Factors Affecting the Outcomes of First in vitro Fertilization and Embryo Transfer: A Retrospective Investigation.

Background: The outcome of embryo transfer (ET) is multifactorial. A variety of patient-related, procedural-related, and operator-related factors are known to play a role. This study aims to evaluate the outcomes of ET and determine the factors that affect the outcome. Methods: The study involved a retrospective design involving 300 first in vitro fertilization and embryo transfer (IVF-ET) cycles between 2011 and 2021. The outcome included 155 unsuccessful cycles and 145 successful IVF-ET leading to pregnancy. The outcomes were examined for different variables, including age, weight, height, body mass index, cause of infertility, number of embryos fertilized during the cycle, day of ET, whether the embryo was frozen, presence of blood or mucus during the procedure, the use of a stylet, tenaculum, uterine sound/dilator, and catheter type. Logistic regression was used to analyze factors affecting the outcomes of ET. Results: The mean age was 27.84 ± 3.77 years. Patients who had blood during the procedure (32.9% vs 17.2%, p = 0.002), mucus (31% vs 20.7%, p = 0.049), or used the tenaculum (16.8% vs 6.9%, p = 0.012) were more likely to have unsuccessful IVF-ET. Logistic regression to adjust for related factors revealed that the presence of blood (AOR = 2.21, 95% CI 1.04 to 4.66, p = 0.038) during the ET had a higher likelihood of an unsuccessful outcome. Conclusion: This study showed that the presence of blood during the ET cycle influenced clinical pregnancy. This highlights the importance of performing the procedure under atraumatic conditions. Level of Evidence: Level III; retrospective comparative study.

Effectiveness of carbohydrate counting and Dietary Approach to Stop Hypertension dietary intervention on managing Gestational Diabetes Mellitus among pregnant women who used metformin: A randomized controlled clinical trial.

BACKGROUND: Gestational diabetes mellitus (GDM) is one of the most common complication of pregnancy that has significant impacts on both mother and her offspring health. The present study aimed to examine the effect of carbohydrate counting, carbohydrate counting combined with DASH, and control dietary interventions on glycemic control, and maternal and neonatal outcomes. METHODS: A total of 75 pregnant women with GDM at 24th - 30th week of gestation were enrolled and randomized to follow one of the three diets: control or carbohydrate counting, or carbohydrate counting combined with Dietary Approach to Stop Hypertension (DASH). Only 70 of them completed the study until delivery. Fasting blood samples were taken at baseline and the end of the study to measure fasting blood glucose (FBG), fasting insulin, glycated hemoglobin (HbA1c), and fructosamine. Homeostatic model assessment-insulin resistance (HOMA-IR) score was calculated using HOMA2 calculator program. The participants recorded at least four blood glucose readings per day. Maternal and neonatal outcomes were collected from medical records. Dietary intake was assessed by three-day food records at the baseline and the end of the study. RESULTS: Adherence to the three dietary interventions, resulted in decreased FBG levels significantly among all the participants (P < 0.05). Consumption of the carbohydrate counting combined with the DASH diet showed significant reduction in serum insulin levels and HOMA-IR score compared to carbohydrate counting group and control group. Means of fructosamine and HbA1c did not differ significantly among the three intervention diet groups. Overall mean of 1-h postprandial glucose (1 h PG) level was significantly lower in the carbohydrate counting combined with DASH group compared with that in the carbohydrate counting group and the control group (P < 0.001). The number of women who were required to commence insulin therapy after dietary intervention was significantly lower in carbohydrate counting group and carbohydrate counting combined with DASH group (P = 0.026). There were no significant differences in other maternal and neonatal outcomes among the three dietary intervention groups. CONCLUSIONS: The carbohydrate counting and the carbohydrate counting combined with DASH dietary interventions resulted in beneficial effects on FBG and 1 h PG compared with the control diet. The three dietary interventions produced similar maternal and neonatal outcomes in women with GDM. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.gov under the identification code: NCT03244579. https://clinicaltrials.gov/ct2/show/NCT03244579.

