Author's response to reviews

Author's response to reviews Title: Validation of Doloplus-2 among nonverbal nursing home patients - An evaluation of Doloplus-2 in a clinical setting An evaluating of Doloplus-2 in a clinical setting Authors: Karin Torvik (karin.torvik@hist.no) Stein Kaasa (stein.kaasa@ntnu.no) Øyvind Kirkevold (oyvind.kirkevold@aldringoghelse.no) Ingvild Saltvedt (ingvild.saltvedt@ntnu.no) Jacob C Hølen (jacob.c.holen@ntnu.no) Peter Fayers (p.fayers@abdn.ac.uk) Tone Rustøen (tone.rustoen@su.hio.no) Version: 3 Date: 22 December 2009 Author's response to reviews: see over

RESPONSE TO THE REVIEWERS COMMENTS Ref. No.: MS: 1615180337298176 Doloplus-2: a valid tool for estimating pain in nursing home patients without ability to self-report pain?an evaluating of Doloplus-2 in a clinical setting Karin Torvik, Stein Kaasa, Øyvind Kirkevold, Ingvild Saltvedt, Jacob C Hølen, Peter Fayers and Tone Rustøen We would like to thank the editor and the reviewers for their thoughtful comments on the above referenced manuscript. Our responses to the editor s and reviewers comments are in italics below each of the comments. Editors note: 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 (http://www.biomedcentral.com/info/ifora/medicine_journals ). It is important that your files are correctly formatted. The revised manuscript confirms to the journal style Reviewer's report: Title: Doloplus-2: a valid tool for estimating pain in nursing home patients without ability to self-report pain? An evaluating of Doloplus-2 in a clinical setting Version: 1 Date: 10 October 2009 Reviewer: Keela Herr Reviewer's report: The authors are contributing research to the growing literature on pain assessment tin persons with dementia that provides an important finding with focus on the nonverbal patients unable to communicate. The tool this study evaluates is one that has potential promise, but has had limited testing cross-culturally/languages. This group has examined the Doloplus 2 in a sample of Norwegian older adults in the NH setting. Their methodology is acceptable and the authors have addressed limitations in the findings resulting from study method issues. The paper is well-written and their discussion and conclusions contribute to the thinking and issues in this important area of study. Discretionary revisions None Minor Essential Revisions 1. Because this study was conducted prior to recent reviews/updates of the tools in available in this area, the narrative on p. 5 is not complete. Although they can t consider additional tools in their study, they should acknowledge the existing work on other tools that might be recommended based on recent reviews (e.g. 1

Hadjstavropolous et al, 2007; Husebo s recent publications) We have added existing work on other tools that might be recommended based on recent reviews 2. P. 6 The verbs in the objectives do not all fit with the lead in sentence. (e.g. change examine to examining; evaluate to evaluating) We have changed the verbs as suggested. 3. No information on who collected other data besides the pain scales, including diagnoses, pain medication, and ADL determination. We have added information on who collected the other data besides the pain scales in the manuscript. Major Compulsory Revisions None 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 that I have no competing interests Reviewer's report Title: Doloplus-2: a valid tool for estimating pain in nursing home patients without ability to self-report pain? An evaluating of Doloplus-2 in a clinical setting Version: 1 Date: 29 September 2009 Reviewer: Sandra MG Zwakhalen Reviewer's report: This article aims to address an important problem, experienced by many elderly patients. A problem which remains to often under detected and therefore undertreated. It describes a small Norwegian study focusing on the DOLOPLUS-2 a scale to assess pain in older geriatric patients. In my opinion the manuscript needs major revisions but I do encourage the authors to resubmit their paper after these revisions. My concerns are addressed more specifically in the next section. Major Comments: Title: a more to the point title would be more informative to the reader. We have changed the title Abstract: Methods section Mini Mental Status Examination should be Mini Mental 2

