|Year : 2022 | Volume
| Issue : 1 | Page : 1-7
Blinding and its quality in clinical trials conducted on patients with breast cancer: A systematic review
Pegah Matourypour1, Azam Ghorbani2, Mokhtar Mahmoudi3, Niloufar Binaei4, Hadi Jafary Manesh5, Nahid Dehghan Nayeri6, Imane Bagheri7
1 Medical-Surgical Nursing Department, School of Nursing and Midwifery, Tehran University of Medical Science, Tehran, Iran
2 >Medical-Surgical Nursing Department, School of Nursing and Midwifery, Tehran University of Medical Science, Tehran, Iran
3 Clinical Care Research Center, Research Institute for Health Development, Kurdistan university of Medical Science, Sanandaj, Iran
4 Department of Adult Health, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Iran
5 Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Tehran, Iran
6 Nursing and Midwifery Care Research center, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran
7 School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran
|Date of Submission||03-May-2020|
|Date of Decision||07-Jul-2020|
|Date of Acceptance||16-May-2021|
|Date of Web Publication||25-Jan-2022|
Dr. Nahid Dehghan Nayeri
Nursing and Midwifery Care Research Center, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran
Source of Support: None, Conflict of Interest: None
Background: Blinding is one of the critical criteria of clinical trials that prevents probable bias. Judgment regarding results of an intervention significantly depends on the quality of such studies, one of which is blinding. This study aimed to investigate blinding and its quality in clinical trials in patients with breast cancer. Materials and Methods: A systematic review was conducted on the online databases of PubMed, ScienceDirect and ProQuest using keywords, MeSH terms and grey literature. Articles were screened by predefined inclusion and exclusion criteria. They were evaluated based on the checklists introduced by Cochrane database. Results: From 22519 articles obtained at the initial stage, 20 articles remained after screening for the inclusion and exclusion criteria. Fifteen articles had used single, five: double and none had used triple or quadruple blinding. Seventeen studies had described the details of blinding. Of the 15 single blind articles, the blinded subjects were patients in five, patients and research assistants in three, research assistants in five studies, and two had not given any details. Conclusions: The majority of researchers had used the single blind method, though using double, triple or quadruple blinding increases the trustworthiness of results and increases the quality of clinical trials. The details of blinding should be explained to other researchers and for a better understanding of the method if it is to be repeated. Thereafter, nurses can apply new interventions and earn their patients' trust and help those with breast cancer by relieving them of their disease symptoms and its treatment complications.
Keywords: Breast neoplasms, clinical trial, double-blind method
|How to cite this article:|
Matourypour P, Ghorbani A, Mahmoudi M, Binaei N, Manesh HJ, Nayeri ND, Bagheri I. Blinding and its quality in clinical trials conducted on patients with breast cancer: A systematic review. Iranian J Nursing Midwifery Res 2022;27:1-7
|How to cite this URL:|
Matourypour P, Ghorbani A, Mahmoudi M, Binaei N, Manesh HJ, Nayeri ND, Bagheri I. Blinding and its quality in clinical trials conducted on patients with breast cancer: A systematic review. Iranian J Nursing Midwifery Res [serial online] 2022 [cited 2022 Nov 29];27:1-7. Available from: https://www.ijnmrjournal.net/text.asp?2022/27/1/1/336444
| Introduction|| |
Based on recent statistics released by the World Health Organization (WHO), cancer is the second cause of death in the world after cardiovascular disease. In Iran, it is the third cause of death. Different interventional studies have been conducted to evaluate the effects of different interventions aimed at relieving the symptoms of the disease and the side-effects of different therapies such as chemotherapy and radiotherapy to reduce morbidity and mortality rates in cancer patients., Any judgment regarding the results of a research and the effect of the intervention involved significantly depends on the quality of such studies.,
Compared to other types of studies in health research, a clinical trial is the most appropriate and valuable method for evaluating the effect of a treatment. High quality clinical trials should be conducted and reported to achieve this goal, and in doing so allow the audience to judge the internal consistency of the study. One of the aspects of a clinical trial that indicates the extent to which it is free from probable bias is using the blinding technique. After controlling the intervention and random allocation, blinding is the most significant criterion in clinical trials, which is included in many quality study tools like the Jadad scale that allocates two fifths of its score to blinding. The Cochrane checklist too is a standard, reliable, and well-known tool for assessing the quality of systematic review articles.,
Blinding is one of the methods of reducing the probability of research bias, which can affect the validity of research results. It is used in different parts of research, such as, concealing data from the participants, data collector and provider, intervention provider, and even data analyzer. Thus, the biases expected to occur in different parts of an interventional study can be avoided., In order to investigate blinding, the standards of blinding and its types should be defined first. Blinding refers to concealing information about the type of treatment provided to a specific group of participants. Simply referring to the types of blinding used is not enough as it can be confusing to the readers. Thus, the authors need to clearly specify who has been blinded in the research process. The accurate interpretation of a clinical trial is possible when there is accurate information on the methods of design and analysis of outcomes. Previous studies indicate that blinding is one of the issues less addressed in clinical trial designs.,,,
Subsequently, as mentioned above, a variety of biases ensue and the study results become questionable. The interpretation of clinical trials' results depends on the quality of methods and blinding as a means to prevent bias. Given that breast cancer is the most prevalent cancer and second cause of mortality in women, a search was conducted in the Cochrane database to check whether the subject was not repetitive. We found several studies that had examined the quality of clinical trials but not specifically in patients with breast cancer.,, Hence, in this study we aimed to investigate blinding and its quality in clinical trials in patients with breast cancer.