Prevalence of endometriosis in women undergoing laparoscopic surgery for various gynaecological indications at a Jordanian referral centre: gaining insight into the epidemiology of an important women's health problem.

BACKGROUND: Endometriosis is a considerable health challenge for women of reproductive age. Information about its prevalence in the Jordanian population is sparse. The objective of this research was to evaluate the presence of endometriosis in gynaecological patients undergoing laparoscopic surgery for various indications and to correlate the finding of endometriosis with variables, including patient demographics, obstetric history, type, and indication of laparoscopic procedure. METHODS: A retrospective cohort study involving 460 women who underwent different laparoscopic procedures for a variety of indications was conducted in the Department of Obstetrics and Gynaecology in Jordan University Hospital, a tertiary referral hospital in Jordan, between January 2015 and September 2020. RESULTS: The prevalence of endometriosis in this patient group was higher than that of the general population (13.7% vs. 2.5%), and the mean age at diagnosis (31.9 years) was younger than the general population's age of peak incidence (35-45 years). It was significantly higher in women with lower numbers of pregnancies (p = 0.01) and a lower number of Caesarean sections (p = 0.05) and in those where the indication for surgery was related to decreased fertility or pelvic pain (p = 0.02). Women with high parity or where the surgery's indication suggested normal fertility, such as family planning, were less likely to have endometriosis. CONCLUSION: To our knowledge, this is the first Jordanian study to assess the prevalence of endometriosis in women undergoing gynaecological laparoscopy. This study suggests that the epidemiology of endometriosis in this region follows similar trends to what has been previously documented in international literature, while emphasizing the need for further research into this important women's health issue in this part of the world.

Anesthesia for Cesarean Section: Retrospective Comparative Study.

BACKGROUND: Cesarean section is a widely performed surgery. OBJECTIVE: To compare anesthetic types regarding feto-maternal outcomes. MATERIALS AND METHODS: Retrospective comparative study of 3599 cesarean sections (emergency and elective categories). RESULTS: Mean APGAR score was statistically higher in the spinal than general anesthesia among the emergency category, P = 0.000 and 0.026, respectively, with no significant difference in the elective category. Estimated blood loss among the elective category was statistically significantly higher in the spinal than general anesthesia, P = 0.001. However, among the emergency category, it was significantly higher in the general than in spinal or epidural anesthesia, P = 0.000. Diclofenac sodium was used more after spinal than general anesthesia (P = 0.000), with no significant difference between epidural and general or between epidural and spinal anesthesia. Pethidine hydrochloride (HCL) was used more after general than after spinal anesthesia (P = 0.000). However, pethidine HCL use was not statistically significantly different between spinal and epidural anesthesia. In the elective category, paracetamol was requested more after spinal than epidural or general anesthesia, P = 0.000. No significant difference was seen between epidural and general anesthesia, P = 1.000. No statistically significant difference was found among the anesthetic types in both categories regarding tramadol HCL. Length of hospital stay, operative time and neonatal intensive care unit admission were not statistically different between anesthetic modes. In the emergency category, significantly higher percentage of patients were satisfied with and would recommend epidural anesthesia. CONCLUSION: There was no statistically significant difference among the three types of anesthesia regarding neonatal intensive care admission and length of hospital stay for emergency and elective categories. APGAR score was higher with spinal than with general anesthesia in the emergency category with no significant difference in the elective category. More diclofenac sodium and paracetamol and less opioids were used after regional than after general anesthesia. Satisfaction was higher with epidural anesthesia. LIMITATIONS: Retrospective and single centered.

Impact of Biopsy Technique on Clinically Important Outcomes for Cutaneous Melanoma: A Systematic Review and Meta-analysis.

