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Hemşirelik Araştırmalarında Randomize Kontrollü Çalışmaların Raporlanması ve Non-farmakolojik CONSORT Uzantısının Kullanımı

Year 2022, Volume: 5 Issue: 3, 433 - 439, 05.12.2022
https://doi.org/10.38108/ouhcd.1011788

Abstract

Kanıta dayalı tıbbın en önem ilkesi; mevcut kanıtların değerlendirilmesi, en iyi kanıtlara ulaşılması ve bu kanıtlar doğrultusunda karar verilmesidir. Kanıta dayalı hemşirelik uygulamalarının temelini ise; hemşirelik alanındaki en iyi kanıtların üretilmesi, bu kanıtların klinik uzmanlık ve hasta tercihleri ile entegrasyonun sağlanarak hemşirelik bakımında kullanımı oluşturmaktadır. Bu kapsamda randomize kontrollü deneysel tasarımlar kanıtların üretilmesi ve hemşireleri klinik hemşirelik kararları konusunda bilgilendirilmesiyle doğrudan ilişkili ve vazgeçilemez konumdadır. Son yıllarda, hemşirelik alanında deneysel olarak tasarlanan ve yayınlanan çalışmaların sayısında artış görülmektedir. Ancak randomize kontrollü deneysel tasarımların metodolojisini, bulgularını eksiksiz, açık ve şeffaf bir şekilde sunulmasını sağlayan raporlama sistemlerinin kullanımıyla ilgili sınırlılıklar devam etmektedir. Bu nedenle randomize kontrollü çalışmaların raporlama standartlarını belirlemek, sistematik raporlama hatalarından kaçınmak için, hemşirelik araştırmalarının uluslararası geçerliliği olan kontrol listelerine göre raporlandırılması önemlidir.
Bu derlemede, hemşirelik alanında randomize kontrollü çalışmaların Konsolide Raporlama Denemeleri Bildirimi (CONSORT) sistemine göre raporlanmasının önemini vurgulamak ve hemşirelik araştırmalarında non-farmakolojik CONSORT uzantısının kullanımı hakkında farkındalık oluşturmak amaçlanmıştır.

