Secondary Outcomes
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2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Zhen-wen Wu ◽  
Sheng-gang Zhan ◽  
Mei-feng Yang ◽  
Yi-teng Meng ◽  
Feng Xiong ◽  
...  

Background and Aims. Simethicone (SIM), as an antifoaming agent, has been shown to improve bowel preparation during colonoscopy. However, the optimal timing of SIM addition remained undetermined. We aimed to investigate the optimal timing of SIM addition to polyethylene glycol (PEG) to improve bowel preparation. Methods. Eligible patients were randomly assigned to two groups: the SIM evening group (SIM addition to PEG in the evening of the day prior to colonoscopy) and the SIM morning group (SIM addition to PEG in the morning of colonoscopy). The primary outcome was Bubble Scale (BS). The secondary outcomes were Boston Bowel Preparation Scale (BBPS) and adenoma detection rate (ADR). Results. A total of 419 patients were enrolled in this study. The baseline characteristics of the patients were similar in both groups. No significant differences were observed in terms of BS (8.76 ± 0.90 vs. 8.65 ± 1.16, P  = 0.81), ADR (34.1% vs. 30.8%, P  = 0.47), Boston Bowel Preparation Scale (BBPS) (8.59 ± 0.94 vs. 8.45 ± 1.00, P  = 0.15), and withdrawal time (8.22 ± 2.04 vs. 8.01 ± 2.51, P  = 0.094) between the two groups. Moreover, safety and compliance were similar in both groups. However, the SIM evening group was associated with shorter cecal intubation time (3.80 ± 1.81 vs. 4.42 ± 2.03, P  < 0.001), higher BS (2.95 ± 0.26 vs. 2.88 ± 0.38, P  = 0.04) in the right colon, and diminutive ADR (62.5% vs. 38.6%, P  = 0.022) in the right colon, when compared to the SIM evening group. Conclusions. The SIM addition to PEG in the evening of the day prior to colonoscopy can shorten cecal intubation time and improve BS scores and diminutive ADR of the right colon compared with the SIM addition to PEG in the morning of colonoscopy in bowel preparation.


2021 ◽  
Author(s):  
Zhengting He ◽  
Xin Cao ◽  
Duan Zhao ◽  
Zemin Tang ◽  
Jiayu Zhao ◽  
...  

Abstract Background Among rural Chinese patients with non-communicable diseases (NCDs), low socioeconomic status increases the risk of developing NCDs and associated financial burdens in paying for medicines and treatments. Despite the chronic disease medicine reimbursement policy of the local government in Nantong City, China, various barriers prevent patients from registering for and benefitting from the policy. This study aims to develop a behavior-science based intervention program for promoting the adoption of the policy and to evaluate the effectiveness of the program compared with usual practices. Methods Barriers and opportunities affecting stakeholders in adopting the policy were identified through contextual research and summarized through behavior mapping. The intervention targets these barriers and opportunities through behavior science theories and will be evaluated through a 6-month cluster randomized controlled trial in Tongzhou District, Nantong, China. A total of 30 villages from two townships are randomized in a 1:1 ratio to either the intervention or the control arm (usual practices). Village doctors in the intervention arm (1) receive systematic training on policy details, registration procedures, and intervention protocol, (2) promote the policy and encourage registration, (3) follow-up with patients in the first, third and sixth month after the intervention, and (4) receive financial incentives based on performance. The primary outcome is policy registration rate and the secondary outcomes include the number of patients registering for the policy, medical costs saved, frequency of village doctor visits, and health conditions such as blood pressure and glucose levels. Discussion This study is one of very few that aims to promote adoption of NCDs outpatient medication reimbursement policies, and the first study to evaluate the impact of these policies on patients’ financial and physical wellbeing in China. The simple, feasible, and scalable intervention is designed based on the theories of behavior science and are applicable to similar low-income regions nationwide where outpatient medical costs remain a financial burden for patients. Trial registration: ClinicalTrials.gov, NCT04731194, registered on 29 January 2021, https://clinicaltrials.gov/ct2/show/NCT04731194?term=PAPMed&draw=2&rank=1; Chinese Clinical Trial Registry, ChiCTR2100042152, registered on 14 January 14 2021, http://www.chictr.org.cn/showproj.aspx?proj=65987.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rasmus Kramer Mikkelsen ◽  
Lars Blønd ◽  
Lisbeth Rosenkrantz Hölmich ◽  
Cecilie Mølgaard ◽  
Anders Troelsen ◽  
...  

