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1.
The use of 3D ultrasound in comparing surgical techniques for posterior wall prolapse repair: a pilot randomised controlled trial.
Derpapas, A, Vijaya, G, Nikolopoulos, K, Nikolopoulos, M, Robinson, D, Fernando, R, Khullar, V
Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology. 2021;(4):594-600
Abstract
The most appropriate method for repairing posterior vaginal wall prolapse is still debatable. Women with symptomatic prolapse scheduled to undergo surgical repair in the posterior compartment were randomised to standard posterior colporrhaphy (SPC) or fascial and vaginal epithelial plication (FEP). Participants were assessed with the Prolapse Quality of Life (P-QOL) questionnaire, pelvic organ prolapse quantification (POP-Q) examination and three-dimensional ultrasound (3D US) prior to surgery and 6 months postoperatively. The research hypothesis is that 3D US of the pelvic floor is a reliable tool in comparing the anatomical outcomes of the two different surgical techniques. Differences in anatomical outcomes, assessed clinically and by ultrasonographic evaluation, were compared between the two groups using the Independent Mann-Whitney U-test and the Wilcoxon signed-rank sum test. Twenty-two women were included in the analysis. Six months postoperatively, women in the FEP arm had better anatomical outcomes compared to those who had undergone SPC (p = .02). Repeatability of the ultrasound technique was confirmed, showing moderate to very good agreement in all parameters and the 3D US evaluation was corroborated with the clinical examination, showing a greater reduction in the urogenital size in the FEP group.Impact statementWhat is already known on this subject? The low cost and universal availability of the ultrasound (US) makes it the most commonly used diagnostic modality. The ability to see beyond surface anatomy is important and useful in the assessment of the posterior vaginal wall prolapse and the obstructed defaecation, where this method may replace the defaecation proctography (Dietz 2019). Recent advances in pelvic floor ultrasonography (3D US) have achieved repeatability in the measurement of the levator hiatal (LH) dimensions, introducing a valid and readily available tool for researchers and clinicians (Dietz et al. 2005). Ultrasound may distinguish a true rectocele due to the weakening of the rectovaginal fascia from an enterocele, a rectal intussusception, or just a deficient perineum (Guzman Rojas et al. 2016).What do the results of this study add? Our study demonstrates that 3D translabial pelvic floor ultrasound is a useful and reliable tool in assessing the anatomical outcome of prolapse surgery.What are the implications of these findings for clinical practice and/or further research? Our study demonstrates that 3D translabial ultrasound of the pelvic floor is a useful and reproducible method in evaluating the anatomical outcomes of surgical repair for posterior wall prolapse. Genital hiatus (GH) and levator hiatus (LH) dimensions measured by ultrasound can be used as surrogate anatomical markers in comparing the efficacy of different surgical techniques.
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2.
Early score fluctuation and placebo response in a study of major depressive disorder.
Targum, SD, Cameron, BR, Ferreira, L, MacDonald, ID
Journal of psychiatric research. 2020;:118-125
Abstract
Early score fluctuation in double-blind, placebo-controlled studies may affect the reliability of the baseline measurement and adversely affect the eventual study outcome. We examined the effect of early score fluctuation during a 2-week double-blind placebo lead-in period in a phase II, double-blind, placebo-controlled trial of adjunctive s-adenosyl methionine (MSI-195) in MDD subjects who had had an inadequate response to ongoing antidepressant treatment. The overall study failed to meet its specified endpoints. We examined the score trajectories of all placebo-assigned subjects during the double-blind placebo lead-in period and subsequent 6-week treatment period. Placebo-assigned subjects with ≥20% HamD17 or MADRS score fluctuations (improvement or worsening) during the double-blind placebo lead-in period (prior to randomization) had significantly higher rates of placebo response and remission at week 8 compared to subjects with <20% response. A post-hoc analysis of evaluable subjects taken from the ITT population that excluded subjects with ≥20% early score response yielded higher effect sizes for both the HamD17 and MADRS sub-groups and statistical significance for MSI-195 over placebo in the MADRS sub-group (p = 0.012) with an effect size of 0.404. A reliable baseline measure is an asset for signal detection. These post-hoc findings suggest that study designs that anticipate and attempt to manage early response prior to randomization may yield more meaningful outcome data for trials of MDD and possibly other disorders as well.
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3.
Individualised nutritional support in medical inpatients at nutritional risk: a randomised clinical trial.