We performed a systematic review and meta-analysis to examine the relationship between the type of biopsy technique employed in the diagnosis of cutaneous melanoma and 4 clinically important outcomes: melanoma-specific mortality, all-cause mortality, Breslow tumor depth, or melanoma recurrence. Our database was obtained by searching PubMed, Ovid MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews, and the Cochrane Library from inception until December 6, 2019. Studies were identified that compared biopsy techniques used to diagnose cutaneous melanoma with any of our study outcomes. We included 7 observational studies for our meta-analysis after screening 3231 titles and abstracts. Pooled data identified a significantly higher all-cause mortality in the punch biopsy group (risk ratio [RR], 1.520; P=.02). A higher, but nonsignificant, rate of melanoma-specific mortality (RR, 1.96; P=.22) and melanoma recurrence (RR, 1.20; P=.186) was also found for the punch biopsy group. Breslow tumor thickness was not significantly lower for punch incision (standardized mean difference, -0.42; P=.27). We found limited evidence for differences in clinically important outcomes across the spectrum of the most common methods employed in clinical practice for the initial diagnosis of cutaneous melanoma. A small, but significant, increase (P=.02) in all-cause mortality with punch biopsies was not seen for the other outcomes and was most likely due to small sample sizes and demographic differences in the included studies and unlikely represents a clinically important outcome. Our findings support the use of existing clinical practice guidelines for evaluating pigmented lesions suspicious for cutaneous melanoma.

Heart failure mortality prediction using PRISM score and development of a classification and regression tree model to refer patients for palliative care consultation.

INTRODUCTION: We sought to assess one-year mortality in heart failure (HF) patients by using (Placement Resource Indicator for Systems Management) PRISM, a disease nonspecific risk stratification score, and use it along with modified Seattle Heart Failure Model (SHFM) to guide patient selection for palliative care consultation. METHODS: A retrospective study design was used to examine 1-year mortality in 689 HF patients admitted from 2012 to 2014. One-year mortality was calculated using Pmort30/PRISM and modified SHFM scores, and the predicted scores were validated using the area under the ROC curve. CART was used to develop an algorithm to classify patients based on their mortality risk. RESULTS: The discriminatory ability of PRISM categorical score (AUC = 0.701) was not significantly different than the discriminatory ability of modified SHFM (AUC = 0.686) (DeLong's test p = 0.56) but improved significantly with the combination of PRISM (categorical) score + modified SHFM (AUC = 0.740) (p = 0.002). The predictive capability of the CART tree model after cross-validation was 72.2% (AUC 0.631). CONCLUSION: Our study suggests PRISM score performed as well as modified SHFM for one-year mortality prediction. Moreover, the addition of modified SHFM to PRISM score increases discriminatory ability in predicting 1-year mortality in heart failure patients compared to either of the two models alone. Together, when combined in a CART model, they can be used to identify the population subset with the highest mortality risk and hence guide goals of care discussion.

Treatment Options for Hirsutism: A Systematic Review and Network Meta-Analysis.

Background: Several pharmacologic treatments for hirsutism are used in practice; however, their relative efficacy is unclear. Methods: We searched MEDLINE, EMBASE, and CENTRAL through January 2017 for randomized controlled trials (RCTs) with follow-up of at least 6 months that evaluated antiandrogens, insulin sensitizers, and oral contraceptives in women with hirsutism. Independent pairs of reviewers selected and appraised trials. Random-effects network meta-analysis was used to compare individual drugs and classes. Results: We included 43 trials. Estrogen-progestin oral contraceptives pills (OCPs), antiandrogens, and insulin sensitizers were superior to placebo, with standardized mean reductions (95% confidence intervals) of -0.94 (-1.49 to -0.38), -1.29 (-1.80 to -0.79), and -0.62 (-1.00 to -0.23), respectively. Antiandrogen monotherapy, the combination of OCP and antiandrogen, the combination of OCPs and insulin sensitizer, and the combination of antiandrogen and insulin sensitizer were superior to insulin sensitizer monotherapy. The combination of OCPs and antiandrogen was superior to OCPs. Antiandrogen monotherapy with flutamide, finasteride, and spironolactone were each superior to placebo but similar to each other in efficacy. OCPs containing levonorgestrel, cyproterone acetate, or drospirenone were similar in effectiveness to other OCPs or had trivial differences. The certainty in comparisons with placebo was moderate and for head-to-head comparisons was low. Conclusions: Estrogen-progestin OCPs, antiandrogens, and insulin sensitizers are superior to placebo for the treatment of hirsutism.

