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1.
J Dev Behav Pediatr ; 2024 Apr 02.
Article in English | MEDLINE | ID: mdl-38564788

ABSTRACT

OBJECTIVE: The aim of this study was to evaluate the added value of primary care clinician (PCC)-indicated concern during primary care universal standardized screening in early identification of autism. METHODS: Toddlers were screened for autism during primary care checkups (n = 7,039, aged 14.24-22.43 months) in 2 studies. Parents completed the Modified Checklist for Autism in Toddlers, Revised, with Follow-Up. For each participant, PCCs indicated whether they had autism concerns (optional in 1 study-before or after viewing screening results, required before viewing screen results in the other). Children at high likelihood for autism from screen result and/or PCC concern (n = 615) were invited for a diagnostic evaluation; 283 children attended the evaluation. RESULTS: Rates of PCC-indicated autism concerns were similar whether PCCs were required or encouraged to indicate concerns. High likelihood of autism indication on both screen and PCC concern resulted in the highest positive predictive value for autism and positive predictive value for any developmental disorder, as well as the highest evaluation attendance, with no significant difference between the positive screen-only and PCC concern-only groups. Although the frequency of PCC-indicated autism concern did not differ significantly based on the child's cognitive level, PCCs were more likely to identify children with more obvious autism characteristics compared with more subtle autism characteristics as having autism. CONCLUSION: The findings support the recommendation of the American Academy of Pediatrics that both screening and surveillance for autism be incorporated into well-child visits. High likelihood of autism on either screen or PCC concern should trigger a referral for an evaluation.

2.
Environ Res ; 239(Pt 1): 117248, 2023 Dec 15.
Article in English | MEDLINE | ID: mdl-37827369

ABSTRACT

BACKGROUND: Exposure to particulate matter ≤2.5 µm in diameter (PM2.5) and ozone (O3) has been linked to numerous harmful health outcomes. While epidemiologic evidence has suggested a positive association with type 2 diabetes (T2D), there is heterogeneity in findings. We evaluated exposures to PM2.5 and O3 across three large samples in the US using a harmonized approach for exposure assignment and covariate adjustment. METHODS: Data were obtained from the Veterans Administration Diabetes Risk (VADR) cohort (electronic health records [EHRs]), the Reasons for Geographic and Racial Disparities in Stroke (REGARDS) cohort (primary data collection), and the Geisinger health system (EHRs), and reflect the years 2003-2016 (REGARDS) and 2008-2016 (VADR and Geisinger). New onset T2D was ascertained using EHR information on medication orders, laboratory results, and T2D diagnoses (VADR and Geisinger) or report of T2D medication or diagnosis and/or elevated blood glucose levels (REGARDS). Exposure was assigned using pollutant annual averages from the Downscaler model. Models stratified by community type (higher density urban, lower density urban, suburban/small town, or rural census tracts) evaluated likelihood of new onset T2D in each study sample in single- and two-pollutant models of PM2.5 and O3. RESULTS: In two pollutant models, associations of PM2.5, and new onset T2D were null in the REGARDS cohort except for in suburban/small town community types in models that also adjusted for NSEE, with an odds ratio (95% CI) of 1.51 (1.01, 2.25) per 5 µg/m3 of PM2.5. Results in the Geisinger sample were null. VADR sample results evidenced nonlinear associations for both pollutants; the shape of the association was dependent on community type. CONCLUSIONS: Associations between PM2.5, O3 and new onset T2D differed across three large study samples in the US. None of the results from any of the three study populations found strong and clear positive associations.