Supporting Institution

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Project Number

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Thanks

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References

  • Akın B, Kocoglu D. (2017). Randomize kontrollü deneyler. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi, 4, 1, 73-92.
  • Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD. (2013). Reporting of patient-reported outcomes in randomized trials: The consort pro extension. The Journal of the American Medical Association, 309, 8, 814-822.
  • Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P. (2017). Consort statement for randomized trials of nonpharmacologic treatments: A 2017 update and a consort extension for nonpharmacologic trial abstracts. Annals of Internal Medicine, 167, 1, 40-47.
  • Boutron I, Guittet L, Estellat C, Moher D, Hrobjartsson A, Ravaud P. (2007). Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. Public Library of Science Medicine, 4, 2, 61.
  • Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. (2012). Consort 2010 statement: Extension to cluster randomised trials. British Medical Journal. 345, 5661.
  • Chan AW, Altman DG. (2005). Epidemiology and reporting of randomised trials published in pubmed journals. The Lancet, 365, 9465, 1159-1162.
  • Cheng CW, Wu TX, Shang HC, Li YP, Altman DG, Moher D, Bian ZX, CONSORT-CHM Formulas 2017 Group (2017). Consort extension for chinese herbal medicine formulas 2017: Recommendations, explanation, and elaboration. Annals of Internal Medicine, 167, 2, 112-121.
  • DiCenso A, Guyatt G, Ciliska D. (2005). Evidence-based nursing: A guide to clinical practice. Elsevier Health Sciences, p. 508-509.
  • Djulbegovic B, Guyatt GH. (2017). Progress in evidence-based medicine: A quarter century on. The Lancet, 390, 10092, 415- 423.
  • Dwan K, Li T, Altman DG, Elbourne D. (2019). Consort 2010 statement: Extension to randomised crossover trials. British Medical Journal, 36, 6, l4378.
  • Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. (2016). CONSORT 2010 statement: Extension to randomised pilot and feasibility trials. British Medical Journal, 355, 5239.
  • Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. (2006). Reporting randomized, controlled trials of herbal interventions: An elaborated Consort statement. Annals of Internal Medicine, 144, 5, 364-367.
  • Glasgow RE, Green LW, Klesges LM, Abrams DB, Fisher EB, Goldstein MG, et al. (2006). External validity: We need to do more. Annals of Behavioral Medicine, 31, 2, 105-108.
  • Gonella S, Di Giulio P, Pales A, Dimonte, V, Campagna, S. (2019). Randomized controlled trials and quasi‐ experimental studies published in nursing journals: Findings from a scoping review with implications for further research. Worldviews on Evidence‐Based Nursing, 16, 4, 299-309.
  • Gustafsson M, Bohman DM, Borglin G. (2014). Challenges of conducting experimental studies within a clinical nursing context. Applied Nursing Research, 27, 2, 133-136.
  • Hariton E, Locascio JJ. (2018). Randomised controlled trials the gold standard for effectiveness research. BJOG: An International Journal of Obstetrics and Gynaecology, 125, 13, 1716.
  • Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman, DG, et al. (2008). Consort for reporting randomised trials in journal and conference abstracts. The Lancet, 371, 9609, 281-283.
  • Ioannidis JP, Evans SJ, Gotzsche PC, Neill RT, Altman DG, Schulz K, et al. (2004). Better reporting of harms in randomized trials: An extension of the Consort statement. Annals of Internal Medicine, 141, 10, 781-788.
  • Jull A, Aye PS. (2015). Endorsement of the consort guidelines, trial registration, and the quality of reporting randomised controlled trials in leading nursing journals: A cross-sectional analysis. International Journal of Nursing Studies, 52, 6, 1071-1079.
  • Juszczak E, Altman DG, Hopewell S, Schulz K. (2019). Reporting of multi-arm parallel group randomized trials: Extension of the Consort 2010 statement. The Journal of the American Medical Association, 321, 16, 1610-1620.
  • Liu X, Rivera SC, Moher D, Calvert MJ, Denniston AK. (2020). Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: The Consort-Ai extension. The Lancet Digital Health, 2, 10, 537-548.
  • MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, et al. (2015). Revised standards for reporting interventions in clinical trials of acupuncture (Stricta): Extending the consort statement. Acupuncture and Related Therapies, 3, 4, 35-46.
  • McKenna H, Pajnkihar M, Murphy F. (2014). Fundamentals of nursing models, theories and practice. 2nd Edition, John Wiley & Sons, p. 23.
  • Melnyk BM. (2016). Level of evidence plus critical appraisal of its quality yields confidence to implement evidence‐based practice changes. Worldviews on Evidence‐Based Nursing, 13, 5, 337-339.
  • Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. (2012). Consort 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. International Journal of Surgery, 10, 1, 28-55.
  • Moher D, Jones A, Lepage L. (2001). Use of the Consort statement and quality of reports of randomized trials: A comparative before and after evaluation. The Journal of the American Medical Association, 28, 15, 1992-1995.
  • Montgomery P, Grant S, Mayo-Wilson E, Macdonald G, Michie S, Hopewell S, et al. (2018). Reporting randomised trials of social and psychological interventions: The CONSORT-SPI 2018 Extension. Trials, 19, 1, 407.
  • Pandis N, Chung B, Scherer RW, Elbourne D, Altman DG. (2019). Consort 2010 statement: Extension checklist for reporting within person randomised trials. British Journal of Dermatology, 180, 3, 534-552.
  • Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG. (2012). Reporting of noninferiority and equivalence randomized trials: Extension of the Consort 2010 statement. The Journal of the American Medical Association, 308, 24, 2594-2604.
  • Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. (1996). Evidence based medicine: What it is and what it isn't. British Medical Journal, 312, 7023, 71-72.
  • Schulz K, Grimes DA. (2018). Essential concepts in clinical research: Randomised controlled trials and observational epidemiology. 2nd Edition, Elsevier Health Sciences.
  • Schulz KF, Altman DG, Moher D. (2010). CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. BMC Medicine, 8, 1, 18.
  • Smith BA, Lee HJ, Lee JH, Choi M, Jones DE, Bausell RB. et al. (2008). Quality of reporting randomized controlled trials in the nursing literature: Application of the consolidated standards of reporting trials (Consort). Nursing Outlook, 56, 1, 31-37.
  • Tam W, Lo K, Woo B. (2020). Reporting sample size calculations for randomized controlled trials published in nursing journals: A cross-sectional study. International Journal of Nursing Studies, 102, 8, 103450.
  • Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, et al. (2012). Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. The Cochrane Database of Systematic Reviews, 11, 11.
  • Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid CH, Tate R, et al. (2015). CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. British Medical Journal, 350, 1738.
  • Welch VA, Norheim OF, Jull J, Cookson R, Sommerfelt H, Tugwell P. (2017). CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials. British Medical Journal, 359, 5085.
  • Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. (2008). Improving the reporting of pragmatic trials: An extension of the CONSORT statement. British Medical Journal, 337, 2390.