Schuetz, P, Fehr, R, Baechli, V, Geiser, M, Deiss, M, Gomes, F, Kutz, A, Tribolet, P, Bregenzer, T, Braun, N, et al
Lancet (London, England). 2019;(10188):2312-2321
Abstract
BACKGROUND Guidelines recommend the use of nutritional support during hospital stays for medical patients (patients not critically ill and not undergoing surgical procedures) at risk of malnutrition. However, the supporting evidence for this recommendation is insufficient, and there is growing concern about the possible negative effects of nutritional therapy during acute illness on recovery and clinical outcomes. Our aim was thus to test the hypothesis that protocol-guided individualised nutritional support to reach protein and caloric goals reduces the risk of adverse clinical outcomes in medical inpatients at nutritional risk. METHODS The Effect of early nutritional support on Frailty, Functional Outcomes, and Recovery of malnourished medical inpatients Trial (EFFORT) is a pragmatic, investigator-initiated, open-label, multicentre study. We recruited medical patients at nutritional risk (nutritional risk screening 2002 [NRS 2002] score ≥3 points) and with an expected length of hospital stay of more than 4 days from eight Swiss hospitals. These participants were randomly assigned (1:1) to receive either protocol-guided individualised nutritional support to reach protein and caloric goals (intervention group) or standard hospital food (control group). Randomisation was done with variable block sizes and stratification according to study site and severity of malnutrition using an interactive web-response system. In the intervention group, individualised nutritional support goals were defined by specialist dietitians and nutritional support was initiated no later than 48 h after admission. Patients in the control group received no dietary consultation. The composite primary endpoint was any adverse clinical outcome defined as all-cause mortality, admission to intensive care, non-elective hospital readmission, major complications, and decline in functional status at 30 days, and it was measured in all randomised patients who completed the trial. This trial is registered with ClinicalTrials.gov, number NCT02517476. FINDINGS 5015 patients were screened, and 2088 were recruited and monitored between April 1, 2014, and Feb 28, 2018. 1050 patients were assigned to the intervention group and 1038 to the control group. 60 patients withdrew consent during the course of the trial (35 in the intervention group and 25 in the control group). During the hospital stay, caloric goals were reached in 800 (79%) and protein goals in 770 (76%) of 1015 patients in the intervention group. By 30 days, 232 (23%) patients in the intervention group experienced an adverse clinical outcome, compared with 272 (27%) of 1013 patients in the control group (adjusted odds ratio [OR] 0·79 [95% CI 0·64-0·97], p=0·023). By day 30, 73 [7%] patients had died in the intervention group compared with 100 [10%] patients in the control group (adjusted OR 0·65 [0·47-0·91], p=0·011). There was no difference in the proportion of patients who experienced side-effects from nutritional support between the intervention and the control group (162 [16%] vs 145 [14%], adjusted OR 1·16 [0·90-1·51], p=0·26). INTERPRETATION In medical inpatients at nutritional risk, the use of individualised nutritional support during the hospital stay improved important clinical outcomes, including survival, compared with standard hospital food. These findings strongly support the concept of systematically screening medical inpatients on hospital admission regarding nutritional risk, independent of their medical condition, followed by a nutritional assessment and introduction of individualised nutritional support in patients at risk. FUNDING The Swiss National Science Foundation and the Research Council of the Kantonsspital Aarau, Switzerland.
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4.
Impact of Personal Health Records and Wearables on Health Outcomes and Patient Response: Three-Arm Randomized Controlled Trial.