Subject(s)
Diabetes Mellitus, Type 2 , Environmental Pollutants , Humans , United States/epidemiology , Diabetes Mellitus, Type 2/epidemiology , Data Collection , Odds Ratio , Particulate Matter/toxicity
3.
Int J Health Geogr ; 22(1): 24, 2023 09 20.
Article in English | MEDLINE | ID: mdl-37730612

ABSTRACT

BACKGROUND: Communities in the United States (US) exist on a continuum of urbanicity, which may inform how individuals interact with their food environment, and thus modify the relationship between food access and dietary behaviors. OBJECTIVE: This cross-sectional study aims to examine the modifying effect of community type in the association between the relative availability of food outlets and dietary inflammation across the US. METHODS: Using baseline data from the REasons for Geographic and Racial Differences in Stroke study (2003-2007), we calculated participants' dietary inflammation score (DIS). Higher DIS indicates greater pro-inflammatory exposure. We defined our exposures as the relative availability of supermarkets and fast-food restaurants (percentage of food outlet type out of all food stores or restaurants, respectively) using street-network buffers around the population-weighted centroid of each participant's census tract. We used 1-, 2-, 6-, and 10-mile (~ 2-, 3-, 10-, and 16 km) buffer sizes for higher density urban, lower density urban, suburban/small town, and rural community types, respectively. Using generalized estimating equations, we estimated the association between relative food outlet availability and DIS, controlling for individual and neighborhood socio-demographics and total food outlets. The percentage of supermarkets and fast-food restaurants were modeled together. RESULTS: Participants (n = 20,322) were distributed across all community types: higher density urban (16.7%), lower density urban (39.8%), suburban/small town (19.3%), and rural (24.2%). Across all community types, mean DIS was - 0.004 (SD = 2.5; min = - 14.2, max = 9.9). DIS was associated with relative availability of fast-food restaurants, but not supermarkets. Association between fast-food restaurants and DIS varied by community type (P for interaction = 0.02). Increases in the relative availability of fast-food restaurants were associated with higher DIS in suburban/small towns and lower density urban areas (p-values < 0.01); no significant associations were present in higher density urban or rural areas. CONCLUSIONS: The relative availability of fast-food restaurants was associated with higher DIS among participants residing in suburban/small town and lower density urban community types, suggesting that these communities might benefit most from interventions and policies that either promote restaurant diversity or expand healthier food options.


Subject(s)
Diet , Inflammation , Humans , Cross-Sectional Studies , Inflammation/diagnosis , Inflammation/epidemiology , Restaurants , Rural Population
4.
Article in English | MEDLINE | ID: mdl-36858436

ABSTRACT

INTRODUCTION: Inequitable access to leisure-time physical activity (LTPA) resources may explain geographic disparities in type 2 diabetes (T2D). We evaluated whether the neighborhood socioeconomic environment (NSEE) affects T2D through the LTPA environment. RESEARCH DESIGN AND METHODS: We conducted analyses in three study samples: the national Veterans Administration Diabetes Risk (VADR) cohort comprising electronic health records (EHR) of 4.1 million T2D-free veterans, the national prospective cohort REasons for Geographic and Racial Differences in Stroke (REGARDS) (11 208 T2D free), and a case-control study of Geisinger EHR in Pennsylvania (15 888 T2D cases). New-onset T2D was defined using diagnoses, laboratory and medication data. We harmonized neighborhood-level variables, including exposure, confounders, and effect modifiers. We measured NSEE with a summary index of six census tract indicators. The LTPA environment was measured by physical activity (PA) facility (gyms and other commercial facilities) density within street network buffers and population-weighted distance to parks. We estimated natural direct and indirect effects for each mediator stratified by community type. RESULTS: The magnitudes of the indirect effects were generally small, and the direction of the indirect effects differed by community type and study sample. The most consistent findings were for mediation via PA facility density in rural communities, where we observed positive indirect effects (differences in T2D incidence rates (95% CI) comparing the highest versus lowest quartiles of NSEE, multiplied by 100) of 1.53 (0.25, 3.05) in REGARDS and 0.0066 (0.0038, 0.0099) in VADR. No mediation was evident in Geisinger. CONCLUSIONS: PA facility density and distance to parks did not substantially mediate the relation between NSEE and T2D. Our heterogeneous results suggest that approaches to reduce T2D through changes to the LTPA environment require local tailoring.


