Impact of missingness on clinical trials on the effectiveness of antenatal vitamin D supplementation in gestational diabetes mellitus patients

Self Cite

Background: Several clinical trials have tested the safety profile of sodium-glucose co-transport inhibitors’ (SGLTis) in adult type 1 diabetes mellitus (T1DM) patients. However, no systematic review has yet compared its variation between large and low dose SGLTis. Henceforth, a review protocol is proposed here to review it. Methods: Different electronic databases will be searched for randomized-controlled trials (published in the English language) studying the above objective, irrespective of their publication date. After selecting the eligible trials, their data on the study design, population characteristics, compared interventions, and outcomes of interest will be extracted. Then, utilizing the Cochrane tool, each trial's risk of selection bias, detection bias, performance bias, attrition bias, reporting bias, and other bias will be judged. Next, depending on clinical heterogeneity among the trials, a random-effect or fixed-effect model meta-analysis will be used to compare the respective outcomes. Via the Chi2 and I2 statistics, the statistical inconsistency among the trials will be estimated. When this is substantial, subgroup analysis will follow. Publication bias will be evaluated by funnel plots and Egger’s test. A sensitivity analysis will be done to check different assumptions. If a quantitative juxtaposition is not possible, a narrative reporting will ensue. Conclusion: The proposed study will perform a dose-wise juxtaposition of the safety profile of SGLTis in insulin-treated T1DM patients. Registration: Prospective Register of Systematic Reviews (PROSPERO) (Registration no. CRD42019146578)

Section: Risk Of Bias Assessmentmentioning

confidence: 99%

A juxtaposition of safety outcomes between various doses of sodium-glucose co-transporter inhibitors, in insulin-treated type-1 diabetes mellitus patients: a protocol for systematic review and meta-analysis of randomized controlled trials

Saha

2020

Self Cite

“…Parallel to the rising number of trials testing prenatal vitamin D supplementation's effect in GDM patients, systematic review and meta-analysis using data from these trials are also increasing. However, best known to this author, the burden and risk of attrition in these trials have not been systematically explored before [24]. Therefore, to study this poorly explored area of the GDM literature, a systematic review protocol is proposed here.…”

Section: Purpose Of the Proposed Reviewmentioning

confidence: 99%

The prevalence and risk of missing outcome data in prenatal vitamin D supplemented gestational diabetes mellitus patients: a systematic review and meta-analysis protocol

