Methodological quality(risk of bias) assessment tools for primary and secondary medical studies: What are they and which is better?

Methodological quality(risk of bias)assessment is an important step before study initiation usage.Therefore,accurately judging study type is the first priority,and the choosing proper tool is also important.In this review,we introduced methodological quality assessment tools for randomized controlled trial(including individual and cluster),animal study,non-randomized interventional studies(including follow-up study,controlled before-and-after study,before-after/pre-post study,uncontrolled longitudinal study,interrupted time series study),cohort study,case-control study,cross-sectional study(including analytical and descriptive),observational case series and case reports,comparative effectiveness research,diagnostic study,health economic evaluation,prediction study(including predictor finding study,prediction model impact study,prognostic prediction model study),qualitative study,outcome measurement instruments(including patient-reported outcome measure development,content validity,structural validity,internal consistency,cross-cultural validity/measurement invariance,reliability,measurement error,criterion validity,hypotheses testing for construct validity,and responsiveness),systematic review and meta-analysis,and clinical practice guideline.The readers of our review can distinguish the types of medical studies and choose appropriate tools.In one word,comprehensively mastering relevant knowledge and implementing more practices are basic requirements for correctly assessing the methodological quality.

A quality evaluation of nursing intervention studies in China's Mainland: From 1979 to 2012

Background:The number of papers published in the field of nursing practice has greatly increased in recent years in China's Mainland,yet the quality of these papers is highly variable.There has been no attempt to comprehensively estimate the overall quantity and quality of these papers.Objectives:To systematically retrieve nursing intervention studies published in simplified Chinese from 1979 to 2012,critically appraise their quality,and provide suggestions for future development.Methods:All of the papers were retrieved from China Biology Medicine disc database.The preliminary screening of retrieved publications was performed prior to conducting a rigorous quality evaluation of the remaining publications.10 characteristics would be included in consideration in quality evaluations.Results:69,150 papers were retrieved according to searching strategy.7391 of them were included after preliminary screening and appraised critically.Among the 10 characteristics considered in quality evaluations,the lowest ratings were observed for the factors of“utilisation of blind method”(13 articles),“description of loss of follow-up”(499 articles),“appropriate calculation of sample size”(511 articles)and“randomised assignment of patients to treatments”(652 articles).Conclusions:Chinese papers published in the field of nursing practice have increased over time,but improvements remain needed to ensure that thorough studies with high-quality research methodologies are being performed.Future nursing researchers should not only improve the design of their intervention studies but also clearly describe the methodology they used,especially in group randomisation,blinded research designs,and estimations of required sample sizes.

Effect of distinct psychological interventions on changes in selfreported distress,depression and loneliness among older adults during COVID-19

BACKGROUND Older adults have been considered a primary at-risk population during the coronavirus disease 2019(COVID-19)pandemic,and many efforts have been and still are directed toward supporting them and enhancing their capacity to cope with the pandemic.Evidence shows that by enhancing proactive coping abilities through psychological interventions,in which cognitive-behavioral and mindfulness techniques are taught and practiced effectively,these interventions have supported older adults throughout the pandemic.However,the underlying mechanisms by which specific intervention components affect various mental states such as distress,depression and loneliness among older adults remain unclear and warrant investigation.AIM To determine the effect of an intervention using cognitive-behavioral and mindfulness techniques on changes in distress,depression and loneliness.METHODS We performed a secondary analysis on data from a previous study in which community-dwelling older adults attended a short-term,internet-based intervention during the first COVID-19 wave in Israel.The intervention included seven sessions during which various cognitive-behavioral and mindfulness techniques were learned and practiced.In-session changes in psychological distress were measured using the Subjective Units of Distress Scale(SUDS),which participants rated at the beginning and end of each session.Participants also filled out questionnaires that evaluated levels of depression[Patient Health Questionnaire(PHQ-9)]and loneliness(UCLA loneliness Scale)prior to and after the entire intervention process.The effect of in-session changes in the SUDS on changes in post-intervention depression and loneliness levels were assessed,as a proxy for distinct technique effectiveness.RESULTS The findings indicated in-session differences in terms of a decrease in psychological distress(SUDS).Sessions that included relaxation exercises and guided imagery,as well as sessions that included cognitive restructuring and mindfulness meditation,demonstrated the largest decreases in in-session psychological distress(≥35%).Two multivariate regression models,one for levels of post-intervention depression(PHQ-9 score)and the other for levels of post-intervention loneliness(UCLA loneliness score),were fitted.The results revealed two statistically significant explanatory variables for depression:The SUDS difference for sessions in which cognitive restructuring and mindfulness meditation were practiced,beta=-0.25,95%CI:-1.23 to-0.1,and the pre-intervention level of depression,beta=0.62,95%CI:0.37-0.75.The second model for loneliness revealed only one significant explanatory variable:The SUDS difference for sessions in which relaxation and guided imagery were practiced,beta=0.41,95%CI:0.14-0.65.CONCLUSION Different psychological techniques seem to have different effects on distress,loneliness and depression.Understanding the pathways by which distinct techniques affect negative mental symptoms has implications for future intervention design.

