Author's response to reviews

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1 Author's response to reviews Title:BMC Geriatrics The effects of increased therapy time on cognition and mood in frail patients with a stroke who rehabilitate on rehabilitation units of nursing homes in the Netherlands: A protocol of a comparative study. Authors: Marleen Huijben-Schoenmakers (marleenhuijben@gmail.com) Arno Rademaker (arno.rademaker@gmail.com) Peter van Rooden (PvRooden@groenhuysen.nl) Erik Scherder (eja.scherder@psy.vu.nl) Version:9Date:9 May 2014 Author's response to reviews: MS: BMC GeriatricsThe effects of increased therapy time on cognition and mood in frail patients with a stroke who rehabilitate on rehabilitation units of nursing homes in the Netherlands: A protocol of a comparative study. Marleen Huijben-Schoenmakers, Arno Rademaker, Peter van Rooden and Erik Scherder Dear Mrs Huijben-Schoenmakers, Your manuscript has now been peer reviewed and the comments are accessible in PDF format from the link below. Do let us know if you have any problems opening the file. Referee 2: Additional material submitted by the reviewers Dear Sir/ Madam, First of all, we would like to thank you again for the time and effort you have put in reviewing our article and for your valuable feedback. We appreciate this very much. Please find the responses to your feedback after your recommendations as well as in the manuscript. While reviewing the last version of your manuscript, a few concerns have arisen. In particular, we would like to know if an Ethics Committee has approved the changes and how they have affected your study, considering that it is an ongoing study. Specifically, please provide a comment on the following issues:

2 -the addition of two more recruitment sites and ethical considerations The Medical Ethical Committee of the Free University Amsterdam, The Netherlands, has approved the protocol of this study in two nursing homes. The reason for adding two more recruitment sites is that during the follow up of our study we concluded that too few patients were eligible to meet the required sample size in a reasonable time frame. For that reason we successfully recruited two more nursing homes meeting our criteria. In this way we were able to include a sufficient number of patients to meet the study objectives. Permission of the Medical Ethical Committee of the Free University Amsterdam was obtained for adding two additional sites. Also the boards as well as the responsible physician of the nursing homes gave approval for the study, taking ethical considerations into account. Please see also page 6 line 9 to 13 of our manuscript: Additionally, oral and written information about the study is given to the patients and/or their legal representatives. Prior to their participation in the study oral and written informed consent is acquired from all the participants, their family or legal representatives. Informed consent is based on veracity, anonymity, privacy, and confidentiality. Did the addition of two more recruitment sites affected our study, considering that it is an ongoing study. No, the additional sites did not affect our study. As mentioned before, two new nursing homes have been added to our study, which consisted of one intervention nursing home and one control nursing home. The added control nursing home provides care according to the Dutch Stroke Guidelines, with limited time spent on therapeutic activities. This was measured with the Behavioural Mapping method (described in the protocol). In the added intervention nursing home we implemented four interventions from the Clinical Nursing Rehabilitation Stroke Guideline. All professionals, especially the nurses, received the same training, intervision and supervision as the original intervention site. The training consisted of 2 sessions of 3 hours each. For 2 month there were supervisory meetings every week. After this period the frequency was reduced to once a month. Before the new intervention site was allowed we measured the time spent on therapeutic activities by the same method in order to make sure that these interventions resulted in an extra 50 minutes a day of exercises for each patient. -the reformulation of the primary and secondary outcomes Although our study is ongoing, the reformulation of which measurement is the primary and secondary outcome did not change or influence the study design or protocol. While expanding our study with two new nursing homes the same dependent variables are present namely cognition, mood and activities of daily living. All patients of all four nursing homes have been tested on or will undergo the same measurements, which assess cognition, mood and activities of daily living. The independent variable in all four nursing homes is the time spent on therapeutic activities. We do understand the wish to formulate this even more

