A randomised controlled trial on the effect of clamping the indwelling urinary catheter in patients with hip fracture

Critical Appraisal

In this quantitative research article, the authors have dealt with one of the most common clinical problem i.e. clamping of urinary catheter after hip surgery. Hip surgery is very common among the people of old age group especially above 75 years. Further, older women are more susceptible to hip fracture and commonly undergo hip injury (Johansson & Christensson, 2010). Bladder catheterization is a common clinical practice in surgeries. It helpful in monitoring urine output in patients. However, it is also associated with one of the major clinical problems, i.e. operative urinary retention (POUR). It can be defined as the inability of a patient to pass urine in spite of full bladder (Baldini, Bagry, Aprikian, & Carli, 2009). It is has been reported that patient of hip surgery are at higher risk of urinary retention (Balderi & Carli, 2010; Johansson & Christensson, 2010; Singh et al., 2010). In the case of hip replacement the incidence of POUR has been reported to be between 12- 84%. Similarly, in case of hip fracture the prevalence of POUR is 18% to 56% (Borghi et al., 2004; Oishi et al., 1995). The most effective intervention reported till date for reducing the risk of urinary retention is clamping of urinary catheter. The main objective of this paper was to investigate the efficacy of clamping of urinary catheter through randomized controlled trial in patients undergone hip surgery for fracture.

Title: The title of the present article seems incomplete. The feature of a good title is that it should reflect the main finding or take home message of the article. However, the title of the present article reflects only the main but not complete objective of the study. The title suggests that suggests that the paper deals with the investigation of effect of clamping urinary catheter. However, the major clinical problem being investigated is not even included in the study. The title does not include the word urinary retention which is the main focus of the study. The main objective of the study was to assess the efficacy of clamping urinary catheter in patients with hip fracture in on reducing the risk of POUR. Here, neither the objective nor the main outcome of the study can be understood from the title, therefore title is not deceptive.

Abstract: The Abstract is précised and written very well. Every part of the article has been described very briefly in abstract section. It includes objective, methodology, results, conclusion and relevance of the study to clinical practice. It is easy to understand the main purpose and finding of the study just by reading the abstract. The abstract alone is able to state the usefulness of the study.

Keywords: Key words are meant for searching the research article from database; therefore this section should include the words which describe the main focus of the study. In this research article, authors have not included the most important word i.e. urinary retention, on which the study has been focused. The main of the study was to find an effective intervention to reduce the risk of urinary retention, but the word “urinary retention” is lacking the keyword section.

Background: The background section is well organized and has been written in a flow. At first the present scenario on the clinical problem addressed in this study has been provided and then eventually the main clinical problem has been identified. This is the standard way of writing a background of a research article and it has been followed very well. The main area of the study i.e. hip injury among older people has been described in the first paragraph of the article. The first paragraph is very well correlated to the study area and the main clinical problem investigated in the study originates from this paragraph. The need for the catheterization and problems associated with it has been explain in this paragraph. Sufficient literature has been cited to support their requirement of catheterization in hip injury cases. In the second paragraph the clinical problem addressed in the study has been defined. Whilst in the first paragraph clinical problem has been introduced, in the second paragraph of the background, evidences on the severity of the clinical problem have been provided. Therefore, the second paragraph, certainly, proves the relevance of the conducted research in present clinical settings. The second paragraph, with the help of relevant literatures, gradually builds up the case for the study. The third paragraph actually justifies the need of the extensive research on efficacy of clamping of catheter on reducing the risk of POUR. In this paragraph, the factors affecting the clinical problem have been described. The literature provided in this section shows that there is a discrepancy in the findings of earlier study in related area. Various authors have shown contradictory data on the factors affecting the urinary retention in case of hip surgery. Though, authors of this article do not aim at studying the factors which affect urinary retention, yet, providing such information prior to defining the objective of the study is quiet helpful. The last paragraph establishes the relevance of the study in clinical setting. In this paragraph, the interventions used for reducing the risk of urinary retention has been described which is also supported by literature. The paragraph also provides some information of the probable mechanism of action of the intervention. The last paragraph, in real sense forms the basis of the study. The contradictory findings of earlier studies on the efficacy of the clamping of urinary catheter raise the need for further research in this field. Therefore, the need for research in this area is justified. Altogether, the background is well written, well organized and assists in the formulation of the objectives of the study.

Objectives: The background section builds up a conceptual framework on which the objectives have been planned. To simplify the study the objective has been divided into main objective and specific aims. The objectives are well defined with hypotheses put forwarded to determine the advantages and disadvantages of the clamping of catheter in hip injury patients.

