April 11, 2012

Painful Movements and Mobility after Urological surgery: Studying the Feasibility of Pre-operative Exercise, A New Mobility Test and a Randomised Controlled Trial Protocol with Cystectomy Patients in Intensive Care

Brach et al.

Article ID: WMC003102

Comments: A very interesting article intended to assess pre-operative motor training on mobility and movement-related pain in patients with medial laparotomy. The background and literature review is quite extensive and informative to me. Because I am not familiar with the clinical information or with the surgical procedure (I am more into exercise and movement in old age), my suggestions for improving this paper relate more to the methodology. I am sorry to say that the paper does not seem sufficiently coherent in terms of aims, intervention program, data analysis, results and interpretation of the results.

1. The aims of the study are not clearly stated in the introduction. On p. 2, at the bottom of the page before the literature review, it says that the research question is: "… which effects does pre-operative motor training have on mobility, movement-related pain and post-operative hospital stay in patients with medial laparotomy?" Then, the authors claim that a new mobility test was developed (MOPTA), and additional aims of the study were defined as: examining the feasibility of the study design, proving the usefulness of the mobility test, and determining effect measures in order to compute a power analysis designing a main study.
   1. Based on the above, there are 2 simultaneous aims: to assess a new intervention program and to assess a new test. Furthermore, data collection was not blinded, a possible problem in terms of assessment objectivity. To assess a new intervention program you need an objective well-established test for that assessment. To introduce a new test, before using it to assess an intervention program, you should apply it along with other well-established tests to examine its validity.
   2. The aims of the study should appear at the end of the introduction (or background) and be clearly stated in operational terms. This will assist the reader in understanding the method, data analysis and results. For example, if one of the aims is to assess movement-related pain, the reader expects to see data (differences between experimental and control groups) on that. Another example: if the aim is to assess post-operative hospital stay, the reader expects to see data (differences between the study groups) on that too.
   3. An introduction (or background) should lead the reader in a funnel-type explanation to the aim of the study. The introduction in this study is full of details regarding Viv-Arte conception, the milestone framework, and other tests (MOTA), making it hard to follow the rationale leading to the aim of the study. For example: a lot of details are provided explaining the MOTA test on p. 4 including test-retest reliability and an illustration of the test. Detailed information should be provided for the new test – the MOPTA.
   4. The authors refer to an appendix containing the complete manual of the new test, and later on to Table 1 (on p. 4). I was not able to find them.
   5. The authors claim that the MOTA test includes 17 items referring to illustration 1. I was able to find only 16.
   6. Methods:
      1. Again, it is stated that "the primary outcomes were functional mobility, pain, and post-operative length of stay. Functional mobility was tested using MOPTA, as described in the corresponding subsection in the section “Background". Then the authors rightfully provide details about the measurements of mobility ("the mobility profile was once recorded before surgery, semi-daily after surgery in intensive care unit…"), and pain (VAS before, during, directly after…")… However, all this information is not provided in the results section! Furthermore, how was the MOTPA scaled? There is an explanation on the functional tasks included in the MOTPA ("Sitting position…: moving forward, keep sitting position, stand up…"). Based on what scale were these functional tasks assessed?
      2. Again, the reader is referred (last paragraph on p. 5) to a full description of all items of the MOTPA. I was not able to find it.
      3. I don't quite understand the selection criteria of study participants. For example: p. 5, under exclusion criteria says: "Chronic pain (duration above 3 months, with pharmacological treatment)". Are there patients who do not have pain? And if they had pain 2 months prior to the surgery, they are included? Later on, the 2^nd paragraph on p. 6 says: "…Possible post-operative complications (artificial ventilation…) were recorded. The presence of one of these complications resulted in the patient’s exclusion from the trial." How often do patients have such complications? If a relatively large number of people have such complications, it means that the whole idea of the intervention before surgery is applicable to only a few people. Further on the same page it says: "A VAS score above 30 mm directly before scheduled mobilization exercise resulted in cancellation of the session." How often does this happen?
      4. On p. 6, one paragraph before the last says: "… Mobilisation and measurements were conducted by the same person". Does this mean that the same person conducted the intervention and the measurements after the intervention? If this is the case, it is quite problematic in terms of the objectivity of the assessment.
      5. Data Analyses and Evaluation methods
         1. The beginning of this section says: "The data were analysed descriptively by means…. The difference of the central tendency… was tested using the Mann-Whitney U test." Where are the data?
         2. The end of this section says: "Several discussions on outcomes, feasibility, usefulness and other aspects of the trial were conducted. The groups of participants were (a) all nurses involved in the trial and (b) managing nurses, scientists and central nursing management." How were the discussions conducted? What were the criteria for assessing feasibility? Usefulness? What were the "other aspects" and how were they assessed?
         3. Preliminary results: sample characteristics
            1. The characteristics of the sample are described in the text and in illustration 7. No need to repeat the information. On the other hand, the figures in illustration 7 and in the text do not match. For example: the text says that the maximum age was 83, the illustration says 76. The text says that the median age of all participants is 56. The illustration says 61.5 for one group and 65 for the other.
            2. Why not provide means and SDs?
            3. I find illustration 7 too informative. In my opinion there is no need to specify all the education levels. Why not provide one figure – years of education? Why provide all the information on occupation? In what way is the information regarding "Employee or self-employed" relevant to the study?
            4. Regarding age – it seems that the control group is significantly older than the experimental control. Is this true?
            5. It says in the text: "Also, no difference was found between the groups concerning the control variables (pain medication, drainages and access canals). Preliminary results were also reported in [37]." Where is this information? It should be included in the article.
            6. Where is all the information on the outcome measurements (the essence of the study)? As a reader I expect to see the 4 measures of functional mobility, the 4 measures of pain and the post-operative length of stay for the experimental and control groups.
            7. Discussion and Conclusion
               1. The first sentence says: "Motor exercise with urological patients, before they undergo cystectomy, seems to be helpful to overcome post-operative mobility restrictions, and so may contribute to regeneration". There is no information in the present study to support this statement. Please see 4F above.
               2. The 2^nd sentence says: "We designed a new mobility test (MOTPA) and a randomized controlled trial to study test feasibility and effects of patient education". There is insufficient information about that test. P. 4 provides information about the milestone framework. Illustration 1 offers some general information about the MOTA. Some information on the MOPTA appears on page 5, but no information about how it is graded. For example: "Standing position: turning 180 degrees, going backward 3 steps, short walk (6m) walk (30m), sitting down".  Please specify what constitutes good performance and bad performance when assessing standing position according to the scale.
               3. P.7 2^nd paragraph says: "Conduction of the trial showed that the trial design as well as the mobility test were feasible in an intensive care setting." There is not sufficient information in the article to support this statement.
               4. The last paragraph of the article is not sufficiently clear.

Despite all the reservations listed above, I believe the article has a contribution to make. With serious rewriting – removing what is excessive and inserting what is missing – it can be improved greatly.

My experience is in exercise sciences and old age.