Randomized controlled trials (RCTs) and cohort studies are the most common study design types used to assess the treatment effects of medical interventions. To evaluate the agreement of effect estimates between bodies of evidence (BoE) from randomized controlled trials (RCTs) and cohort studies and to identify factors associated with disagreement.Systematic reviews were published in the 13 medical journals with the highest impact factor identified through a MEDLINE search. BoE-pairs from RCTs and cohort studies with the same medical research question were included. We rated the similarity of PI/ECO (Population, Intervention/Exposure, Comparison, Outcome) between BoE from RCTs and cohort studies. The agreement of effect estimates across BoE was analyzed by pooling ratio of ratios (RoR) for binary outcomes and difference of mean differences for continuous outcomes. We performed subgroup analyses to explore factors associated with disagreements.One hundred twenty-nine BoE pairs from 64 systematic reviews were included. PI/ECO-similarity degree was moderate: two BoE pairs were rated as "more or less identical"; 90 were rated as "similar but not identical" and 37 as only "broadly similar". For binary outcomes, the pooled RoR was 1.04 (95% CI 0.97-1.11) with considerable statistical heterogeneity. For continuous outcomes, differences were small. In subgroup analyses, degree of PI/ECO-similarity, type of intervention, and type of outcome, the pooled RoR indicated that on average, differences between both BoE were small. Subgroup analysis by degree of PI/ECO-similarity revealed high statistical heterogeneity and wide prediction intervals across PI/ECO-dissimilar BoE pairs.On average, the pooled effect estimates between RCTs and cohort studies did not differ. Statistical heterogeneity and wide prediction intervals were mainly driven by PI/ECO-dissimilarities (i.e., clinical heterogeneity) and cohort studies. The potential influence of risk of bias and certainty of the evidence on differences of effect estimates between RCTs and cohort studies needs to be explored in upcoming meta-epidemiological studies.
Introduction: the demand for urgent obstetric and gynecology care has progressively increased: in the United States approximately 1.4 million gynecologic visits are made to the emergency department (ED) annually, while almost 75% of women make at least 1 unscheduled visit during pregnancy. Moreover, research has recently focused on setting standards in unscheduled care, and developing quality indicators to improve patients’ health. Therefore, we investigated the characteristics of women with acute gynecological or pregnancy complaints using quality indicators developed for emergency medicine, to better define the needs of this population and improve care. Methods: Retrospective cohort study on ED, and Obstetrics and Gynecology (ObGyn) triage visits, at a tertiary care hospital in Italy, during 2012. Data were analyzed with population-averaged logistic regression and Poisson regression. Results: When compared to the 33,557 ED visits, the 9245 ObGyntriage referrals were more frequently associated with pregnancy (≤12 weeks’ gestation, OR: 30.7, 95%CI; 24.5 - 38.4; >12 weeks’ gestation, OR 81.2, 95%CI; 64.8 - 101.4), vaginal bleeding (OR 156.6, 95%CI; 82.7 - 294.4), diurnal (night access OR 0.87, 95% CI; 0.78 - 0.96) and weekday access (holiday access OR 0.87, 95%CI; 0.78 - 0.95), frequent users (recurrent ED visits IRR 0.87, 95%CI; 0.83 - 0.9) and lower hospital admissions (ED admission OR 1.6, 95%CI; 1.4 - 1.8). Conclusion: ObGyn triage patients differed from ED users, and were at higher risk of “crowding”. Such diversities should be considered to improve female healthcare services and allocate resources more efficiently.
