Prospective observational study on clinical profile of congenital anomalies of kidney and urinary tract (CAKUT) in children in central India: A study protocol

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This study aims to comprehensively understand the clinical profile of CAKUT in children in Central India, an area with unique socio-demographic characteristics and limited prior research on this topic. Methods A prospective observational study will be conducted over three years in the pediatric department of AVBRH, a tertiary healthcare center in Central India. Data were collected through interviews with parents or guardians of children up to 18 admitted to the hospital. Clinical symptoms, prenatal history, physical examinations, and diagnostic investigations were meticulously documented. Expected outcome The study is expected to reveal the prevalence and clinical profile of CAKUT in Central Indian children. Anticipated outcomes include insights into anomalies, clinical symptoms, and potential correlations with factors like prenatal care and consanguineous marriages. Diagnostic investigations will help assess the severity of renal impairment. The results may also uncover regional variations and have implications for public health initiatives aimed at early intervention and improved patient care. However, these are preliminary expectations that are subject to confirmation through the completion of the study. " } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/13-445/v1", "name": "Prospective observational study on clinical profile of congenital..." } } ] } Home Browse Prospective observational study on clinical profile of congenital... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Kommareddy A and Vagha J. Prospective observational study on clinical profile of congenital anomalies of kidney and urinary tract (CAKUT) in children in central India: A study protocol [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2024, 13 :445 ( https://doi.org/10.12688/f1000research.143897.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Prospective observational study on clinical profile of congenital anomalies of kidney and urinary tract (CAKUT) in children in central India: A study protocol [version 1; peer review: 1 approved with reservations, 1 not approved] Anirudh Kommareddy https://orcid.org/0009-0008-7294-3370 1 , Jayant Vagha 1 Anirudh Kommareddy https://orcid.org/0009-0008-7294-3370 1 , Jayant Vagha 1 PUBLISHED 03 May 2024 Author details Author details 1 Pediatrics, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India Anirudh Kommareddy Roles: Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Jayant Vagha Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Datta Meghe Institute of Higher Education and Research collection. Abstract Background Congenital anomalies of the kidney and urinary tract (CAKUT) are a group of structural abnormalities affecting these vital organs, frequently leading to chronic kidney disease in children. This study aims to comprehensively understand the clinical profile of CAKUT in children in Central India, an area with unique socio-demographic characteristics and limited prior research on this topic. Methods A prospective observational study will be conducted over three years in the pediatric department of AVBRH, a tertiary healthcare center in Central India. Data were collected through interviews with parents or guardians of children up to 18 admitted to the hospital. Clinical symptoms, prenatal history, physical examinations, and diagnostic investigations were meticulously documented. Expected outcome The study is expected to reveal the prevalence and clinical profile of CAKUT in Central Indian children. Anticipated outcomes include insights into anomalies, clinical symptoms, and potential correlations with factors like prenatal care and consanguineous marriages. Diagnostic investigations will help assess the severity of renal impairment. The results may also uncover regional variations and have implications for public health initiatives aimed at early intervention and improved patient care. However, these are preliminary expectations that are subject to confirmation through the completion of the study. READ ALL READ LESS Keywords CAKUT, Congenital anomalies, Kidney, Urinary tract, Children, Central India Corresponding Author(s) Anirudh Kommareddy ( [email protected] ) Close Corresponding author: Anirudh Kommareddy Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2024 Kommareddy A and Vagha J. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Kommareddy A and Vagha J. Prospective observational study on clinical profile of congenital anomalies of kidney and urinary tract (CAKUT) in children in central India: A study protocol [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2024, 13 :445 ( https://doi.org/10.12688/f1000research.143897.1 ) First published: 03 May 2024, 13 :445 ( https://doi.org/10.12688/f1000research.143897.1 ) Latest published: 03 May 2024, 13 :445 ( https://doi.org/10.12688/f1000research.143897.1 ) Introduction Congenital anomalies of the kidney and urinary tract (CAKUT) encompass a spectrum of structural abnormalities affecting the kidneys, ureters, bladder, and urethra that are present at birth. These anomalies represent a significant burden of disease in the pediatric population, contributing to a substantial proportion of cases of chronic kidney disease and end-stage renal disease in children. 