Subject(s)
Diabetes Mellitus, Type 2 , Humans , Case-Control Studies , Prospective Studies , Exercise , Socioeconomic Factors , Leisure Activities
5.
Autism ; 27(7): 2112-2123, 2023 10.
Article in English | MEDLINE | ID: mdl-36786236

ABSTRACT

LAY ABSTRACT: This study examined a widely used autism screening tool, the Modified Checklist for Autism in Toddlers, Revised, with Follow-Up to identify differences in screening for autism between toddler males and females. Examining sex differences in screening for autism in toddlerhood is important as it determines who will be referred for evaluations and receive diagnoses, which is critical for access to autism-specific early intervention. This study found that females were less likely to screen positive and be invited for evaluations compared with males. Females at high likelihood for autism were less likely to be diagnosed with autism, which decreases confidence in the screener's results. Importantly, the Modified Checklist for Autism in Toddlers, Revised, with Follow-Up accurately identified both males and females with autism. Future research should examine ways to improve accuracy in screening results for females.


Subject(s)
Autism Spectrum Disorder , Autistic Disorder , Humans , Male , Child, Preschool , Female , Infant , Autistic Disorder/diagnosis , Autism Spectrum Disorder/diagnosis , Follow-Up Studies , Checklist/methods , Sex Characteristics , Mass Screening/methods
6.
Article in English | MEDLINE | ID: mdl-35369036

ABSTRACT

Existing classifications of community type do not differentiate urban cores from surrounding non-rural areas, an important distinction for analyses of community features and their impact on health. Inappropriately classified community types can introduce serious methodologic flaws in epidemiologic studies and invalid inferences from findings. To address this, we evaluate a modification of the United States Department of Agriculture's Rural Urban Commuting Area codes at the census tract, propose a four-level categorization of community type, and compare this with existing classifications for epidemiologic analyses. Compared to existing classifications, our method resulted in clearer geographic delineations of community types within urban areas.

7.
J Urban Health ; 99(3): 457-468, 2022 06.
Article in English | MEDLINE | ID: mdl-35484371

ABSTRACT

Area-level neighborhood socioeconomic status (NSES) is often measured without consideration of spatial autocorrelation and variation. In this paper, we compared a non-spatial NSES measure to a spatial NSES measure for counties in the USA using principal component analysis and geographically weighted principal component analysis (GWPCA), respectively. We assessed spatial variation in the loadings using a Monte Carlo randomization test. The results indicated that there was statistically significant variation (p = 0.004) in the loadings of the spatial index. The variability of the census variables explained by the spatial index ranged from 60 to 90%. We found that the first geographically weighted principal component explained the most variability in the census variables in counties in the Northeast and the West, and the least variability in counties in the Midwest. We also tested the two measures by assessing the associations with county-level diabetes prevalence using data from the CDC's US Diabetes Surveillance System. While associations of the two NSES measures with diabetes did not differ for this application, the descriptive results suggest that it might be important to consider a spatial index over a global index when constructing national county measures of NSES. The spatial approach may be useful in identifying what factors drive the socioeconomic status of a county and how they vary across counties. Furthermore, we offer suggestions on how a GWPCA-based NSES index may be replicated for smaller geographic scopes.


Subject(s)
Residence Characteristics , Social Class , Censuses , Humans , Socioeconomic Factors
8.
Behav Anal Pract ; 13(3): 674-678, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32953395

ABSTRACT

We evaluated written instructions plus video modeling-and when necessary, in vivo prompting and feedback-to teach 3 parents to implement a structured meal procedure to decrease food selectivity among their children with autism. In addition to data on correct parent implementation, we also collected data on child bite acceptance. Results showed that instructions and video modeling were effective to achieve the mastery criteria for 1 parent; the other 2 parents required in vivo prompts and feedback. Two of the children exhibited an increase in bite acceptance during the structured meal procedure.