Melanoma screening: A plan for improving early detection.

Malignant melanoma ranks fifth in the number of new cases annually in the United States (US). Despite increasing incidence and lack of recent improvement in mortality, national melanoma screening guidelines are currently not in existence. Our purpose was to review the evidence regarding screening whole-body skin examinations for early detection and a possible mortality benefit for malignant melanoma. Data sources for our review were MEDLINE Complete, PubMed, Cochrane Library, Cochrane Database of Systematic Reviews, and ClinicalTrials.gov. Study selection included: epidemiologic data from the US and European cancer surveillance registries, population-based case-control screening trials, computer-simulated Markov model trials, and survey trials. Studies were limited to those published in the English language. Data was extracted using a dual extraction method. Data from studies have shown that the mortality of malignant melanoma is highly predicated on the tumor thickness at the time of diagnosis. Our data review is in support of the implementation of whole-body skin examinations, performed by primary care physicians, for the purpose of early detection of melanoma. A large national population-based, case-control, skin cancer screening trial in Germany has shown a reduction in melanoma-specific mortality. In conclusion, our review of the evidence supports physicians performed whole-body skin examination can lead to the detection of earlier stage melanomas as well as to a reduction in disease-specific mortality. We found a paucity of randomized trials to be a limitation of screening studies for many cancers, including melanoma. To improve screening rates and early detection of malignant melanoma, we propose making skin cancer education part of the curriculum in US primary care residency programs to become the genesis for widespread melanoma screening. Our study had no funding.

A systematic review and meta-analysis of glycemic control for the prevention of diabetic foot syndrome.

OBJECTIVE: The objective of this review was to synthesize the available randomized controlled trials (RCTs) estimating the relative efficacy and safety of intensive vs less intensive glycemic control in preventing diabetic foot syndrome. METHODS: We used the umbrella design (systematic review of systematic reviews) to identify eligible RCTs. Two reviewers determined RCT eligibility and extracted descriptive, methodologic, and diabetic foot outcome data. Random-effects meta-analysis was used to pool outcome data across studies, and the I(2) statistic was used to quantify heterogeneity. RESULTS: Nine RCTs enrolling 10,897 patients with type 2 diabetes were included and deemed to be at moderate risk of bias. Compared with less intensive glycemic control, intensive control (hemoglobin A1c, 6%-7.5%) was associated with a significant decrease in risk of amputation (relative risk [RR], 0.65; 95% confidence interval [CI], 0.45-0.94; I(2) = 0%). Intensive control was significantly associated with slower decline in sensory vibration threshold (mean difference, -8.27; 95% CI, -9.75 to -6.79). There was no effect on other neuropathic changes (RR, 0.89; 95% CI, 0.75-1.05; I(2) = 32%) or ischemic changes (RR, 0.92; 95% CI, 0.67-1.26; I(2) = 0%). The quality of evidence is likely moderate. CONCLUSIONS: Compared with less intensive glycemic control therapy, intensive control may decrease the risk of amputation in patients with diabetic foot syndrome. The reported risk reduction is likely overestimated because the trials were open and the decision to proceed with amputation could be influenced by glycemic control.

A systematic review and meta-analysis of débridement methods for chronic diabetic foot ulcers.

BACKGROUND: Several methods of débridement of diabetic foot ulcers are currently used. The relative efficacy of these methods is not well established. METHODS: This systematic review and meta-analysis was conducted to find the best available evidence for the effect of débridement on diabetic foot wound outcomes. We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus through October 2011 for randomized controlled studies (RCTs) and observational comparative studies. RESULTS: We identified 11 RCTs and three nonrandomized studies reporting on 800 patients. The risk of bias was moderate overall. Meta-analysis of three RCTs showed that autolytic débridement significantly increased the healing rate (relative risk [RR], 1.89; 95% confidence interval [CI] 1.35-2.64). Meta-analysis of four studies (one RCT) showed that larval débridement reduced amputation (RR, 0.43; 95% CI, 0.21-0.88) but did not increase complete healing (RR, 1.27; 95% CI, 0.84-1.91). Surgical débridement was associated with shorter healing time compared with conventional wound care (one RCT). Insufficient evidence was found for comparisons between autolytic and larval débridement (one RCT), between ultrasound-guided and surgical débridement, and between hydrosurgical and surgical débridement. CONCLUSIONS: The available literature supports the efficacy of several débridement methods, including surgical, autolytic, and larval débridement. Comparative effectiveness evidence between these methods and supportive evidence for other methods is of low quality due to methodologic limitations and imprecision. Hence, the choice of débridement method at the present time should be based on the available expertise, patient preferences, the clinical context and cost.

