March 2023 Wound and Ostomy Journal
Randomised controlled trial to assess
and compare the performance and
safety of two-piece ostomy appliances
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Bethany Sobesto 4/14/23
ReplyDeleteDiscuss the limitations of the article.
A limitation of the study is that only 38 patients were in it. That is a small number of patients. Another limitation of the study is it was no a blind study. The patients knew which ostomy device products they were using. This makes the subjective variables unreliable. The subjective variables assessed, in the study, were patient acceptability and user friendliness.
Describe the method used by the author.
It was a randomized, controlled, non-blind, crossover study which compared two ostomy devices. Wear time was assessed as well as skin condition, safety, and patient acceptability.
1. Discuss the sample size used in the study.
ReplyDeleteThis study involved 38 patients with colostomies and ileostomies and compared the test device to a similar device from the same manufacturer but with no take border. Patients included were female and male adults consenting to participate in the study and able to comply with the study requirements. Patients experiencing peristomal skin complications or receiving chemotherapy and/or steroids over the past month were excluded from the study.
1. Describe the method used by the author of the study.
The study was designed as a randomized, prospective, controlled, comparative, cross-over, open-label, multicenter clinical trial. Patients were randomized to group A or group B. The assessment included three visits, and each product was used for approximately 21 days. Randomized controlled trials (RCTs) are considered the second highest level of evidence to establish causal associations in clinical research. There are many RCT designs and features that can be selected to address a research hypothesis.
Discuss the limitations of the article.
ReplyDeleteLimitations include the number of participants which are only 38 patients with colostomies and ileostomies and that this study lacked blinding. Individual assessments of products acceptability and user friendly are subjective, may involve larger participants.
What are the advantages to the proposed recommendations in the article?
The study showed that both devices demonstrated non inferiority. patients stated that both devices were user friendly. Both devices showed safety use, maintaining healthy stoma. Maintaining healthy peristomal skin is critical in ostomy management.Choosing appropriate ostomy collection appliance is important and different factors should be considered.
1. Describe the method used by the author of the study
ReplyDeleteThis article is a randomized, prospective, controlled, comparative, non-blinded, multicentered, cross-over study involving 38 patients (with colostomies and ileostomies) compared the test device to a similar device from the same manufacturer but without the tape border. First, the study assessed wear time for non-inferiority as a measure of efficacy. Secondly, peristomal skin condition was assessed by the DET (discoloration, erosion and tissue growth score and patient acceptability. Lastly, the study assessed the incidence and intensity of device related adverse events and the condition of the peristomal skin.
2. Discuss the sample size used in the study.
According to the study, the samples of patients were 38 who can be female and male adults but pregnant and breast-feeding women did not involve in the study. The participants have either a colostomy or an ileostomy for at least one month and the stoma was limited one with a diameter <65mm. The study excluded the population who are experiencing peristomal skin complication or had received any treatment including chemotherapy over the previous month.
Describe method use of author of the study:
ReplyDeleteThe author used randomized, controlled , non-blinded cross over study comparing the test device from same manufacture but without tape border.
Discuss the sample size: Only 38 patients with colostomy and ileostomy are involved in the study .
Method:
ReplyDeleteThe study was a randomized, prospective, controlled, comparative, cross-over, open-label multicentre clinical trial comparing two two-piece collecting systems for ostomy patients. All participants used both products in a sequential order with each patient serving as their own control. Patients were randomized into group A or B indicating which device they would use first and second. The assessment included 3 visits and each product was used for 21 +/- 3 days and the total follow up time for each patient was 42 +/-6 days. Forty patients participated with data analyzed from 38 of those participants.
Limitations:
Blinding was impossible for this type of study as each participate was aware of which product they were using when. While the objective assessments of this study can be applied to any clinical environment, the subjective assessment results apply particularly to patients similar to those in this trial and in environments similar to that in which this study was conducted. The small sample size was enough to show “non-inferiority” because ware time of the product is an objective variable, however a larger sample size would be needed when the main objectives of the study are based on subjective variables.
Describe the method used by the author of the study.
