Title: Urinary incontinence and risk of functional decline in older women: Data from the Norwegian HUNT-study

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1 Author's response to reviews Title: Urinary incontinence and risk of functional decline in older women: Data from the Norwegian HUNT-study Authors: Ragnhild Omli Steinar Hunskaar Arnstein Mykletun Ulla Romild Esther Kuhry Version: 3 Date: 26 October 2012 Author's response to reviews: see over

2 Dear Editor, I would like to resubmit the revised manuscript: Urinary incontinence and risk of functional decline in older women: Data from the Norwegian HUNT-study. The paper is reorganized according to the Consort Statement/ guidelines of the Vancouver protocol. An acknowledgement is included in the manuscript. This letter should bring information to get an oversight over the changes that are made in the revised version of the manuscript. I hope that the manuscript will be considered for publication. Best regards Ragnhild Omli Corresponding author Due to the reviewers suggestions the following changes are made in the manuscript: Referee 2 Background ADL not IADL`s In the whole manuscript ADL`s and IADL`s is replaced by ADL and IADL Most studies involve older people that live in nursing homes, residential care homes and hospitals. Few studies. (ref required) The reference by Mc Dowell BJ et al and Mohide EA et al are included in the paper. Method: The final paragraph saying the present study is part of the Norwegian. Is grate and should be after the second paragraph.

3 Changes are made regarding to the advises In the sentence regarding medical diagnoses, the participants answered the following question has a doctor...osteoporosis, arthritis, bechterew (also known as ankylosing spondylitis ) is partially irrelevant as these have not been included in results (eg osteoporosis and ank spond). Would it not be better to include the disease states you show in Table 1. - We have excluded osteoporosis and bechterew from the manuscript. Athritis is included in Table 1. The question regarding whether the time period is actually 10 years has never been addressed ie someone could be seen in 1984 and then not again until 1997 ie 13 years, Please could the authors give some indication of the distribution in follow up time Urinary incontinence section - Analyses were performed for the time period. The mean period of follow-up for the participants was 11 (± 2) years. This is included in the Method section. How can one answer yes on type of incontinence? - This is removed from the manuscript. The final sentence data on urinary incontinence was extracted from the HUNT 2... has already been said in the previous paragraph relating to EPINCONT it is presumed. - The sentence data on urinary incontinence was extracted from the HUNT 2... is removed from the manuscript. Functional decline ADL and IADL not ADL s and IADL s - ADL`s and IADL`s are replaced by ADL and IADL in the whole manuscript Functional decline was defined as a decline...not during the 10 year follow up period but in the time between HUNT 2 and HUNT 3. - The suggestion is changed in the manuscript. Statistics: Fine would ANOVA be more appropriate? Results of the ANOVA is shown in Table 2

4 You write this in an attached document include this in the manuscript it is helpful. We did not perform an analysis on concomitant diseases, which could represent a limitation. We had no data from the non-responders and therefore have no non-responder analysis. - This is included in the Strengths and Limitations in the Discussion section. More co-morbid conditions are included in the new version of the paper. Unfortunately, we did not have data on dementia and Parkinson`s disease. We have described the outcome of the logistic regression more clearly: The decline in ADL/IADL functions was used as dependent variables in the regression models. The status of ADL was computed as the number of ADL items not functioning at HUNT 2 and at HUNT 3. Decline was identified as an increase in the number of not functioning items from HUNT 2 to HUNT 3. The decline in IADL was computed accordingly. The decline variable is thus dichotomous. The nature of the different items varies, and the number of increased items is not a continuous variable and could not be used as such. Declined ADL was defined as at least one not functioning item and need for help. The 10-year decline was defined as the difference between HUNT 2 and HUNT 3. Since both the status at HUNT 2 and the declineare dichotomous there should not be any multicollinearity problem. The status at HUNT 2 was used as an explanatory factor and the decline was the dependent variable. - The marked text is included in the Statistical Analysis section. Results: Was there a significant difference in the ADL / IADL scores at baseline between the continent and incontinent women? - No significant difference in ADL/IADL at baseline between continent and incontinent women were found. Slightly confusing 770 were in HUNT 2 and EPINCONT and those participants were reevaluated in HUNT 3 10 years later.

