Title: Patients' experiences and perceived causes of persisting discomfort following day surgery

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Author's response to reviews Title: Patients' experiences and perceived causes of persisting discomfort following day surgery Authors: Helena I Rosén HR (helena.rosen@his.se) Ingrid HE Bergh IB (ingrid.bergh@his.se) Berit Lundman BL (berit.lundman@nurs.umu.se) Lena B Mårtensson LM (lena.martensson@his.se) Version: 3 Date: 10 July 2010 Author's response to reviews: see over

Adrian Aldcroft, Assistant Scientific Editor BioMed Central Floor 6, 236 Gray's Inn Road London, WC1X 8HL Dear Sir, Enclosed, please find a revised version of our manuscript entitled Patients' experiences and perceived causes of persisting discomfort following day surgery (Manuscript MS: 1775694315388882). We have read the valuable comments made by the reviewers with great interest and we have revised our manuscript accordingly in response to most comments (see below). The changes are marked in red in the revised manuscript as well as in this letter. Yours sincerely, Helena Rosén, Ingrid Bergh, Berit Lundman, Lena Mårtensson 1

Reviewer's report Title: Patients' experiences and perceived causes of persisting discomfort following day surgery Version: 2 Date: 8 June 2010 Reviewer: Lenore Manderson Reviewer's report: This paper provides an account of patient perceptions and experiences of day surgery, with patients reporting higher levels of pain and discomfort than expected, and expressing concern about poor quality or lack of follow-up care, and concern that they had received sub-optimal or inappropriate treatment. Essentially, I believe that the paper needs to be rewritten, with attention to: (a) differences among respondents to identify difference in complaints of pain by age and type of procedure We agree with the reviewer that this is an interesting issue. Patients symptoms and complaints probably vary with age as well as type of procedure. However, it was not the main purpose of this study to investigate these differences. Therefore, there is substantial variation both in procedures and patients age, making it impossible to identify differences in complaints of pain related to any specific procedure or to age. We also state, under the heading Limitations and strengths, One strength of this study is that the results are based on the patients own descriptions of their problems over time. The advantage of the descriptive results is that they can serve as a basis for further research. They can be used as the basis for purely quantitative, experimental or qualitative, interview studies. In such future studies, relationships between complaints at different time-points, type of procedure and age might be investigated. (b) clarification that the problem is one of false exectation of 'day' surgery - rather than, for instance, poor follow up by health personnel In some cases, patients problems might be a result of false expectations concerning day surgery. However, in the first paragraph of the Discussion section, we have mentioned this issue: Hence, the patients expressed that they were left to rely on their own advice/care due to insufficient access to health care and/or information or to incorrect or suboptimal treatment. (c) significance of this for health and hospital policy. With revisions, this paper provides an interesting perspective on changes in medical/surgical interventions. The heading Conclusions has been changed to Conclusions and clinical implications. We have also discussed the clinical implications in more detail in this section. The paper would benefit from a brief background section on the context of day surgery in Sweden, the extent to which patients now have day rather than inpatient procedures, and the acceptance of this change. 2

