutive patients were enrolled; 6 were lost to follow-up, and 52 subjects completed the study. Patients were recruited on the basis of symptoms, distribution of pain, and the findings of a physical examination. Radiographic measurements of the hip were obtained for all subjects to describe the presence or absence and extent of deformity and/or osteoarthritis. All subjects completed a directed course of conservative treatment. After 3 months of conservative care, subjects with continued limitations, reduction of symptoms with a diagnostic intra-articular hip injection, and a surgically amenable lesion found on a magnetic resonance arthrogram proceeded to surgery. Numeric Pain Score (0-10), Short Form-12, Modified Harris Hip Score, Western Ontario and McMaster Universities Osteoarthritis Index, Nonarthritic Hip Score, Baecke Questionnaire of Habitual Activity, and patient choice to have surgery. Fifty-eight patients (9 men and 49 women) with a mean age of 35 ± 11 years (range, 18-50 years) enrolled in the study. Fifty-two subjects completed the study. Twenty-three subjects (44%) reported satisfaction with conservative care. Twenty-nine subjects (56%) chose to have surgery. Both groups demonstrated equally significant improvement (P value ranges: P = .03 to P = .0001) in all outcome measures from baseline to 1-year follow-up. Subjects who chose surgery had higher baseline activity scores compared with the conservative treatment group (P = .02). All subjects with signs and symptoms of prearthritic, intra-articular hip disorders who were treated with conservative treatment alone and with conservative treatment followed by surgery demonstrated significant improvement in pain and functioning from baseline to 1 year. Forty-four percent of patients improved with conservative care alone, and 56% chose to have surgery after receiving conservative care. Persons with more active lifestyles were more likely to choose surgery. These data suggest that a trial of conservative management for persons with prearthritic, intra-articular hip disorders should be considered before engaging in surgical intervention.

Pain and Interference of Pain With Function and Mood in Elderly Adults Involved in a Motor Vehicle Collision: A Pilot Study

Background/Study Context: Musculoskeletal pain after motor vehicle collision is a substantial public health problem. The number of elderly individuals experiencing motor vehicle collision is increasing. The authors conducted analyses of data collected as part of a prospective observational study of outcomes after motor vehicle collision to estimates rates of persistent pain, pain interference, and change in physical function in patients 65 or older. Methods: Adults presenting to one of four emergency departments following motor vehicle collision without severe or life-threatening injury were recruited. Outcomes were assessed using 1-month follow-up surveys. Results: The frequencies of persistent moderate or severe pain resulting from the motor vehicle collision were similar among elderly and nonelderly participants, both in the neck region (27% vs. 30%) and in any region (60% vs. 56%). For both elderly and nonelderly patients, persistent pain was associated with high levels of interference with physical activity and mood. Conclusion: Further studies of this vulnerable and rapidly increasing injury population are needed.

Disease‐specific quality of life outcomes in functional rhinoplasty

The goal of this study was to assess disease-specific quality of life as well as cosmetic outcomes following functional rhinoplasty in adults with nasal obstruction. Prospective observational outcomes study. Disease-specific quality of life determinations and cosmetic outcome assessments were performed using the Nasal Obstruction Symptom Evaluation scale (NOSE), the Sleep Outcomes Survey (SOS), and a cosmetic outcomes scale. Ratings were ascertained preoperatively and postoperatively at 1 to 3 and at 6 to 12 months for patients with internal nasal valve dysfunction, external nasal valve dysfunction, and both (groups 1, 2, and 3, respectively). All groups showed a significant improvement in NOSE scores at the early and the late time points (P < .0005). SOS scores significantly improved from baseline to 1-3 months after surgery (P < .0005) and to 6-12 months (P < .0005). Snoring cessation was reported in 30% of patients who snored preoperatively. The cosmetic appearance of the nose significantly improved after surgery (P < .0005). This study utilized standardized terminology to diagnosis and treat nasal valve dysfunction, and validated disease-specific quality of life measures to quantify the improvements made with specific techniques. In particular, this study showed improvement in nasal obstruction and snoring in patients with nasal valve dysfunction treated surgically, without negatively impacting nasal cosmesis. Studies utilizing consistent methods of assessment and analysis will allow for future meta-analysis, increasing the level of evidence available in the field of functional rhinoplasty, and facilitate the creation of evidence-based management algorithms.

