scholarly journals The case for randomized controlled trials to assess the impact of clinical information systems

2011 ◽  
Vol 18 (2) ◽  
pp. 173-180 ◽  
Author(s):  
J. L. Y. Liu ◽  
J. C. Wyatt
Author(s):  
Manon Egnell ◽  
Pilar Galan ◽  
Morgane Fialon ◽  
Mathilde Touvier ◽  
Sandrine Péneau ◽  
...  

Abstract Background The Nutri-Score summary graded front-of-pack nutrition label has been identified as an efficient tool to increase the nutritional quality of pre-packed food purchases. However, no study has been conducted to investigate the effect of the Nutri-Score on the shopping cart composition, considering the type of foods. The present paper aims to investigate the effect of the Nutri-Score on the type of food purchases, in terms of the relative contribution of unpacked and pre-packed foods, or the processing degree of foods. Methods Between September 2016 and April 2017, three consecutive randomized controlled trials were conducted in three specific populations – students (N = 1866), low-income individuals (N = 336) and subjects suffering from cardiometabolic diseases (N = 1180) – to investigate the effect of the Nutri-Score on purchasing intentions compared to the Reference Intakes and no label. Using these combined data, the proportion of unpacked products in the shopping carts, as well as the distribution of products across food categories taking into account the degree of processing (NOVA classification) were assessed by trials arm. Results The shopping carts of participants simulating purchases with the Nutri-Score affixed on pre-packed foods contained higher proportion of unpacked products – especially raw fruits and meats, i.e. with no FoPL –, compared to participants purchasing with no label (difference of 5.93 percentage points [3.88–7.99], p-value< 0.0001) or with the Reference Intakes (difference of 5.27[3.25–7.29], p-value< 0.0001). This higher proportion was partly explained by fewer purchases of pre-packed processed and ultra-processed products overall in the Nutri-Score group. Conclusions These findings provide new insights on the positive effect of the Nutri-Score, which appears to decrease purchases in processed products resulting in higher proportions of unprocessed and unpacked foods, in line with public health recommendations.


2015 ◽  
Vol 8 (8) ◽  
pp. 74 ◽  
Author(s):  
Maryam Kardan-Souraki ◽  
Zeinab Hamzehgardeshi ◽  
Ismail Asadpour ◽  
Reza Ali Mohammadpour ◽  
Soghra Khani

<p><strong>BACKGROUND:</strong> Lack of intimacy is currently the main concern rather than main concern of the experts in psychology and counseling. It is considered as one of the most important causes for divorce and as such to improve marital intimacy a great number of interventions have been proposed in the literature. Intimacy training and counseling make the couples take effective and successful steps to increase marital intimacy. No study has reviewed the interventions promoting marital intimacy after marriage. Thus, this review study aimed to classify the articles investigating the impact of interventional programs on marital intimacy after marriage.</p><p><strong>SEARCH METHODS:</strong> In April 2015, we performed a general search in Google Scholar search engines, and then we did an advanced search the databases of Science Direct, ProQuest, SID, Magiran, Irandoc, Pubmed, Scopus, <a href="http://www.cochranelibrary.com/">Cochrane Library</a>, and Psych info; Cumulative Index to Nursing and Allied Health Literature (CINAHL). Also, lists of the references of the relevant articles were reviewed for additional citations. Using Medical Subject Headings (MESH) keywords: Intervention (Clinical Trials, Non-Randomized Controlled Trials, Randomized Controlled Trials, Education), intimacy, marital (Marriage) and selected related articles to the study objective were from 1995 to April 2015. Clinical trials that evaluated one or more behavioral interventions to improve marital intimacy were reviewed in the study.</p><p><strong>MAIN RESULTS:</strong> 39 trials met the inclusion criteria. Eleven interventions had follow-up, and 28 interventions lacked follow-up. The quality evidence for 22 interventions was low, for 15 interventions moderate, and for one intervention was considered high. Findings from studies were categorized in 11 categories as the intimacy promoting interventions in dimensions of emotional, psychological, physical, sexual, temporal, communicational, social and recreational, aesthetic, spiritual, intellectual intimacy, and total intimacy.</p><p><strong>AUTHORS’ CONCLUSIONS:</strong> Improving and promoting communication, problem solving, self-disclosure and empathic response skills and sexual education and counseling in the form of cognitive-behavioral techniques and based on religious and cultural context of each society, an effective step can be taken to enhance marital intimacy and strengthen family bonds and stability. Health care providers should consider which interventions are appropriate to the couple characteristics and their relationships.</p>


2021 ◽  
Vol 12 ◽  
Author(s):  
Dana Abdelrahim ◽  
MoezAlIslam E. Faris ◽  
Mohamed Hassanein ◽  
Ayman Z. Shakir ◽  
Ayesha M. Yusuf ◽  
...  