Saha

2020

Self Cite

Background: Missing outcome data in clinical trials are important determinants of internal validity; however, its burden and risk in gestational diabetes mellitus (GDM) mothers supplemented with vitamin D remain poorly studied. Therefore, a systematic review and meta-analysis protocol is proposed here to study it. Methods: The English language publications, irrespective of its publication date, will be searched in electronic databases for randomized controlled trials studying the above outcome. The eligible trials will undergo the risk of bias assessment by the Cochrane tool. Data on its trial design, population characteristics, interventions compared, and the outcome will be abstracted. The prevalence and incidence (in risk ratio) of missing outcome data will be estimated meta-analytically. The statistical heterogeneity assessment will include the use of Chi2 and I2 statistics. For the explanation of any substantial heterogeneity, a meta-regression analysis will ensue. The statistical significance will be determined at P <0.05 and 95% CI. All analyses will be done in Stata statistical software. If the quantitative analysis is not possible, narrative reporting will happen. Results: The reporting of the review will follow the PRISMA guideline. Statistically significant pairwise meta-analysis finding's grading will occur by the GRADE approach. Conclusion: The proposed review will estimate the prevalence of missing outcome data in vitamin D supplemented GDM mothers in clinical trials and compare its risk with the placebo recipients. PROSPERO registration ID: CRD42020180634 References Quintanilla Rodriguez BS, Mahdy H. Gestational Diabetes. [Updated 2019 Dec 23]. StatPearls. Treasure Isl StatPearls Publ. 2020. Available from: https://www.ncbi.nlm.nih.gov/books/NBK545196/ Committee on Practice Bulletins—Obstetrics. ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018;131: e49–64. Available from: http://www.ncbi.nlm.nih.gov/pubmed/29370047 Mack LR, Tomich PG. Gestational Diabetes: Diagnosis, Classification, and Clinical Care. Obstet Gynecol Clin North Am [Internet]. 2017; 44:207–17. Available from: http://www.ncbi.nlm.nih.gov/pubmed/28499531 Coustan DR. Gestational Diabetes Mellitus. Clin Chem. 2013; 59:1310–21. Available from: http://www.clinchem.org/cgi/doi/10.1373/clinchem.2013.203331 Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes—2019. Diabetes Care. 2019;42: S165–72. Available from: http://care.diabetesjournals.org/lookup/doi/10.2337/dc19-S014 Saha S. Compliance and barriers to self-monitoring of blood glucose in patients with gestational diabetes mellitus: A systematic review. Int J Health Sci (Qassim).2019;13:44–52. Available from: http://www.ncbi.nlm.nih.gov/pubmed/31123440 Akbari M, Mosazadeh M, Lankarani K, Tabrizi R, Samimi M, Karamali M, et al. The effects of vitamin d supplementation on glucose metabolism and lipid profiles in patients with gestational diabetes: a systematic review and meta-analysis of randomized controlled trials. Horm Metab Res.Germany; 2017;49:647–53. Available from: http://www.thieme-connect.de/DOI/DOI?10.1055/s-0043-115225 Saha S, Saha S. A comparison of the risk of cesarean section in gestational diabetes mellitus patients supplemented antenatally with vitamin D containing supplements versus placebo: A systematic review and meta-analysis of double-blinded randomized controlled trials. J Turkish-German Gynecol Assoc. 2020; 21:201–12. https://dx.doi.org/10.4274%2Fjtgga.galenos.2020.2019.0164 Saha SS, Saha SS. The risk of morbidities in newborns of antenatal vitamin D supplemented gestational diabetes mellitus patients. Int J Health Sci (Qassim). Qassim University; 2020; 14:3–17. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7475207/ Saha S, Saha S. A Comparison of the Changes in Gestational Weight, Body Mass Index, and Serum Vitamin D Level in Gestational Diabetes Mellitus Patients Complemented with Vitamin D in Contrast to Those Who Did Not Receive the Supplement: A Protocol for Systematic Review a. Int J Diabetes Metab. S. Karger AG; 2019; 25:74–9. https://doi.org/10.1159/000505269 Mavridis D, White IR. Dealing with missing outcome data in meta‐ Res Synth Methods.2020;11:2–13. Available from: https://onlinelibrary.wiley.com/doi/abs/10.1002/jrsm.1349 Higgins JPT GS (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. Cochrane Collab. 2011 [cited 2020 Aug 27]. Available from: https://training.cochrane.org/handbook/archive/v5.1/ Asemi Z, Hashemi T, Karamali M, Samimi M, Esmaillzadeh A. Effects of vitamin D supplementation on glucose metabolism, lipid concentrations, inflammation, and oxidative stress in gestational diabetes: a double-blind, randomized controlled clinical trial. Am J Clin Nutr.2013;98:1425–32. https://doi.org/10.3945/ajcn.113.072785 Asemi Z, Karamali M, Esmaillzadeh A. Effects of calcium–vitamin D co-supplementation on glycaemic control, inflammation and oxidative stress in gestational diabetes: a randomised placebo-controlled trial. Diabetologia .2014;57:1798–806. https://doi.org/10.1007/s00125-014-3293-x Institute of Medicine (US) Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. Dietary Reference Intakes for Calcium and Vitamin D. Ross AC, Taylor CL, Yaktine AL, Del Valle HB, editors. Washington (DC): National Academies Press (US); 2011. Available from: https://books.google.co.in/books?id=VF2aRQJ6IZ4C Gossman W, Chauhan K, Huecker MR. Vitamin D. StatPearls. 2019. Available from: http://www.ncbi.nlm.nih.gov/pubmed/28722941 Curtis EM, Moon RJ, Harvey NC, Cooper C. Maternal vitamin D supplementation during pregnancy. Br Med Bull. 2018; 126:57–77. https://doi.org/10.1093/bmb/ldy010 Knabl J, Vattai A, Ye Y, Jueckstock J, Hutter S, Kainer F, et al. Role of Placental VDR Expression and Function in Common Late Pregnancy Disorders. I Int J Mol Sci. 2017;18(11):2340. https://doi.org/10.3390/ijms18112340 Yazdchi R, Gargari BP, Asghari-Jafarabadi M, Sahhaf F. Effects of vitamin D supplementation on metabolic indices and hs-CRP levels in gestational diabetes mellitus patients: a randomized, double-blinded, placebo-controlled clinical trial. Nutr Res Pract. 2016; 10:328. Available from: http://synapse.koreamed.org/DOIx.php?id=10.4162/nrp.2016.10.3.328 Jamilian M, Samimi M, Ebrahimi FA, Hashemi T, Taghizadeh M, Razavi M, et al. The effects of vitamin D and omega-3 fatty acid co-supplementation on glycemic control and lipid concentrations in patients with gestational diabetes. J Clin Lipidol. 2017; 11:459–68. https://doi.org/10.1016/j.jacl.2017.01.011 Li Q, Xing B. Vitamin D3-Supplemented Yogurt Drink Improves Insulin Resistance and Lipid Profiles in Women with Gestational Diabetes Mellitus: A Randomized Double Blinded Clinical Trial. Ann Nutr Metab. 2016; 68:285–90. https://doi.org/10.1159/000447433 Karamali M, Bahramimoghadam S, Sharifzadeh F, Asemi Z. Magnesium–zinc–calcium–vitamin D co-supplementation improves glycemic control and markers of cardiometabolic risk in gestational diabetes: a randomized, double-blind, placebo-controlled trial. Appl Physiol Nutr Metab. 2018; 43:565–70. Available from: http://www.nrcresearchpress.com/doi/10.1139/apnm-2017-0521 Hosseinzadeh-Shamsi-Anar M, Mozaffari-Khosravi H, Salami M-A, Hadinedoushan H, Mozayan MR. The efficacy and safety of a high dose of vitamin d in mothers with gestational diabetes mellitus: a randomized controlled clinical trial. Iran J Med Sci. 2012; 37:159–65. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23115447 Saha S. Impact of missingness on clinical trials on the effectiveness of antenatal vitamin D supplementation in gestational diabetes mellitus patients. J Ideas Heal. 2020; 3:138–9. https://doi.org/10.47108/jidhealth.Vol3.Iss1.47 Saha S, Saha S. The variation in participant attrition between prenatal vitamin D supplemented and not supplemented gestational diabetes mellitus patients: a systematic review and meta-analysis of randomized controlled trials. PROSPERO. 2020. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020180634 Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015; 4:1. https://doi.org/10.1186/2046-4053-4-1 Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan—a web and mobile app for systematic reviews. Syst Rev. 2016; 5:210. https://doi.org/10.1186/s13643-016-0384-4 American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014;37 Suppl 1: S81-90. https://doi.org/10.2337/dc14-s081 Rossi G, American Diabetes Association. [Diagnosis and classification of diabetes mellitus]. Recenti Prog Med. 2010; 101:274–6. http://www.ncbi.nlm.nih.gov/pubmed/20842952 Nyaga VN, Arbyn M, Aerts M. Metaprop: a Stata command to perform meta-analysis of binomial data. Arch Public Heal. 2014; 72:39. http://archpublichealth.biomedcentral.com/articles/10.1186/2049-3258-72-39 Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003; 327:557–60. http://www.bmj.com/cgi/doi/10.1136/bmj.327.7414.557 Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S, et al. Grading quality of evidence and strength of recommendations. BMJ. 2004; 328:1490. http://www.bmj.com/lookup/doi/10.1136/bmj.328.7454.1490 Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JPA, et al. 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“…As a consequence, a higher number of people are finding themselves deficient in this essential nutrient. This situation underscores the intricate interplay between global health crises and nutritional status, shedding light on the multifaceted nature of public health challenges in the face of unprecedented events [10,11].…”