3 specific with one specific outcome measure taken at one time point but cognition is an extensive concept which consists of many brain processes e.g. attention, executive functions, visual perception and construction, memory. In this patient based study we decided to investigate cognition as an integral concept with different outcome measurements. The reformulation of the secondary outcomes mood and activities of daily living did not change or influence the study protocol. We use the same measurements to assess these dependant variables. To measure mood all patients have been tested on or will undergo the assessment of the Beck Depression Inventory as well as the symptoms checklist 90 ( SCL 90). The activities of daily living are measured by the Barthel Index. Moreover, we have noticed that Title, Abstract, TRN and authors' details are not included in the last version of your manuscript. We have added this to the new version of our manuscript. We would be grateful if you could address the comments in a revised manuscript and provide a cover letter giving a point-by-point response to the concerns. Please also ensure that your revised manuscript conforms to the journal style ( ). It is important that your files are correctly formatted. We look forward to receiving your revised manuscript by 13 April If you imagine that it will take longer to prepare please give us some estimate of when we can expect it. You should upload your cover letter and revised manuscript through You will find more detailed instructions at the base of this . Please don't hesitate to contact me if you have any problems or questions regarding your manuscript. With best wishes, Giulia Mangiameli Executive Editor, BMC-series BioMed Central Tel: +44 (0) editorial@biomedcentral.com Web: To submit your revised manuscript When you have revised your manuscript in light of the reviewer's comments and

4 made any required changes to the format of your paper, please upload the revised version by following these instructions: 1. Go to and log on with your address and password. 2. With the 'Manuscript details' tab, please update the title, abstract and author details if they have changed since the previous version. It is very important that all changes are updated on this page, as well as in the manuscript file as the information on this page will be used in PubMed and on BioMed Central if your manuscript is accepted for publication. 3. With the 'Cover letter' tab, please provide a covering letter with a point-by-point description of the changes made. 4. With the 'Upload files' tab, please upload the revised version of the manuscript and press 'Submit new version'. Please wait for the co Reviewer's report Title:BMC Geriatrics The effects of increased therapy time on cognition and mood in frail patients with a stroke who rehabilitate on rehabilitation units of nursing homes in the Netherlands: A protocol of a comparative study. Version:7Date:6 March 2014 Reviewer:Coralie English Reviewer's report: Thank you for taking the time to make the revisions to this paper. It is much improved. Dear Mrs. Coralie English, First of all, we would like to thank you again for the time and effort you have put in reviewing our article and for your valuable feedback. We appreciate this very much. It is very nice to read that our article has much improved. We did make another revision as you suggested in this letter. Please see below for our response to your feedback. Discretionary revisions I still feel it lacks some clarity in regards to the primary outcomes. While the effect of increased therapy time on cognition and mood is stated as the primary aim, there are many outcome measures listed to assess this. Ideally, only one outcome measure at one time point should be selected for the primary measure, with all others being secondary.

5 We do understand your wish to formulate cognition even more specific with one outcome measure taken at one point in time. However, cognition is an extensive concept which consists of many brain processes e.g. attention, executive functions, visual perception and construction, memory. Patients who suffered from a stroke often face many affected domains of cognition. Since we have a patient based study we decided to investigate cognition as an integral concept. It is of key importance to know what impaired cognitive domain will improve by the increase of therapy time. To assess cognition in this way different tests are needed. For example to assess global cognitive functioning, the Mini- Mental State Examination is used. The Mini- Mental State Examination is also the most common used test for global cognitive functioning. In addition for verbal and non-verbal memory we use the Eight words test. In the primary outcome we will be more specific about the primary post measurement. We expected to see a rehabilitation period of at least 8 weeks for each patient, based on our previous observational studies. Nowadays the moment of discharge of the patients varies considerably and is often much shorter than 8 weeks, depending on the patient s condition and personal situation. Therefore the moment of discharge of each individual patient is selected as the primary post measurement. Please see the text in our manuscript page 5 line 3-7: In sum, the primary goal of the present study is to investigate whether an increase in therapy time has a beneficial influence on the various dimensions of cognition of frail stroke patients at discharge of rehabilitation units of nursing homes. The secondary goal is to examine whether an increase in therapy time improves mood, resulting in an improvement in activities of daily living (ADL). Level of interest:an article whose findings are important to those with closely related research interests Quality of written English:Acceptable Statistical review:no, the manuscript does not need to be seen by a statistician. Declaration of competing interests: I declare I have no competing inte