BACKGROUND: Peritoneal dialysis (PD) is a home-based kidney replacement therapy (KRT) performed in people with kidney failure. PD can be performed by manual filling and draining of the abdominal cavity, i.e. continuous ambulatory PD (CAPD), or using a device connected to the PD catheter that is programmed to perform PD exchanges, i.e. automated PD (APD). APD is considered to have several advantages over CAPD, such as a lower incidence of peritonitis, fewer mechanical complications, and greater psychosocial acceptability. Acknowledging the increasing uptake of APD in incident and prevalent patients undergoing PD, it is important to re-evaluate the evidence on the comparative clinical and patient-reported outcomes of APD compared to CAPD. This is an update of a Cochrane review published in 2007.
OBJECTIVE: To compare clinical and patient-reported outcomes of APD to CAPD in people with kidney failure.
METHODS: In this update, we searched the Cochrane Kidney and Transplant Register of Studies until 29 August 2024. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov.
METHODS: Randomised controlled trials (RCTs) comparing APD with CAPD in adults (≥ 18 years) with kidney failure.
METHODS: Two authors independently screened the search results and extracted data. Data synthesis was performed using random-effects meta-analyses, expressing effect estimates as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous data and mean differences (MD) with 95% CIs for continuous data. Certainty in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
RESULTS: Two RCTs (131 randomised people) comparing APD with CAPD were included in this update. One RCT had a follow-up of six months, and one RCT had a follow-up of 24 months. The risk of bias in the included studies was mostly low, except for the high risk of performance bias for subjective outcomes. The evidence is very uncertain about the effect of APD compared to CAPD on death, hospitalisations, PD-related peritonitis, change of dialysis modality, residual kidney function, health-related quality of life (HRQoL), overhydration, blood pressure, exit-site infections, tunnel infections, mechanical complications, PD catheter removal, or dialysis adequacy measures. These results were largely based on low to very low certainty evidence; hence, caution is warranted when drawing conclusions.
CONCLUSIONS: Insufficient evidence exists to decide between APD and CAPD in kidney failure patients with regard to clinical and patient-reported outcomes. Therefore, current evidence is insufficient as a guide for clinical practice. Given that the sample sizes of existing studies are generally small with insufficient follow-up, there is a need for large-scale, multicentre studies. Future research should focus on possible differences between APD and CAPD in residual kidney function, euvolaemia, and patient-reported outcomes such as HRQoL, symptoms, patient satisfaction and life participation.

暂无摘要。

BACKGROUND: Comparing causal effect estimates obtained using observational data to those obtained from the gold standard (i.e., randomized controlled trials [RCTs]) helps assess the validity of these estimates. However, comparisons are challenging due to differences between observational data and RCT generated data. The unknown treatment assignment mechanism in the observational data and varying sampling mechanisms between the RCT and the observational data can lead to confounding and sampling bias, respectively.
OBJECTIVE: The objective of this study is to propose a two-step framework to validate causal effect estimates obtained from observational data by adjusting for both mechanisms.
METHODS: An estimator of causal effects related to the two mechanisms is constructed. A two-step framework for comparing causal effect estimates is derived from the estimator. An R package RCTrep is developed to implement the framework in practice.
RESULTS: A simulation study is conducted to show that using our framework observational data can produce causal effect estimates similar to those of an RCT. A real-world application of the framework to validate treatment effects of adjuvant chemotherapy obtained from registry data is demonstrated.
CONCLUSIONS: This  study constructs a framework for comparing causal effect estimates between observational data and RCT data, facilitating the assessment of the validity of causal effect estimates obtained from observational data.