9.
JAAPA ; 33(7): 31-36, 2020 Jul.
Article in English | MEDLINE | ID: mdl-32590531

ABSTRACT

Osteoporosis commonly affects postmenopausal women and accounts for 300,000 hip fractures in the United States each year. More women are deferring or discontinuing pharmacologic treatment because of intolerable adverse reactions or fear of long-term safety. Supplementing dietary intake of certain vitamins and minerals can have positive effects on bone parameters. Calcium is frequently recommended for osteoporotic patients but many not confer much benefit toward bone density. Certain forms of vitamins A and K have been shown to increase bone density. Isoflavones and phytates are phytochemicals found in soy foods that are comparable to bisphosphonates when consumed at certain levels. Lastly, increasing certain daily fruit and vegetable servings can improve bone health. Nutritional interventions are typically safe alternatives that should be considered for postmenopausal women who are seeking nonpharmacologic treatment options for osteoporosis.


Subject(s)
Diet , Dietary Supplements , Osteoporosis, Postmenopausal/diet therapy , Osteoporosis, Postmenopausal/prevention & control , Aged , Aged, 80 and over , Bone Density , Female , Fruit , Humans , Isoflavones/administration & dosage , Middle Aged , Phytic Acid/administration & dosage , Phytochemicals/administration & dosage , Severity of Illness Index , Vegetables , Vitamin A/administration & dosage , Vitamin K/administration & dosage
10.
Female Pelvic Med Reconstr Surg ; 25(1): 56-62, 2019.
Article in English | MEDLINE | ID: mdl-29189386

ABSTRACT

OBJECTIVES: Bladder drainage can be achieved by clean intermittent self-catheterization (CISC), transurethral indwelling catheterization (TIC), or with a suprapubic tube (SPT). The primary objective of this study was to determine patient preference for catheter type in the management of potential voiding dysfunction after pelvic organ prolapse (POP) surgery. METHODS: Between 2012 and 2016, patients scheduled for POP surgery were recruited into the study. Before surgery, patients were informed of the potential for postoperative voiding dysfunction and the catheter choices were discussed. Each patient's choice was recorded along with baseline information, surgery performed, and perioperative details. After surgery, voiding dysfunction, length of catheter use, scores on a catheter satisfaction questionnaire, as well as uroflowmetry and urine culture testing were assessed. RESULTS: Of those recruited to the study (N = 150), 6.7% chose CISC, 7.3% chose TIC, and 86% chose SPT. Catheter satisfaction score 1 week after surgery was significantly better for SPT compared with CISC and TIC (P = 0.005). In addition, at week 1, 33% of CISC, 25% of TIC, and 13% of SPT had a PVR of more than 30% (P = 0.002) on uroflowmetry, and 33% of CISC, 50% of TIC, and 24% of SPT had a positive urine culture (P = 0.05). CONCLUSIONS: This study has shown that patients prefer SPT over CISC and TIC for management of voiding dysfunction after POP surgery. Use of SPT showed better satisfaction rates, better uroflowmetry results, and lower infection rates 1 week after surgery. Patient preference is an important factor in this decision and can help facilitate a clinical approach.


Subject(s)
Catheters, Indwelling , Patient Preference , Postoperative Complications/therapy , Urinary Catheterization/psychology , Urination Disorders/therapy , Adult , Aged , Female , Humans , Longitudinal Studies , Middle Aged , Pelvic Organ Prolapse/surgery , Postoperative Complications/diagnosis , Plastic Surgery Procedures/adverse effects , Surveys and Questionnaires , Urinary Catheterization/methods
11.
Anal Verbal Behav ; 35(2): 113-133, 2019 Dec.
Article in English | MEDLINE | ID: mdl-31976226

ABSTRACT

The inclusion of instructive feedback in discrete-trial training has been shown to increase the efficiency of learning. However, the behavioral mechanism underlying the effectiveness of this procedure has not yet been determined. Researchers have suggested that learners covertly self-echo the feedback, which mediates later responding. The present study sought to understand the role of self-echoics in the acquisition of untaught targets. Participants were directly taught to tact pictures, then given instructive feedback after the praise statement. The 3 experimental conditions were (a) a typical instructive feedback procedure; (b) a vocal mediation-blocking procedure, in which the participants were asked to engage in a competing vocal response immediately after the instructive feedback; and (c) a motor-distraction procedure, in which the participants were asked to engage in a motor response immediately after the instructive feedback. The inclusion of the vocal mediation-blocking task had little effect on the participants' ability to learn the instructive feedback targets for all 3 participants.