A systematic review and meta-analysis of adjunctive therapies in diabetic foot ulcers.

BACKGROUND: Multiple adjunctive therapies have been proposed to accelerate wound healing in patients with diabetes and foot ulcers. The aim of this systematic review is to summarize the best available evidence supporting the use of hyperbaric oxygen therapy (HBOT), arterial pump devices, and pharmacologic agents (pentoxifylline, cilostazol, and iloprost) in this setting. METHODS: We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus through October 2011. Pairs of independent reviewers selected studies and extracted data. Predefined outcomes of interest were complete wound healing and amputation. RESULTS: We identified 18 interventional studies; of which 9 were randomized, enrolling 1526 patients. The risk of bias in the included studies was moderate. In multiple randomized trials, the addition of HBOT to conventional therapy (wound care and offloading) was associated with increased healing rate (Peto odds ratio, 14.25; 95% confidence interval, 7.08-28.68) and reduced major amputation rate (odds ratio, 0.30; 95% confidence interval, 0.10-0.89), compared with conventional therapy alone. In one small trial, arterial pump devices had a favorable effect on complete healing compared with HBOT and in another small trial compared with placebo devices. Neither iloprost nor pentoxifylline had a significant effect on amputation rate compared with conventional therapy. No comparative studies were identified for cilostazol in diabetic foot ulcers. CONCLUSIONS: There is low- to moderate-quality evidence supporting the use of HBOT as an adjunctive therapy to enhance diabetic foot ulcer healing and potentially prevent amputation. However, there are only sparse data regarding the efficacy of arterial pump devices and pharmacologic interventions.

A systematic review and meta-analysis of off-loading methods for diabetic foot ulcers.

BACKGROUND: Increased plantar foot pressure is one of several key factors that lead to diabetic foot ulcers. Multiple methods have been proposed to relieve this pressure and thus enhance wound healing and potentially prevent relapse. We aimed in this systematic review to find the best available evidence for off-loading methods. METHODS: We searched MEDLINE, Embase, Cochrane CENTRAL, Web of Science, and Scopus through October 2011. Pairs of independent reviewers selected studies and extracted data. Predefined outcomes of interest included complete wound healing, time to complete wound healing, amputation, infection, and relapse rates. RESULTS: We identified 19 interventional studies, of which 13 were randomized controlled trials, including data from 1605 patients with diabetic foot ulcers using an off-loading method. The risk of bias in the included studies was moderate. This analysis demonstrated improved wound healing with total contact casting over removable cast walker, therapeutic shoes, and conventional therapy. There was no advantage of irremovable cast walkers over total contact casting. There was improved healing with half-shoe compared with conventional wound care. Therapeutic shoes and insoles reduced relapse rate in comparison with regular footwear. Data were sparse regarding other off-loading methods. CONCLUSIONS: Although based on low-quality evidence (ie, evidence warranting lower certainty), benefits are demonstrated for use of total contact casting and irremovable cast walkers in the treatment of diabetic foot ulcers. Reduced relapse rate is demonstrated with various therapeutic shoes and insoles in comparison with regular footwear.

Patient and service user engagement in research: a systematic review and synthesized framework.