We have added the following text under the heading Methods/Data sample and collection: According to official national Swedish health statistics, approximately 623 000 operations were performed on adults (20-85+) as day surgery in Sweden during 2008. This represents 64% of all operations in Sweden (The Swedish National Board of Health and Welfare Official national Swedish health statistics in) (2010). Most hospitals have standardized routines for discharge and follow-up telephone calls. Approximately 40% of the day surgery units make follow-up telephone calls to all patients (Segerdahl, Warren-Stomberg et al. 2008). The authors note that period at home following day surgery is more profound and lasts longer than was known. But surely this depends on surgery, and the likelihood of follow up of complications, etc. Cataract surgery, for instance, is a 7 minute procedure with no usual complications. What we don t know from this study are the types of surgery performed ( general orthopedic and urological are vague categories) and we do not know the ages of those who had day surgery. And as notes, Factors unrelated to the surgery type, such as the individual level of dependence in daily life and other contextual factors, must be taken into consideration, in addition to the standard length of the recovery period on the group level. None of the data here are analysed taking these factors into account. Although data may not have been collected on family, care, support and related factors, I assume there are data on age and procedure, and the disaggregation will help explain patients complaints. We agree with the reviewer that these are interesting questions; however, exploring them was not the main purpose of the study. There is substantial variation in the procedures undergone by the patients included in this study, making it impossible to identify differences in complaints of pain related to any specific procedure. We have, however, added (Methods/ Data sample and collection section) examples of the procedures as well as the number of patients having undergone the most common ones: The patients included in this study underwent a wide range of surgical procedures (e.g. ligation/resection of vena saphena magna, radical surgery inguinal hernia, hemorrhoidectomy, arthroscopy). The authors also report that the majority (n=34) of those with persisting discomfort had undergone their procedures at a general surgery clinic while six were orthopedic surgery patients and six were urology patients. It is hard to interpret this without knowing the total number of general surgical patients, and total orthopaedic and urology patients. What matters is within each group (that is, proportion of general patients experiencing continuing discomfort, cf proportion of urology patients or orthopaedic patients with discomfort. But again, this must also be related to type of surgery. We have added the following information under the heading Methods/Data sample and collection: general surgery n=205; urology n=60; orthopedic surgery n=33. The point of the paper is somewhat unclear: is it that people did not realise that after day surgery they would still have after effects? Or that they were unprepared for the levels of discomfort? Or did they assume that because they were having day surgery, they thought they would have no side effects? Are 3

people unrealistic? Are people complaining because of false expectations created by the confusion between day surgery and minor surgery that is, if people had been in hospital overnight or for longer, would there have been any difference in outcomes? And if no, then what is the point? Authors expressed dissatisfaction with services and had negative views on quality of care this is an important point (pp.13-14), but again, is this unique to day surgery patients? Patients expressed that they were left to rely on their own advice/care due to insufficient access to health care and/or information or to incorrect or suboptimal treatment again is this unique to day surgery? No, this is probably not unique to day surgery, but patients undergoing day surgery become responsible for their own postoperative care. Consequently, nursing tasks are shifted from the professionals to patients and their families. This shift in responsibility makes it even more important to obtain an adequate understanding of patients symptom experience following day surgery, which we have also, to some extent, pointed out in the Background section. Further, the authors noted that patients were convinced that the surgery had been incorrectly performed and/or had experienced unsatisfactory encounters with health care professionals and conclude that this finding indicates a need for interventions, including improved possibilities to obtain help and professional information on what basis is this conclusion made? Some respondents made statements of this kind. Whether or not they are true is unknown; however, these are their expressed experiences. We think that something went wrong in the communication between the patient and the health care professionals and have added the following to the Discussion section: This indicates that something went wrong in the communication between the patient and the health care professionals, which is serious and indicates a need for enhanced professional information. most patients are also offered a follow-up call after surgery the follow up call seems early, and this is problematic given that some patients had discomfort up to three months later? Were there no further follow-up calls? No, there were no further follow-up calls. What about visits back to doctors? Surely that occurred/ how many visits with the surgeon? Questions about visits back to doctors were not included in the questionnaire. The authors note that The main finding in this study is the occurrence of discomfort, e.g. pain and wound problems and their impact on daily living, up to three months following day surgery. Did the authors explicitly ask participants whether the recovery period was extended over a longer period than expected?? No Postoperative signs and symptoms tend to persist for a longer period than doctors expect: why is this the case??? We do not know the answer to this question. To our best knowledge, there are no previous studies elucidating patients perceptions of postoperative signs and symptoms up to three months after day surgery. 4

It is thus important, in order to increase compliance with what?? - to ask the patient his/her opinion of the cause of the discomfort, resulting in knowledge that will facilitate mutual decision-making with patients and increase adherence to management and advice, leading to improved well-being. We have clarified this thus: It is thus important, in order to increase compliance, e.g. regarding the use of analgesics, How is wellbeing assessed in this context? We have not assessed well-being. However, we believe that a high degree of compliance to recommended medication for symptom relief would result in increased well-being. Page 5 --- and female 5%) (fix numeral) This error has been corrected in the manuscript. Finally, the paper is very repetitive of its key findings, and some editing is in order. Level of interest: An article of limited interest Quality of written English: Needs some language corrections before being published The manuscript has been reviewed by a medical professional who is a native English speaker. Statistical review: No, the manuscript does not need to be seen by a statistician. 5