State We thank the reviewer for this comment, and the corrections are made as suggested throughout the manuscript. Different fonts are used in this section. Delete the word The before Results and discussion. We have corrected the fonts and deleted the word The Result section. Absence of the behavior should be absence of the pain behavior The correction is made as suggested. Conclusion section. The fact that nurses could not report the patient s pain in one third of the patients support that Doloplus-2 is recommended. In my opinion, this can not be concluded. The sample size is rather small and limited to non verbal patients. And perhaps even more important, Doloplus-2 seems to overestimate pain. Prevalence in this study measured by Doloplus-2 demonstrates also very high prevalence rates. Especially in patients with behavioral problems it is almost impossible to score less than 5 points. One could question its validity and especially the discriminant validity. When authors end with the statement that further research is needed, it is valuable to specify this further research needed. On what topic etc Thank you for this comment. We have moderated our conclusion according to the reviewer s suggestion. This point is also made clearer in the limitation section of the manuscript. Intro: Page 4: Pain is a well documented problem. This could suggests that it is clearly Registered We have changed this sentence to Pain is a major problem. Delete sentence Furthermore the prevalence.. of pain-related diagnoses. Already implied by the second sentence previous studies have shown. Self reporting pain The sentence is deleted as suggested Please add a reference towards in addition, those with severe. That they are not in pain. The reference is added 3

Given the fact that this article aims to focus on pain in non-verbal elderly people (often dementia patients), this section needs some explanations on this. More specific information on the difficulties of pain assessment in demented elderly persons is missing. The focus is on mainly on language loss although there are many other problems that complicate the assessment of pain in this population. Yes, we agree, and have added other problems that complicate the assessment of pain in this population as suggested. Many of these studies have eliminated However, self report is successfully used in moderate and even sometimes severely impaired patients. We have changed the sentence Page 5: The study reported that. Showed best psychometric qualities. Add the words at that time and please add one or two references of other more recent reviews. There has been a lot of progress in this area. Thanks for this comment. We have added more recent reviews However, the second follow up study Is this actually the second follow up or just the second study or follow up study? We have corrected this. It was the second study by Hølen et. al. We have changed this in the manuscript Page 6: Last objective add how nurses estimate the pain. Delete the word without in this last objective. The last objective is changed as suggested Methods: It remains unclear why verbal patients were excluded. Doloplus-2 is validated initially for geriatric patients. Furthermore including verbal patients could have served as a reference group which could be used as a silver standard. This is a good suggestion. However, as one of the criteria for using Doloplus-2 is that the patients cannot verbally express their pain (Lefebvre-Chapiro S, 2001), we did not use Doloplus- 2 on the sample that could self report their pain. Data from the verbal patients in the present study is published elsewhere. I have some concerns about the use of the MMSE as an inclusion criterion. It is implied that when patients were not applicable for scoring the MMSE this means that they are severely impaired. This is very doubtful. Patients after a stroke often can not complete the MMSE although might be perfectly able to use a NRS or 4

other self-report scale. Why not use the MMSE the way it is intended. Please provide information on the patients cognitive impairment using MMSE (mean) scores. No detailed information is provided on the cognitive status of the target group yet. The MMSE score in this group was zero. We have added this information on Table 1. The information about the inclusion of the patients is made clearer at page 7 in the manuscript. Page 7: Pain-relieving medication Nygaard et al., Please add one or two more sentences to explain the way of categorization. Explanation for the categorization on pain- relieving medication is added to the manuscript Page 7: Pain relating diagnoses. And gastritis Was this based on record based information? Yes, and this is added to the manuscript at page 8 under data collection. How was dementia assessed? We collected data about the dementia diagnosis from the patients medical records. This is added to the manuscript and it is also added as an limitation ino the manuscript at page 17. Terms of nonverbal and non communicative are used both. Non-verbal does not mean that patients are non communicative. Please use the term non verbal. Yes, we agree. The term non-communicative have been changed into nonverbal in the manuscript. More detailed information is desired on setting, patients inclusion criteria etc. More information on patents inclusion criteria is added. The procedure of data collection / assessed moments remains unclear. When and how were patients assessed and by how many different nurse raters? More information about data collection is added to the manuscript. As some nurses rated more than one patient we do not know exactly how many different nurses that rated the patients. The scoring was always done by the primary nurse (the registered nurses with the best knowledge of the patient s behaviour). This nurse cared for the patient regularly and had to have been present for the last two days prior to assessing the patients. This is made clear in the manuscript. Please add more information and explain why pain was assesses by nurses using the NRPR. Why was this used since it is not validated to assess pain in this population? 5

