Transabdominal and transperineal ultrasound versus routine care before instrumental vaginal delivery – a randomized controlled trial

Introduction. Stable angina (SA) in coronary heart disease is a common ischemic heart disease endangering the patient’s quality of life and longevity. Clinical trials have demonstrated that the Chinese herbal formula Xuefu Zhuyu (XFZY) has benefits for SA patients. However, there remains a lack of high-quality evidence to support clinical decision-making. Therefore, we designed a randomized controlled trial (RCT) to evaluate the efficacy and safety of XFZY for SA. Methods and Analysis. This multicenter, double-blinded RCT will be conducted in China. 152 eligible participants will be randomly assigned to either an XFZY group or a control group at a 1 : 1 ratio. Participants in the XFZY group will receive XFZY plus routine care, while those in the control group will receive placebo plus routine care. The study period is 26 weeks, including a 2-week run-in period, a 12-week treatment period, and a 12-week follow-up. The primary outcome is the change in visual analogue scale score for angina pain intensity from baseline to 12 weeks. The secondary outcomes are the angina attack frequency and duration, the nitroglycerin dosage consumed, the Canadian Cardiovascular Society grading of effort angina, the Seattle Angina Questionnaire, the EuroQol-5-Dimensions-5-Level, the incidence of major adverse cardiac events, health cost evaluation, and overall assessment for study drugs. Ethics and Dissemination. The study has been approved by the ethics committee of Guangdong Provincial Hospital of Chinese Medicine (approval no. BF2019-175-01). Results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences. This trial is registered with ChiCTR1900026899, registered on 26 October 2019.

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Reduction of the long-term use of proton pump inhibitors by a patient-oriented electronic decision support tool (arriba-PPI): study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-019-3728-2 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Anja Rieckert ◽

Annette Becker ◽

Norbert Donner-Banzhof ◽

Annika Viniol ◽

Bettina Bücker ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Decision Support ◽

Controlled Trial ◽

Decision Support Tool ◽

Routine Care ◽

Electronic Decision Support ◽

Support Tool ◽

Randomized Controlled ◽

Cluster Randomized

Abstract Background Proton pump inhibitors (PPIs) are increasingly being prescribed, although long-term use is associated with multiple side effects. Therefore, an electronic decision support tool with the aim of reducing the long-term use of PPIs in a shared decision-making process between general practitioners (GPs) and their patients has been developed. The developed tool is a module that can be added to the so-called arriba decision support tool, which is already used by GPs in Germany in routine care. In this large-scale cluster-randomized controlled trial we evaluate the effectiveness of this arriba-PPI tool. Methods The arriba-PPI tool is an electronic decision support system that supports shared decision-making and evidence-based decisions around the long-term use of PPIs at the point of care. The tool will be evaluated in a cluster-randomized controlled trial involving 210 GP practices and 3150 patients in Germany. GP practices will be asked to recruit 20 patients aged ≥ 18 years regularly taking PPIs for ≥ 6 months. After completion of patient recruitment, each GP practice with enrolled patients will be cluster-randomized. Intervention GP practices will get access to the software arriba-PPI, whereas control GPs will treat their patients as usual. After an observation period of six months, GP practices will be compared regarding the reduction of cumulated defined daily doses of PPI prescriptions per patient. Discussion Our principal hypothesis is that the application of the arriba-PPI tool can reduce PPI prescribing in primary care by at least 15% compared to conventional strategies used by GPs. A positive result implies the implementation of the arriba-PPI tool in routine care. Trial registration German Clinical Trials Register, DRKS00016364. Registered on 31 January 2019.

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The effect of cryotherapy on chemotherapy induced oral mucositis in Egyptian cancer patients: A randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v9n11p63 ◽

2019 ◽

Vol 9 (11) ◽

pp. 63

Author(s):

Hanan Mohamed Mohamed Soliman

Keyword(s):

Randomized Controlled Trial ◽

Cancer Patients ◽

Oral Mucositis ◽

Health Care Professionals ◽

Controlled Trial ◽

Routine Care ◽

Control Group ◽

Adverse Side Effect ◽

Randomized Controlled ◽

Oral Cryotherapy

Background and objective: Oral Mucositis (OM) is a common adverse side-effect caused by cancer treatments (chemotherapy and/or radiotherapy). And can lead to mucosa toxicity. Patients with OM may experience extreme pain and may not be able to eat, drink and talk and, as a result, their quality of life is impaired. Treatment and prevention of OM in adult patients treated with chemotherapy are challenging issues for health care professionals. The aim of this study was to evaluate the effect of cryotherapy on incidence and severity of chemotherapy-induced OM and OM related pain in patients treated with combined chemotherapy (Fluorouracil and Leucovorin).Methods: This study is a randomized controlled trial with a random assignment to cryotherapy and control groups. The study was conducted on 40 cancer patients who underwent chemotherapy. The 20 patients in cryotherapy group were received instructions for sucking ice cubes in their mouth for five minutes before, during and shortly after chemotherapy. The 20 patients in control group received routine care. OM and pain severity were evaluated at 7th, 14th and 21st days of the study after chemotherapy using WHO Mucositis grading and-Numeric Pain Rating Scale.Results: In the majority of patients in cryotherapy group, oral Mucositis was not detected (Grade 0) at 7th, 14th and 21st days similarly incidence of grade 1 and 2 of OM in cryotherapy group significantly lowered when compared with control group where p < .001. During the study period, patients in the control group exhibit a significantly higher level of oral discomfort (p = .001).Conclusions: Oral cryotherapy due to its easy administration, tolerability and lack of adverse effects which makes it a very important method for decreasing the severity and incidence of OM and OM associated pain. The oncology nurses have a pivotal role in the application and success of cryotherapy.

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