Method: The study is a quantitative study based on randomized controlled trial (RCT). RCT is a type of research in which the efficacy of an intervention is determined by random assignment of participants to an intervention group or a control group. A Well designed RCT is viewed as a gold standard for evaluation of the effectiveness of an intervention. It is applied in various fields such as, education, psychology, medicine, clinical research, welfare, and employment. There are persuasive evidences about the validity of RCT which prove that (a) RCT is better than any other methods for measuring the true effect of an intervention; and (b) it is the most popular study design which comprises of “pre-post” studies and “quasi- experimental” studies.
In the method section, the basis of RCT design has been clearly stated. A description of research area and duration has been provided. The main advantage of selecting such research area is also provided. Eligibility criteria for the inclusion of participants in the study have been provided in the method section. The authors have included only those participants which fulfil the eligibility criteria. Ethical issues have been considered before the start of the experiment. Proper consent from the participants was obtained and patients were informed about the research. Any study involving patients should be approved by certain ethical committee. The present study was approved by regional ethical review board of Uppsala, Sweden. Since the study was an RCT, randomization should be proper in order to obtain a valid outcome. According to the information provided in the method section, the process of randomization seems proper. In order to abolish the gender effect stratification of men and women were achieved. The method of randomization has been described. The main demerit of the methodology was that the different groups in the study could not be blinded. The detail methodology of research has been provided along with appropriate literature. The methodology section is written in simple and ordered form that it can be easily repeated by any other researcher. This is an important feature of a good methodology section. For proper evaluation, a definition of normal bladder function was chosen and then accordingly, the time for the measurement of normal bladder function was determined. For data analysis, the expected outcomes were first defined and then analyzed accordingly. Base line correction is a characteristic of a good RCT. In present study, authors have performed baseline correction. The calculation for sample size was performed according to previously described protocol. According to the protocol, the mean time deviation for bladder to return to normal function was 5 hours; therefore, the mean difference was kept to 3 hours; accordingly, the required sample size was 100. This indicates that authors have chosen the sample size on the basis of predetermined deviation of expected mean. To nullify the attrition effect, the sample size was kept more than the required one i.e. 100. To validate and determine the significance of the study, various statistical tools have been employed. The detail information about the statistical analysis and corresponding software used for it has been provided.

Results: The result section is descriptive. The details of the events which took place during the research have been provided. The degree of randomization was quiet significant (95%). Since the base line data did not vary among the participants, therefore authors did not perform any base line correction which is quiet justifiable. However, the primary outcome of the study is not clear. It is somewhat confusing that why authors concluded that the time required returning to normal bladder function did not vary significantly among the groups. However, tables of this articles are quiet helpful to understand the outcomes of this research. From table 2 it is understandable that the time required to return to normal bladder function did not differ significantly among the groups. The foot note has been provided below the table that provides information on the tests conducted to evaluate the level of significance.
The secondary outcome fails to prove other two hypothesis postulated in the objective section, i.e. clamping has any effect on need for recatheterization and length of hospital stay.
Overall, the result section is quiet clear and well organized in spite of less description. The flow chart is able to explain the entire procedure of the sampling. Data presentation is good, the main finding can be made out just by looking at table.

Discussion: Discussion should begin with a short background followed by the main objectives and discussion on each outcome one by one. Instead, in present article the conclusion is written first. In this article, authors start their discussion directly with the major outcome of the study. In discussion, authors have tried to justify their conclusion by providing adequate literature. Further, they have also mentioned the merits and demerits of their study as compared to previous studies. In discussion, authors have given explanation for excluding the patients with cognitive impairment. The inclusion criteria have been justified in this section. One unique feature of the article is that methodology has also been discussed in discussion section and proper explanation for gender stratification has been provided.

Conclusion: Conclusion is specific, clear and accurate and. It delivers the take home message perfectly.
Relevance to clinical practice: The article ends with the section, “relevance to clinical practice”. This section established the importance of the present study in the area of research under study. Based on the findings of the study, authors have presented the merits and demerits of the clamping urinary catheter in patient undergone surgery for hip injury. At the end they have they have recommended that clamping of urinary catheter is not required as it does not affect the time to return to normal bladder function.

Overall, the study is well planned, organized and systematic. All the sections have been well written. Data presentation is quiet good. However, title is not suitable. Overall organization and format of the paper meets the journal’s requirement.

References:
Balderi, T., & Carli, F. (2010). Urinary retention after total hip and knee arthroplasty. [Research Support, Non-U.S. Gov't Review]. Minerva Anestesiol, 76(2), 120-130.
Baldini, G., Bagry, H., Aprikian, A., & Carli, F. (2009). Postoperative urinary retention: anesthetic and perioperative considerations. [Research Support, Non-U.S. Gov't Review]. Anesthesiology, 110(5), 1139-1157. doi: 10.1097/ALN.0b013e31819f7aea
Borghi, B., Agnoletti, V., Ricci, A., van Oven, H., Montone, N., & Casati, A. (2004). A prospective, randomized evaluation of the effects of epidural needle rotation on the distribution of epidural block. [Clinical Trial Randomized Controlled Trial]. Anesth Analg, 98(5), 1473-1478, table of contents.
Johansson, R. M., & Christensson, L. (2010). Urinary retention in older patients in connection with hip fracture surgery. J Clin Nurs, 19(15-16), 2110-2116. doi: 10.1111/j.1365-2702.2010.03261.x

Oishi, C. S., Williams, V. J., Hanson, P. B., Schneider, J. E., Colwell, C. W., Jr., & Walker, R. H. (1995). Perioperative bladder management after primary total hip arthroplasty. [Comparative Study]. J Arthroplasty, 10(6), 732-736.

Singh, J. A., Vessely, M. B., Harmsen, W. S., Schleck, C. D., Melton, L. J., 3rd, Kurland, R. L., & Berry, D. J. (2010). A population-based study of trends in the use of total hip and total knee arthroplasty, 1969-2008. [Comparative Study
Research Support, N.I.H., Extramural]. Mayo Clin Proc, 85(10), 898-904. doi: 10.4065/mcp.2010.0115