Kim, JW, Ryu, B, Cho, S, Heo, E, Kim, Y, Lee, J, Jung, SY, Yoo, S
JMIR mHealth and uHealth. 2019;(1):e12070
Abstract
BACKGROUND Although using the technologies for a variety of chronic health conditions such as personal health record (PHR) is reported to be acceptable and useful, there is a lack of evidence on the associations between the use of the technologies and the change of health outcome and patients' response to a digital health app. OBJECTIVE This study aimed to examine the impact of the use of PHR and wearables on health outcome improvement and sustained use of the health app that can be associated with patient engagement. METHODS We developed an Android-based mobile phone app and used a wristband-type activity tracker (Samsung Charm) to collect data on health-related daily activities from individual patients. Dietary record, daily step counts, sleep log, subjective stress amount, blood pressure, and weight values were recorded. We conducted a prospective randomized clinical trial across 4 weeks on those diagnosed with obstructive sleep apnea (OSA) who had visited the outpatient clinic of Seoul National University Bundang Hospital. The trial randomly assigned 60 patients to 3 subgroups including 2 intervention groups: (1) mobile app and wearable device users (n=20), (2) mobile app-only users (n=20), and (3) controls (n=20). The primary outcome measure was weight change. Body weights before and after the trial were recorded and analyzed during clinic visits. Changes in OSA-related respiratory parameters such as respiratory disturbance, apnea-hypopnea, and oxygenation desaturation indexes and snoring comprised the secondary outcome and were analyzed for each participant. RESULTS We collected the individual data for each group during the trial, specifically anthropometric measurement and laboratory test results for health outcomes, and the app usage logs for patient response were collected and analyzed. The body weight showed a significant reduction in the 2 intervention groups after intervention, and the mobile app-only group showed more weight loss compared with the controls (P=.01). There were no significant changes in sleep-related health outcomes. From a patient response point of view, the average daily step counts (8165 steps) from the app plus wearable group were significantly higher than those (6034 steps) from the app-only group because they collected step count data from different devices (P=.02). The average rate of data collection was not different in physical activity (P=.99), food intake (P=.98), sleep (P=.95), stress (P=.70), and weight (P=.90) in the app plus wearable and app-only groups, respectively. CONCLUSIONS We tried to integrate PHR data that allow clinicians and patients to share lifelog data with the clinical workflow to support lifestyle interventions. Our results suggest that a PHR-based intervention may be successful in losing body weight and improvement in lifestyle behavior. TRIAL REGISTRATION ClinicalTrials.gov NCT03200223; https://clinicaltrials.gov/ct2/show/NCT03200223 (Archived by WebCite at http://www.webcitation.org/74baZmnCX).
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5.
Impact of Financial Incentives on Health Outcomes and Costs of Care among Medicaid Beneficiaries with Diabetes in Hawai'i.
Fernandes, R, Chinn, CC, Li, D, Halliday, T, Frankland, T, Ozaki, RR
Hawai'i journal of medicine & public health : a journal of Asia Pacific Medicine & Public Health. 2019;(1):19-25
Abstract
The Hawai'i Patient Reward And Incentives to Support Empowerment (HI-PRAISE) project, part of the Medicaid Incentives for Prevention of Chronic Diseases program of the Affordable Care Act, examined the impact of financial incentives on Medicaid beneficiaries with diabetes. It included an observational pre-post study which was conducted at nine Federally Qualified Health Centers (FQHCs) between 2013 to 2015. The observational study enrolled 2,003 participants. Participants could earn up to $320/year in financial incentives. Primary outcomes were change in hemoglobin A1c, blood pressure, and cholesterol; secondary outcomes included compliance with American Diabetes Association (ADA) standards of diabetes care and cost effectiveness. Generalized estimating equation models were used to assess differences in clinical outcomes and general linear models were utilized to estimate the medical costs per patient/day. Changes in clinical outcomes in the observational study were statistically significant: mean hemoglobin A1c decreased from 8.56% to 8.24% (P < .0001); mean systolic blood pressure decreased from 125.16 to 124.18 mm Hg (P = .0137); mean diastolic blood pressure decreased from 75.54 to 74.78 mm Hg (P = .0005); total cholesterol decreased from 180.77 to 174.21 mg/dl (P < .0001); and low-density lipoprotein decreased from 106.17 to 98.55 mg/dl (P < .0001). Improved ADA compliance was also observed. A key limitation was a reduced sample size due to participant's fluctuating Medicaid eligibility status. HI-PRAISE showed no reduction in total health cost during the project period.
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6.
Childhood adversities, negative life events and outcomes of non-pharmacological treatments for depression in primary care: A secondary analysis of a randomized controlled trial.
Yacaman-Mendez, D, Hallgren, M, Forsell, Y
Journal of psychiatric research. 2019;:152-158
Abstract
Non-pharmacological treatments for depression are effective and available in primary care, but useful prognostic factors are lacking. Childhood adversities (CA) and negative recent life events (RLE) increase the risk and severity of depression, though their effect on treatment outcomes remains understudied. Using a sample of 737 adult participants of a multicenter randomized controlled trial receiving physical exercise, internet based cognitive-behavioral therapy or treatment as usual, alone or in combination with antidepressants, this prospective study aimed to determine the impact of CA, RLE and their interaction as predictors of outcomes of non-pharmacological treatments for mild-moderate depression in primary care. Outcomes were depression severity (MADRS score) and response to treatment (≥50% reduction in MADRS score) after three months. Linear regression and modified Poisson regression were used, interaction was assessed with a product term (CA*RLE) and epidemiological measures of interaction. The number of CA and RLE were associated with higher depression severity at follow-up (CA: β = 0.79, 95% CI: 0.14 to 1.44 and RLE: β = 0.52, 95% CI: 0.14 to 0.72) and showed a trend towards lower rates of response to treatment (RR = 0.94, 95% CI: 0.86 to 1.03; and RLE: RR = 0.95, 95% CI: 0.90 to 0.99). Interaction between CA and RLE was not significant for depression severity (β = 0.10, 95% CI: -2.12 to 0.41) nor for response to treatment (RERI = -0.05, 95% CI = -0.33 to 0.24). CA and RLE are associated with worse outcomes of non-pharmacological treatments in primary care. Further studies to identify predictors of outcomes of non-pharmaological treatments for depression are needed.