Reviewer's report Title: Patients' experiences and perceived causes of persisting discomfort following day surgery Version: 2 Date: 24 May 2010 Reviewer: Anne Dewar Reviewer's report: 1. Is the question posed by the authors well defined? Yes, 2. Are the methods appropriate and well described? Compulsory revisions 1) The methods need more development- as examples- were there any reasons for the 93 who were invited to take part in the study declined? What were the types of day surgery- or surgical specialties. Since these 93 patients declined participation in the study, we had no possibility to approach them with any question related to the study (according to the ethical regulations). 2) How were the patients approached? Research assistant? registered nurse? We have added the following text in the manuscript under the heading Methods/ Data sample and collection Data collection was performed by one of the authors (HR), aided by a research assistant. 3) All patients were offered a follow-up call the morning after surgery - did most accept, This follow-up phone call is routine at the day surgery unit and was not related to the data collection; to avoid confusion, we have deleted this sentence from the manuscript. was there any relationship between those who received a phone call and those who remained in the study? No 4) Patients were recruited from a survey carried out May 2006-May 2007 at a day surgery unit in a county hospital in Sweden. What are the details of the recruitment? We have added the following text to the Methods/Data sample and collection section: Patients were consecutively selected from a waiting list. The material is a part of the patient material in a larger study. 5) How were the questionnaires returned? We have added the following sentence under the heading Methods/ Procedure: All questionnaires were requested to be returned by mail and stamps and envelopes were provided by the researchers. 3. Are the data sound? Yes, the data focus on one open-ended question. The qualitative methods are clearly described. However, the qualitative data is quite descriptive, I do not see formation of conceptual categories. 6

We had no intention of creating conceptual categories in the qualitative analysis. However, we did intend to describe a pattern in the patients experiences and perceived causes of persisting discomfort following day surgery. The aim of the analysis of data was to describe the concrete and obvious content in the patients accounts, i.e. the manifest content, which is an appropriate level of analysis when the aim is to respond to concrete clinical questions. This is linked to the principle of lowinference interpretation (Graneheim and Lundman 2004). In qualitative analysis, the meaning of the content can be interpreted to a varying degree and with a varying degree of abstraction. However, a prevalent principle, according to Sandelowski (Sandelowski 2000), is that descriptions derived from a qualitative analysis should have a high degree of concurrence among researchers and clinics in the same field. This is in contrast to the "high-inference interpretation" approaches such as phenomenology, that focus to a greater extent on the latent content, i.e. on the meaning and content that exists "between the lines" of what is stated in an interview (Graneheim and Lundman 2004). In light of this, this analysis does not claim to do anything other than highlight the manifest content in the responses to the openended question. Compulsory revision The researchers say that the groups did not differ in relation to surgical specialty but it would be helpful to the reader to know how the patients were categorized and how many surgical specialties. They indicate general surgery, orthopedic surgery and urology later on in the paper, were there others. This should be made clearer earlier- for example in the methods section. We have added the following information: general surgery n=205, urology n=60, orthopedic surgery n=33 under the heading Methods/Data sample and collection. 4. Does the manuscript adhere to the relevant standards for reporting and data deposition? Ethics approval was obtained. 5. Are the discussion and conclusions well balanced and adequately supported by the data? The discussions are supported by the data. 6. Are limitations of the work clearly stated? Discretionary revisions Yes, the authors have outlined the limitations, there are limitations to the qualitative analysis developed that could be specified. 7. Do the authors clearly acknowledge any work upon which they are building, both published and unpublished? Yes, this research was part of another research project. 8. Do the title and abstract accurately convey what has been found? Yes. 9. Is the writing acceptable? Minor essential revisions 7

Some editing would improve the caliber of the paper, it could be more concisely written. as examples: a)- the phrase due to the fact could be edited without losing meaning. b) patient had tried to contact the surgeon c) I am attaching the paper with some suggested revisions. The manuscript has been reviewed by a medical professional who is a native English speaker. Level of interest: An article of importance in its field Quality of written English: Needs some language corrections before being published The manuscript has been reviewed by a medical professional who is a native English speaker.. Statistical review: No, the manuscript does not need to be seen by a statistician. Declaration of competing interests: I have no competing interests 8