ReplyDeleteAn open-label trial was used in this study. Both investigators and
trial participants are fully aware of which treatment group the
participants are in and what treatments are assigned to them.
Open-label trials are used to compare different treatments or gather
further information on the long-term effects of new treatments. All
patients used both products F3S andF3STBi n a sequential order with
each patient serving as their own control.
Discuss the sample size used in the study.
A sample size of 38 patients is small for this study. After
analysis of results, this study concluded that the average wear time
for both devices is 4.5 days and demonstrated non-inferiority.
Describe the Method used by the author if the study.
ReplyDeleteThis study was designed as a randomized, prospective, controlled, comparative, cross-over, open-label, multicenter clinical trial. All patients used both products in a sequential order with each patient serving as their own control. At inclusion, patients were randomized to group A (who used F3S first then F3STB) or group B (who used F3STB first then F3S). The assessment included three visits (first: inclusion visit; second: cross-over visit; and third: end-of-trial-visit). Each product was used for 21±3 days so the total follow-up time for each patient was 42±6 days (Figure 2).
Describe the Sample size.
40 patients were included in the study, including me nand women. One patient was excluded because he was not evaluated for the main endpoint. Therefore, the full analysis set included 39 patients: 28 men and 11 women; 31 of whom (79.5%) were colostomies and eight (20.5%) ileostomies; there were no significant differences between groups.
Patricia Rios
ReplyDeleteHow does this research article compare to our practice, policy and/or procedure?
Regardless of whether or not the stoma surgery was planned, the patient will be overwhelmed by the physical changes in their body, which may lead to emotional issues. Patients with ostomies should seek the guidance of professionals for ordering correct supplies, and teaching process for better outcome in caring of colostomies and ileostomy. The PSJMC policy, requires that nurses must assess the colostomies and ileostomy stoma for proper fit, but at the same time nurses must assess for tissue integrity. At PSJMC, nurses insure that patients’ must understand the supplies needed and how every piece are putted together for the proper care and better outcome.
what are the advantages and disadvantages to the proposed recommendations in the article?
The advantage of this study is that data it is randomized controlled, non-blinded, cross-over study. according to researchers this type of study has a better outcome than control ones. Patients completed the diary at each base plate change, specified the reason for base-plate removal and indicated accessory use, if applicable.
The disadvantage of that sample only represents 38 patients. This study has approved on Malaysia that mostly not represent the PSJMC community. Each patient has its own control sample. Based on information of this sample, it is difficult to assume the study could apply to every patient with colostomy and ileostomy
One objective missing is that the study did not touch the possible embarrassing or awkward but it’s best to remain objective and neutral, showing openness to explore finding answers with patient.
1. Describe the Method used by the author if the study.
ReplyDeleteThe study is base on a randomized controlled, non-blinded; cross over study involved 38 patients with existence of colostomy and illeostomies compared the test device to a similar test device the the same manufacture but without tape border.
* Ostomy management; Two-piece ostomy device; Tape border; Flat base plate; extended wear time
The main objective of the study was to compare the clinical performance of an ostomy collection device with a tape border (F3STB) in terms of wear time with a similar device without a tape border (F3S) and assess for non-inferiority.
2. Discuss the sample size used in the study.
The sample size calculation was based on existing evidence that wear time for the F3S for about 5 days. The non-inferiority assessment, a decrease of 10% in wear time was considered an acceptable limit without practical consequences. The non-inferiority margin for F3STB was set as 0.5 days. For a 2x2 cross-over study design, with a level of significance alpha=2.5% (unilateral test), power=90 %, an estimated standard deviation of 0.9 and a true mean difference (mean for F3STB–mean for F3S)=0, the required population was estimated to be 38 patients. If a patient who withdrew would have to be replaced.
The studies includes 39 patients: 28 men (71.8%) and 11 women (28.2%), 31 of whom (79.5%) were colostomates and eight (20.5%) ileostomates; there were no significant differences between groups.
1.Describe the method used by the author.
ReplyDeleteIt was a randomized, controlled, non-blind, crossover study which compared two ostomy devices from the same manufacturer that were with and without a tape border.