Reporting of Randomized Controlled Studies in Nursing Research and the Use of Non-pharmacological CONSORT Extension

Year 2022, Volume: 5 Issue: 3, 433 - 439, 05.12.2022
https://doi.org/10.38108/ouhcd.1011788

Abstract

The most crucial principle of evidence-based medicine; evaluating available evidence, obtaining the best evidence, and making a decision based on that evidence. The basis of evidence-based nursing practices; the production of the best available evidence in the field of nursing, the use of this evidence in nursing care by integrating with clinical expertise and patient preferences. In this context, randomized controlled experimental designs are directly related and indispensable for producing evidence and informing nurses about clinical nursing decisions. In recent years, there has been an increase in the number of experimentally designed and published studies in nursing. However, limitations remain regarding the use of reporting systems that provide a complete, open, and transparent presentation of randomized controlled experimental designs' methodology and findings. For this reason, it is crucial to report randomized controlled studies according to internationally validated checklists in nursing studies to determine reporting standards and to avoid systematic reporting errors.
In this review, it is aimed to emphasize the importance of reporting randomized controlled studies in the field of nursing according to the Consolidated Standards of Reporting Trials system and to raise awareness about the use of the nonpharmacological CONSORT extension in nursing research.

Project Number

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References

  • Akın B, Kocoglu D. (2017). Randomize kontrollü deneyler. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi, 4, 1, 73-92.
  • Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD. (2013). Reporting of patient-reported outcomes in randomized trials: The consort pro extension. The Journal of the American Medical Association, 309, 8, 814-822.
  • Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P. (2017). Consort statement for randomized trials of nonpharmacologic treatments: A 2017 update and a consort extension for nonpharmacologic trial abstracts. Annals of Internal Medicine, 167, 1, 40-47.
  • Boutron I, Guittet L, Estellat C, Moher D, Hrobjartsson A, Ravaud P. (2007). Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. Public Library of Science Medicine, 4, 2, 61.
  • Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. (2012). Consort 2010 statement: Extension to cluster randomised trials. British Medical Journal. 345, 5661.
  • Chan AW, Altman DG. (2005). Epidemiology and reporting of randomised trials published in pubmed journals. The Lancet, 365, 9465, 1159-1162.
  • Cheng CW, Wu TX, Shang HC, Li YP, Altman DG, Moher D, Bian ZX, CONSORT-CHM Formulas 2017 Group (2017). Consort extension for chinese herbal medicine formulas 2017: Recommendations, explanation, and elaboration. Annals of Internal Medicine, 167, 2, 112-121.
  • DiCenso A, Guyatt G, Ciliska D. (2005). Evidence-based nursing: A guide to clinical practice. Elsevier Health Sciences, p. 508-509.
  • Djulbegovic B, Guyatt GH. (2017). Progress in evidence-based medicine: A quarter century on. The Lancet, 390, 10092, 415- 423.
  • Dwan K, Li T, Altman DG, Elbourne D. (2019). Consort 2010 statement: Extension to randomised crossover trials. British Medical Journal, 36, 6, l4378.
  • Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. (2016). CONSORT 2010 statement: Extension to randomised pilot and feasibility trials. British Medical Journal, 355, 5239.
  • Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. (2006). Reporting randomized, controlled trials of herbal interventions: An elaborated Consort statement. Annals of Internal Medicine, 144, 5, 364-367.
  • Glasgow RE, Green LW, Klesges LM, Abrams DB, Fisher EB, Goldstein MG, et al. (2006). External validity: We need to do more. Annals of Behavioral Medicine, 31, 2, 105-108.
  • Gonella S, Di Giulio P, Pales A, Dimonte, V, Campagna, S. (2019). Randomized controlled trials and quasi‐ experimental studies published in nursing journals: Findings from a scoping review with implications for further research. Worldviews on Evidence‐Based Nursing, 16, 4, 299-309.
  • Gustafsson M, Bohman DM, Borglin G. (2014). Challenges of conducting experimental studies within a clinical nursing context. Applied Nursing Research, 27, 2, 133-136.
  • Hariton E, Locascio JJ. (2018). Randomised controlled trials the gold standard for effectiveness research. BJOG: An International Journal of Obstetrics and Gynaecology, 125, 13, 1716.
  • Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman, DG, et al. (2008). Consort for reporting randomised trials in journal and conference abstracts. The Lancet, 371, 9609, 281-283.