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7.
Randomized controlled trial of a coordinated care intervention to improve risk factor control after stroke or transient ischemic attack in the safety net: Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities (SUCCEED).
Towfighi, A, Cheng, EM, Ayala-Rivera, M, McCreath, H, Sanossian, N, Dutta, T, Mehta, B, Bryg, R, Rao, N, Song, S, et al
BMC neurology. 2017;(1):24
Abstract
BACKGROUND Recurrent strokes are preventable through awareness and control of risk factors such as hypertension, and through lifestyle changes such as healthier diets, greater physical activity, and smoking cessation. However, vascular risk factor control is frequently poor among stroke survivors, particularly among socio-economically disadvantaged blacks, Latinos and other people of color. The Chronic Care Model (CCM) is an effective framework for multi-component interventions aimed at improving care processes and outcomes for individuals with chronic disease. In addition, community health workers (CHWs) have played an integral role in reducing health disparities; however, their effectiveness in reducing vascular risk among stroke survivors remains unknown. Our objectives are to develop, test, and assess the economic value of a CCM-based intervention using an Advanced Practice Clinician (APC)-CHW team to improve risk factor control after stroke in an under-resourced, racially/ethnically diverse population. METHODS/DESIGN In this single-blind randomized controlled trial, 516 adults (≥40 years) with an ischemic stroke, transient ischemic attack or intracerebral hemorrhage within the prior 90 days are being enrolled at five sites within the Los Angeles County safety-net setting and randomized 1:1 to intervention vs usual care. Participants are excluded if they do not speak English, Spanish, Cantonese, Mandarin, or Korean or if they are unable to consent. The intervention includes a minimum of three clinic visits in the healthcare setting, three home visits, and Chronic Disease Self-Management Program group workshops in community venues. The primary outcome is blood pressure (BP) control (systolic BP <130 mmHg) at 1 year. Secondary outcomes include: (1) mean change in systolic BP; (2) control of other vascular risk factors including lipids and hemoglobin A1c, (3) inflammation (C reactive protein [CRP]), (4) medication adherence, (5) lifestyle factors (smoking, diet, and physical activity), (6) estimated relative reduction in risk for recurrent stroke or myocardial infarction (MI), and (7) cost-effectiveness of the intervention versus usual care. DISCUSSION If this multi-component interdisciplinary intervention is shown to be effective in improving risk factor control after stroke, it may serve as a model that can be used internationally to reduce race/ethnic and socioeconomic disparities in stroke in resource-constrained settings. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT01763203 .
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Metformin vs myoinositol: which is better in obese polycystic ovary syndrome patients? A randomized controlled crossover study.
Tagliaferri, V, Romualdi, D, Immediata, V, De Cicco, S, Di Florio, C, Lanzone, A, Guido, M
Clinical endocrinology. 2017;(5):725-730
Abstract
CONTEXT Due to the central role of metabolic abnormalities in the pathophysiology of polycystic ovary syndrome (PCOS), insulin sensitizing agents have been proposed as a feasible treatment option. OBJECTIVE To investigate which is the more effective between metformin and myoinositol (MYO) on hormonal, clinical and metabolic parameters in obese patients with PCOS. STUDY DESIGN Crossover randomized controlled study. PATIENTS Thirty-four PCOS obese women (age: 25·62 ± 4·7 years; BMI: 32·55 ± 5·67 kg/m2 ) were randomized to receive metformin (850 mg twice a day) or MYO (1000 mg twice a day) for 6 months. After a 3 month washout, the same subjects received the other compound for the following 6 months. MEASUREMENTS Ultrasonographic pelvic examinations, hirsutism score, anthropometric and menstrual pattern evaluation, hormonal profile assays, oral glucose tolerance test (OGTT) and lipid profile at baseline and after 6 months of treatment were performed. RESULTS Both metformin and MYO significantly reduced the insulin response to OGTT and improved insulin sensitivity. Metformin significantly decreased body weight and improved menstrual pattern and Ferriman-Gallwey score. Metformin treatment was also associated with a significant decrease in LH and oestradiol levels, androgens and anti-müllerian hormone levels. None of these clinical and hormonal changes were observed during MYO administration. CONCLUSIONS Both treatments improved the glyco-insulinaemic features of obese PCOS patients, but only metformin seems to exert a beneficial effect on the endocrine and clinical features of the syndrome.
