Title: Protocol-based management of older adults with hip fractures in Delhi, India: a feasibility study

Transcription

1 Reviewer s report Title: Protocol-based management of older adults with hip fractures in Delhi, India: a feasibility study Version: 0 Date: 16 Nov 2015 Reviewer: Cristin Ryan Reviewer's report: This paper aims to assess the feasibility of implementing protocol based management of older adults with hip fractures in India, determine appropriateness and acceptability of the adoption of internationally accepted best practices in care pathways and identify barriers and facilitators for recruitment and retention for future intervention studies. General comment The overall flow and stages of the work doesn't seem quite right. If UK & Swedish protocols are being used, how (or if) these protocols have been tailored, given the diversity in healthcare service provision globally, has not been described. I suggest that firstly, current practice and current procedures for the management of patients with hip -factures in India should be described, with commentary on the effectiveness of these services. This will establish the need for a protocol approach to patient care post-hip fracture. Also, the authors should consider the range of approaches to provision of care post-hip fracture in the study sites involved. Protocols may need to be tailored for the Indian context, and may also need to be tailored for the individual hospital sites involved. Specific comments I have listed comments below relating to specific areas within the manuscript. My comments are in chronological order rather than in order of importance. Abstract: Note in the background of the abstract what recruitment and retention refers to; i.e. sites, patients and healthcare providers

2 In the methods section, it states that patients over 50 years will be recruited, yet the literature cited in the background in the abstract and in the main manuscript, refers to patients over 60 years. The reason for this difference should be explained, if not in the abstract, then certainly throughout the text. The data, particularly the quantitative data that will be collected, has not been described. The fact that the COM-B theoretical framework is being used as part of the feasibility assessment should be highlighted. Introduction In the first sentence, note if "Fractures" refers only to hip fractures, or any fracture type. Also clarify what age "older adults" refers to. In the final sentence of the introduction note what the percentage of people over 60 years is rising from. The second paragraph presents data from the UK noting some patient outcomes post hip-facture. Similar figures for India should also be presented. Rephrase the second sentence in this paragraph, "Health services utilization " as it is not clear what is meant. Protocols developed in the UK and Sweden are mentioned, but no comparisons are made between them, and the reader does not have a sense of whether these protocols are the same/ similar, what they involve, who they involve. Details are provided in support of the UK derived protocols, but not for the Swedish derived protocols; is this because there isn't evidence in support of Swedish protocols? Or does Sweden come under the "high income countries" umbrella? This should be clarified. The description of the protocol provided should give more details, particularly in terms of what will be discussed within the focus group discussions described later. The order of objectives presented at the end of the introduction need some consideration (see point above regarding the need to establish / define current practice and then to determine the level of adaptation required for existing protocols in order to contextualise them to the Indian setting. Method I find it difficult to establish how the acceptability and appropriateness of the ICP can be determined as the ICP has not yet been developed/ tailored for the Indian setting.

3 Define what is meant by "routine practice". Is the same "routine practice" provided in all hospitals? Is there diversity? This should be considered. The paragraph relating to the COM-B model should be restructured, with the concept of the COM-B being a theoretical framework explained first. Study sites The selection/ recruitment of study sites should be described in more detail, rather than merely stating "selected opportunistically". E.g. By whom, how, what level of detail was provided when recruiting? Were more than the four sites originally approached? These details will be required to meet the study objective regarding recruitment and retention. Study participants What is a resident in this context? A doctor in training / a qualified doctor? Key Informant Interviews In order to ascertain people's opinions of implementing an ICP, the ICP will need to be presented to them, and therefore should be developed, all be it in draft form, prior to the interviews. Focus Group Discussions Why are nursing staff not included in the list of HCPs involved? The reason for including only patients with unilateral hip fracture should be justified. Is the ICP only for patients with unilateral hip fractures? Why are patients with bilateral hip fractures (even though rare) being excluded? I feel that these should be conducted prior to the development of the ICP for local use in the Indian context. Findings from these focus groups should inform the development of the protocol. Quantitative data collection It's not clear if at this stage the IPC itself is being tested for feasibility. The type of data being collect at each stage should be described Inclusion criteria The reasons for including patients 50 years and over should be justified. All background literature cited refers to patients 60 years and over. As with focus groups, will only patients with unilateral hip fractures be included?

4 Exclusion criteria See above re inclusion/ exclusion of hip fracture type. The "Fragility Fracture Network" should be explained; what is it, what data are recorded? Are data for all hip fractures recorded? Is it a national database? On admission to hospital & at discharge: All data recorded should reflect what will be in the ICP, therefore further detail should be added. E.g. the example ICP provided in the introduction refers to having a policy on pressure ulcers, yet details regarding pressure ulcers are not noted as being important to collect. Explain how quality of life will be determined/ measured. What instrument? What will it involve? 30-day post fracture Should read 30-days Explain EQ-5D (but this can be explained in the previous section, presuming the same measure will be used) Data management and analysis Explain how "findings from quantitative survey of hospitalized patients will be corroborated with the statements recorded through FGSs and KIIs. References These are not formatted correctly, and spacing is not consistent. Table 1 Provide details regarding the professional groups considered to be HCPs The font within this table is different in some instances e.g. "30 days follow up" Remove the phrase "push backs" and use barriers as the alternative Refer to this table in the text Table 2

5 Provide details re quality of life measure used, how mobility and functional status will be measured These measurements should be noted in the text Level of interest Please indicate how interesting you found the manuscript: An article of limited interest Quality of written English Please indicate the quality of language in the manuscript: Not suitable for publication unless extensively edited Declaration of competing interests Please complete a declaration of competing interests, considering the following questions: 1. Have you in the past five years received reimbursements, fees, funding, or salary from an organisation that may in any way gain or lose financially from the publication of this manuscript, either now or in the future? 2. Do you hold any stocks or shares in an organisation that may in any way gain or lose financially from the publication of this manuscript, either now or in the future? 3. Do you hold or are you currently applying for any patents relating to the content of the manuscript? 4. Have you received reimbursements, fees, funding, or salary from an organization that holds or has applied for patents relating to the content of the manuscript? 5. Do you have any other financial competing interests? 6. Do you have any non-financial competing interests in relation to this paper? If you can answer no to all of the above, write 'I declare that I have no competing interests' below. If your reply is yes to any, please give details below. I declare that I have no competing interests

6 I agree to the open peer review policy of the journal. I understand that my name will be included on my report to the authors and, if the manuscript is accepted for publication, my named report including any attachments I upload will be posted on the website along with the authors' responses. I agree for my report to be made available under an Open Access Creative Commons CC-BY license ( I understand that any comments which I do not wish to be included in my named report can be included as confidential comments to the editors, which will not be published. I agree to the open peer review policy of the journal