  • Ioannidis JP, Evans SJ, Gotzsche PC, Neill RT, Altman DG, Schulz K, et al. (2004). Better reporting of harms in randomized trials: An extension of the Consort statement. Annals of Internal Medicine, 141, 10, 781-788.
  • Jull A, Aye PS. (2015). Endorsement of the consort guidelines, trial registration, and the quality of reporting randomised controlled trials in leading nursing journals: A cross-sectional analysis. International Journal of Nursing Studies, 52, 6, 1071-1079.
  • Juszczak E, Altman DG, Hopewell S, Schulz K. (2019). Reporting of multi-arm parallel group randomized trials: Extension of the Consort 2010 statement. The Journal of the American Medical Association, 321, 16, 1610-1620.
  • Liu X, Rivera SC, Moher D, Calvert MJ, Denniston AK. (2020). Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: The Consort-Ai extension. The Lancet Digital Health, 2, 10, 537-548.
  • MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, et al. (2015). Revised standards for reporting interventions in clinical trials of acupuncture (Stricta): Extending the consort statement. Acupuncture and Related Therapies, 3, 4, 35-46.
  • McKenna H, Pajnkihar M, Murphy F. (2014). Fundamentals of nursing models, theories and practice. 2nd Edition, John Wiley & Sons, p. 23.
  • Melnyk BM. (2016). Level of evidence plus critical appraisal of its quality yields confidence to implement evidence‐based practice changes. Worldviews on Evidence‐Based Nursing, 13, 5, 337-339.
  • Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. (2012). Consort 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. International Journal of Surgery, 10, 1, 28-55.
  • Moher D, Jones A, Lepage L. (2001). Use of the Consort statement and quality of reports of randomized trials: A comparative before and after evaluation. The Journal of the American Medical Association, 28, 15, 1992-1995.
  • Montgomery P, Grant S, Mayo-Wilson E, Macdonald G, Michie S, Hopewell S, et al. (2018). Reporting randomised trials of social and psychological interventions: The CONSORT-SPI 2018 Extension. Trials, 19, 1, 407.
  • Pandis N, Chung B, Scherer RW, Elbourne D, Altman DG. (2019). Consort 2010 statement: Extension checklist for reporting within person randomised trials. British Journal of Dermatology, 180, 3, 534-552.
  • Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG. (2012). Reporting of noninferiority and equivalence randomized trials: Extension of the Consort 2010 statement. The Journal of the American Medical Association, 308, 24, 2594-2604.
  • Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. (1996). Evidence based medicine: What it is and what it isn't. British Medical Journal, 312, 7023, 71-72.
  • Schulz K, Grimes DA. (2018). Essential concepts in clinical research: Randomised controlled trials and observational epidemiology. 2nd Edition, Elsevier Health Sciences.
  • Schulz KF, Altman DG, Moher D. (2010). CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. BMC Medicine, 8, 1, 18.
  • Smith BA, Lee HJ, Lee JH, Choi M, Jones DE, Bausell RB. et al. (2008). Quality of reporting randomized controlled trials in the nursing literature: Application of the consolidated standards of reporting trials (Consort). Nursing Outlook, 56, 1, 31-37.
  • Tam W, Lo K, Woo B. (2020). Reporting sample size calculations for randomized controlled trials published in nursing journals: A cross-sectional study. International Journal of Nursing Studies, 102, 8, 103450.
  • Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, et al. (2012). Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. The Cochrane Database of Systematic Reviews, 11, 11.
  • Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid CH, Tate R, et al. (2015). CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. British Medical Journal, 350, 1738.
  • Welch VA, Norheim OF, Jull J, Cookson R, Sommerfelt H, Tugwell P. (2017). CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials. British Medical Journal, 359, 5085.
  • Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. (2008). Improving the reporting of pragmatic trials: An extension of the CONSORT statement. British Medical Journal, 337, 2390.
There are 38 citations in total.

Details

Primary Language Turkish
Subjects Nursing
Journal Section Review
Authors

Aliye Doğan 0000-0002-7467-6455

Hazal Özdemir Koyu 0000-0002-4418-613X

Naile Bilgili 0000-0002-7639-0303

Project Number -
Early Pub Date December 5, 2022
Publication Date December 5, 2022
Submission Date October 19, 2021
Published in Issue Year 2022 Volume: 5 Issue: 3

Cite

APA Doğan, A., Özdemir Koyu, H., & Bilgili, N. (2022). Hemşirelik Araştırmalarında Randomize Kontrollü Çalışmaların Raporlanması ve Non-farmakolojik CONSORT Uzantısının Kullanımı. Ordu Üniversitesi Hemşirelik Çalışmaları Dergisi, 5(3), 433-439. https://doi.org/10.38108/ouhcd.1011788