547 Background: Optimal adjuvant endocrine therapy for HER2+/HR+ patients treated with chemotherapy and trastuzumab is still unclear. We evaluated the impact of the type of endocrine therapy on DFS in patients with HER2+/HR+ breast cancer enrolled in the phase III ShortHER trial. Methods: The Short-HER study randomized 1254 patients with HER2+ early breast cancer to receive 9 weeks vs 1 year of adjuvant trastuzumab combined with anthracycline-taxane chemotherapy. The type of adjuvant endocrine was collected every 6 months during the first 5 years of follow-up and was classified as: aromatase inhibitor (AI), tamoxifen and aromatase inhibitor (TAM-AI, in case of both drugs were administered for at least 1 year each), or tamoxifen (TAM). For premenopausal patients, the use of GnRH analogue was also collected. DFS was calculated from randomization to disease recurrence (locoregional or metastatic), second primary invasive cancer, or death. Results: 853 patients with HR+ BC (ER and/or PgR >10%) were included: 60% postmenopausal, 40% premenopausal. The pattern of endocrine therapy was: 55% AI, 22% TAM, 15% TAM-AI (8% missing data). Among premenopausal patients, 51% received GnRH. At a median follow up of 8.7 years (IQR 7.6-9.0), patients who received AI had a significantly better DFS as compared to patients who received TAM or TAM-AI: 7-yr DFS 87.3% vs 81.7%, log-rank P=0.017 (HR 1.46, 95%CI 1.05-2.03). In multivariate analysis including menopausal status, stage, and treatment arm, the type of endocrine therapy maintained a significant association with DFS (Table). In the subgroup of premenopausal patients, the use of GnRH was associated with numerically improved DFS: 86.6% vs 81.6%, log-rank P=0.168 (HR=0.70, 95%CI 0.43-1.16). Conclusions: In this post-hoc analysis of the ShortHER trial, adjuvant treatment with aromatase inhibitor was independently associated with improved DFS. Subgroup analysis in premenopausal patients suggests potential benefit with ovarian suppression. Clinical trial information: NCT00629278. [Table: see text]
The optimal adjuvant endocrine therapy for HR-positive/HER2-positive breast cancer patients is unknown. We included in this analysis 784 patients with HR-positive/HER2-positive BC from the randomized ShortHER trial of adjuvant trastuzumab (1 year vs 9 weeks) + chemotherapy. At a median follow-up of 8.7 years, patients who received AI had a significantly better DFS vs patients who received TAM or TAM-AI: 8-yr DFS 86.4 vs 79.7%, log-rank P = 0.013 (HR 1.52, 95% CI 1.09-2.11). In multivariate analysis, the type of endocrine therapy maintained a significant association with DFS (HR 1.64, 95% CI 1.07-2.52, p = 0.025 for TAM/TAM-AI vs AI). Among premenopausal patients aged ≤45 years, the use of GnRHa was associated with longer DFS: 8-yr DFS rate 85.2 vs 62.6% (log-rank p = 0.019, HR 0.41, 95% CI 0.19-0.88). In this post-hoc analysis of the ShortHER trial adjuvant treatment with AI was independently associated with improved DFS. Subgroup analysis in premenopausal patients suggests benefits with ovarian suppression.Trial registration: NCI ClinicalTrials.gov number: NCT00629278.
Fibromyalgia (FM) is an heterogeneous and complex condition that deeply impact the quality of live of affected patients. Moreover FM imposes also a significant economic burden on society, mainly driven by indirect costs from lost productivity. FM treatment is based on a multidisciplinary approach, with a combination of pharmacological and non-pharmacological therapies. As indicated in the EULAR recommendations for the treatment of FM, individual tailored exercise programs, including aerobic exercise and strength training, can be beneficial in these patients; although this point has been confirmed in several studies, the adherence to various kind of exercise's programs is generally poor when the patients had to exercise on their own.
Objectives
To evaluate the effectiveness and patients' adherence to a simple program of home-made stretching exercises in fibromyalgia.
Methods
We enrolled all FM patients (ACR 1990 classification criteria), referring consecutively to our outpatients clinic from March to June 2011 and on stable treatment in the previous 6 months. Patients were randomly allocated in 2 groups. Group 1 was trained in a simple home-made stretching program based on 8 exercises; patients were asked to perform at least 4 exercises, for at least 20 minutes, for at least 3 days a week. Paper supports with explanations and cartoons representing exercises were handed to all these patients; moreover the patients were asked to sign in a daily diary the exercises performed and the time employed. Group 2 was first motivated about the effectiveness of a correct physical activity and then asked to perform stretching exercises, scheduled similarly to group 1. No treatment changes were planned in both groups. A well validated questionnaire, Fibromyalgia impact questionnaire (FIQ), was used as outcome measure; FIQ was assessed at baseline and then after three months of exercises; results were analyzed by the Paired-Samples T Test. Adherence of patients to the program was also evaluated.
Results
We enrolled 44 patients, 22 in group 1 (mean age 46.8 years, standard deviation ± 10 years) and 22 in group 2 (mean age 47.7 years, standard deviation ± 10.5 years). Mean basal FIQ was 70 (standard deviation ± 18) in group 1 and 68 (standard deviation ± 19) in group 2. After 3 months FIQ was significantly reduced in group 1 (mean value 45, standard deviation ± 15, p value 0.001), whereas no substantial changes were observed in group 2 (mean value 69, standard deviation ± 18, p value 0.232). Program adherence in group 1 was 100% (at least 6 exercises for at least 30 minutes in each training section; at least 4 training section every week); group 2 patients did not perform any kind of exercises.
Conclusions
Our results indicate that an easily designed program of home-made stretching may improve the impact of FM on affected patients. The enhancement of adherence with an extended support program (eg direct explanation of exercises, cartoons representing the exercises, report of training sections in a diary) is the key point for FM patients improvement.
References
Wolfe F, et al. Arthritis Rheum 1990;33:160-72. Salaffi F, et al. Clin Exp Rheumatol 2009;27:S67-74. Sarzi-Puttini P, et al. Clin Exp Rheumatol 2003;21:459-64. Carville SF, et al. Ann Rheum Dis 2008;67:536-41.