2.Discuss the sample size used in the study.
this study involved 38 patients with colostomies and ileostomies that had similar devices from the same manufacter that were with and without a tape border. Exclusions included patients experiencing peristomal skin complications or receiving chemotherapy and/or steroids over the past month.
-alexandria ordonez
Discuss the sample size used in the study:
ReplyDeleteThis was a randomized controlled, non-blinded, cross-over study involving 38 patients. The primary objective of the study was to compare the clinical performance of two ostomy collection devices in relation to wear time and to assess for non-inferiority. One device has a taped border (F3STB), and the other has a non-taped border ((F3S). The study patient population included both males and females. The patients needed to willingly participate, and be able to comply with the studies requirement that they had a colostomy or ileostomy for at least one month. In addition, they needed to have an ostomy with a diameter <65mm, and wear flat based appliances with an average of 5 days between base plate changes. Patients were excluded if they were experiencing skin complications, receiving any chemotherapy, or receiving any treatment with corticosteroids over the previous month. Finally, any pregnant or breastfeeding women were excluded.
Limitations of the article: sample size:
This study contained only 38 patients. They were divided into two groups, Group A and Group B. Group A used F3S first and then F3STB. Group B used F3STB first and then F3B. There were three patient visits included in the study. First, the inclusion visit, second, the cross-over visit, and third, the end-of-trial visit. Each product was used for 21 +/- 3 days. The total follow-up time for each patient was 42 +/- 6 days. All the patients completed the follow-up visits. The study concluded that the F3STB was not inferior to the F3S in terms of wear time. In addition, the F3S and the F3STB could be considered similar in clinical effectiveness and safety. The participating patients also found both devices highly acceptable and easy to use. I just feel that having only 38 patients participate in this study was totally inadequate. The published results of the study basically states that both devices were fundamentally the same. I think a larger group study could possibly identify a clear front-runner between the two devices.
Describe the method used by the author.
ReplyDeleteThe method used by the author was a randomized, controlled, non-blind, crossover study. It compared two ostomy devices from eh same manufacturer; with and without a tape border. Patient exclusion included those with established skin complications, on chemotherapeutics or corticosteroids within the last month, or any breastfeeding or pregnant female.
Discuss the sample size used in the study.
The sample size used in the study was comprised of 38 gender-inclusive patients who were divided into two groups to test the two varying ostomy devices. Although the findings indicated that one device (F3S) was not worst than the other (F3STB), I do believe that the sample size is far too small to make the determination. The “n” factor should be greater to establish a clearer result between the two.
Discuss the sample size used in the study:
ReplyDelete38 adults willing to participate in the study and comply with all requirements who had a colostomy or ileostomy for at least one month, wore appliances with a flat base plate with an average of 5 days between plate changes, and had an ostomy with a diameter <65mm. Excluded adults were those who had peristomal skin complications, had received chemo or corticosteroids over the past month, and pregnant and breastfeeding women.
Describe the method used by the author of the study:
The method used in this study was a randomized, prospective, controlled, comparative, cross-over, open-label multicentre clinical trial. All patients used appliances in sequential order with each patient serving as their own control, and were either in randomized in group A or B. The assessment consisted of 3 visits and each product was used for an average of 21 days and the total follow-up time was 42 days plus or minus 6 days.
1. Describe the method used by the author of the study.
ReplyDeleteThe method used in the study was a randomized controlled, non-blinded, cross-over study involving 38 patients with colostomies and ileostomies that compared the test device to a similar device from the same manufacturer without the tape border.
2. Discuss the sample size used in the study.
The sample size used in the study included 38 patients with colostomy or ileostomy but excluded those with existing peristomal skin complications or has received treatment including chemotherapy in the last month.
Discuss the sample size used in the study.
ReplyDeleteThe sample size of 38 patients was sufficient given the randomization and considerations to variables such as changes in the wear time and contingencies in the event of study participants dropping out. In other words, the sample size was chosen to ensure that the study had a good chance of detecting the expected difference in wear time between the two products if it truly existed.