BACKGROUND: There is growing attention towards increasing patient and service user engagement (PSUE) in biomedical and health services research. Existing variations in language and design inhibit reporting and indexing, which are crucial to comparative effectiveness in determining best practices. OBJECTIVE: This paper utilizes a systematic review and environmental scan to derive an evidence-based framework for PSUE. DESIGN: A metanarrative systematic review and environmental scan/manual search using scientific databases and other search engines, along with feedback from a patient advisory group (PAG). ELIGIBLE SOURCES: English-language studies, commentaries, grey literature and other sources (including systematic and non-systematic reviews) pertaining to patient and public involvement in biomedical and health services research. DATA EXTRACTED: Study description (e.g. participant demographics, research setting) and design, if applicable; frameworks, conceptualizations or planning schemes for PSUE-related endeavours; and methods for PSUE initiation and gathering patients'/service users' input or contributions. RESULTS: Overall, 202 sources were included and met eligibility criteria; 41 of these presented some framework or conceptualization of PSUE. Sources were synthesized into a two-part framework for PSUE: (i) integral PSUE components include patient and service user initiation, reciprocal relationships, colearning and re-assessment and feedback, (ii) sources describe PSUE at several research stages, within three larger phases: preparatory, execution and translational. DISCUSSION AND CONCLUSIONS: Efforts at developing a solid evidence base on PSUE are limited by the non-standard and non-empirical nature of much of the literature. Our proposed two-part framework provides a standard structure and language for reporting and indexing to support comparative effectiveness and optimize PSUE.

Charged particle therapy versus photon therapy for paranasal sinus and nasal cavity malignant diseases: a systematic review and meta-analysis.

BACKGROUND: Malignant tumours arising within the nasal cavity and paranasal sinuses are rare and composed of several histological types, rendering controlled clinical trials to establish the best treatment impractical. We undertook a systematic review and meta-analysis to compare the clinical outcomes of patients treated with charged particle therapy with those of individuals receiving photon therapy. METHODS: We identified studies of nasal cavity and paranasal sinus tumours through searches of databases including Embase, Medline, Scopus, and the Cochrane Collaboration. We included treatment-naive cohorts (both primary and adjuvant radiation therapy) and those with recurrent disease. Primary outcomes of interest were overall survival, disease-free survival, and locoregional control, at 5 years and at longest follow-up. We used random-effect models to pool outcomes across studies and compared event rates of combined outcomes for charged particle therapy and photon therapy using an interaction test. FINDINGS: 43 cohorts from 41 non-comparative observational studies were included. Median follow-up for the charged particle therapy group was 38 months (range 5-73) and for the photon therapy group was 40 months (14-97). Pooled overall survival was significantly higher at 5 years for charged particle therapy than for photon therapy (relative risk 1·51, 95% CI 1·14-1·99; p=0·0038) and at longest follow-up (1·27, 1·01-1·59; p=0·037). At 5 years, disease-free survival was significantly higher for charged particle therapy than for photon therapy (1·93, 1·36-2·75, p=0·0003) but, at longest follow-up, this event rate did not differ between groups (1·51, 1·00-2·30; p=0·052). Locoregional control did not differ between treatment groups at 5 years (1·06, 0·68-1·67; p=0·79) but it was higher for charged particle therapy than for photon therapy at longest follow-up (1·18, 1·01-1·37; p=0·031). A subgroup analysis comparing proton beam therapy with intensity-modulated radiation therapy showed significantly higher disease-free survival at 5 years (relative risk 1·44, 95% CI 1·01-2·05; p=0·045) and locoregional control at longest follow-up (1·26, 1·05-1·51; p=0·011). INTERPRETATION: Compared with photon therapy, charged particle therapy could be associated with better outcomes for patients with malignant diseases of the nasal cavity and paranasal sinuses. Prospective studies emphasising collection of patient-reported and functional outcomes are strongly encouraged. FUNDING: Mayo Foundation for Medical Education and Research.

Comparative systematic review and meta-analysis of compression modalities for the promotion of venous ulcer healing and reducing ulcer recurrence.