Abstract Background Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro-fragmented adipose tissue has been suggested to relieve symptoms. Methods/Design The study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grades 2–3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro-fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total, 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months; the Tegner activity score; treatment failure; and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis. Discussion This trial is the first to investigate the efficacy of autologous, micro-fragmented adipose tissue in a randomized controlled trial. The study uses the patient-reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient’s opinion about their knee and associated problems when suffering from osteoarthritis.


2021 ◽  
Author(s):  
RAFAELA PERON ◽  
Érika Patrícia Rampazo ◽  
Richard Eloin Liebano

Abstract Background: Nonspecific neck pain is a multifactorial and very common condition in adult individuals. No reports were found in the literature comparing the effectiveness of Traditional Acupuncture (TA) and Laser Acupuncture (LA) in cases of chronic nonspecific neck pain. Therefore, the aim of the present study is to investigate the effectiveness of TA and LA therapies in individuals with chronic nonspecific neck pain.Methods/design: This study will be a controlled and randomized clinical trial. A total of 60 individuals will be randomized into two groups (30 each). The TA group will receive the acupuncture treatment using needles, while the LA group will receive the laser acupuncture treatment. The acupuncture points (Tianzhu, Fengchi, Jianjing, and Jianzhongshu) will be stimulated bilaterally with needles or laser. The primary outcome will be pain intensity, determined using the numerical rating scale. The secondary outcomes will be pressure pain threshold, temporal summation of pain, conditioned pain modulation, use of analgesic drugs after treatment, and the global perceived effect scale. The assessments will be performed immediately before and after treatment. At the follow-up, 1 months after the end of the treatments, evaluation will be made of the pain intensity and the global perceived effect. Statistical analysis of the data obtained will consider a significance level of p < 0.05.Discussion: This study will provide evidence concerning the effects of LA treatment, in comparison to TA, leading to benefits for individuals suffering from chronic nonspecific neck pain.Trial registration: RBR-7vbw5gd (Brazilian Registry of Clinical Trials - ​ReBEC)


Planta Medica ◽  
2021 ◽  
Author(s):  
Moritz Winker ◽  
Amy Marisa Zimmermann-Klemd ◽  
Seema Devi ◽  
Aljoscha Waterstradt ◽  
Ann-Kathrin Lederer ◽  
...  

Abstract Equisetum arvense tea (TEA) contains high concentrations of silicon and has been used in folk medicine for the treatment of inflammatory ailments. We examined the resorption of silicon after TEA consumption. Safety and immunological effects were secondary outcomes. A monocentric, randomized, three-armed pilot study was conducted with 12 voluntary, healthy, male subjects. The study is registered in the German register for clinical trials (DRKS-ID: DRKS00016628). After a low silicon diet for 36 hours, 1000 mL TEA1 with approximately 200 000 µg silicon/L, TEA2 with approximately 750 000 µg silicon/L, or Si-low-Water (approximately 10 – 10 000 µg silicon/L as a control) were ingested on three consecutive days. Blood and urine samples were collected at baseline, day 1 examining silicon kinetics, day 3 examining silicon accumulation, and day 8 (safety, immunological parameters). Si-low-Water intake did not change silicon serum (Cmax 294 µg/L) or urine (19 000 µg/24 h) concentrations compared to baseline. Cmax was 2855 µg/L for TEA1 and 2498 µg/L for TEA2; tmax was 60 and 120 min, respectively. Silicon accumulation did not occur. Urine silica within 24 h (E24 h) was higher after TEA2 compared to TEA1 ingestion (142 000 vs. 109 000 µg/24 h). Serum silicon levels at t = 120 min differed significantly after intake of TEA2 or intake of Si-low-Water (p = 0.029). The immunological parameters did not show any significant changes indicating immunosuppressive effects in volunteers. TEA1 was well tolerated, while TEA2 caused diarrhoea in 4 subjects. Our investigations show that intake of TEA1 leads to significant rise in serum silicon concentration.


2021 ◽  
pp. emermed-2021-211706
Author(s):  
James Vassallo ◽  
Saisakul Chernbumroong ◽  
Nabeela Malik ◽  
Yuanwei Xu ◽  
Damian Keene ◽  
...  

