Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions. We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator. We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.

Objective: To examine the effectiveness of behavioural weight management interventions for adults with obesity delivered in primary care.Design: Systematic review and meta-analysis of randomised controlled trials.Eligibility criteria for selection of studies: Randomised controlled trials of behavioural weight management interventions for adults with a body mass index ≥25 delivered in primary care compared with no treatment, attention control, or minimal intervention and weight change at ≥12 months follow-up.Data sources: Trials from a previous systematic review were extracted and the search completed using the Cochrane Central Register of Controlled Trials, Medline, PubMed, and PsychINFO from 1 January 2018 to 19 August 2021.Data extraction and synthesis: Two reviewers independently identified eligible studies, extracted data, and assessed risk of bias using the Cochrane risk of bias tool. Meta-analyses were conducted with random effects models, and a pooled mean difference for both weight (kg) and waist circumference (cm) were calculated.Main outcome measures: Primary outcome was weight change from baseline to 12 months. Secondary outcome was weight change from baseline to ≥24 months. Change in waist circumference was assessed at 12 months.Results: 34 trials were included: 14 were additional, from a previous review. 27 trials (n=8000) were included in the primary outcome of weight change at 12 month follow-up. The mean difference between the intervention and comparator groups at 12 months was −2.3 kg (95% confidence interval −3.0 to −1.6 kg, I²=88%, P<0.001), favouring the intervention group. At ≥24 months (13 trials, n=5011) the mean difference in weight change was −1.8 kg (−2.8 to −0.8 kg, I²=88%, P<0.001) favouring the intervention. The mean difference in waist circumference (18 trials, n=5288) was −2.5 cm (−3.2 to −1.8 cm, I²=69%, P<0.001) in favour of the intervention at 12 months.Conclusions: Behavioural weight management interventions for adults with obesity delivered in primary care are effective for weight loss and could be offered to members of the public.Systematic review registration: PROSPERO CRD42021275529.

Practitioners who deliver enhanced empathy may improve patient satisfaction with care. Patient satisfaction is associated with positive patient outcomes ranging from medication adherence to survival. To evaluate the effect of health care practitioner empathy on patient satisfaction, using a systematic review of randomized trials. Ovid MEDLINE, CINAHL, PsycInfo, Cochrane Central Register of Controlled Trials, and Scopus to 23 October 2023. Randomized trials published in any language that evaluated the effect of empathy on improving patient satisfaction as measured on a validated patient satisfaction scale. Data extraction, risk-of-bias assessments, and strength-of-evidence assessments were done by 2 independent reviewers. Disagreements were resolved through consensus. Fourteen eligible randomized trials (80 practitioners; 1986 patients) were included in the analysis. Five studies had high risk of bias, and 9 had some concerns about bias. The trials were heterogeneous in terms of geographic locations (North America, Europe, Asia, and Africa), settings (hospital and primary care), practitioner types (family and hospital physicians, anesthesiologists, nurses, psychologists, and caregivers), and type of randomization (individual patient or clustered by practitioner). Although all trials suggested a positive change in patient satisfaction, inadequate reporting hindered the ability to draw definitive conclusions about the overall effect size. Heterogeneity in the way that empathy was delivered and patient satisfaction was measured and incomplete reporting leading to concerns about the certainty of the underpinning evidence. Various empathy interventions have been studied to improve patient satisfaction. Development, testing, and reporting of high-quality studies within well-defined contexts is needed to optimize empathy interventions that increase patient satisfaction. Stoneygate Trust. (PROSPERO: CRD42023412981).

Context: The impact of unhealthy foods and beverages, namely those high in sugar, salt, and saturated or trans fats, has been studied extensively in relation to weight, body composition, and noncommunicable diseases, but less so in relation to the risk of dental caries. Few previous reviews have examined the evidence from all countries globally. Objective: A systematic review was conducted to assess the impact of unhealthy food and beverage consumption on the risk of dental caries in children aged ≤10 years, commissioned by the World Health Organization to inform updated complementary feeding recommendations. Data Sources: Systematic searches were conducted in the PubMed, Cochrane, and Embase databases for articles meeting the inclusion criteria dating from January 1971 to March 2022; supplementary searches were undertaken for articles from that period to June 2022. Data Extraction: Unhealthy foods and beverages were identified using nutrient- and food-based approaches. Risk of bias was assessed using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I). Data Analysis: A total of 30 023 unique citations were screened, yielding 37 studies for inclusion. Studies were conducted in high-income (n = 23 [62.2%]) or middle-income countries (n = 14 [37.8%]). Evidence synthesis was performed narratively, stratified by age (0 years to <2 years, 2 years to 5 years at baseline, are recommended in order to build a more robust evidence base for use in the development of policy recommendations. Systematic Review Registration: PROSPERO registration no. CRD42020218109.

Evidence about the health effects of weight cycling is not consistent, with some studies suggesting it is harmful for health. Here we investigated whether weight cycling was associated with weight change and mental health outcomes in 10,428 participants in the mid-age cohort of The Australian Longitudinal Study of Women's Health (ALSWH) over 12years. In 1998 the women were asked how many times they had ever intentionally lost at least 5kg and how many times had they regained this amount. Women were categorised into four weight pattern groups: frequent weight cyclers (FWC, three or more weight cycles), low frequency weight cyclers (LFWC, one or two weight cycles), non-weight cyclers (NWC), and weight loss only (WL). We used generalised linear modelling to investigate relationships between weight pattern group, weight change and mental health outcomes. In 1998, 15% of the women were FWC, 24% LFWC, 46% NWC and 15% were WL. Weight change was similar across weight pattern groups in women with obesity, however healthy weight and overweight FWC gained more weight than women who did not weight cycle. We found no difference in overall mental health scores between groups, but both LFWC and FWC had higher odds of depressive symptoms (adjusted OR 1.5, 95%CI: 1.1 to 1.9 and 1.7, 95%CI: 1.1 to 2.4, respectively) than NWC. Our results suggest that, although weight cycling is not associated with greater weight gain in women with obesity, it may increase depressive symptoms.