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Discusses the deficiencies of the Good Clinical Practice (GCP) guideline developed by the International Conference on Harmonisation (ICH) and proposes some practical solutions. Criticism of the manner in which the GCP was developed; How the GCP has not been updated since 1996 and how it uses wording from the United States Food and Drug Administration regulations and guidelines; Description of solutions to described problems.

Background: The World Health Organization recommends that human growth should be monitored with the use of international standards. However, in obstetric practice, we continue to monitor fetal growth using numerous local charts or equations that are based on different populations for each body structure. Consistent with World Health Organization recommendations, the INTERGROWTH-21 st Project has produced the first set of international standards to date pregnancies; to monitor fetal growth, estimated fetal weight, Doppler measures, and brain structures; to measure uterine growth, maternal nutrition, newborn infant size, and body composition; and to assess the postnatal growth of preterm babies. All these standards are based on the same healthy pregnancy cohort. Recognizing the importance of demonstrating that, postnatally, this cohort still adhered to the World Health Organization prescriptive approach, we followed their growth and development to the key milestone of 2 years of age., Objective: The purpose of this study was to determine whether the babies in the INTERGROWTH-21 st Project maintained optimal growth and development in childhood., Study Design: In the Infant Follow-up Study of the INTERGROWTH-21 st Project, we evaluated postnatal growth, nutrition, morbidity, and motor development up to 2 years of age in the children who contributed data to the construction of the international fetal growth, newborn infant size and body composition at birth, and preterm postnatal growth standards. Clinical care, feeding practices, anthropometric measures, and assessment of morbidity were standardized across study sites and documented at 1 and 2 years of age. Weight, length, and head circumference age- and sex-specific z-scores and percentiles and motor development milestones were estimated with the use of the World Health Organization Child Growth Standards and World Health Organization milestone distributions, respectively. For the preterm infants, corrected age was used. Variance components analysis was used to estimate the percentage variability among individuals within a study site compared with that among study sites., Results: There were 3711 eligible singleton live births; 3042 children (82%) were evaluated at 2 years of age. There were no substantive differences between the included group and the lost-to-follow up group. Infant mortality rate was 3 per 1000; neonatal mortality rate was 1.6 per 1000. At the 2-year visit, the children included in the INTERGROWTH-21 st Fetal Growth Standards were at the 49th percentile for length, 50th percentile for head circumference, and 58th percentile for weight of the World Health Organization Child Growth Standards. Similar results were seen for the preterm subgroup that was included in the INTERGROWTH-21 st Preterm Postnatal Growth Standards. The cohort overlapped between the 3rd and 97th percentiles of the World Health Organization motor development milestones. We estimated that the variance among study sites explains only 5.5% of the total variability in the length of the children between birth and 2 years of age, although the variance among individuals within a study site explains 42.9% (ie, 8 times the amount explained by the variation among sites). An increase of 8.9 cm in adult height over mean parental height is estimated to occur in the cohort from low-middle income countries, provided that children continue to have adequate health, environmental, and nutritional conditions., Conclusion: The cohort enrolled in the INTERGROWTH-21 st standards remained healthy with adequate growth and motor development up to 2 years of age, which supports its appropriateness for the construction of international fetal and preterm postnatal growth standards., (Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate the publication and quality of reporting of abstracts of systematic reviews presented at scientific medical conferences., Study Design and Setting: We included all abstracts of systematic reviews published in the proceedings of nine leading international conferences in 2010. For each conference abstract, we searched PubMed (January 1, 2010, to June 2013) to identify their corresponding full publication. We assessed the extent to which conference abstracts and their corresponding journal abstract reported items included in the Preferred Reporting Items for Systematic reviews and Meta-Analysis for Abstracts checklist and recorded any important discrepancies between sources., Results: We identified 197 abstracts of systematic reviews, representing <1% of the total number of conference abstracts presented. Of these 53% were published in full, the median time to publication was 14 months (interquartile range, 6.6-20.1 months). Although most conference and journal abstracts reported details of included studies (conference n = 83 of 103; 81% vs. journal n = 81 of 103; 79%), size and direction of effect (76% vs. 75%), and conclusions (79% vs. 81%), many failed to report the date of search (27% vs. 25%), assessment of risk of bias (18% vs. 12%), and the result for the main efficacy outcome(s) including the number of studies (37% vs. 31%) and participants (30% vs. 20%), harms(s) (17% vs. 17%), strengths (17% vs. 13%) and limitations (36% vs. 30%) of the evidence, or funding source (1% vs. 0%). There were discrepancies between journal and corresponding conference abstracts including deletion of studies (13%), changes in reported efficacy (11%), and harm (10%) outcome(s) and changes in the nature or direction of conclusions (24%)., Conclusion: Despite the importance of systematic reviews in the delivery of evidence-based health care, very few are presented at scientific conferences and only half of those presented are published in full. Serious deficiencies in the reporting of abstracts of systematic reviews make it difficult for readers to reliably assess their findings., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Our primary objective was to develop, disseminate, and implement systematic reporting guidelines for case reports., Methods: We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case reporting guidelines., Results: This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent., Conclusions: We believe the implementation of the CARE (CAse REporting) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery.

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word 'controlled' in STRICTA is replaced by 'clinical', to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.