IntroductionTriage is a key principle in the effective management of major incidents. There is currently a paucity of evidence to guide the triage of children. The aim of this study was to perform a comparative analysis of nine adult and paediatric triage tools, including the novel ‘Sheffield Paediatric Triage Tool’ (SPTT), assessing their ability in identifying patients needing life-saving interventions (LSIs).MethodsA 10-year (2008–2017) retrospective database review of the Trauma Audit Research Network (TARN) Database for paediatric patients (<16 years) was performed. Primary outcome was identification of patients receiving one or more LSIs from a previously defined list. Secondary outcomes included mortality and prediction of Injury Severity Score (ISS) >15. Primary analysis was conducted on patients with complete prehospital physiological data with planned secondary analyses using first recorded data. Performance characteristics were evaluated using sensitivity, specificity, undertriage and overtriage.Results15 133 patients met TARN inclusion criteria. 4962 (32.8%) had complete prehospital physiological data and 8255 (54.5%) had complete first recorded physiological data. The majority of patients were male (69.5%), with a median age of 11.9 years. The overwhelming majority of patients (95.4%) sustained blunt trauma, yielding a median ISS of 9 and overall, 875 patients (17.6%) received at least one LSI. The SPTT demonstrated the greatest sensitivity of all triage tools at identifying need for LSI (92.2%) but was associated with the highest rate of overtriage (75.0%). Both the Paediatric Triage Tape (sensitivity 34.1%) and JumpSTART (sensitivity 45.0%) performed less well at identifying LSI. By contrast, the adult Modified Physiological Triage Tool-24 (MPTT-24) triage tool had the second highest sensitivity (80.8%) with tolerable rates of overtriage (70.2%).ConclusionThe SPTT and MPTT-24 outperform existing paediatric triage tools at identifying those patients requiring LSIs. This may necessitate a change in recommended practice. Further work is needed to determine the optimum method of paediatric major incident triage, but consideration should be given to simplifying major incident triage by the use of one generic tool (the MPTT-24) for adults and children.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
M. Abdel-fattah ◽  
C. Chapple ◽  
K. Guerrero ◽  
S. Dixon ◽  
N. Cotterill ◽  
...  

Abstract Background Overactive bladder (OAB) syndrome is a symptom complex affecting 12–14% of the UK adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary frequency and nocturia. OAB has a negative impact on women’s social, physical, and psychological wellbeing. Initial treatment includes lifestyle modifications, bladder retraining, pelvic floor exercises and pharmacological therapy. However, these measures are unsuccessful in 25–40% of women (refractory OAB). Before considering invasive treatments, such as Botulinum toxin injection or sacral neuromodulation, most guidelines recommend urodynamics to confirm diagnosis of detrusor overactivity (DO). However, urodynamics may fail to show evidence of DO in up to 45% of cases, hence the need to evaluate its effectiveness and cost-effectiveness. FUTURE (Female Urgency, Trial of Urodynamics as Routine Evaluation) aims to test the hypothesis that, in women with refractory OAB, urodynamics and comprehensive clinical assessment is associated with superior patient-reported outcomes following treatment and is more cost-effective, compared to comprehensive clinical assessment only. Methods FUTURE is a pragmatic, multi-centre, superiority randomised controlled trial. Women aged ≥ 18 years with refractory OAB or urgency predominant mixed urinary incontinence, and who have failed/not tolerated conservative and medical treatment, are considered for trial entry. We aim to recruit 1096 women from approximately 60 secondary/tertiary care hospitals across the UK. All consenting women will complete questionnaires at baseline, 3 months, 6 months and 15 months post-randomisation. The primary outcome is participant-reported success at 15 months post-randomisation measured using the Patient Global Impression of Improvement. The primary economic outcome is incremental cost per quality-adjusted life year gained at 15 months. The secondary outcomes include adverse events, impact on other urinary symptoms and health-related quality of life. Qualitative interviews with participants and clinicians and a health economic evaluation will also be conducted. The statistical analysis of the primary outcome will be by intention-to-treat. Results will be presented as estimates and 95% CIs. Discussion The FUTURE study will inform patients, clinicians and policy makers whether routine urodynamics improves treatment outcomes in women with refractory OAB and whether it is cost-effective. Trial registration ISRCTN63268739. Registered on 14 September 2017.


2021 ◽  
Author(s):  
Claire Shackleton ◽  
Robert Evans ◽  
Sacha West ◽  
Wayne Derman ◽  
Yumna Albertus

