Title: Co-morbidities, complications and causes of death among people with femoral neck fracture - A three-year follow-up study.

Transcription

1 Author s response to reviews Title: Co-morbidities, complications and causes of death among people with femoral neck fracture - A three-year follow-up study. Authors: Monica Berggren (monica.langstrom@umu.se) Michael Stenvall (michael.b.stenvall@vll.se) undis Englund (undis.englund@umu.se) Birgitta Olofsson (birgitta.olofsson@umu.se) Yngve Gustafson (yngve.gustafson@umu.se) Version: 1 Date: 17 May 2016 Author s response to reviews: Dear Editor-in-Chief, Thank you for the encouraging letter regarding our manuscript with the title: Co-morbidities, complications and causes of death among people with femoral neck fracture A three-year follow-up study (BGTC-D ). We have undertaken a revision and rewritten the manuscript according to the suggestions from you and the reviewers. Thank you for giving us the opportunity to resubmit the paper. The comments from the reviewers are copied and our responses are specified as Respons as follows; Reviewers' comments: Reviewer #1: Thank you for giving me the opportunity to review this interesting paper which looks at the relationship between co-morbidities, complications and death in patients who have had a hip fracture. Overall, this is a paper which brings additional insight to an important area. My specific comments are outlined below:

2 Introduction Page 3- Line 39 "One study found that 33%:, I presume you are referring to patients? This word needs to be added in to the text. Response: Yes, we do refer to the patients. The sentence has been changed (highlighted red in text): One study found that 33% of the participants had at least one complication after an operation for hip-fracture which led to prolonged hospitalization. Line 46, add a comma after complications. Response: A comma has been added (highlighted red in text): Another study found heart failure and chest infections to be the most common postoperative complications [12], while a more recent study showed that falls, fractures and pneumonia were the most common [13]. Line 51-'Interventions to reduce the rate of in-hospital postoperative complications and mortality have been described'. Re-write this sentence- too much use of the word 'described'- something like 'a range of interventions...have been reported in the literature?' Response: The sentence has been re-written (highlighted red in text): A range of interventions to reduce the rate of in-hospital postoperative complications and mortality have been reported in the literature. Line 58- add 'in a previous study' Response: The sentence has been re-written (highlighted red in text):

3 We have shown earlier that a multidisciplinary, multi-factorial rehabilitation program reduced in-hospital complications, including significant fewer in hospital falls but there was no difference in the number of falls during one year after discharge. Page 4, Line 39, add a comma after research Response: A comma has been added (highlighted red in text): In spite of earlier research, the poor outcome for people with hip fracture has not improved and mortality has not been reduced. Line 46- I suggest replacing 'situation' with- 'these factors'. Response: The sentence has been re-written (highlighted red in text): Since neither the events leading to death, nor the causes of death or the patient s outcome after discharge have been fully investigated, we decided to explore these factors in order to discover factors that might be adjusted in order to improve outcome. Materials and methods Page 5, Line 15- received 'oral' not orally and 'where' not 'were' Response: The sentence has been re-written (highlighted red in text): All participants received oral and written information and in those cases where they were not able to answer themselves their next of kin was also asked. Line what is the data not shown? Can you provide a reference to where it is? Response: Thank you for putting attention to this section, which we agree needs a better description. Data are derived from a randomized controlled trial, evaluating a multidisciplinary intervention program for persons with a femoral neck fracture

4 compared to conventional care. The program had the aim to prevent, detect and treat postoperative complications and improve rehabilitation. The program is described in detail in previous articles, referred to in Study design. The intervention resulted in fewer complications during hospitalization, but no differences were found after discharge. Data not shown represents analyses of complications and mortality, comparing intervention and control group. No reference can be provided. Since no difference was found after discharge we wanted in the present article to describe the prevalence of co-morbidities, complications and causes of death in the whole sample. The section has been rewritten. Study design Data are derived from a randomized controlled trial, evaluating a multidisciplinary intervention program for persons with a femoral neck fracture compared to conventional care. The intervention resulted in fewer complications during hospitalization, but there were no differences in the incidence of complications and mortality between the intervention and control groups after discharge (data not shown). Therefore, the participants are analysed as one group in the present study and they were followed from admission to hospital until death, relocation or the end of 36 months of follow-up. The description of the recruitment and randomization as well as the content of the intervention has been presented in detail in earlier articles [15] [16]. All participants received oral and written information and in those cases where they were not able to answer themselves their next of kin was also asked. A written informed consent for participation in the study was required. Line 36- where it says figure 1- do you mean the figure should be placed here? The formatting does not make this clear. Response: Yes, the figure might be placed close to the sample section. Figure 1 is a flow chart including all persons with a femoral-neck fracture during study period. Page 6, Line 51- How was your definition of a fall agreed? Is this a standard definition? If so please add the reference- if not, why not? Response: In this article we have used the definition of falls by Jensen et al [1], an unexpected event in which the participant comes to rest on the ground, floor, or lower level. The reference has been added.

5 Page 7 (top of)- 'the complications were forwarded to the next follow-up'. Can you please clarify? I was not certain what was meant by this and what was done. Response: If a participant died between follow-ups, complications that occurred between last follow-up and death were forwarded, which means they were registered at the next follow-up. The sentence has been re-written (highlighted red in text): If a participant died between follow-ups, complications that occurred between last follow-up and death were forwarded, which means they were registered at the next follow-up. Reviewer #2: Tittle: Co-morbidities, complications and causes of death among people with femoral neck fracture - A three-year follow-up study. Version: 20th April BMC Geriatrics Reviewer: Fernando Gomez Reviewer's report: This is a prospective randomized, controlled trial that identify co-morbidities, complications and causes of death in old people with femoral neck fracture admitted to the Orthopedic Department in Sweden. The topic of the manuscript is appropriate for the Journal. It could be of interest to investigators and clinicians. Minor essential revisions are necessary. Minor essential revisions Tittle: * The title is accurate and sufficiently descriptive of the content. Abstract: * Abstract: Concise and specific. * The main objective of the study is presented. * The statistical methods used to prove the hypothesis is mentioned.