Reviewer's report Title: Patients' experiences and perceived causes of persisting discomfort following day surgery Version: 2 Date: 3 June 2010 Reviewer: Mark Mitchell Reviewer's report: Patient s perceptions of perceived causes of persistent discomfort following DS Overall, an interesting paper with a number of important findings for the future of nursing intervention following Day Surgery. Main points for consideration Reporting of findings, data collection and use of quantitative data. Reporting the findings I found a little confusing, that is, the use of the terms Group 1, 2 and 3. I found myself searching back to determine which group was which. Also these were not strictly groups but time intervals for data collection. We have tried to clarify this by adding in groups 1 (48 hours), 2 (7 days) and 3 (3 months) under the heading in which we refer to the groups. In the Discussion section the themes type of surgery, incorrect treatment, insufficient access to health care providers and information were far easier points to flow. These terms may prove more useful throughout as a number of participants could have been interviewed on all 3 occasions. While the information reported under these headings was valuable a number of quotes were lengthy and the many points were merely raised in bold. We agree with the reviewer that an additional interview with these patients might have provided useful information. However, our intention with this study was to present a first overview of the patients experiences and perceived causes of persisting discomfort following day surgery. We also state under the heading Limitations and strengths: One strength of this study is that the results are based on the patients own descriptions of their problems over time. The advantage of the descriptive results is that they can serve as a basis for further research. They can be used as the basis for purely quantitative, experimental or qualitative, interview studies. A little more information would be helpful on data collection. By telephone, one-to-one, tape recorded, demographical detail collection, arrangements made for further contact. Survey as stated in abstract or mix-methods not very clear. If it was a survey much more information is required regarding the questionnaire. This follow-up phone call is a routine at the day surgery unit and was not related to the data collection; to avoid confusion, we have deleted this sentence from the manuscript. We have made the following changes in the abstract This study is a part from a study carried out. We have added the following text to the Methods/Data sample and collection section: Patients were consecutively selected from a waiting list. The material is a part of the patient material in a larger study. 9

Regarding quantitative analysis gender and discomfort at different time intervals evaluated but nothing further. Why include this if no explanation regarding findings or further reporting of this in the Discussion. Are gender and discomfort related in contemporary elective surgery? We agree with the reviewer that this is an interesting point. It is probably the case that patients symptoms and complaints vary with age as well as type of procedure and at different time-points. However, it was not our main purpose to focus on these differences in the study. Therefore there is substantial variation in procedures as well as in age among the patients included in the study. This fact makes it impossible to identify differences in complaints of pain related to any specific procedure or to age or at different time-points. We have merely reported age and gender to describe the sample responding to the open-ended question. We also state under the heading Limitations and strengths: One strength of this study is that the results are based on the patients own descriptions of their problems over time. The advantage of the descriptive results is that they can serve as a basis for further research. They can be used as the basis for purely quantitative, experimental or qualitative, interview studies. In such future studies, relationships between complaints at different time-points, type of procedure and age might be investigated. Further points of consideration!st page 4 sentence requires academic support and Ref 3 is a little old (13yrs). Page 5 Barthelsson (2009) Longitudinal changes in health and symptoms following laparoscopic cholecystectomy. Amb Surg 15(4) 80. This needs including in text. Reference number 3 has been changed to Susilahti, H., Suominen, T., & Leino-Kilpi, H. (2004). Recovery of Finnish short-stay surgery patients. MEDSURG Nursing, 13(5), 326-335. On page 4, one sentence has been given some academic support: (Mitchell 2007). Furthermore, additional academic support is presented on page 4: When studied from postoperative day one to seven and after one month and six months, patients perceptions of symptom occurrence and distress decreased during the first week. However, 30% of participating patients still reported at least one episode of distress or one symptom at six months (Barthelsson 2009). Page 5 No mention of how the patients were recruited nor who obtained the patients addresses. We have added the following text under the heading Methods/ Data sample and collection: Patients who were about to undergo day surgery received information about the study in a letter that was sent out simultaneously with the notification of the scheduled operation. At admission, patients who were willing to participate in the study gave written consent, together with their address and telephone number. Ethical section required with design and procedure. Information provision a considerable issue for DS patients globally. Greater support from the literature in Discussion thereby required. 10