Objective: Activity-based Training (ABT) represents the current standard of neurological rehabilitation. Robotic Locomotor Training (RLT) is an innovative technique that aims to enhance rehabilitation outcomes, however, its efficacy in SCI rehabilitation, particularly within a low-middle income setting, is currently unclear. The primary aim of this study was to determine the feasibility of a locomotor training program within XX, in terms of recruitment, attendance, drop-out rates and safety. Secondary aims were to determine the effects of RLT compared to ABT on functional capacity in people with chronic SCI. Design: Participants with chronic traumatic motor incomplete tetraplegia (n = 16) were recruited. Each intervention involved 60-minute sessions, 3x per week, over 24-weeks. RLT involved walking in the Ekso GTTM suit. ABT involved a combination of resistance, cardiovascular and weight-bearing exercise. Primary feasibility outcomes included recruitment rate, adherence rate, and adverse events. Validated tests were performed at baseline, 6, 12 and 24-weeks to assess the secondary outcomes of functional capacity. Results: Out of 110 individuals who expressed interest in participating in the study, 17 initiated the program (recruitment rate = 15.4 %). Of these, 16 individuals completed the program (drop-out rate = 5.8 %) and attended sessions (attendance rate = 93.9%). There were no significant differences between the intervention groups for lower or upper extremity motor scores (UEMS effect size (ES) = 0.09; LEMS ES = 0.05), back strength (ES = 0.14) and abdominal strength (ES = 0.13) after training. However, both groups showed a significant increase of 2.00 points in UEMS and a significant increase in abdominal strength from pre- to post intervention. Only the RLT group showed a significant change in LEMS, with a mean increase of 3.00 [0.00; 16.5] points over time. Distance walked in the Functional Ambulatory Inventory (SCI-FAI) increased significantly (p = 0.02) over time only for the RLT group. Conclusions: Recruitment, attrition and adherence rates of the intervention and outcomes justify a subsequent powered RCT comparing RLT to ABT as an effective rehabilitation tool for potentially improving functional strength and walking capacity in people with incomplete SCI.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Carole Ruault ◽  
Nathalie Zappella ◽  
Julien Labreuche ◽  
Pierrick Cronier ◽  
Baptiste Claude ◽  
...  

AbstractAscitic fluid infection (AFI) is a life-threatening complication of cirrhosis. We aimed to identify early indicators of secondary peritonitis (SP), which requires emergency surgery, and to describe the outcomes of SP and spontaneous bacterial/fungal peritonitis (SBFP). Adults with cirrhosis and AFI admitted to 16 university or university-affiliated ICUs in France between 2002 and 2017 were studied retrospectively. Cases were identified by searching the hospital databases for relevant ICD-10 codes and hospital charts for AFI. Logistic multivariate regression was performed to identify factors associated with SP. Secondary outcomes were short- and long-term mortality and survivors’ functional outcomes. Of 178 included patients (137 men and 41 women; mean age, 58 ± 11 years), 21 (11.8%) had SP, confirmed by surgery in 16 cases and by abdominal computed tomography in 5 cases. Time to diagnosis exceeded 24 h in 7/21 patients with SP. By multivariate analysis, factors independently associated with SP were ascitic leukocyte count > 10,000/mm3 (OR 3.70; 95%CI 1.38–9.85; P = 0.009) and absence of laboratory signs of decompensated cirrhosis (OR 4.53; 95%CI 1.30–15.68; P = 0.017). The 1-year mortality rates in patients with SBFP and SP were 81.0% and 77.5%, respectively (Log-rank test, P = 0.92). Patients with SP vs. SBFP had no differences in 1-year functional outcomes. This multicenter retrospective study identified two indicators of SP as opposed to SBFP in patients with cirrhosis. Using these indicators may help to provide early surgical treatment.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Alessandro Belletti ◽  
Corrado Campochiaro ◽  
Marilena Marmiere ◽  
Valery Likhvantsev ◽  
Andrey Yavorovskiy ◽  
...  

Abstract Purpose COVID-19 is characterized by dysregulated immune response, respiratory failure and a relevant mortality rate among hospitalized patients. Interleukin-6 (IL-6) is involved in COVID-19-associated cytokine storm, and several trials investigated whether its inhibition could improve patients’ outcome. We performed a meta-analysis of randomized trials (RCT) to test this hypothesis. Materials and methods Two independent investigators searched PubMed, Scopus, ClnicalTrials.gov and medRxiv up to September 1st, 2021. Inclusion criteria were: administration of tocilizumab or sarilumab; COVID-19 adult patients with pneumonia; and being a RCT. Primary outcome was mortality at the longest follow-up. Secondary outcomes included intubation rate and incidence of adverse events. Two independent investigators extracted data from eligible trials. Results Of the 763 studies assessed, 15 RCTs were included (9,320 patients), all were multicentre, and the majority open-label vs standard treatment. IL-6 inhibitors were associated with reduced all-cause mortality at the longest follow-up (1315/5,380 [24.4%] in the IL-6 inhibitors group versus 1080/3,814 [28.3%] in the control group, RR = 0.90; 95% CI 0.84 to 0.96; p for effect = 0.003, I2 = 0%, with 13 studies included), with reduction in 28/30-day mortality and intubation rates, and with no increase in adverse events and secondary infections. Conclusion IL-6 inhibitors reduced longest follow-up mortality and intubation in COVID-19 patients. Findings need to be confirmed in high-quality RCTs.


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