OBJECTIVE: This was a systematic review of the literature to determine which compression method is superior in promoting ulcer healing and reducing recurrence in patients with lower extremity venous ulcer disease. METHODS: We conducted a comprehensive search of multiple databases for randomized and nonrandomized comparative studies from 1990 to December 2013. RESULTS: We identified 36 studies and two Cochrane systematic reviews. Many studies had moderate risk of bias. We found no overall difference between compression stockings vs compression bandages with respect to ulcer healing, time to ulcer healing, or ulcer recurrence outcomes. When we compared stockings vs short stretch bandages, stockings were superior with respect to ulcer healing. However, stockings compared with four-layer systems showed no difference in ulcer healing outcomes. When four-layer systems were compared with compression with less than four layers, there was also no significant difference in ulcer healing outcomes. Similarly, short stretch bandages were not superior to long stretch bandages with respect to ulcer healing, time to ulcer healing, or ulcer recurrence. One Cochrane review presented many additional comparisons and reported increased wound healing with compression compared with no compression, with multicomponent systems over single component systems, and compression systems with an elastic component over no elastic component. Another Cochrane review demonstrated a reduction in recurrence with compression in patients with healed ulcers. CONCLUSIONS: At least moderate-quality evidence supports compression over no compression, multicomponent systems over single component systems, and systems with an elastic component over those without. We did not find significant differences with respect to ulcer healing outcomes for other comparisons. Low-quality evidence supports the effect of compression on ulcer recurrence.

Systematic review and meta-analysis of surgical interventions versus conservative therapy for venous ulcers.

OBJECTIVE: This goal of this study was to systematically review the literature to determine if surgical intervention (open or endovascular) is superior to compression alone with respect to ulcer healing, ulcer recurrence, and time to ulcer healing in patients with lower extremity venous ulcer disease. METHODS: We conducted a comprehensive search of multiple databases for randomized controlled trials (RCTs) and comparative observational studies from 1990 to December 2013. The interventions of interest were any open or endovascular surgical interventions on the venous system in the lower extremity compared with compression alone. RESULTS: We included 11 studies (seven RCTs and four observational studies) with moderate to increased risk of bias. The meta-analysis of all studies demonstrated increased healing rate (pooled risk ratio [RR], 1.06; 95% confidence interval [CI], 1.00-1.13; I(2) = 10%) and lower risk of recurrence (RR, 0.54; 95% CI, 0.34-0.85; I(2) = 27%) with open surgical procedures compared with compression. However, the meta-analysis of only RCTs showed no difference, possibly due to imprecision. The meta-analysis of three RCTs showed no difference in time to ulcer healing, -0.41 (95% CI, -0.89 to 0.07). Two studies of endovascular surgical procedures compared with compression showed no significant difference in ulcer healing (RR, 1.65; 95% CI, 0.43-6.32). One study of open surgical venous ligation and stripping compared with endovenous laser also showed no significant difference in ulcer recurrence (RR, 0.83; 95% CI, 0.21-3.27). CONCLUSIONS: Open surgical interventions may improve lower extremity venous ulcer healing. The quality of this evidence is low because the analysis was dominated by the results of observational studies. The current evidence does not definitively support the superiority of endovascular surgical interventions compared with compression alone.

Patient engagement in research: a systematic review.

BACKGROUND: A compelling ethical rationale supports patient engagement in healthcare research. It is also assumed that patient engagement will lead to research findings that are more pertinent to patients' concerns and dilemmas. However; it is unclear how to best conduct this process. In this systematic review we aimed to answer 4 key questions: what are the best ways to identify patient representatives? How to engage them in designing and conducting research? What are the observed benefits of patient engagement? What are the harms and barriers of patient engagement? METHODS: We searched MEDLINE, EMBASE, PsycInfo, Cochrane, EBSCO, CINAHL, SCOPUS, Web of Science, Business Search Premier, Academic Search Premier and Google Scholar. Included studies were published in English, of any size or design that described engaging patients or their surrogates in research design. We conducted an environmental scan of the grey literature and consulted with experts and patients. Data were analyzed using a non-quantitative, meta-narrative approach. RESULTS: We included 142 studies that described a spectrum of engagement. In general, engagement was feasible in most settings and most commonly done in the beginning of research (agenda setting and protocol development) and less commonly during the execution and translation of research. We found no comparative analytic studies to recommend a particular method. Patient engagement increased study enrollment rates and aided researchers in securing funding, designing study protocols and choosing relevant outcomes. The most commonly cited challenges were related to logistics (extra time and funding needed for engagement) and to an overarching worry of a tokenistic engagement. CONCLUSIONS: Patient engagement in healthcare research is likely feasible in many settings. However, this engagement comes at a cost and can become tokenistic. Research dedicated to identifying the best methods to achieve engagement is lacking and clearly needed.