5 UI was reported by 24% in HUNT 2 but you wait until the final line to say 46% by HUNT 3 this must be significant and these should be reported together. - These findings are reported together in revised manuscript. Discussion: In the regression analysis UI was significantly associated with ADL decline but this seems to have no effect on needing more care this is interesting. -This is discussed more thoroughly in the discussion section In the regression analysis UI was significantly associated with ADL decline but this seems to have no effect on needing more care this is interesting. -This is discussed more thoroughly in the discussion section In the regression analysis UI was significantly associated with ADL decline but this seems to have no effect on needing more care this is interesting. -This is discussed more thoroughly in the discussion section I am not sure what the point of Table 3 is I am really unsure about this data here. - Table 3 is removed In the results it is said that there is no significant association between UI and IADL decline found. In the discussion it says the main finding is... UI is associated with IADL- functions in homebound older women over a 10 year period after adjusting for... what does this mean Repetition of the same sentence twice we defined functional decline... - Repetition of the sentence has been removed Huang decline in physica is not right. Physical function decline accounted for an estimated 9% of clinically frequent incontinence, whereas cognitive decline accounted for 3% of disruptive incontinence in this population. I have already mentioned this before. actually.

6 - -In the result section in the revised manuscript the sentence: No significant association between urinary incontinence and IADL-decline was found - -In the discussion section however it says that: The main findings of this longitudinal study confirms Ui to be a significant risk factor for ADL-decline and that UI is not associated with decline in IADL-functions - Huang decline in physica is not right. Physical function decline accounted for an estimated - 9% of clinically frequent incontinence, whereas cognitive decline accounted for 3% of disruptive - -Huangs results are presented in a proper way in discussion section of the manuscript After 10 years of follow up 46% of women reported that they had UI can you comment on this what does this suggest etc - -The presence of UI rises with increasing age, which might be the explanation - Summed ADL or IADL score may not have clinical relevance could the authors - justify their definitions? - -Functional decline was defined as a decline in the ADL or IADL score in the period between HUNT 2 and HUNT 3. The ability to perform ADL and IADL when participating in HUNT 2 was measured by the sum of the ADL-items and IADL-items the participants did not need help to perform. Describe the limitations you found in more detail. You mention some in your comments - -The limitations is described in more detail in the Strengths and Limitation section Referee 3 I am satisfied with most of the revised manuscript with an exception of the following 2 issues. Minor essential revision 1). Methods The decline in ADL and IADL in the logistic regression models were and dichotomised, please provide the cut-off point (with appropriate references) that you used for both ADL and IADL. Minor essential revision - Functional decline was defined as a decline in the ADL and IADL score in the period between HUNT 2 and HUNT 3. The ability to perform ADL and IADL when participating in HUNT 2 was measured by the sum if the ADL-items and the IADL-items the participants did not need help to perform. We did not define any cut-off point. 2). Statistical analyses The inclusion of ADL at baseline in the multiple logistic regression model may be redundant and causing multi co-linearity in the model. As the decline in the ADL and ADL at baseline are highly correlated, one is calculated using the other one. This caused an exceptionally high odds ratio and wide confidence interval in

7 the final model. The same is applied to the IADL model. -The status of ADL was computed as the number of ADL items not functioning at HUNT 2 and at HUNT 3. Decline was defined as an increase in the number of not functioning items from HUNT 2 to HUNT 3. The decline in IADL was computed accordingly. The decline variable is thus dichotomous. The nature of the different items varies, and the number of increased items is not a continuous variable and could not be used as such. Declined ADL was defined as at least one not functioning item and need for help. The decline during follow-up was defined as the difference between HUNT 2 and HUNT 3. Since both the status at HUNT 2 and the decline are dichotomous there should not be any multicollinearity problem. The status at HUNT 2 was used as an explanatory factor and the decline was the dependent variable.

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