We do not understand what the reviewer is requesting. We have, however, added a reference to the Helsinki declaration (World Medical Association 2008). How many participants were in some discomfort prior to their surgery? Taking a history of prior pain or other discomfort was not routine at this day surgery ward; this information was thus unfortunately not obtained in this study. All participants were, however, distinctly informed that the item referred to surgeryrelated discomfort How many in your survey received a follow-up call and was this beneficial? This follow-up phone call is a routine at the day surgery unit and was not related to the data collection; to avoid confusion, we have deleted this sentence from the manuscript As you intimate, the participants at 3 months may have replied as they were having more problems. This may have distorted your findings as the majority who did not respond to your letter, telephone call?? were all fine and back at work We have tried to throw light upon this under the heading Limitations and strengths: One strength of this study is that the results are based on the patients own descriptions of their problems over time. This highlights how persisting problems can be experienced. Those who responded actually experienced discomfort. The experiences of the patients who did not answer the open-ended question are unknown to us. Furthermore, we have, under the heading Data sample and collection, stated that all patients were distinctly informed that the item referred to surgery-related discomfort. The open-ended question was constructed as follows: If you are still experiencing discomfort related to the surgery, what is the reason, in your opinion? All patients were distinctly informed that the item referred to surgery-related discomfort. This follow-up phone call is a routine at the day surgery unit and was not related to the data collection; to avoid confusion, we have deleted this sentence from the manuscript. Level of interest: An article of importance in its field Quality of written English: Acceptable The manuscript has been reviewed by a medical professional who is a native English speaker. Statistical review: Yes, but I do not feel adequately qualified to assess the statistics. 11

Reviewer's report Title: Patients' experiences and perceived causes of persisting discomfort following day surgery Version: 2 Date: 8 June 2010 Reviewer: Katja Heikkinen Reviewer's report: I found your paper interesting, well written and relevant for BioMed Study guestion is well defined and the methods are appropriate and well described. The data is sound. There is only one mistake in the amount of patients: female not 5% but 51%? This error has been corrected in the manuscript. Manuscript is well written and the data is reported adequately. In the procedure the description of questionnaires is unclear. We have attempted to clarify that this is a part of a larger study. We have added the following sentence to the manuscript (Methods/ Data sample and collection): Patients were consecutively selected from a waiting list. The material is a part of the patient material in a larger study carried out May 2006-May 2007. We also state (Methods/Data sample and collection section) that Other data concerning these 298 patients have been analyzed and will be presented elsewhere (not yet published). The open-ended question was constructed as follows: If you are still experiencing discomfort related to the surgery, what is the reason, in your opinion? All patients were distinctly informed that the item referred to surgery-related discomfort. Data concerning demographic and background data were also collected Discussion and conclussion could be more balanced the conlusion should contain clear and relevant ideas for clinical practice. The heading Conclusions has been changed to Conclusions and clinical implications.. We have also discussed the clinical implications in more detail in this section. The limitations of the study are clearly stated, but the strengths are missing. One strength of this study is that the results are based on the patients own descriptions of their problems over time. The advantage of the descriptive results is that they can serve as a basis for further research. They can be used as the basis for purely quantitative, experimental or qualitative, interview studies. Title and abstrackt are accurate. Writing is acceptable after discretionary revisions. The manuscript has been reviewed by a medical professional who is a native English speaker Level of interest: An article of importance in its field Quality of written English: Acceptable Statistical review: Yes, and I have assessed the statistics in my report 12

(2010). "The Swedish National Board of Health and Welfare Official national Swedish health statistics in ". Retrieved June 30. Barthelsson, C. (2009). "Longitudinal changes in health and symptoms following laparoscopic cholecystectomy." Ambulatory Surgery 15(4): 80. Graneheim, U. H. and B. Lundman (2004). "Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness." Nurse Education Today 24(2): 105-112. Mitchell, M. (2007). "Nursing intervention for day-case laparoscopic cholecystectomy." Nurs Stand 22(6): 35-41. Sandelowski, M. (2000). "Focus on research methods. Whatever happened to qualitative description?" Res Nurs Health Aug; 23(4): 334-340. Segerdahl, M., M. Warren-Stomberg, et al. (2008). "Clinical practice and routines for day surgery in Sweden: results from a nation-wide survey." Acta Anaesthesiol Scand 52(1): 117-124. World Medical Association, I. (2008). "WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects ". Retrieved june 30, 2010. 13