UNASSIGNED: Addressing systemic bias in medical school assessment is an urgent task for medical education. This paper outlines recommendations on topic areas for further research on systemic bias, developed from a workshop discussion at the 2023 annual meeting of the Society of Directors of Research in Medical Education.
UNASSIGNED: During the workshop, directors engaged in small-group discussions on guidelines to address bias in assessment practices following a proposed categorization of \'Do\'s,\' \'Don\'ts,\' and \'Don\'t knows\' and listed their insights using anonymous sticky notes, which were shared and discussed with the larger group of participants. The authors performed a content analysis of the notes through deductive and inductive coding. We reviewed and discussed our analysis to reach consensus.
UNASSIGNED: The workshop included 31 participants from 28 institutions across the US and Canada, generating 51 unique notes. Participants identified 23 research areas in need of further study. The inductive analysis of proposed research areas revealed four main topics: 1) The role of interventions, including pre-medical academic interventions, medical-education interventions, assessment approaches, and wellness interventions; 2) Professional development, including the definition and assessment of professionalism and professional identity formation; 3) Context, including patient care and systemic influences; and 4) Research approaches.
UNASSIGNED: While limited to data from a single workshop, the results offered perspectives about areas for further research shared by a group of directors of medical education research units from diverse backgrounds. The workshop produced valuable insights into the need for more evidence-based interventions that promote more equitable assessment practices grounded in real-world situations and that attenuate the effects of bias.

While undisputedly important, and part of any systematic review (SR) by definition, evaluation of the risk of bias within the included studies is one of the most time-consuming parts of performing an SR. In this paper, we describe a case study comprising an extensive analysis of risk of bias (RoB) and reporting quality (RQ) assessment from a previously published review (CRD42021236047). It included both animal and human studies, and the included studies compared baseline diseased subjects with controls, assessed the effects of investigational treatments, or both. We compared RoB and RQ between the different types of included primary studies. We also assessed the \"informative value\" of each of the separate elements for meta-researchers, based on the notion that variation in reporting may be more interesting for the meta-researcher than consistently high/low or reported/non-reported scores. In general, reporting of experimental details was low. This resulted in frequent unclear risk-of-bias scores. We observed this both for animal and for human studies and both for disease-control comparisons and investigations of experimental treatments. Plots and explorative chi-square tests showed that reporting was slightly better for human studies of investigational treatments than for the other study types. With the evidence reported as is, risk-of-bias assessments for systematic reviews have low informative value other than repeatedly showing that reporting of experimental details needs to improve in all kinds of in vivo research. Particularly for reviews that do not directly inform treatment decisions, it could be efficient to perform a thorough but partial assessment of the quality of the included studies, either of a random subset of the included publications or of a subset of relatively informative elements, comprising, e.g. ethics evaluation, conflicts of interest statements, study limitations, baseline characteristics, and the unit of analysis. This publication suggests several potential procedures.

The inability to correctly account for unmeasured confounding can lead to bias in parameter estimates, invalid uncertainty assessments, and erroneous conclusions. Sensitivity analysis is an approach to investigate the impact of unmeasured confounding in observational studies. However, the adoption of this approach has been slow given the lack of accessible software. An extensive review of available R packages to account for unmeasured confounding list deterministic sensitivity analysis methods, but no R packages were listed for probabilistic sensitivity analysis. The R package unmconf implements the first available package for probabilistic sensitivity analysis through a Bayesian unmeasured confounding model. The package allows for normal, binary, Poisson, or gamma responses, accounting for one or two unmeasured confounders from the normal or binomial distribution. The goal of unmconf is to implement a user friendly package that performs Bayesian modeling in the presence of unmeasured confounders, with simple commands on the front end while performing more intensive computation on the back end. We investigate the applicability of this package through novel simulation studies. The results indicate that credible intervals will have near nominal coverage probability and smaller bias when modeling the unmeasured confounder(s) for varying levels of internal/external validation data across various combinations of response-unmeasured confounder distributional families.