Effects of a theory of planned behavior-based intervention on breastfeeding behaviors after cesarean section:A randomized controlled trial

Objectives:To examine the efficacy of an intervention based on the theory of planned behavior(TPB)in improving breastfeeding behavior among women with cesarean sections(C-sections).Methods:This research was a randomized controlled trial.Women with planned elective C-sections were recruited to participate in a randomized controlled trial between June and September 2020.One hundred thirty-two women were divided randomly into the intervention(n=66)and control group(n=66)by systematic random sampling.In the intervention group,an intervention project was implemented after Keywords:Breastfeeding Cesarean section Intervention studies Theory of planned behavior the C-section to establish positive breastfeeding attitudes,cultivate supportive subjective norms,enhance perceived behavioral control,and strengthen breastfeeding intention to change behaviors.Those in the control group received routine pre-and post-delivery care.Exclusive breastfeeding rate and breast problem were collected at 5 days,2 weeks,and 1 month after C-section.The modified Breastfeeding Attrition Prediction Tool(BAPT)on the first day in the hospital,two weeks,and one month after C-section and Numerical Rating Scale(NRS)24 h postoperatively were used to compare the intervention effect between the two groups.Results:After the intervention,the intervention group had significantly higher exclusive breastfeeding rates than the control group at five days(86.4%vs.60.6%),two weeks(77.3%vs.57.6%),and one month(74.2%vs.50.0%)after the C-section.Besides,the intervention group was less likely to have sore nipples at five days(6.1%vs.18.2%in the control group,P<0.05)and two weeks(9.1%vs.12.1%in the control group,P<0.05).After two weeks of intervention,attitude scores(90.64±8.31 vs.87.20±8.15,P<0.05),subjective norm scores(88.07±24.65 vs.79.42±19.47,P<0.05)and behavior control scores in the intervention group were significantly higher than those in the control group.After one month of intervention,attitude scores(90.34±10.35 vs.84.22±10.51,P<0.05)and behavior control scores(43.13±5.02 vs.39.15±4.69,P<0.05)in the intervention group were significantly higher than those in the control group,which resulted in the higher breastfeeding intention in the intervention group.Conclusion:This study indicated that the TPB-based interventions effectively improved women's breastfeeding behaviors after C-sections.

The effect of a urinary incontinence selfmanagement program for older women in South Korea:A pilot study

Background:Although self-management approaches have shown strong evidence of positive outcomes for urinary incontinence prevention and management,few programs have been developed for Korean rural communities.Objectives:This pilot study aimed to develop,implement,and evaluate a urinary incontinence self-management program for community-dwelling women aged 55 and older with urinary incontinence in rural South Korea.Methods:This study used a one-group pre-post-test design to measure the effects of the intervention using standardized urinary incontinence symptom,knowledge,and attitude measures.Seventeen community-dwelling older women completed weekly 90-min group sessions for 5 weeks.Descriptive statistics and paired t-tests and were used to analyze data.Results:The mean of the overall interference on daily life from urine leakage(pre-test:M=5.76±2.68,post-test:M=2.29±1.93,t=4.609,p<0.001)and the sum of International Consultation on Incontinence Questionnaire scores(pre-test:M=11.59±3.00,post-test:M=5.29±3.02,t=-5.881,p<0.001)indicated significant improvement after the intervention.Improvement was also noted on the mean knowledge(pre-test:M=19.07±3.34,post-test:M=23.15±2.60,t=7.550,p<0.001)and attitude scores(pre-test:M=2.64±0.19,post-test:M=3.08±0.41,t=5.150,p<0.001).Weekly assignments were completed 82.4%of the time.Participants showed a high satisfaction level(M=26.82±1.74,range 22e28)with the group program.Conclusions:Implementation of a urinary incontinence self-management program was accompanied by improved outcomes for Korean older women living in rural communities who have scarce resources for urinary incontinence management and treatment.Urinary incontinence self-management education approaches have potential for widespread implementation in nursing practice.