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9.
Serious Adverse Events Associated with Readmission Through One Year After Vertebral Augmentation with Either a Polyetheretherketone Implant or Balloon Kyphoplasty.
Beall, DP, Coe, JD, McIlduff, M, Bloch, D, Hornberger, J, Warner, C, Tutton, S
Pain physician. 2017;(6):521-528
Abstract
BACKGROUND The KAST (Kiva Safety and Efficacy) investigation device exempt (IDE) study indicated that the majority of patients responded equally well to vertebral augmentation using either an implant-based approach or balloon kyphoplasty (BK). Additional investigation has suggested that a subset of patients may benefit further by avoiding repeated readmissions due to serious adverse events (SAEs) if they receive one vertebral augmentation approach over another. OBJECTIVES The primary aim was to assess the effect of 2 different augmentation procedures on readmission rates for SAEs. STUDY DESIGN The KAST trial is a pivotal, multicenter, randomized, controlled trial conducted to evaluate an implant-based vertebral augmentation approach (implant) against BK. Post-hoc analysis was performed to evaluate SAEs and readmission rates. SETTING Twenty-one sites in North America and Europe. METHODS The treatment effect of vertebral implant versus BK on SAEs requiring unplanned readmission was evaluated by estimating the risk of SAEs associated with readmissions in KAST while controlling for key baseline covariates using multivariate Poisson regression modeling. RESULTS Forty (27.8%) patients with implants had 69 SAEs associated with readmission compared to 44 (31.2%) patients with BK having 103 events. The risk for all SAEs leading to readmission was 34.4% lower with the implant than for BK (95% confidence interval = 11.1%, 51.7%; P < 0.01). Multivariate analysis showed that the risk of SAEs associated with readmission was decreased in subjects treated with the implant compared to BK, and increased in patients with prior histories of vertebral compression fractures (VCFs) or significant osteoporosis. LIMITATIONS The power of the KIVA study was based on clinical efficacy criteria to meet FDA requirements and recommendations for equivalency or noninferiority. The primary endpoint in this post-hoc analysis is SAEs associated with readmissions; as a result, the sample size is underpowered, although the results remain significant. CONCLUSION The augmentation approaches compared here have similar pain relief and quality of life effects; the implant showed a lower risk of readmissions. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01123512. Key words: Vertebral compression fracture, kiva implant, balloon kyphoplasty, vertebroplasty, health economics, osteoporosis.
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10.
Characteristics and Outcomes of Very Elderly Enrolled in a Prehospital Stroke Research Study.
Sanossian, N, Apibunyopas, KC, Liebeskind, DS, Starkman, S, Burgos, AM, Conwit, R, Eckstein, M, Pratt, F, Stratton, S, Hamilton, S, et al
Stroke. 2016;(11):2737-2741
Abstract
BACKGROUND AND PURPOSE Greater numbers of individuals aged ≥80 years enjoy a high quality of life, yet historically stroke trials have excluded this population. We aimed to describe a population of very elderly successfully enrolled into an acute stroke trial and compare their characteristics and outcomes with the younger cohort. METHODS We analyzed consecutive patients enrolled <2 hours of symptom onset in a prehospital stroke treatment trial, the FAST-MAG clinical trial (Field Administration of Stroke Therapy-Magnesium). We gathered demographic, treatment, and outcome data for nonelderly (<80 years old), very elderly (≥80 years old), and extreme elderly (≥90 years old). We describe key differences in the population of elderly and the impact of their inclusion on the clinical trial. RESULTS Of 1700 participants in FAST-MAG, there were 1210 nonelderly, 490 very elderly, and 60 extreme elderly subjects. Very elderly stroke patients successfully enrolled in a research study were more likely to be women, white, and have an ischemic mechanism rather than an intracerebral hemorrhage. Although the very elderly had generally poorer outcomes, 4 in 10 were functionally independent at 90 days. CONCLUSIONS Inclusion of the very elderly population in acute stroke clinical trials would both significantly increase study participation and generalizability of future acute stroke clinical trials. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00059332.