Health and nutrition claims for infant formula: international cross sectional survey.

OBJECTIVES: To review available health and nutrition claims for infant formula products in multiple countries and to evaluate the validity of the evidence used for substantiation of claims. DESIGN: International cross sectional survey. SETTING: Public facing and healthcare professional facing company owned or company managed formula industry websites providing information about products marketed for healthy infants delivered at full term in 15 countries: Australia, Canada, Germany, India, Italy, Japan, Nigeria, Norway, Pakistan, Russia, Saudi Arabia, South Africa, Spain, the United Kingdom, and the United States in 2020-22. MAIN OUTCOME MEASURES: Number and type of claims made for each product and ingredient. References cited were reviewed and risk of bias was assessed for registered clinical trials using the Cochrane risk of bias tool, and for systematic reviews using the Risk Of Bias in Systematic reviews tool. RESULTS: 757 infant formula products were identified, each with a median of two claims (range from 1 (Australia) to 4 (US)), and 31 types of claims across all products. Of 608 products with ≥1 claims, the most common claim types were "helps/supports development of brain and/or eyes and/or nervous system" (323 (53%) products, 13 ingredients), "strengthens/supports a healthy immune system" (239 (39%) products, 12 ingredients), and "helps/supports growth and development" (224 (37%) products, 20 ingredients). 41 groups of ingredients were associated with ≥1claims, but many claims were made without reference to a specific ingredient (307 (50%) products). The most common groups of ingredients cited in claims were long chain polyunsaturated fatty acids (278 (46%) products, 9 different claims); prebiotics, probiotics, or synbiotics (225 (37%) products, 19 claims); and hydrolysed protein (120 (20%) products, 9 claims). 161/608 (26%) products with ≥1 claims provided a scientific reference to support the claim-266 unique references were cited for 24 different claim types for 161 products. The reference types most frequently cited were clinical trials (50%, 134/266) and reviews (20%, 52/266). 28% (38/134) of referenced clinical trials were registered, 14% (19/134) prospectively. 58 claims referred to 32 registered clinical trials, of which 51 claims (27 trials) related to a randomised comparison. 46 of 51 claims (90%) referenced registered clinical trial outcomes at high risk of bias, and all cited systematic reviews and pooled analyses, carried a high risk of bias. CONCLUSIONS: Most infant formula products had at least one health and nutrition claim. Multiple ingredients were claimed to achieve similar health or nutrition effects, multiple claims were made for the same ingredient type, most products did not provide scientific references to support claims, and referenced claims were not supported by robust clinical trial evidence.

Optimising risk factors for atrial fibrillation post-cardiac surgery.

Postoperative atrial fibrillation (POAF) is an ongoing complication following cardiac surgery, with an incidence of 15%-60%. It is associated with substantial mortality and morbidity, as well increased hospital stays and healthcare costs. The pathogenesis is not fully understood, but the literature suggests that POAF occurs when transient, postoperative triggers act on vulnerable atrial tissue produced by preoperative, procedure-induced and postoperative processes such as inflammation, oxidative stress, autonomic dysfunction and electrophysiological remodelling of the atrial tissues. This sets the stage for arrhythmogenic mechanisms, such as ectopic firing secondary to triggered activity and re-entry mechanisms generating POAF. Preoperative factors include advanced age, sex, ethnicity, cardiovascular risk factors, preoperative drugs, electrocardiogram and echocardiogram abnormalities. Procedural factors include: the use of cardiopulmonary bypass and aortic cross clamp, type of cardiac surgery, use of hypothermia, left ventricular venting, bicaval cannulation and exclusion of the left atrial appendage. Postoperative factors include postoperative drugs, electrolyte and fluid balance and infection. This review explores the pathogenesis of POAF and the contribution of these perioperative factors in the development of POAF. Patients can be risk stratified for targeted treatment and prophylaxis, and how these factors can be attenuated to improve POAF outcomes following cardiac surgery.

Effect of Religious Fasting in Ramadan on Blood Pressure: Results From LORANS (London Ramadan Study) and a Meta-Analysis.