Resistance Training in People at Risk of Developing Type 2 Diabetes and Their Experience of Health-Related Quality of Life

Background: Research indicates an association between impaired glucose metabolism and overweight, a serious public health problem involving an increased risk of Type 2 diabetes, related hypertension, and a reduced quality of life. Aim: The first aim is to assess different dimensions of Health-Related Quality of Life (HRQoL) in overweight individuals at risk of developing Type 2 diabetes compared to a normal population. The second aim is to examine the impact of resistance training on the pre-post HRQoL dimension scores of the intervention group. Methods: Eighteen participants were randomly assigned to one of the two resistance training groups. Group 1 engaged in supervised maximal resistance training (Bernstein inverted pyramid system: 5× 3 - 4, 60% - 85% of 1 Repetition Maximum (RM)), three days/week over four months, and Group 2 performed endurance resistance training (including lower weight loads and more repetitions over four months). The intervention consisted of eight exercises involving the entire body. The subjects completed the Short-Form Health Survey (SF-36) on HRQoL. The HRQoL scores of the norm population were higher than those of people at risk of developing Type 2 diabetes, and resistance training seemed to have a limited significant positive effect on the different HRQoL dimensions.

COVID-19 Lockdown in India: An Experimental Study on Promoting Mental Wellness Using a Chatbot during the Coronavirus

India imposed the largest lockdown in the world in response tofight the spread of the Novel Coronavirus disease(COVID-19)from 19 March till 31 May 2020.The onset of the pandemic left the general public feeling psycho-socially distressed,helpless,and anxious.The researcher developed a Messenger supported Chatbot,based on the broaden and build model,to cater to the healthy general public to promote positivity and mental well-being.31 participants between 22 and 45 years old consensually took a pre-test,Chatbot intervention,and post-test.The Chatbot provided guided activities out of which positive affirmations,meditation,and exercises were mostly used.The qualitative data from the study shows that the majority of the participants strongly feel positivity is within themselves and that the tool provided a self-help approach to be me well,mentally during the lockdown.The intervention helped significantly reducing symptoms of psychosocial distress in six of the individual’s post-chatbot interventions.Participants’impressions of the tool suggest more preponderant opportunities for future research in technology-driven mental health support.

Motor-Cognitive Intervention in Mexican Older Adults

Two motor-cognitive interventions were implemented to evaluate their efficacy in cognitive improvement in Mexican older adults 65 years and more. The intervention group received a dance video games plus a cognitive task (dual-task);the comparison group received only the dance video game, in sessions of 45 minutes, 3 times a week, for 12 weeks. The Barthel Index and Lawton and Brody Index, the Center for Epidemiologic Studies Depression Scale-Revised were applied the Digit Span Test, the Stroop Test, and Color Trail Making. Gait parameters were assessed by GAITRite? electronic walkway (CIR Systems). The design was quasi-experimental. Sites were randomly assigned to intervention groups. The intervention group started with 32 participants and finished with 15;the comparison group started with 20 participants and finished with 18. Participants in the intervention group had to mimic the dance movement of a video game and, after the second week to name progressively three objects without stopping dancing. A multivariate repeated measures model (MANO-VA) was fit with four variables. A time-by-group interaction was observed in the Stroop test, and Digits Span Backwards was in favor of the dual task group. The Stroop test, Digit Span Backwards, gait speed, and step length showed effect time. Both groups improved in gait speed and step length by the end of the intervention. Results show it is feasible for Mexican older adults with little schooling to perform dual tasks and improve cognitive tasks and gait speed. Limitations were high attrition due to unforeseen situations and small sample size.

Impact of nutritional education on knowledge,attitude and practice regarding anemia among school children in Belgaum,India

Background:Anemia is a common public health problem throughout the globe with its main effect not only on health of people but also impact on socioeconomic development.A high prevalence of anemia among school children is an indication of a severe problem highlighting the necessity of proper action to prevent further deterioration.This study sought to study the impact of nutritional education on knowledge,attitude,and practice regarding anemia among school children.Methods:This is an interventional study among school children of Kendriye Vidyalaya,No.2 Belgaum district,India.Structured and self-administered questionnaires were used to know the knowledge,attitude and practice of student anemia.The data were analyzed using paired t-test and McNemar test.Results:There was significant increment in the mean knowledge and attitude scores of the school children at the post-test evaluation.Overall increase of 51.2%in mean score of knowledge and overall increase of 20.7%in mean score of attitudes was found(P<0.05).Increase in frequency of consumption pattern of iron rich foods especially ragi,jaggery,green leafy vegetables and sprouted grains was reported.Conclusion:The nutritional education resulted in improvement of knowledge and change in attitude regarding anemia as well as increase in consumption of foods rich in Iron.Therefore,nutritional education is one of the cost-effective and sustainable method for lowering the cases of anemia.