Ramadan is the 9th month of the lunar calendar during which Muslims abstain from food and drink between dawn and sunset for 30 consecutive days. Ramadan fasting is observed by all healthy Muslim adults, as well many Muslims with type 2 diabetes (T2DM). Hypoglycemic events (HE) are a serious complication associated with diabetes management and are associated with increased cardiovascular disease risk. Conflicting results have been reported concerning the incidence of HE among people with T2DM observing Ramadan fasting. This review summarizes available scientific evidence on the occurrence of HE and the effects of different moderators on the incidence of HE among patients with T2DM during Ramadan. We conducted a systematic review of available observational studies and randomized controlled trials (RCTs) for patients with T2DM who fasted during Ramadan, with HE as the primary outcome. Ten databases were searched for relevant studies from inception until October 31, 2020. In total, 68 studies (35 RCTs and 33 observational studies) met the inclusion criteria. Non-sulfonylureas hypoglycemic medications showed superior effects in lowering the incidence of HE over sulfonylureas hypoglycemic medications. Variable moderators were associated with experiencing HE during Ramadan in both observational studies and RCTs, including sex, geographical location, body anthropometric indicators, season, dietary behaviors, fasting duration, time since diagnosis, and pre-fasting education. This comprehensive systematic review covered the largest number of observational and clinical studies investigating the impact of Ramadan on HE among patients with T2DM. The study highlights the significance of different moderators that influence the effect of Ramadan fasting on HE, including dietary behaviors, fasting time duration, sex, season, country, pre-fasting education, age, and time since diagnosis. The study also highlighted the impact of different hypoglycemic medications on HE and noted the superiority of non-sulfonylureas over sulfonylureas hypoglycemic medications in lowering the risk for hypoglycemia in people with T2DM during Ramadan fasting.


Cartilage ◽  
2020 ◽  
pp. 194760352090659 ◽  
Author(s):  
Davide Previtali ◽  
Giulia Merli ◽  
Giorgio Di Laura Frattura ◽  
Christian Candrian ◽  
Stefano Zaffagnini ◽  
...  

Objectives To quantify the placebo effect of intraarticular injections for knee osteoarthritis in terms of pain, function, and objective outcomes. Factors influencing placebo effect were investigated. Design Meta-analysis of randomized controlled trials; Level of evidence, 2. PubMed, Web of Science, Cochrane Library, and grey literature databases were searched on January 8, 2020, using the string: (knee) AND (osteoarthritis OR OA) AND (injections OR intra-articular) AND (saline OR placebo). The following inclusion criteria were used: double-blind, randomized controlled trials on knee osteoarthritis, including a placebo arm on saline injections. The primary outcome was pain variation. Risk of bias was assessed using the RoB 2.0 tool, and quality of evidence was graded following the GRADE (Grading of Recommendations Assessment, Development and Evaluation) guidelines. Results Out of 2,363 records, 50 articles on 4,076 patients were included. The meta-analysis showed significant improvements up to the 6-month follow-up: Visual Analogue Scale (VAS)-pain −13.4 mean difference (MD) (95% confidence interval [CI]: −21.7/−5.1; P < 0.001), Western Ontario and McMaster Osteoarthritis Index (WOMAC)-pain −3.3 MD (95% CI: −3.9/−2.7; P < 0.001). Other significant improvements were WOMAC-stiffness −1.1 MD (95% CI: −1.6/−0.6; P < 0.001), WOMAC-function −10.1 MD (95% CI: −12.2/−8.0; P < 0.001), and Evaluator Global Assessment −21.4 MD (95% CI: −29.2/−13.6; P < 0.001). The responder rate was 52% (95% CI: 40% to 63%). Improvements were greater than the “minimal clinically important difference” for all outcomes (except 6-month VAS-pain). The level of evidence was moderate for almost all outcomes. Conclusions The placebo effect of knee injections is significant, with functional improvements lasting even longer than those reported for pain perception. The high, long-lasting, and heterogeneous effects on the scales commonly used in clinical trials further highlight that the impact of placebo should not be overlooked in the research on and management of knee osteoarthritis.


Nutrients ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 2520 ◽  
Author(s):  
Christine Tørris ◽  
Hilde Mobekk

Obesity and metabolic syndrome are considered major public health problems, and their negative impact on cardiovascular disease (CVD) and diabetes mellitus type 2 (DM2) is profound. Targeting modifiable risk factors such as dietary habits is therefore of great importance. Many of today’s health challenges with overweight and obesity may have behavioral roots, and traditional methods such as regulations and campaigns are often insufficient to improve dietary choices. Nudging or choice architecture might be a viable tool to influence people’s everyday choices and behaviors to better outcomes. This paper reviews the current state of the rapidly expanding number of experimental field studies that investigate the effects/associations of nudging on healthy food choices. A systematic literature search was conducted in PubMed, where 142 citations were identified. Based on selection criteria, six randomized controlled trials and 15 non-randomized controlled trials were ultimately included. The results of this systematic review show that many of the studies included traffic-light labeling, which may be a promising strategy. The reviewed findings, however, also highlight the challenges that confront experimental studies examining the impact of nudging on diet.


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