1 This study delves into the clinical profile of CAKUT in children up to 18 years of age in Central India, where limited research exists on this topic. The investigation is crucial, as a comprehensive understanding of CAKUT in this region can inform early diagnosis, targeted management, and public health initiatives, ultimately improving the quality of life for affected children. 2 CAKUT encompasses various anomalies, including renal agenesis, hypoplasia, dysplasia, and structural obstructions. These anomalies can present with varying degrees of severity, from asymptomatic conditions to life-threatening renal failure. 3 In children, CAKUT may manifest with symptoms such as recurrent urinary tract infections, hypertension, renal dysfunction, or developmental issues. Understanding these anomalies’ clinical presentation and severity is imperative for timely intervention and improved patient outcomes. 4 While CAKUT is a global health concern, the prevalence, presentation, and outcomes can vary significantly based on geographical and ethnic factors. There is a strong genetic etiology of CAKUT, with 10% to 25% of cases attributable to genetic disorders. 5 Central India, a region marked by a unique socio-demographic landscape, has yet to be extensively studied in this context. Therefore, this study seeks to fill a critical knowledge gap by focusing on CAKUT in children in this region. Central India, characterized by a mix of urban and rural areas, faces unique challenges related to healthcare accessibility and infrastructure. Factors like consanguineous marriages and prenatal care practices may contribute to the prevalence and presentation of CAKUT. As such, an in-depth exploration of this region is warranted to understand the interplay of various factors in the context of CAKUT. 6 The anticipated outcome of this study is a richer understanding of how CAKUT presents in Central Indian children, offering insights into the prevalence of associated anomalies and the severity of renal impairment. This knowledge will not only benefit the medical community by informing early diagnosis and tailored treatment but also directly impact the quality of life for affected children and their families. Furthermore, the findings may inform public health initiatives to prevent or identify CAKUT earlier, ultimately reducing the burden of these conditions in Central India. Aim To study the clinical profile of congenital anomalies of kidney and urinary tract (CAKUT) in children till 18 years of age at a tertiary health care center in a rural Hospital in Central India. Objectives 1. To determine the severity of renal impairment. 2. To study the other associated anomalies. Methods Study design This study will be conducted as a prospective observational study, collecting data on children with CAKUT over three years. Study setting The study will take place in the pediatric department of AVBRH (Acharya Vinoba Bhave Rural Hospital), which is affiliated with JNMC (Jawaharlal Nehru Medical College) Wardha, located in the state of Maharashtra, Central India. This tertiary healthcare center is a referral center for children with various medical conditions. Participants Inclusion criteria 1. Children up to 18 years of age. 2. Children diagnosed with congenital anomalies of the kidney and urinary tract (CAKUT). 3. Patients admitted to the Pediatric Intensive Care Unit (PICU), wards, and Neonatal Intensive Care Unit (NICU) of AVBRH. Exclusion criteria 1. Children with acquired kidney diseases or non-CAKUT-related conditions. Variables Outcomes Primary outcome: • Incidence of CAKUT: The primary outcome is the occurrence of any congenital anomalies of the kidney and urinary tract diagnosed in the study population during the study period. Secondary outcomes: • Progression of disease: Measured by changes in kidney function over time, such as alterations in serum creatinine or estimated glomerular filtration rate (eGFR). • Morbidity related to CAKUT: Frequency of urinary tract infections, hypertension, or renal failure. Diagnostic criteria for CAKUT: • Diagnosed based on prenatal ultrasound findings or postnatal imaging (ultrasound, VCUG, MRI, etc.). • Specific anomalies include renal agenesis, kidney dysplasia, ureteropelvic junction obstruction, posterior urethral valves, etc. Exposures Primary exposure: • Genetic factors: Family history of CAKUT or genetic syndromes associated with renal anomalies. Secondary exposures: • Environmental exposures: Prenatal exposure to specific medications, toxins, or infections that have been linked to fetal renal anomalies. • Maternal health: Conditions such as diabetes or hypertension during pregnancy. Predictors • Socio-demographic factors: Age at diagnosis, gender, socioeconomic status. • Biological markers: Genetic markers or specific biomarkers associated with renal development. Potential confounders • Genetic predisposition: Family history of renal diseases or congenital anomalies. • Maternal factors: Age, health status, medication use, and lifestyle factors during pregnancy (e.g., smoking, alcohol consumption). • Access to healthcare: Frequency and quality of prenatal care, which might influence early detection and management of anomalies. Effect modifiers • Age at diagnosis: The age at which CAKUT is diagnosed may modify the effect of interventions on outcomes. • Gender: Differences in CAKUT prevalence and severity between males and females. • Socioeconomic status: May modify the relationship between exposure and outcome due to differences in nutrition, environmental exposure, and access to healthcare. Statistical considerations To handle these variables appropriately: • Multivariable regression models will be used to adjust for potential confounders. • Stratified analyses or interaction terms in regression models will be used to explore potential effect modifiers. Data collection process The data collection process for this prospective observational study on the clinical profile of congenital kidney and urinary tract (CAKUT) anomalies in children in Central India will follow a systematic and ethical approach. Data will be collected over three years at the pediatric department of AVBRH, a tertiary healthcare center affiliated with JNMC Wardha. Upon admission of a pediatric patient to the hospital’s PICU, wards, or NICU, the first step will be to obtain informed consent from the child’s father or nearest relative. This is a crucial ethical consideration to ensure that the child’s information is collected with proper consent. Structured interviews will then be conducted with the parents or guardians of eligible children. These interviews will serve as the primary source of information. Key data points to be gathered include the child’s age, sex, family socioeconomic status, chief complaints, and prevalent clinical symptoms. The research team will also inquire about the child’s medical history, including any previous treatments they may have received. An in-depth exploration of the prenatal history will be conducted, particularly emphasizing details from the second and third-trimester scans. Researchers will also document the child’s gestational age at birth and inquire about any history of consanguinity or blood-relation marriages within the family. Finally, the interviews will seek to identify pregnancy-related risk factors for mothers, such as the presence of oligohydramnios or diabetes mellitus. Interviews were performed to collect in-depth information on family history, environmental exposures, and impacts of the condition on the family. Interviews allow for collecting nuanced information that is not always available or detailed in medical records, such as the subjective impact of CAKUT, detailed family histories, and lesser-known environmental exposures. After the interviews, a comprehensive physical examination will be performed on each child, focusing on vital signs and anthropometry measurements. This examination will provide valuable clinical data, helping to form a complete picture of the child’s health. A systematic, systemic examination encompassing all body systems will follow the physical examination. The clinical signs and symptoms related to CAKUT will be meticulously documented during this process. The objective is to identify any abnormalities, complications, or kidney and urinary tract anomalies. All relevant information, including demographic details, chief complaints, prenatal history, gestational age, and physical and systemic examination findings, will be meticulously recorded throughout the data collection process. Additionally, diagnostic investigations such as complete blood count (CBC), kidney function tests (KFT), and ultrasonography (USG) of the abdomen will be performed, and the results will be incorporated into the dataset. Bias Selection bias • Random sampling: Whenever possible, use random sampling methods to select participants from the target population to ensure that the sample represents the broader population. • Inclusion/Exclusion criteria: Clearly define and uniformly apply inclusion and exclusion criteria to avoid selective enrollment that could skew results. Information bias • Standardization of data collection: Use standardized forms and protocols for data collection. Train all data collectors to ensure consistency in how data is gathered, recorded, and interpreted. • Blinding: While blinding can be challenging in observational studies, try to blind assessors to the study objectives or participant groupings when measuring outcomes to prevent observer bias. • Validation of instruments: Use validated measurement instruments and procedures. For example, ensure that diagnostic tests and equipment are reliable and validated for the population under study. Confounding bias • Proper study design: Design the study to include a comprehensive set of variables that might influence the outcome, such as socioeconomic status, genetic factors, and environmental exposures. • Statistical control: Use statistical methods such as stratification and multivariable regression analyses to adjust for potential confounders identified during the design phase. Reporting bias • Encouraging complete reporting: Ensure that participants understand the importance of providing complete and accurate information. Reassure them about confidentiality and