Health Promotion to Patients with Pelvic Floor Dysfunction: An Integrative Review

Introduction and Hypothesis: The Pelvic Floor Dysfunction (PFD) is a common gynecological condition that causes significant morbidity in the affected population, increasing clinical and financial challenge for the Public Health Services. Methods: This study aimed to review the available evidence and interventions to promote the health of women with PFD. We used the following databases to select papers for this review: Scopus, PubMed, CINAHL, LILACS and Cochrane. The sample consists of seven articles, with evidence levels 1 and 2. Results: The results of the articles point out to a greater number of activities related to the management of Urinary Incontinence (UI) behavioral support to the patient and physical therapy of the pelvic floor muscles. They were both beneficial to UI prevention and treatment. Conclusions: The physical therapy approach, when associated with cognitive and behavioral strategies, leverages UI outcomes in patients.

The effect of sustained, long-term changes in alcohol intake on cardiovascular risk

Objective: To investigate whether sustained long-term changes in alcohol intake are predictive of cardiovascular risk. Methods: The study population was a subpopulation of the five-year intervention study, Inter99 study, (1999-2006), Copenhagen, Denmark (n = 2117;30 - 60 years). Alcohol intake was assessed by questionnaires at baseline, one-, three- and five-year follow-up. The associations between sustained long-term changes in alcohol intake and cardiovascular risk factors (HDL and non-HDL cholesterol, systolic and diastolic blood pressure (BP);the absolute risk of ischemic heart disease (CRS)) at five-year follow-up were explored by linear regression models. The alcohol variables were tested for linear association with the response variable. Results: Sustained increased alcohol intake was significantly associated with increased CRS (β = 0.0028;P = 0.006) and a decreased HDL cholesterol (β = -0.0028;P = 0.005). Among participants with a moderate overall alcohol in-take at baseline increased alcohol intake was significantly associated with an increased plasma triglyceride (β = 0.0069;P = 0.04). No association with triglyceride was found for participants with a high alcohol intake. Change in wine intake was significantly negatively associated with changes in diastolic BP (β = 0.0015;P = 0.02). Conclusions: Sustained increase in the long-term intake of alcohol was a significant risk factor for an increased CRS, increased triglyceride level and decreased HDL cholesterol. Increased wine intake was associated with decreased diastolic BP.

An intervention study to prevent gastric cancer by micro-selenium and large dose of allitridum

Background People have more and more concerned about allitridum as studies have shown that taking more raw garlic associated with a lower risk for cancers of the alimentary system In the present study, we tried to examine whether a large dose of allitridum and a microdose of selenium prevent gastric cancer Methods A double-blind intervention study was performed on the participants aged (35-74) years, who had matched at least one of the following criteria: (1) a medical history of stomach disorder, (2) a family history of tumour, or (3) smoking and/or alcohol consumption A total of 2526 and 2507 persons were randomly enrolled into intervention group and control group respectively from 288 natural villages of seven communities in Qixia County, Shandong Province, China Each person of the intervention group orally took 200 mg synthetic allitridum every day and 100 μg selenium every other day for one month of each year during November 1989 to December 1991. At the same time, people in control group were given 2 placebo capsules containing corn oid with the identical appearance to that in the intervention group Results For all subjects the large dose of allitridum was accepted and no harmful side effects were found during the study In the first follow-up five years (1992-1997) after stopping the intervention, the morbidity rates of malignant tumours in the intervention group declined by 22%, in contrast to the control group, declined by 47 3% After adjusting for age, gender, and other potential confounders, relative risks (RRs) for all tumours and gastric cancer of the whole population were 0 67 (95%CL: 0 43-1 03) and 0 48 (95%CL: 0 21-1 06), respectively, and for male group they were 0 51 (95%CL: 0 30-0 85) and 0 36 (95%CL: 0 14-0 92), respectively. No signigicantly protective effect was found for the female subgroup DConclusion The present study proves that large doses of allitridum and microdorse of selenium may effectively prevent gastric cancer ,especially in men.