| Materials and Methods|| |
This research is a systematic review conducted between 2012 and 2019. The search strategy, article selection, and evaluation of articles' quality are explained in details below: Search was conducted in the valid medical science databases of PubMed with the MeSH term 'single blind method' and 'double blind study' and, 'breast neoplasm' and other databases such as ScienceDirect and ProQuest with the keywords of breast cancer/neoplasm and blind study and single/double blind study on clinical trials in humans as well as the Iranian database 'SID' with the keywords 'breast cancer' and 'Blinding' [Table 1]. Then, the articles were evaluated based on the checklists introduced by the Cochrane database.
The inclusion criteria included, the presence of the keywords 'breast cancer' and 'blinding' in the title and abstract, the interventional nature of the research, English or Persian language articles, the intervention being conducted in the nursing field. The exclusion criteria included, not having used blinding methods, the acquisition of less than 12 points from the checklist, and the lack of availability of the articles' full texts.
During the first stage, all the articles were reviewed by three researchers in terms of relevancy of the titles and abstracts (interventional method/application of blinding/patients with breast cancer) and irrelevant articles were removed. Then, the articles' full texts were acquired and after omitting the names of the authors and the journals the reviewers began reviewing the articles. Thereafter, the section on the type and manner of blinding by the corresponding checklist was completed for each English and Persian article. Obtaining at least 12 scores from 20 was mandatory for inclusion., Finally, an expert on research methodology evaluated the assessment procedures on the final articles and made suggestions to be applied. After the first search we screened the final articles' references as our second search, but no new article was found.
The checklist was designed based on the items introduced by Cochrane for systematic reviews. Its validity and reliability were measured and confirmed by ten experts in the research methodology, epidemiology, and nursing groups. The calculated Content Validity Index (CVI) was 0.87 and the reliability of all the items on the checklist was estimated at 0.92 Cronbach's Alpha, both of which were acceptable. The checklist is demonstrated in [Table 2].
|Table 2: Clinical trials conducted on breast cancer in the field of nursing that have used the blind method|
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This study was approved by the ethics committee of the Nursing and Midwifery Research Centre of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.FNM.REC.1399). In this systematic review and meta-analysis, the collected data were only used for scientific purposes, and intellectual property was observed in the reporting and publication of the results.
| Results|| |
Of the 22519 articles retrieved at the initial stage of the search, first the duplicate articles were removed (6832 articles). Twenty articles were finally included in the review based on the inclusion and exclusion criteria and checklist scores [Figure 1]. The final results are shown in [Table 2] in terms of the intervention, outcome, type of blinding, sample and randomization.
|Figure 1: Figure showing the different phases involved in searching relevant publications|
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Clinical trials conducted on various types of patients with breast cancer,,,,,,,,,,,,,,,,,,, were included, the risk of breast cancer incidence among this population,,, breast cancer survivors,,,,,,, those suffering from breast cancer,,,,,,,,, patients undergoing chemotherapy,,, patients undergoing radiotherapy, and patients awaiting surgery.