Background Ramadan fasting is practiced by hundreds of millions every year. This ritual practice changes diet and lifestyle dramatically; thus, the effect of Ramadan fasting on blood pressure must be determined. Methods and Results LORANS (London Ramadan Study) is an observational study, systematic review, and meta-analysis. In LORANS, we measured systolic blood pressure (SBP) and diastolic blood pressure (DBP) of 85 participants before and right after Ramadan. In the systematic review, studies were retrieved from PubMed, Embase, and Scopus from inception to March 3, 2020. We meta-analyzed the effect from these studies and unpublished data from LORANS. We included observational studies that measured SBP and/or DBP before Ramadan and during the last 2 weeks of Ramadan or the first 2 weeks of the month after. Data appraisal and extraction were conducted by at least 2 reviewers in parallel. We pooled SBP and DBP using a random-effects model. The systematic review is registered with PROSPERO (International Prospective Register of Systematic Reviews; CRD42019159477). In LORANS, 85 participants were recruited; mean age was 45.6±15.9 years, and 52.9% (n=45) of participants were men. SBP and DBP after Ramadan fasting were lower by 7.29 mm Hg (-4.74 to -9.84) and 3.42 mm Hg (-1.73 to -5.09), even after adjustment for potential confounders. We identified 2778 studies of which 33 with 3213 participants were included. SBP and DBP after/before Ramadan were lower by 3.19 mm Hg (-4.43 to -1.96, I2=48%) and 2.26 mm Hg (-3.19 to -1.34, I2=66%), respectively. In subgroup analyses, lower blood pressures were observed in the groups who are healthy or have hypertension or diabetes but not in patients with chronic kidney disease. Conclusions Our study suggests beneficial effects of Ramadan fasting on blood pressure independent of changes in weight, total body water, and fat mass and supports recommendations for some governmental guidelines that describe Ramadan fasting as a safe religious practice with respect to blood pressure.

What drives general practitioners in the UK to improve the quality of care? A systematic literature review.

BACKGROUND: In the UK, the National Health Service has various incentivisation schemes in place to improve the provision of high-quality care. The Quality Outcomes Framework (QOF) and other Pay for Performance (P4P) schemes are incentive frameworks that focus on meeting predetermined clinical outcomes. However, the ability of these schemes to meet their aims is debated. OBJECTIVES: (1) To explore current incentive schemes available in general practice in the UK, their impact and effectiveness in improving quality of care and (2) To identify other types of incentives discussed in the literature. METHODS: This systematic literature review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Six databases were searched: Cochrane, PubMed, National Institute for Health and Care Excellence Evidence, Health Management Information Consortium, Embase and Health Management. Articles were screened according to the selection criteria, evaluated against critical appraisal checklists and categorised into themes. RESULTS: 35 articles were included from an initial search result of 22087. Articles were categorised into the following three overarching themes: financial incentives, non-financial incentives and competition. DISCUSSION: The majority of the literature focused on QOF. Its positive effects included reduced mortality rates, better data recording and improved sociodemographic inequalities. However, limitations involved decreased quality of care in non-incentivised activities, poor patient experiences due to tick-box exercises and increased pressure to meet non-specific targets. Findings surrounding competition were mixed, with limited evidence found on the use of non-financial incentives in primary care. CONCLUSION: Current research looks extensively into financial incentives, however, we propose more research into the effects of intrinsic motivation alongside existing P4P schemes to enhance motivation and improve quality of care.