Integrated treatment for lower-limb stage Ⅱ thromboangiitis obliterans by interventional therapy and oral administration of Chinese medicine: a randomized controlled clinical trial

OBJECTIVE： To observe if integrated treatment is better than other therapies for lower-limb stage Ⅱ thromboangiitis obliterans （TAO）. METHODS： Ninety lower-limb stage Ⅱ or worse TAO patients were randomly divided into three groups： group A （30 cases） treated by intervention and oral administration of Chinese medicine; group B （30 cases） treated by intervention alone; and group C （30 cases） treated only with oral adminis- tration of Chinese medicine. Therapeutic effects were observed, including the cure rate; the recurrence rate after one month, three months, six months, nine months, and one year; the ankle brachial indexes; the incidence of complications; and the level of C-reactive protein and erythrocyte sedimentation rate.RESULTS： Group A had significantly better clinically curative effects, related indexes, and outcomes during the long-term follow-up survey, than that of groups B and C. CONCLUSION： Integrated treatment is more effective for treating lower-limb stage Ⅱ or worseTAO.

Analysis of Interventional Clinical Research Protocols Related to Coronavirus Disease 2019 and Future Expectations

Coronavirus disease 2019(COVID-19)is a newly emerging infectious disease.After its outbreak,researchers started a large number of clinical interventional studies,using a variety of interventions to study the different types of COVID-19 cases.In this article,we searched the websites of Chinese Clinical Trial Registry,Clinical Trials.gov,etc.,to study the publicly registered research information.Through the classification and summary of interventional methods,evaluation indicators,research design,etc.,this article provided readers with the outline of clinical research about COVID-19,and looked forward to the scientificity,feasibility,and future evidence of the clinical researches.

Initial experience of occluding special type patent ductus arterioses using the Amplatzer vascular plug

Background Occluders licensed for clinical use are not fit for some special Krichenko E patent ductus arterioses. The Amplatzer vascular plug I （AVP1） has not been licensed for use for closure of patent ductus arteriose. We report our initial experience to occluding special type patent ductus arterioses with the AVPI-a single lobe device of single layer Nitinol mesh for short vessel landing zones. Methods Patients referred with small and long Krichenko E patent ductus arterioses 1 mm to 3 mm in diameter underwent occlusion using AVPI. All cases underwent pre-, intra- and post-procedural echocardiography and chest X-ray at the completion of the procedure, the next day and at a 30-day, 3-month and 6-month follow-up visits. Device sizing for device waist diameter and length was based on aortography. Results From April 2008 to June 2012, 26 patients with a mean age of （7.6±8.0） years （range 6 months-32 years） and a mean weight of （23.8±14.8） kg （range 7-67 kg） underwent successful patent ductus arteriose closure. The mean ductus diameter was （2.1±0.7） mm （range 1-3 mm）. Transpulmonary （22/26） and transaortic approaches （4/26） were used. No persistent patency was observed after 24 hours and after one month. No device displacement, residual flow and iatrogenic coarctation of the aorta were observed after three months and six months. Conclusions The AVP1 makes it easy to close some Krichenko E patent ductus arterioses. Smaller delivery catheter profile and symmetric cylindrical device shape allow for use for small and long Krichenko E patent ductus arterioses 1 mm to 3 mm in diameter and small patients through transaortic approaches. Broader experience is required to further delineate device and patient selection as well as to document its long-term efficacy and safety.

Swine model of arterial bifurcation aneurysm

Objective To create an arterial bifurcation aneurysm model in swine and evaluate it with digital subtraction angiography (DSA).Methods Ten swine were used for constructing the arterial bifurcation aneurysm models. Seven pigs underwent subsequent intraarterial DSA. Both surgical procedure and transarterial angiography were carried out under anesthesia with mechanical ventilation after tracheal intubation.Results Bifurcation aneurysms were surgically created in ten animals. After surgical procedure, 2 pigs died from aneurysmal rupture and one died of anesthetic overdose. DSA was performed in all other 7 animals and it demonstrated 6 patent aneurysms and one occluded. Three of the 6 patent bifurcation aneurysms were wide necked and 3 were narrow necked.Conclusion Arterial bifurcation aneurysm model can be successfully constructed in swine. It will provide us with an in vivo model to observe and develop therapeutic devices, teach endovascular techniques, and study aneurysmal hemodynamics.