the non-judgmental nature of data collection. • Independent verification: Where possible, verify reported information through medical records or other objective data sources. Sample size calculation • Population size (N): 100,000 • Hypothesized percentage frequency of the outcome factor in the population (p): 7% ± 5% • Confidence limits as a percentage of 100 (absolute ± percentage) (d): 5% • Design effect (for cluster surveys - DEFF): 1 • Confidence level: 95% Using these parameters, the formula for calculating the required sample size is as follows: Sample size ( Required ) = [ DEFF ∗ N ∗ p ∗ ( 1 − p ) ] / [ ( d 2 / Z ( 1 − α / 2 ) 2 ∗ ( N − 1 ) + p ∗ ( 1 − p ) ] Where: • DEFF (Design Effect) is 1. • N represents the population size (100,000). • p represents the hypothesized percentage frequency of the outcome factor in the population (7%). • d represents the confidence limits (5%). • Z ( 1 − α / 2 ) 2 corresponds to the critical value from the standard normal distribution for a 95% confidence level. After substituting these values into the formula, the calculated sample size is 105. Statistical analysis In the study on congenital anomalies of the kidney and urinary tract (CAKUT), our data analysis approach is methodically structured to ensure precise interpretation across both quantitative and qualitative data sets. Quantitative analysis: Initially, we will employ descriptive statistics to review data distributions, central tendencies, and variabilities of all quantitative variables using software like R version 4.3.1. For inferential analysis, binary logistic regression will be implemented to examine the odds of developing CAKUT based on predictors such as genetic markers and environmental exposures. This method is apt for our binary outcomes (presence or absence of CAKUT) and will involve careful variable selection and multicollinearity checks using Variance Inflation Factor (VIF). In scenarios involving longitudinal data, the Cox Proportional Hazards Model will allow us to evaluate the time to CAKUT onset, adjusting for time-dependencies and censoring in the data. Confounders will be managed through multivariable adjustments to ensure the integrity of our regression models. Sensitivity analyses will further validate our findings by testing model assumptions and the impact of data anomalies. Qualitative analysis: Thematic analysis will be utilized to dissect the qualitative data from interviews. This will involve the transcription of interviews, followed by the generation of initial codes which will be meticulously grouped into themes. Tools such as NVivo or ATLAS.ti will aid in this rigorous process of coding and thematic development. The resultant themes will be critically evaluated and refined to ensure they genuinely reflect the interview data and address the research questions. Integrating findings: Both datasets will be analyzed independently and subsequently integrated using a convergent parallel design. This dual analysis allows for a nuanced understanding of how the qualitative experiences align with or differ from the quantitative data, providing a comprehensive view of the factors influencing CAKUT. Ethical considerations The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) approved the study protocol on 27/06/2022. Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives. Reference Number: DMIHER (DU)/IEC/2022/1072. Dissemination This study protocol will be published in an indexed journal. Study status The study has not yet begun. Expected outcome The expected outcome includes improved diagnostic insights, better management, and tailored treatment for these children. We anticipate identifying patterns in the severity of renal impairment and associated anomalies, ultimately leading to enhanced patient care and a potentially reduced burden of CAKUT in the region. In summary, this research can potentially improve the quality of life for affected children and inform public health initiatives. Discussion Congenital anomalies of the kidneys and urinary tract (CAKUT) represent a diagnostic term encompassing a diverse array of anomalies. These anomalies encompass alterations in kidney size and positioning, dysplastic modifications within the kidney parenchyma, and irregular structures of the collecting system, ureters, bladder, and urethra. 7 The etiology of CAKUT remains partially elusive. It is known that exposure to teratogens, folate, and retinoic acid contributes to a portion of the reported cases. 8 A substantial genetic component underlies the etiology of CAKUT, with genetic disorders accounting for approximately 10% to 25% of the reported cases. 9 The association between genetic disorders and the phenotypic manifestations of CAKUT is notably intricate. Individuals sharing identical genomic abnormalities can display a range of CAKUT variations, and conversely, similar phenotypic anomalies can result from disparate genetic disorders. This complexity underscores the multifactorial nature of CAKUT etiology. 10 Genetic disorders linked to CAKUT often exhibit concurrent extrarenal manifestations, including developmental delays, congenital heart disease (CHD), immunodeficiencies, and endocrine disruptions. This points to the systemic and multi-organ impact of these genetic conditions. 