12.
J Acquir Immune Defic Syndr ; 78 Suppl 2: S81-S87, 2018 08 15.
Article in English | MEDLINE | ID: mdl-29994829

ABSTRACT

BACKGROUND: Viral suppression is the desired outcome for children and adolescents with HIV. In this article, data from districts supporting community interventions (implementation districts) were reviewed and compared with data from districts without community interventions (nonimplementation districts) to explore a potential correlation between community interventions and clinical outcomes. SETTING: The study was based on data collected from facilities in 6 districts in Lesotho. METHODS: Twelve-month retention, viral load coverage, and viral suppression data from patients with ART between ages 5 and 24 from facilities in both district types were collected retrospectively. RESULTS: Implementation districts showed retention rates of 75%, with 5365 patients (47% of all patients on ART) having documented viral load results and 4641 (87%) being virally suppressed. Retention comparison demonstrated significantly higher rates in implementation districts (73%) as compared to (63%) in nonimplementation districts (P = 0.023). Viral load coverage and suppression comparison found that implementation district hospitals reported 632 (37% of total on ART) patients with a documented viral load, with 539 (85%) virally suppressed, whereas nonimplementation district hospitals reported 220 (31%) patients with viral load results, of whom 181 (82%) were suppressed. CONCLUSIONS: Overall, retention rates in the implementation districts were reasonable and were significantly better than the rates in the nonimplementation districts.


Subject(s)
Anti-Retroviral Agents/therapeutic use , Child Health Services , Community Health Services , HIV Infections/drug therapy , Adolescent , Child , Child, Preschool , HIV Infections/epidemiology , Health Facilities , Health Plan Implementation , Humans , Lesotho/epidemiology , Program Evaluation , Retention in Care , Retrospective Studies , Viral Load , Young Adult
13.
Vaccine ; 35(5): 842-848, 2017 02 01.
Article in English | MEDLINE | ID: mdl-28062124

ABSTRACT

OBJECTIVE: To evaluate if text message reminders increase the likelihood of receiving the influenza vaccine among pregnant women. METHODS: Pregnant women were randomized to either receive or not receive weekly text messages. Women were told the messages would be about health-related behavior in pregnancy. Those randomized to the intervention group received two messages weekly for four consecutive weeks reinforcing that the influenza vaccine is recommended for all pregnant women and safe during pregnancy and breastfeeding. Women were contacted six weeks postpartum to determine if they had received the vaccine. Sample size calculation determined that 108 women were required in both groups to see a 75% increase in vaccination rates over baseline in the text message group compared to the control group. RESULTS: Recruitment began November 4, 2013, and 317 women were randomized. The mean gestational age at recruitment was 22weeks. There were 40/129 (31%) women in the text message group and 41/152 (27%) women in the control group who received the vaccine (p=0.51). Significant predictors of vaccine acceptance were being married compared to single (95% vs. 67%, p<0.001), having higher household income (55% vs. 39%, p=0.03) and having received the vaccine before (77% vs. 36%, p<0.001). Among women receiving text messages, the majority were satisfied, with only 15/129 (12%) reporting that they did not like receiving the messages, and 24/129 (19%) stating that the information in the messages was not helpful. CONCLUSION: Weekly text messages reinforcing the recommendation for and safety of the influenza vaccine in pregnancy did not increase the likelihood of actually receiving the vaccine among pregnant women. Overall vaccination rates were low, highlighting the need for patient education and innovative techniques to improve vaccine acceptance. Registered with ClinicalTrials.gov at http://www.clinicaltrials.gov, registration number NCT 02428738.