Screening for gestational diabetes: a systematic review and meta-analysis.

CONTEXT: Gestational diabetes mellitus (GDM) is defined as any degree of hyperglycemia with first recognition during pregnancy. The optimal time to screen for GDM that would maximize the yield and benefits remains unclear. OBJECTIVE: Our objective was to appraise the evidence regarding screening for GDM (accuracy, correlation with adverse outcomes, and harms). DATA SOURCES: We searched Ovid Medline, OVID EMBASE, OVID Cochrane Library, Web of Science, Scopus, PsycInfo, and CINAHL through May 2011. STUDY SELECTION: We included randomized controlled trials and observational studies that enrolled pregnant woman who were evaluated using different GDM screening tests. DATA EXTRACTION: Two reviewers working independently abstracted the data. RESULTS: We did not find any randomized controlled trials of GDM screening that measured feto-maternal outcomes. A 1-hour 50-g glucose challenge test with a cutoff point at 140 mg/dL was the most commonly used screening method. The results of this test were statistically associated with feto-maternal outcomes (P < .001), even though only 11% of individuals with a positive test (according to Carpenter and Coustan criteria) developed GDM. Positive Carpenter and Coustan criteria were associated with macrosomia (odds ratio [OR] = 2.4, 95% confidence interval [CI] = 1.9-3.1, P < .001) and gestational hypertension (OR = 1.7, CI = 1.3-2.1, P < .001). Positive National Diabetes Data Group criteria were also associated with macrosomia (OR = 3.2, CI = 2.3-4.4, P < .001) and gestational hypertension (OR = 2.1, CI = 1.6-2.8, P < .001). CONCLUSIONS: Indirect evidence supports the use of contemporary screening tests for GDM to identify pregnancies at increased risk of adverse feto-maternal outcomes. It also suggests that use of these tests will place some women under unnecessary treatment for GDM.

Glucose targets in pregnant women with diabetes: a systematic review and meta-analysis.

BACKGROUND: Glucose-lowering treatments are used during pregnancy to reduce the risk for complications in the mother and offspring, yet treatment targets have not been established. OBJECTIVE: Our objective was to appraise and summarize the available evidence regarding the association between different blood glucose targets during pregnancy and fetal and maternal outcomes. METHODS: We searched Medline, EMBASE, Cochrane Library, Web of Science, Scopus, PsycInfo, and CINAHL through May 2011 for randomized trials and observational studies that enrolled women with diabetes during pregnancy and reported planned or achieved glucose targets. We used random-effects meta-regression models to estimate the odds ratio for the association of outcomes of interest and glucose targets. When possible, we adjusted for diabetes type, trimester, and diabetes treatment. RESULTS: We included 34 studies enrolling 9433 women. The studies had moderate to high risk of bias due to evidence of reporting bias and insufficient adjustment for important covariates, particularly maternal body mass index. A fasting glucose target of <90 mg/dL was the most commonly reported and the one most strongly associated with reduced risk of macrosomia (odds ratio = 0.53, 95% confidence interval = 0.31-0.90, P = .02) for women with gestational diabetes during the third trimester. For type 1 and type 2 diabetes, and for pre- and postprandial targets, data were sparse and inconclusive. CONCLUSIONS: Evidence warranting very low confidence in the estimates suggests that a fasting glucose target of <90 mg/dL is associated with a lower risk of macrosomia and other outcomes of different importance in women with gestational diabetes. Whether this target can be extrapolated to women with pregestational diabetes or whether targets above or below this threshold offer a better benefit/risk balance remains unclear.