10 Population-based studies have reported a prevalence range for CAKUT, with estimates spanning from 4 to more than 100 cases per 10,000 individuals. This wide variation underscores the variability in CAKUT incidence across different populations and geographic regions. 5 Infants born prematurely face a significant burden of morbidity and early-life mortality. While certain risk factors, such as the degree of prematurity, birth weight, sex, and antenatal steroid use, have been identified, the outcomes for these infants can vary widely. Notably, recent discoveries have revealed that genetic disorders can independently contribute to perinatal disease, adding a new dimension to our understanding of these complex health challenges. 5 Ethics and consent The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) approved the study protocol on 27/06/2022. Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives. Reference Number: DMIHER (DU)/IEC/2022/1072. Data availability Underlying data No data are associated with this article. Extended data Zenodo: Interview Guide: Understanding Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) in Children. https://zenodo.org/doi/10.5281/zenodo.10983150 . 11 Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). References 1. Huang Z, Shen Q, Wu B, et al. : Genetic Spectrum of Congenital Anomalies of the Kidney and Urinary Tract in Chinese Newborn Genome Project. Kidney Int. Rep. 2023 Aug 14 [cited 2023 Oct 15]; 8 : 2376–2384. PubMed Abstract | Publisher Full Text | Free Full Text Reference Source 2. Sanna-Cherchi S, Westland R, Ghiggeri GM, et al. : Genetic basis of human congenital anomalies of the kidney and urinary tract. J. Clin. Invest. 128 (1): 4–15. PubMed Abstract | Publisher Full Text | Free Full Text 3. Vivante A, Kohl S, Hwang DY, et al. : Single-Gene Causes of Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) in Humans. Pediatr. Nephrol. 2014 Apr; 29 (4): 695–704. PubMed Abstract | Publisher Full Text | Free Full Text 4. Chevalier RL: CAKUT: A Pediatric and Evolutionary Perspective on the Leading Cause of CKD in Childhood. Pediatr. Rep. 2023 Feb 10; 15 (1): 143–153. PubMed Abstract | Publisher Full Text | Free Full Text 5. Hays T, Thompson MV, Bateman DA, et al. : The Prevalence and Clinical Significance of Congenital Anomalies of the Kidney and Urinary Tract in Preterm Infants. JAMA Netw. Open. 2022 Sep 14; 5 (9): e2231626. PubMed Abstract | Publisher Full Text | Free Full Text 6. Deb Roy A, Das D, Mondal H: The Tribal Health System in India: Challenges in Healthcare Delivery in Comparison to the Global Healthcare Systems. Cureus. 2023 Jun 2; 15 (6): e39867. PubMed Abstract | Publisher Full Text | Free Full Text 7. Murugapoopathy V, Gupta IR: A Primer on Congenital Anomalies of the Kidneys and Urinary Tracts (CAKUT). Clin. J. Am. Soc. Nephrol. 2020 May 7; 15 (5): 723–731. PubMed Abstract | Publisher Full Text | Free Full Text 8. Nicolaou N, Renkema KY, Bongers EMHF, et al. : Genetic, environmental, and epigenetic factors involved in CAKUT. Nat. Rev. Nephrol. 2015 Dec; 11 (12): 720–731. PubMed Abstract | Publisher Full Text 9. Sanna-Cherchi S, Kiryluk K, Burgess KE, et al. : Copy-number disorders are a common cause of congenital kidney malformations. Am. J. Hum. Genet. 2012 Dec 7; 91 (6): 987–997. PubMed Abstract | Publisher Full Text | Free Full Text 10. Hays T, Groopman EE, Gharavi AG: Genetic testing for kidney disease of unknown etiology. Kidney Int. 2020 Sep; 98 (3): 590–600. PubMed Abstract | Publisher Full Text | Free Full Text 11. Kommareddy A: Interview Guide: Understanding Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) in Children. [Dataset]. Zenodo. 2024. Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 03 May 2024 ADD YOUR COMMENT Comment Author details Author details 1 Pediatrics, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India Anirudh Kommareddy Roles: Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Jayant Vagha Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 03 May 2024, 13:445 https://doi.org/10.12688/f1000research.143897.1 Copyright © 2024 Kommareddy A and Vagha J. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Kommareddy A and Vagha J. Prospective observational study on clinical profile of congenital anomalies of kidney and urinary tract (CAKUT) in children in central India: A study protocol [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2024, 13 :445 ( https://doi.org/10.12688/f1000research.143897.