In the final stage, the effects of different interventions were evaluated to decrease or eliminate certain variables including fatigue,,,, musculoskeletal symptoms,,, conditional and acute nausea and vomiting due to chemotherapy (intensity, duration),,, interventions on lifestyle, physical and mental quality of life, cognitive function and physical activity, physical function,, the incidence of breast cancer, mental stress,, cognitive function (memory and information processing speed), preoperative anxiety, treatment-related symptoms (pain and stress, radiotherapy), lymphedema, remembering routine screening times, cellular immunity, and depression.
Interventions in clinical trials
Interventions conducted in different clinical trials included, therapeutic touch (energy therapy),,, short-term psychotherapy, Chinese medicinal herbs, physical therapy, Tai Chi and Qigong Day,, SMS reminders, short dance moves, aromatherapy, cognitive therapy, acupressure, recognition of behavioral therapy, support groups, green tea extract consumption, acupuncture, weight lifting, progressive muscle relaxation and mindfulness meditation and lifestyle interventions.
Types of blinding and their quality
From a total of 20 articles, 15 had used single, 5 had used double and neither study had used triple or quadruple blinding. Of the 15 single blind articles, the blinded subjects were patients in five studies,,,,; they were patients and research assistants in three studies,, and were research assistants in five studies.,,,, Two studies failed to explain the blinded subjects and their details., In five articles, double blinding was used.,,,, In these studies, except for one study, the details of blinding had not been mentioned. In the remaining four cases, blinding had been performed on the samples and the researcher and the samples and subjects, who analyzed data, on the samples and the physician/nurse/other member of the treatment team were unaware of the intervention type.
| Discussion|| |
Of the 20 final articles retrieved from nursing – related studies, 15 had used the single blind method while five studies had used double blinding. No study had used triple or quadruple blinding. This is not a desirable finding, as unintentional systematic bias may occur and it can threaten the reliability of the research results, which can be minimized by blinding. Polit and Beck introduced blinding as a technique that can reduce bias through single, double, triple and quadruple blind methods. The greater the number of blinded parties in the research, the lower the probability of bias that is out of the researcher's control. Thus, indicating the importance of employing robust methods in clinical trials to raise the validity of results.
Of the 15 single-blind articles, the blinded subjects were patients in five studies,,,,; they were patients and research assistants in three studies,, and were research assistants in five studies.,,,, Two studies failed to give any explanations regarding the blinded subjects and their details., In five articles, the double blind method was used.,,,, Seventeen out of 20 studies had described the details of their blinding, although some studies had not done so. The quality with which clinical trials are conducted and describing blinding along with its details are of great importance, as nurses can use reliable research results that can improve patient care. Therefore, blinding along with other positive advantages of the method like multi-group random allocation, and allocation concealment can increase the quality of a clinical trial and yield more accurate and reliable results. Paying attention to blinding improves the quality of such studies because of their significant impact on patient care. In fact, attention is paid to the quality of studies in terms of design to enable the generalization of their results, at the same time that analyzing the quality of the reported findings is of great value to the readers and/or users of research results.
Since blinding is one of the criteria for evaluating the quality of research, double or even triple or quadruple blind methods are recommended. Given that this kind of methodology has higher quality the results of a clinical trial that has employed this methodology can be trusted more too. Thus, future overviews on other factors affecting the quality of the methods employed, such as sampling, sample size calculation formula, data collection, etc., are also suggested.
This research has certain limitations. We did not have access to the full texts of some of the articles, despite the correctness of their titles and abstracts and their suitability for inclusion in the review. Moreover, limiting the language of the articles to English/Persian and restricting our search to four databases were other limitations of our study, whereas, other databases could contain further relevant and valuable researches.
| Conclusion|| |
Blinding has a critical role in preventing bias, so using double, triple or quadruple blinding increases the trustworthiness of clinical trial results. Thus, in any clinical trial, it should be clearly specified who has been blinded to raise the trustworthiness of results. Thereafter, nurses can apply new interventions and earn their patients' trust and help those with breast cancer by relieving them of their disease symptoms and its treatment complications by using such trustworthy results.
This research has been approved by the Nursing and Midwifery Care Research Center of Tehran University of Medical sciences under project number 47816.
Financial support and sponsorship
Tehran University of Medical Sciences
Conflicts of interest
Nothing to declare.
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[Table 1], [Table 2]