Discuss the limitations of the article: limited sample size, design flaws, and/or author bias
Given the description of the methodology, no bias appears to exist, but the lack of bias cannot doesn't exclude the possibility that it is present in a subtle or unconscious way. However, the methodology does seem to follow best practices for clinical trials (e.g., randomization, blinding, and predefined endpoints).
1. Describe the method used by the author of the study:
ReplyDeleteIn a non-blinded, randomized controlled crossover study, 38 patients who had colostomies and ileostomies were involved in comparing the test device to a similar device from the same manufacturer, with the only difference being the absence of a tape border. The primary aim of the study was to evaluate the wear time of the test device to establish its non-inferiority as an efficacy measure. Secondary evaluations included assessing the condition of the peristomal skin using the DET (discoloration, erosion, and tissue growth) score and gauging patient acceptability through questionnaires with Likert-scale options.
2. Discuss the sample size used in the study:
The full analysis set included 39 patients: 28 men (71.8%) and 11 women (28.2%), 31 of whom (79.5%) were colostomates and eight (20.5%) ileostomates
Describe the method used by the author of the study
ReplyDeleteA randomized controlled, non-blinded, cross-over study involving 38 patients (with colostomies and ileostomies) compared the test device to a similar device from the same manufacturer but without the tape border. The main objective was to assess wear time for non-inferiority as a measure of efficacy.
Discuss the sample size used in the study.
This study compared the test device to an identical device from the same manufacturer but without a take border, involving 38 patients with colostomies and ileostomies. Adult female and male patients who gave their consent and could follow the study's instructions were enrolled in the trial. Patients who had peristomal skin problems or had recently had steroids, chemotherapy, or both were not included in the study.
1. Describe the method used by the author of the study
ReplyDeleteThe method of study was in aa randomized controlled, non-blinded, cross over study. Each of the patients used both of the devices in a sequential order. Patients were randomized with group A (who first used F3S then F3STB) or group B ( who first used F3STB then F3S). The F3S has a base plate with full hydrocolloid adhesive skin protector and a mechanical coupling ring. While, F3STB has the same base plate, but with an additional acrylate-based non woven adhesive extension.
2. Discuss the sample size used in the study.
The sample size used for this study was 38 patients with 346 base plate changes. These 38 patients either had colostomies or ileostomies. The main objective for this study is to compare the performance of the ostomy collection device wit the tape border. The participants consisted both of male and female adults and had the ostomy for at least 1 month and had the ostomy with a diameter less than 65 mm.
Discuss the sample size used in the study.
ReplyDeletePatients included were 11 females and 28 males adult who had a colostomy or an ileostomy for at least one month (31 colostomates and 8 ileostomates), using appliances with a flat base plate with an average of 5 days between base plate changes, and had an ostomy with a diameter less than 65 mm. They excluded patients receiving chemo or steroid therapy over the previous month.
Mean age 56.7 ±15.2 years.
Describe the method used by the author of the study:
This study was designed as a randomized, prospective, controlled, comparative, cross-over, open-label, multicenter clinical trial. Patients were split in two groups, group A and group B. The assessment included 3 visits; 1st visit was inclusion visit; second visit was cross-over visit; and third was end-of-trial-visit. Each product was used for 21±3 days so the total follow-up time for each patient was 42±6 days.
1. Discuss the sample size used in the study.
ReplyDelete39 Patients included were female and male adults, willing to participate and able to comply with the study requirements, they had had a colostomy or an ileostomy for at least one month, were appliances with a flat base plate with an average of 5 days between base plate changes, and had an ostomy with a diameter <65 mm.
2. what are the advantages and disadvantages to the proposed recommendations in the article?
Both devices showed similar safety profiles with a very low incidence of adverse events.Patients found both devices highly acceptable and easy to use, and these results should be taken within the context of individual patient requirements and specific local healthcare circumstances.
choosing the ostomy appliance should be based on patients preference whichever is easier for the to use,that can remain intact to prevent often ostomy changes that can lead skin stripping, it should be cost effective, or can be covered by their insurance