Section: Introductionmentioning

confidence: 99%

Knowledge and practice regarding prevention of osteoporosis among Iraqi women

Yahyaa,

Al-Samarrai

2023

Background: Osteoporosis is known to cause long-acting disability. This study aimed to explore the knowledge, and preventive practice among women attending the primary health centers (PHC) in Al Ramadi City, west of Iraq. Methods: A cross-sectional study was conducted between January and March 2022. A simple random sampling technique was recruited to collect samples using face-to-face interviews of women during the routine visit to PHCs. Univariate and bivariate were used to analyze the data. The statistical package for the social sciences was used for data analysis. Results: Two hundred and fifty women were interviewed with a mean age of 37.9 ±11.3 years. The majority of them were married (87.0%), and unemployed or housewives (66.0%). Although, most of the participants heard about osteoporosis (238, 95.2%), and the possibility to cause pain before the occurrence of fracture (67.6%), the average knowledge score on osteoporosis was 55.75 ± 18.87. Furthermore, the surveyed women reported that practices of sunlight exposure (p=0.000), calcium-rich foods (p=0.003), and Vitamin D supplementation (p=0.022) are significantly related to reducing the risk of Osteoporosis. Healthcare providers played a significant role to support women with osteoporosis-related knowledge. Conclusion: Although most women heard about the disease, their level of knowledge was modest, which might affect the measures necessary to prevent the disease.