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 03 May 2024 Views 0 Cite How to cite this report: Matsell D. Reviewer Report For: Prospective observational study on clinical profile of congenital anomalies of kidney and urinary tract (CAKUT) in children in central India: A study protocol [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2024, 13 :445 ( https://doi.org/10.5256/f1000research.157619.r288960 ) The direct URL for this report is: https://f1000research.com/articles/13-445/v1#referee-response-288960 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 09 Sep 2024 Douglas Matsell , Division of Nephrology, Department of Pediatrics, The University of British Columbia, Vancouver, British Columbia, Canada Not Approved VIEWS 0 https://doi.org/10.5256/f1000research.157619.r288960 The report submitted by Dr. Kommareddy entitled "Prospective observational study on clinical profile of congenital anomalies of the kidney and urinary tract (CAKUT)children in central India: A study protocol" is an outline of a proposed clinical study. ... Continue reading READ ALL The report submitted by Dr. Kommareddy entitled "Prospective observational study on clinical profile of congenital anomalies of the kidney and urinary tract (CAKUT)children in central India: A study protocol" is an outline of a proposed clinical study. I offer the following comments 1. While the proposal sets out to define the incidence, prevalence and clinical profile of children with CAKUT in Central India in a prospective fashion, a major drawback is that the results will be limited given the proposed inclusion criteria. The investigators set out to study CAKUT only in children admitted to hospital. Most children with CAKUT do not require admission to hospital and those that do are often those with severe bilateral kidney dysplasia and/or boys with posterior urethral valves at diagnosis or later on life when they progress to end stage kidney disease. In its present form the study will miss/exclude all the other forms of CAKUT seen in outpatient pediatric and general nephrology clinics. To achieve the study objectives and aims they will need to incorporate the data from their outpatient experience and perhaps from their local antenatal datasets. 2. The investigators also need to be clear about their study aims and objectives. The previous comment notwithstanding, studying the clinical profile of children with CAKUT, determining their kidney impairment, and identifying associated anomalies is feasible. However the protocol includes the possibility of regression modelling, identifying risk factors for the development of CAKUT. These analyses will likely not be feasible given the study population size and the low prevalence of the outcome in their included population over the course of 3 years. It is not clear from where the "frequency of the outcome factor of 7%" is derived. 4. Regarding outcomes, the study protocol should provide detail on how kidney outcomes will be defined and measured and how and when the associated anomalies will be defined and measured. 4. The study protocol also needs to clarify exactly which conditions they are considering to be CAKUT and how these are diagnosed and defined. For example do they intend to include children with isolated hydronephrosis, or with vesicoureteral reflux? 5. Structured interviews are proposed to enable detailed data collection. It seems however that most of the data should already be included in the standardized hospital admission record. This should be clarified. 6. The section defining the various forms of bias appears generic. It should include the specifics of and reference to the details of the proposed study. 7. Biological markers or risk factors such as "genetic markers" and "specific biomarkers" should be defined clearly. 8. In effect modifiers, by "gender" do the investigators mean "sex"? Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? No Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: CAKUT, kidney development, regression modelling, pediatrics I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Matsell D. Reviewer Report For: Prospective observational study on clinical profile of congenital anomalies of kidney and urinary tract (CAKUT) in children in central India: A study protocol [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2024, 13 :445 ( https://doi.org/10.5256/f1000research.157619.r288960 ) The direct URL for this report is: https://f1000research.com/articles/13-445/v1#referee-response-288960 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Landau D. Reviewer Report For: Prospective observational study on clinical profile of congenital anomalies of kidney and urinary tract (CAKUT) in children in central India: A study protocol [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2024, 13 :445 ( https://doi.org/10.5256/f1000research.157619.r288968 ) The direct URL for this report is: https://f1000research.com/articles/13-445/v1#referee-response-288968 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 12 Jun 2024 Daniel Landau , Department of Nephrology, School of Medicine, Schneider Children's Medical Center, Tel Aviv University, Petah Tikva, Tel Aviv, Israel Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.157619.r288968 The authors suggest here to explore the clinical profile (including the extent of renal impairment and the presence of associate anomalies) of children with CAKUT in central India, based on admissions to a single tertiary care rural center in central ... Continue reading READ ALL The authors suggest here to explore the clinical profile (including the extent of renal impairment and the presence of associate anomalies) of children with CAKUT in central India, based on admissions to a single tertiary care rural center in central India. This study design by itself may suffer from several potential problems that may impair the future ability to make any generalizations beyond the data collected from that single medical center. Specific critiques: 1) Introduction: the authors should quote the Global Burden of Disease articles related to pediatric CKD and CAKUT (Dr A. Bagga is a co-author in some of them) (He et al.,2024) (Ref-1), because they elaborated on these questions, specifically for India as an example of a developing country. 