ATLANTIC-DIP: Raised Maternal Body Mass Index (BMI) Adversely Affects Maternal and Fetal Outcomes in Glucose-Tolerant Women According to International Association of Diabetes and Pregnancy Study Groups (IADPSG) Criteria

Raised maternal body mass index (BMI) in association with hyperglycemia is associated with adverse pregnancy outcome. The contribution of raised BMI as an independent risk factor for adverse pregnancy outcome is of growing concern and increasing prevalence. The aim of this study was to investigate the effects of raised maternal BMI on pregnancy outcome in glucose-tolerant women using the International Association of Diabetes and Pregnancy Study Groups criteria. We studied a cohort of glucose-tolerant, pregnant women (n = 3656) who were attending antenatal obstetric clinics and were recruited to a universal screening program for gestational diabetes under the ATLANTIC-DIP partnership. We conducted a prospective observational study of pregnancy outcome. Maternal outcomes include glucose, delivery mode, pregnancy-induced hypertension, preeclampsia, antepartum hemorrhage, and postpartum hemorrhage. Fetal outcomes included birthweight, congenital malformation, fetal death, neonatal jaundice, hypoglycemia, and respiratory distress. Increasing maternal BMI was associated with adverse pregnancy outcomes: higher cesarean section rates, preeclampsia, pregnancy-induced hypertension, increased birth weight, and congenital malformation. The association of glucose with adverse pregnancy outcome was weak and did not interact with raised BMI. A BMI threshold of 28 kg/m(2) was associated with a significant rise in adverse pregnancy outcome. Raised maternal BMI, within the overweight range, is associated with adverse pregnancy outcomes. These adverse effects of BMI occur independently of maternal glucose. It is apparent that pregnancy unmasks an underlying unhealthy metabolic milieu in obese and overweight women.

Five-year follow-up of a one-year self-management program for patients with COPD

ObjectiveInvestigate long-term effects 4 years after the end of a 1-year self-management program (SMP) with 30 hours of education and 16 hours of physical activity in patients with chronic obstructive pulmonary disease (COPD).MethodsProspective observational outcome study. SMP focused on improving disease related self-care skills. Main outcome measures were health-related quality of life, HRQoL, (St Georges Respiratory Questionnaire, SGRQ total) and exercise capacity (6-minute walk test, 6MWT).ResultsThirty patients participated, 47% women. Baseline mean age was 67 years and mean pre-bronchodilator FEV1 (forced expiratory volume in 1 second) percentage predicted was 41.3. HRQoL showed a statistical significant improvement during the 1-year intervention. Four years after the end of the program SGRQ total was similar to baseline value, 1.4 points (95% CI: −3.6 to 6.3, P = 0.580). Also 6MWT was similar to baseline value at the same test point, −10 m (95% CI: −27 to 8, P = 0.262), and 63% reported having continued to exercise regularly a minimum of three times per week during the follow-up period.ConclusionThe participants in a 1-year self-management program with additional training had maintained their pre-intervention level of HRQoL and exercise capacity 4 years after the end of the program. Two out of three participants had continued to exercise regularly.

Pediatric Minor Injury Outcomes

The objectives were (1) to present a preliminary evaluation of outcomes after pediatric emergency department (PED) minor injury care (not previously described) and (2) to test the feasibility of study methods and of a HRQOL tool in this acute care setting. A prospective observational study of clinical and functional short-term outcomes in PED patients with minor injury was performed. Thirty-five (80%) of 44 families completed telephone follow-up. Children had a median of 3 days of pain; 24% had pain for more than 7 days. Children returned to normal activity in a median of 3 days, and 37%, in more than 7 days. Fifty percent of families had normal activities disrupted, with median of 5 days and 39% in more than 7 days. Among children with school/scheduled activities, 55% missed more than 3 days, and 20% missed more than 7 days. Among parents who missed work/school, the mean was 1 day, and 22% missed more than 3 days. The acute Pediatric Quality of Life Inventory (PedsQL) was feasible for emergency department/follow-up use and had the expected inverse correlations with poor outcomes. We found significant morbidity after PED treatment of minor injury. The study methods and PedsQL patient and proxy forms were feasible for emergency department use. The PedsQL had some initial indications of construct validity for this population.

Nasal Airway Preservation Using the Autospreader Technique

To measure the efficacy of a specific midvault reconstruction technique (the autospreader flap) in dorsal reductive rhinoplasty with a validated quality-of-life instrument. A prospective observational outcomes study of patients desiring reduction of the nasal dorsum who either (1) had no breathing obstruction, who underwent purely aesthetic rhinoplasty, or (2) had concomitant severe nasal obstruction due to septal deviation, internal valve narrowing, and/or turbinate hypertrophy, who subsequently underwent combined functional and aesthetic rhinoplasty. Preoperative and postoperative evaluation was performed using the Nasal Obstruction Symptoms Evaluation (NOSE) scale. Thirty-eight patients completed preoperative and postoperative evaluation. No complications occurred. Patients in the purely aesthetic group were noted to have low preoperative NOSE scores, with no change postoperatively. There was a significant improvement in mean NOSE score postoperatively for the combined functional and aesthetic group (P < .001). Midvault reconstruction using the autospreader graft may help prevent postoperative nasal obstruction due to midvault collapse. Combining this procedure with dorsal reduction in functional rhinoplasty patients with traditional airway reconstruction techniques is effective in improving nasal airway function as measured by a patient-based, disease-specific quality-of-life instrument.