6 * The conclusion highlights the contribution of this work. Introduction: * The background of the study is clear and helpful to readers unfamiliar with the subject. * The purpose of the article is clearly presented. Material and methods: * Sufficient details about the process are provided. * Statistical analyses used are appropriate. * The methods are appropriate and well described. * Line 19: What is exactly meaning: "Since there were no differences in the incidence of complications and mortality between the intervention and control groups after discharge (data not shown) the participants are analysed as one group in the present study". The authors no mentioned what kind of intervention in the main text (sic)? Response: Thank you for putting attention to this section, which we agree needs a better description. Data are derived from a randomized controlled trial, evaluating a multidisciplinary intervention program for persons with a femoral neck fracture compared to conventional care. The program had the aim to prevent, detect and treat postoperative complications and improve rehabilitation. The program is described in detail in previous articles, referred to in Study design. The intervention resulted in fewer complications during hospitalization, but no differences were found after discharge. Data not shown represents analyses of complications and mortality, comparing intervention and control group. No reference can be provided. Since no difference was found after discharge we wanted in the present article to describe the prevalence of co-morbidities, complications and causes of death in the whole sample. The section has been re-written. Study design Data are derived from a randomized controlled trial, evaluating a multidisciplinary intervention program for persons with a femoral neck fracture compared to conventional care. The intervention resulted in fewer complications during hospitalization, but there were no differences in the incidence of complications and mortality between the intervention and

7 control groups after discharge (data not shown). Therefore, the participants are analysed as one group in the present study and they were followed from admission to hospital until death, relocation or the end of 36 months of follow-up. The description of the recruitment and randomization as well as the content of the intervention has been presented in detail in earlier articles [15] [16]. All participants received oral and written information and in those cases where they were not able to answer themselves their next of kin was also asked. A written informed consent for participation in the study was required. Results: * Three tables and an figure well presented. * Sufficient details are provided to allow others to evaluate and/or replicate the work. Discussion * It is clear and precise. * Strengths and limitations are described. Conclusion: It is clear References: There were 42 and all are appropriate. Thanks for letting me review this manuscript. This could be a nice paper. Level of interest: An article whose findings are important to those with closely related research interests. Quality of written English: Well. Statistical review: No. Declaration of competing interests: I declare that I have no competing interest.

8 Editorial Requests Please note that all submissions to BMC Geriatrics must comply with our editorial policies. Please read the following information and revise your manuscript as necessary. If your manuscript does not adhere to our editorial requirements this will cause a delay whilst the issue is addressed. Failure to adhere to our policies may result in rejection of your manuscript. Ethics: If your study involves humans, human data or animals, then your article should contain an ethics statement which includes the name of the committee that approved your study. If ethics was not required for your study, then this should be clearly stated and a rationale provided. Response: The study was approved by The Ethics Committee of the Faculty of Medicine at Umea University ( ), stated in the Data collection (last line). Consent: If your article is a prospective study involving human participants then your article should include a statement detailing consent for participation. If individual clinical data is presented in your article, then you must clarify whether consent for publication of these data was obtained. Response: A statement of consent is presented in the Study design. All participants received oral and written information and in those cases where they were not able to answer themselves their next of kin was also asked. A written informed consent for participation in the study was required. Availability of supporting data: BioMed Central strongly encourages all data sets on which the conclusions of the paper rely be either deposited in publicly available repositories (where available and appropriate) or presented in the main papers or additional supporting files, in machine-readable format whenever possible. Authors must include an Availability of Data and Materials section in their

9 article detailing where the data supporting their findings can be found. The Accession Numbers of any nucleic acid sequences, protein sequences or atomic coordinates cited in the manuscript must be provided and include the corresponding database name. Response: A declaration of the availability of supporting data is found in the Availability of Data and Materials. The dataset supporting the conclusions of this article will not be shared since an informed consent for publication of patient data was not obtained before the study was performed. Authors Contributions: Your 'Authors Contributions' section must detail the individual contribution for each individual author listed on your manuscript. Response: The authors contributions are stated in the Authors contributions. MB has participated in the implementation of the study protocol, the data collection, the statistical analysis and is the primary author of the manuscript. MS, UE and BO have made substantial contributions to the conception of the study, research design, intervention and implementation of the protocol. MS and BO have contributed to the testing and data collection. YG supervised all phases of the study and revised the manuscript. All authors contributed to the writing and review of the manuscript and approved the final version. References: 1. Jensen J, Lundin-Olsson L, Nyberg L, Gustafson Y (2002) Fall and injury prevention in older people living in residential care facilities. A cluster randomized trial. Annals of internal medicine 136: Hopefully you will find this manuscript acceptable for publication after our revision and rewriting.

10 Yours sincerely, Monica Berggren MD, Yngve Gustafson, MD, PhD Geriatric Medicine, Michael Stenvall, PT, PhD Department of Community Birgitta Olofsson, RN, PhD Medicine and Rehabilitation, Undis Englund, MD, PhD Umeå University SE Umeå, Sweden Phone: ,