Subject(s)
Influenza Vaccines/administration & dosage , Influenza, Human/prevention & control , Pregnant Women/psychology , Reminder Systems , Text Messaging , Vaccination/statistics & numerical data , Adult , Female , Gestational Age , Humans , Income/statistics & numerical data , Influenza, Human/immunology , Influenza, Human/virology , Likelihood Functions , Marital Status/statistics & numerical data , Patient Satisfaction/statistics & numerical data , Pregnancy , Vaccination/psychology
14.
BMC Musculoskelet Disord ; 17(1): 340, 2016 08 15.
Article in English | MEDLINE | ID: mdl-27527912

ABSTRACT

BACKGROUND: Frozen shoulder is a common yet poorly understood musculoskeletal condition, which for many, is associated with substantial and protracted morbidity. Understanding the pathology associated with this condition may help to improve management. To date this has not been presented in a systematic fashion. As such, the aim of this review was to summarise the pathological changes associated with this primary frozen shoulder. DATABASES: Medline, Embase, CINAHL, AMED, BNI and the Cochrane Library, were searched from inception to 2nd May, 2014. To be included participants must not have undergone any prior intervention. Two reviewers independently conducted the; searches, screening, data extraction and assessment of Risk of Bias using the Cochrane Risk of Bias Assessment Tool for non-Randomised Studies of Interventions (ACROBAT-NRSI). Only English language publications reporting findings in humans were included. The findings were summarised in narrative format. RESULTS: Thirteen observational studies (involving 417 shoulders) were included in the review. Eight studies reported magnetic resonance imaging or arthrography findings and 5 recorded histological findings. When reported mean ages of the participants ranged from 40.0 to 59.8 years. Duration of symptoms ranged from 0 to 30 months. The majority of studies (n = 7) were assessed to be of moderate risk of bias, two studies at high risk and the remaining four were rated as low risk of bias. Study characteristics were poorly reported and there was widespread variety observed between studies in respect of data collection methods and inclusion criteria employed. Pathological changes in the anterior shoulder joint capsule and related structures were commonly reported. Imaging identified pathological changes occurring in the coracohumeral ligament, axillary fold and rotator interval. Obliteration of the subcoracoid fat triangle also appeared to be pathognomonic. Histological studies were inconclusive but suggested that immune, inflammatory and fibrotic changes where associated with primary frozen shoulder. CONCLUSIONS: This systematic review presents a summary of what is currently known about the tissue pathophysiology of primary frozen shoulder. Further studies that use standardised inclusion and exclusion criteria and investigate changes in naïve tissue at different stages of the condition are required.


Subject(s)
Bursitis/physiopathology , Ligaments, Articular/physiopathology , Shoulder Joint/physiopathology , Shoulder Pain/physiopathology , Adult , Arthrography , Bursitis/diagnostic imaging , Bursitis/pathology , Humans , Ligaments, Articular/diagnostic imaging , Ligaments, Articular/pathology , Magnetic Resonance Imaging , Middle Aged , Shoulder Joint/diagnostic imaging , Shoulder Joint/pathology , Shoulder Pain/diagnostic imaging , Shoulder Pain/pathology
15.
J Emerg Med ; 49(6): 901-6, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26433424

ABSTRACT

BACKGROUND: Although first-generation antipsychotics (FGAs) have long been used in the emergency department (ED) to treat acute agitation, little is known about how these medications are used in modern clinical practice. In particular, little work has been published about whether ED clinicians administer FGAs with adjunctive medications in accordance with expert guidelines or the prescribing practices of FGAs over time. OBJECTIVES: 1) To provide a comparison of the frequency with which FGAs are administered with adjunctive benzodiazepines or anticholinergic medications. 2) To analyze the prescribing trends for FGAs over time, particularly in the years after the U.S. Food and Drug Administration (FDA) black-box warning for droperidol. METHODS: This is a structured review of a retrospective cohort of patients receiving haloperidol or droperidol in two EDs over a 7-year period. RESULTS: Haloperidol or droperidol was administered on 2833 patient visits during the study period, with haloperidol being administered most often. Adjunctive medications are administered less than half of the time. The use of droperidol has remained relatively static, whereas the use of haloperidol has increased. CONCLUSIONS: First-generation antipsychotics are still widely utilized in the ED. When administered, these medications are used with adjunctive medications that may decrease side effects less than half of the time. Droperidol use has remained unchanged in the years after the FDA black-box warning, whereas use of haloperidol has continued to rise.