Intermittent fasting for the prevention of cardiovascular disease.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death worldwide. Lifestyle changes are at the forefront of preventing the disease. This includes advice such as increasing physical activity and having a healthy balanced diet to reduce risk factors. Intermittent fasting (IF) is a popular dietary plan involving restricting caloric intake to certain days in the week such as alternate day fasting and periodic fasting, and restricting intake to a number of hours in a given day, otherwise known as time-restricted feeding. IF is being researched for its benefits and many randomised controlled trials have looked at its benefits in preventing CVD. OBJECTIVES: To determine the role of IF in preventing and reducing the risk of CVD in people with or without prior documented CVD. SEARCH METHODS: We conducted our search on 12 December 2019; we searched CENTRAL, MEDLINE and Embase. We also searched three trials registers and searched the reference lists of included papers. Systematic reviews were also viewed for additional studies. There was no language restriction applied. SELECTION CRITERIA: We included randomised controlled trials comparing IF to ad libitum feeding (eating at any time with no specific caloric restriction) or continuous energy restriction (CER). Participants had to be over the age of 18 and included those with and without cardiometabolic risk factors. Intermittent fasting was categorised into alternate-day fasting, modified alternate-day fasting, periodic fasting and time-restricted feeding. DATA COLLECTION AND ANALYSIS: Five review authors independently selected studies for inclusion and extraction. Primary outcomes included all-cause mortality, cardiovascular mortality, stroke, myocardial infarction, and heart failure. Secondary outcomes include the absolute change in body weight, and glucose. Furthermore, side effects such as headaches and changes to the quality of life were also noted. For continuous data, pooled mean differences (MD) (with 95% confidence intervals (CIs)) were calculated. We contacted trial authors to obtain missing data. We used GRADE to assess the certainty of the evidence.  MAIN RESULTS: Our search yielded 39,165 records after the removal of duplicates. From this, 26 studies met our criteria, and 18 were included in the pooled analysis. The 18 studies included 1125 participants and observed outcomes ranging from four weeks to six months. No studies included data on all-cause mortality, cardiovascular mortality, stroke, myocardial infarction, and heart failure at any point during follow-up. Of quantitatively analysed data, seven studies compared IF with ab libitum feeding, eight studies compared IF with CER, and three studies compared IF with both ad libitum feeding and CER. Outcomes were reported at short term (≤ 3 months) and medium term (> 3 months to 12 months) follow-up. Body weight was reduced with IF compared to ad libitum feeding in the short term (MD -2.88 kg, 95% CI -3.96 to -1.80; 224 participants; 7 studies; low-certainty evidence). We are uncertain of the effect of IF when compared to CER in the short term (MD -0.88 kg, 95% CI -1.76 to 0.00; 719 participants; 10 studies; very low-certainty evidence) and there may be no effect in the medium term (MD -0.56 kg, 95% CI -1.68 to 0.56; 279 participants; 4 studies; low-certainty evidence). We are uncertain about the effect of IF on glucose when compared to ad libitum feeding in the short term (MD -0.03 mmol/L, 95% CI -0.26 to 0.19; 95 participants; 3 studies; very-low-certainty of evidence) and when compared to CER  in the short term: MD -0.02 mmol/L, 95% CI -0.16 to 0.12; 582 participants; 9 studies; very low-certainty; medium term: MD 0.01, 95% CI -0.10 to 0.11; 279 participants; 4 studies; low-certainty evidence). The changes in body weight and glucose were not deemed to be clinically significant. Four studies reported data on side effects, with some participants complaining of mild headaches. One study reported on the quality of life using the RAND SF-36 score. There was a modest increase in the physical component summary score. AUTHORS' CONCLUSIONS: Intermittent fasting was seen to be superior to ad libitum feeding in reducing weight. However, this was not clinically significant. There was no significant clinical difference between IF and CER in improving cardiometabolic risk factors to reduce the risk of CVD. Further research is needed to understand the safety and risk-benefit analysis of IF in specific patient groups (e.g. patients with diabetes or eating disorders) as well as the effect on longer-term outcomes such as all-cause mortality and myocardial infarction.

Achieving better quality care in general practice: are incentives the answer?

BACKGROUND: The introduction of financial incentives, such as the quality and outcomes framework (QOF), historically lead to improvements in standardising practice. However, with shifting demands on healthcare providers, are these schemes still enough to drive high-quality care? AIM: To explore current incentives, intrinsic and extrinsic, their role and effectiveness in improving quality of care and how they are perceived by GPs. METHOD: Mixed methods study using two systematic literature reviews including 44 papers and 18 semi-structured interviews with GPs. RESULTS: In the literature, QOF was associated with reduced socioeconomic inequalities, decreased mortality and improved outcomes. However, the absence of control groups and the simultaneous analysis of multiple indicators complicates the findings. GPs agreed with the literature and viewed financial incentives as beneficial, however, they felt the key driver in providing good-quality care was their intrinsic motivation. Financial incentives were found to contribute to depersonalised care, diluted provision of non-incentivised activities and hindered overall practice. The results from the second literature review were in keeping with the views of the participants. They illustrated the importance of managing factors contributing to physician burnout, reduced performance, and low job satisfaction, which can result in the provision of low-quality care. CONCLUSION: Financial incentives have the potential to induce behaviour change, however, their use in quality improvement is limited when used alone. If used in an environment that nurtures intrinsic motivation, healthcare providers will be more driven to achieve a higher quality of care and will be better able to cope with shifting demands.