2) Methods: what is the exact population coverage of the pediatric department of AVBRH ? Is it the only tertiary care center for the region? How would data collected from this single pediatrics dept. be used to generalize to the area of Central India? 3) Methods: more data is needed on the AVBRH pediatrics department: What is the activity of this pediatrics department? How many newborns per year? How many pediatric admission/yr? Is there a pediatric nephrology and/or pediatric urology in the hospital? 4) How will CAKUT be exactly defined? If by ICD-9 or -10 codes, they should be specified. Will unilateral CAKUT cases (most of them mild, such as congenital mild unilateral Hydronephrosis be included? 5) For the sample size calculation, the authors assume a CAKUT prevalence of 7%. This is too high in my opinion. The numbers I know for any kidney or urinary tract abnormality are up to 2% of pregnancies (most of them with mild hydronephrosis). This is also the number found in newborns in the research article quoted in REF#5. This is crucial for the sample size calculation. 6) If population size is 100,000 (relatively small for a tertiary care center) and CAKUT prevalence will end up being no more than 1%, and only 0.1% will have CKD, then how many years should the authors devote to prospectively collect the needed sample size? Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable References 1. He G, Liu Y, Bagga A, Onubogu CU, et al.: Trends and socioeconomic inequality of the burden of congenital abnormalities of the kidney and urinary tract among children and adolescents. Nephrol Dial Transplant . 2024. PubMed Abstract | Publisher Full Text Competing Interests: No competing interests were disclosed. Reviewer Expertise: Pediatric Nephrology. Genetic kidney diseases, childhood CKD epidemiology and pathophysiology. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Landau D. Reviewer Report For: Prospective observational study on clinical profile of congenital anomalies of kidney and urinary tract (CAKUT) in children in central India: A study protocol [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2024, 13 :445 ( https://doi.org/10.5256/f1000research.157619.r288968 ) The direct URL for this report is: https://f1000research.com/articles/13-445/v1#referee-response-288968 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 03 May 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 Version 1 03 May 24 read read Daniel Landau , Schneider Children's Medical Center, Tel Aviv University, Petah Tikva, Tel Aviv, Israel Douglas Matsell , The University of British Columbia, Vancouver, Canada Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Matsell D. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 09 Sep 2024 | for Version 1 Douglas Matsell , Division of Nephrology, Department of Pediatrics, The University of British Columbia, Vancouver, British Columbia, Canada 0 Views copyright © 2024 Matsell D. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Not Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The report submitted by Dr. Kommareddy entitled "Prospective observational study on clinical profile of congenital anomalies of the kidney and urinary tract (CAKUT)children in central India: A study protocol" is an outline of a proposed clinical study. I offer the following comments 1. While the proposal sets out to define the incidence, prevalence and clinical profile of children with CAKUT in Central India in a prospective fashion, a major drawback is that the results will be limited given the proposed inclusion criteria. The investigators set out to study CAKUT only in children admitted to hospital. Most children with CAKUT do not require admission to hospital and those that do are often those with severe bilateral kidney dysplasia and/or boys with posterior urethral valves at diagnosis or later on life when they progress to end stage kidney disease. In its present form the study will miss/exclude all the other forms of CAKUT seen in outpatient pediatric and general nephrology clinics. To achieve the study objectives and aims they will need to incorporate the data from their outpatient experience and perhaps from their local antenatal datasets. 2. The investigators also need to be clear about their study aims and objectives. The previous comment notwithstanding, studying the clinical profile of children with CAKUT, determining their kidney impairment, and identifying associated anomalies is feasible. However the protocol includes the possibility of regression modelling, identifying risk factors for the development of CAKUT. These analyses will likely not be feasible given the study population size and the low prevalence of the outcome in their included population over the course of 3 years. It is not clear from where the "frequency of the outcome factor of 7%" is derived. 4. Regarding outcomes, the study protocol should provide detail on how kidney outcomes will be defined and measured and how and when the associated anomalies will be defined and measured. 