As the present standard in the clinic is nurses subjective evaluation of the patients pain, we judged the use of the single question to be a way to compare the score with the Doloplus -2. This was added to the manuscript. Pain section page 8: what was the education about? The education of the nurses is added in the method section Each item is scored..the highest expression of the behaviour. Replace highest expression of the behaviour by highest score, since absence of behaviour could result in a score of 3. Yes, we agree and change the highest expression of the behaviour into highest score Page 9: Immediately before is experiencing pain? Why was the primary nurse asked for her estimation before using a scale since this might influence scoring? As we wanted to test the properties of Doloplus-2 we asked that question to look for congruence between the scoring of Doloplus-2 and this single item question about if they believed or not that the patients were in pain. It was important that these two different pain estimates was done close in time to get the best comparisons. Ethics section. Page 9: When relatives legal guardians? The research group has discussed this ethical challenge with both the Regional Committees for Medical Research in Ethics and the Ministry of Health and Care Service in Norway. Very few Norwegians have legal guardians, and when guardians are appointed it is usually only for economical issues. The Ministry of Health and Care Service in Norway ordered that if the patients had a legal guardians, they should consent on behalf of the patient, if not their relatives should consent. We have added that to the manuscript under Ethics. Statistics. Page 9: What is meant by completeness of Doloplus-2? Be more specific. We have changed this in the statistics section in the manuscript.. The percentages were calculated, why not use mean scores as well. We have added the mean data in Table 2. The information on alpha if deleted is not quite clear; add why this information is provided. This information is added to the manuscript at page 10. Results 6

Sample section, page 10: 93 participants did not participate because they refused. This suggests that not relatives were asked for consent but patients were. However it is stated that all patients were severely impaired? Page 10; Furthermore 128 patients were excluded because they were able to self-report there pain This could only be stated when patients were actually ask for there pain report. The fact that patients were not able to complete an MMSE does not mean that they could not use a self report pain scale. We are sorry for this misleading information. The information of the total sample and the nonverbal sample is made clearer in the manuscript. Table 1: add information on MMSE scores/ cognitive status. The information are added. Page 11: Forty per cent of the patients were not receiving any prescribed pain medication In the presentation of patients characteristics it is more common to tell how many patients received analgesics and or psychotropic s instead of telling how many patients did not. We have changed this information as suggested. Page 11 Doloplus-2: not scored. Maximum score section. Please use other title as well as more clear information. This section is difficult to follow. Please describe more clearly. Do revise the table as well. Table 2 does not seem to be very appropriate / needs some more explanation. There is recently an article in press in the European Journal of Pain which might be helpful. The article is entitled. Reliability study in five languages of the translation of the pain behavioural scale Doloplus_G. Pickering a,b,c,*, S.J. Gibson d, et al., 2009 Thank you for this information. We have changed this section and provided additional information in Table 2. Page 12: When using NPRP.. (indicating no pain) Don t use the abbreviation NPRP. Add percentages and further in the text percentages are used however no absolute figures were used. The abbreviation is deleted. More information is added to make this clearer. Neither NPRP in the NPRP group. How was this tested/ verified? It implies a causal relationship. The validity was estimated by comparing registered nurses subjective assessment and Doloplus- 2 pain assessments for each patient by Fisher s Exact test as described in the Statistic section. Table 4 the information in the lowest section of this table does not add much. 7

We agree and have deleted the information in the lowest section in Table 4. Perhaps revise the table by just using % of agreement. The reason why we were using both frequencies and per cent was because of the small sample size. Discussion: The discussion section in general could be more structured with regard to your aim. Please revise this section. It is quite long and detailed. On the other hand it does not highlight most important result and reflect on these results by addressing the research questions. We have revised the discussed section and restructured it after the aims of the study. I agree with the authors that DOLOPLUS is perhaps overestimating pain. However this finding has major consequences which should be addressed. When the authors reflect on other literature in relation to the Doloplus they often refer to Holen et al., However several other studies have been done by various research groups. These other articles could be used to support the findings of this study Thank you for this comment. We have revised this section and also added many references to be more updated. Level of interest: An article of limited interest 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 that I have no competing interests' 8