暂无摘要。

Obesity biases in healthcare are detrimental. We explored medical student beliefs underlying perceptions that child-mother dyads with obesity are less likely to be treatment adherent. Participants viewed scenes of a 12-year-old, female virtual human presenting to a physician with back pain, accompanied by her mother. Patient and mother weight cues were manipulated across scenes. Out of 120, 35 participants perceived dyads with obesity as less adherent to hypothetical pain-related treatment recommendations relative to dyads with healthy weight. These participants were informed and asked why. Responses were analyzed for themes. Fifty-two responses revealed three codes relating to participants\' explanation of why they perceived lower adherence for dyads with obesity-obesity is associated with: 1) non-compliance with general health recommendations, 2) internal traits/factors (i.e., mothers\' less health consciousness, mental strength), 3) external factors (i.e., lower health literacy, socioeconomic status). The association of obesity with lower adherence is a bias that may exist among medical students and originate from assumptions about prior health adherence and maternal traits, some disparaging in nature. Such bias has potential to contribute to healthcare disparities. Findings highlight the utility of qualitative methods to understand beliefs driving perceptions and design bias-reducing interventions to trainee needs.

BACKGROUND: When sufficient maternal milk is not available, donor human milk or formula are the alternative forms of enteral nutrition for very preterm or very low-birthweight (VLBW) infants. Donor human milk may retain the non-nutritive benefits of maternal milk and has been proposed as a strategy to reduce the risk of necrotising enterocolitis (NEC) and associated mortality and morbidity in very preterm or VLBW infants.
OBJECTIVE: To assess the effectiveness of donor human milk compared with formula for preventing NEC and associated morbidity and mortality in very preterm or VLBW infants when sufficient maternal milk is not available.
METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Maternity and Infant Care (MIC) database, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), from the earliest records to February 2024. We searched clinical trials registries and examined the reference lists of included studies.
METHODS: Randomised or quasi-randomised controlled trials comparing feeding with donor human milk versus formula in very preterm (< 32 weeks\' gestation) or VLBW (< 1500 g) infants.
METHODS: Two review authors evaluated the risk of bias in the trials, extracted data, and synthesised effect estimates using risk ratio, risk difference, and mean difference, with associated 95% confidence intervals. The primary outcomes were NEC, late-onset invasive infection, and all-cause mortality before hospital discharge. The secondary outcomes were growth parameters and neurodevelopment. We used the GRADE approach to assess the certainty of the evidence for our primary outcomes.
RESULTS: Twelve trials with a total of 2296 infants fulfilled the inclusion criteria. Most trials were small (average sample size was 191 infants). All trials were performed in neonatal units in Europe or North America. Five trials were conducted more than 40 years ago; the remaining seven trials were conducted in the year 2000 or later. Some trials had methodological weaknesses, including concerns regarding masking of investigators and selective reporting. Meta-analysis showed that donor human milk reduces the risk of NEC (risk ratio (RR) 0.53, 95% confidence interval (CI) 0.37 to 0.76; I² = 4%; risk difference (RD) -0.03, 95% CI -0.05 to -0.01; 11 trials, 2261 infants; high certainty evidence). Donor human milk probably has little or no effect on late-onset invasive infection (RR 1.12, 0.95 to 1.31; I² = 27%; RD 0.03, 95% CI -0.01 to -0.07; 7 trials, 1611 infants; moderate certainty evidence) or all-cause mortality (RR 1.00, 95% CI 0.76 to 1.31; I² = 0%; RD -0.00, 95% CI -0.02 to 0.02; 9 trials, 2116 infants; moderate certainty evidence).
CONCLUSIONS: The evidence shows that donor human milk reduces the risk of NEC by about half in very preterm or VLBW infants. There is probably little or no effect on late-onset invasive infection or all-cause mortality before hospital discharge.

How to cite this article: Sundarsingh V, Kumar M. Emphasizing Patient-centered Outcomes and Improved Exclusion Criteria in Randomized Controlled Trials for Clinical Nutrition in Critically Ill Patients. Indian J Crit Care Med 2024;28(8):804-805.