4. The study protocol also needs to clarify exactly which conditions they are considering to be CAKUT and how these are diagnosed and defined. For example do they intend to include children with isolated hydronephrosis, or with vesicoureteral reflux? 5. Structured interviews are proposed to enable detailed data collection. It seems however that most of the data should already be included in the standardized hospital admission record. This should be clarified. 6. The section defining the various forms of bias appears generic. It should include the specifics of and reference to the details of the proposed study. 7. Biological markers or risk factors such as "genetic markers" and "specific biomarkers" should be defined clearly. 8. In effect modifiers, by "gender" do the investigators mean "sex"? Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? No Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise CAKUT, kidney development, regression modelling, pediatrics I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (0) Matsell D. Peer Review Report For: Prospective observational study on clinical profile of congenital anomalies of kidney and urinary tract (CAKUT) in children in central India: A study protocol [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2024, 13 :445 ( https://doi.org/10.5256/f1000research.157619.r288960) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-445/v1#referee-response-288960 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Landau D. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 12 Jun 2024 | for Version 1 Daniel Landau , Department of Nephrology, School of Medicine, Schneider Children's Medical Center, Tel Aviv University, Petah Tikva, Tel Aviv, Israel 0 Views copyright © 2024 Landau D. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The authors suggest here to explore the clinical profile (including the extent of renal impairment and the presence of associate anomalies) of children with CAKUT in central India, based on admissions to a single tertiary care rural center in central India. This study design by itself may suffer from several potential problems that may impair the future ability to make any generalizations beyond the data collected from that single medical center. Specific critiques: 1) Introduction: the authors should quote the Global Burden of Disease articles related to pediatric CKD and CAKUT (Dr A. Bagga is a co-author in some of them) (He et al.,2024) (Ref-1), because they elaborated on these questions, specifically for India as an example of a developing country. 2) Methods: what is the exact population coverage of the pediatric department of AVBRH ? Is it the only tertiary care center for the region? How would data collected from this single pediatrics dept. be used to generalize to the area of Central India? 3) Methods: more data is needed on the AVBRH pediatrics department: What is the activity of this pediatrics department? How many newborns per year? How many pediatric admission/yr? Is there a pediatric nephrology and/or pediatric urology in the hospital? 4) How will CAKUT be exactly defined? If by ICD-9 or -10 codes, they should be specified. Will unilateral CAKUT cases (most of them mild, such as congenital mild unilateral Hydronephrosis be included? 5) For the sample size calculation, the authors assume a CAKUT prevalence of 7%. This is too high in my opinion. The numbers I know for any kidney or urinary tract abnormality are up to 2% of pregnancies (most of them with mild hydronephrosis). This is also the number found in newborns in the research article quoted in REF#5. This is crucial for the sample size calculation. 6) If population size is 100,000 (relatively small for a tertiary care center) and CAKUT prevalence will end up being no more than 1%, and only 0.1% will have CKD, then how many years should the authors devote to prospectively collect the needed sample size? Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable References 1. He G, Liu Y, Bagga A, Onubogu CU, et al.: Trends and socioeconomic inequality of the burden of congenital abnormalities of the kidney and urinary tract among children and adolescents. Nephrol Dial Transplant . 2024. PubMed Abstract | Publisher Full Text Competing Interests No competing interests were disclosed. Reviewer Expertise Pediatric Nephrology. Genetic kidney diseases, childhood CKD epidemiology and pathophysiology. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Landau D. Peer Review Report For: Prospective observational study on clinical profile of congenital anomalies of kidney and urinary tract (CAKUT) in children in central India: A study protocol [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2024, 13 :445 ( https://doi.org/10.5256/f1000research.157619.r288968) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-445/v1#referee-response-288968 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Adjust parameters to alter display View on desktop for interactive features Includes Interactive Elements View on desktop for interactive features Competing Interests Policy Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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