Subject(s)
Antipsychotic Agents/administration & dosage , Droperidol/administration & dosage , Emergency Service, Hospital , Haloperidol/administration & dosage , Practice Patterns, Physicians'/statistics & numerical data , Adult , Female , Humans , Male , Retrospective Studies
16.
Stud Fam Plann ; 46(1): 41-54, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25753058

ABSTRACT

In rural Ethiopia, environmental degradation and a shortage of arable land impose a major toll on the population. Population, health, and environment (PHE) programs, such as that of the Ethio-Wetlands and Natural Resources Association (EWNRA), have evolved to address these issues. This article examines the community-based distribution (CBD) of family planning commodities in rural Ethiopia through EWNRA's large, multisectoral PHE program. Participants indicated that the integrated program encouraged acceptance of family planning and reduced geographic barriers to access. Through peer education and collaboration across government ministries, EWNRA leveraged integrated population-environment messages to garner support for its network of CBD providers. These integration strategies are a model for PHE programs worldwide, especially amid the global response to climate change. Because of the complex nature of PHE organizations, researchers often find it difficult to effectively document and evaluate their programs. With this in mind, we propose a framework to assess PHE integration.


Subject(s)
Contraception/methods , Family Planning Services/organization & administration , Health Services Accessibility/organization & administration , Rural Health Services/organization & administration , Age Factors , Community Health Workers/organization & administration , Cooperative Behavior , Ethiopia , Health Education/organization & administration , Humans , Interviews as Topic , Sex Factors , Socioeconomic Factors
17.
Thorax ; 70(5): 442-50, 2015 May.
Article in English | MEDLINE | ID: mdl-25714615

ABSTRACT

BACKGROUND: We conducted a placebo-controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation. METHODS: We compared azithromycin (250 mg alternate days, 12 weeks) with placebo. Primary outcome was FEV1 change at 12 weeks. RESULTS: 48 patients were randomised; (25 azithromycin, 23 placebo). It was established, post randomisation that two did not have BOS. 46 patients were analysed as intention to treat (ITT) with 33 'Completers'. ITT analysis included placebo patients treated with open-label azithromycin after study withdrawal. OUTCOME: The ITT analysis (n=46, 177 observations) estimated mean difference in FEV1 between treatments (azithromycin minus placebo) was 0.035 L, with a 95% CI of -0.112 L to 0.182 L (p=0.6). Five withdrawals, who were identified at the end of the study as having been randomised to placebo (four with rapid loss in FEV1, one withdrawn consent) had received rescue open-label azithromycin, with improvement in subsequent FEV1 at 12 weeks. Study Completers showed an estimated mean difference in FEV1 between treatment groups (azithromycin minus placebo) of 0.278 L, with 95% CI for the mean difference: 0.170 L to 0.386 L (p=<0.001). Nine of 23 ITT patients in the azithromycin group had ≥10% gain in FEV1 from baseline. No patients in the placebo group had ≥10% gain in FEV1 from baseline while on placebo (p=0.002). Seven serious adverse events, three azithromycin, four in the placebo group, were deemed unrelated to study medication. CONCLUSIONS: Azithromycin therapy improves FEV1 in patients with BOS and appears superior to placebo. This study strengthens evidence for clinical practice of initiating azithromycin therapy in BOS. TRIAL REGISTRATION NUMBER: EU-CTR, 2006-000485-36/GB.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Azithromycin/therapeutic use , Bronchiolitis Obliterans/drug therapy , Lung Transplantation/adverse effects , Adult , Bronchiolitis Obliterans/diagnosis , Bronchiolitis Obliterans/etiology , Double-Blind Method , Female , Forced Expiratory Volume , Humans , Male , Middle Aged , Syndrome , Treatment Outcome
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