Title: Health-related quality of life outcomes for older Taiwanese with hip fracture after an interdisciplinary intervention

Transcription

1 Author's response to reviews Title: Health-related quality of life outcomes for older Taiwanese with hip fracture after an interdisciplinary intervention Authors: Yea-Ing L Shyu (yeaing@mail.cgu.edu.tw) Jersey Liang (jliang@umich.edu) Chi-Chuan Wu (ccwu@mail.cgu.edu.tw) Huey-Shinn Cheng (hscheng@adm.cgmh.org.tw) Min-Chi Chen (mcc@mail.cgu.edu.tw) Version: 4 Date: 25 August 2010 Author's response to reviews: see over

2 CHANG GUNG UNIVERSITY SCHOOL OF NURSING CHANG GUNG UNIVERSITY 259 Wen-Hwa 1st Road Kwei-Shan Taoyuan 333 Taiwan (R. O. C.) TEL: ext FAX: yeaing@mail.cgu.edu.tw August 25, 2010 Manuscript ID An interdisciplinary intervention for older Taiwanese patients after surgery for hip fracture improves health-related quality of life Dear Editor: Thank you for the thoughtful review of our manuscript. I have revised the manuscript following the reviewers comments, as described in the following pages. I hope that these changes clarify this manuscript. Again, thank you for the very thoughtful review. The comments of reviewers have helped to greatly strengthen our manuscript. Sincerely, Yea-Ing Lotus Shyu Professor, School of Nursing Chang Gung University 1

3 Responses to Reviewer's comments Reviewer 1: Michelle Ghert Reviewer's report: Major Compulsory Revisions: 1. The outcome assessors should be blinded to the treatment group. Response: We agree that double blinding is the ideal study design. However, due to the small scale of this study and the very different intervention deliveries to subjects in the experimental and control groups, it was almost technically impossible to blind the assessors because they would know right away from conversations with subjects to which group they belonged. To minimize the potential influence of bias, we assigned different research duties to the personnel delivering the intervention and assessing outcomes, as explained in the limitations (p. 16). 2. What does an effect size of 0.50 mean in the power analysis? What scale is being used? Response: To clarify, we added in the participants section that based on our pilot study data, a power of 0.80, and an alpha of 0.05, we estimated a sample size of 65 subjects in each group to obtain a median effect size of 0.50 [29] for improved performance of activities of daily living (ADLs) measured by the CBI (experimental vs control = 38.5 vs 31.5) and 61 subjects in each group for improved physical functioning measured by the physical function scale of the Taiwan version of the Medical Outcomes Study Short-Form 36 (SF-36)[30] from post-surgery to the third month after discharge (experimental vs control = 22.9 vs 11.1) [21,22]. (p. 6) 21. Shyu YIL, Liang J, Wu CC, Su JY, Cheng HS, Chou, S. W., & Yang, C. T: A pilot investigation of the short-form effects of an interdisciplinary intervention program on elderly patients with hip fracture in Taiwan. JAGS 2005, 53: Shyu YI, Liang J, Wu CC, Su JY, Cheng HS, Chou SW, Chen MC, Yang CT: Interdisciplinary intervention for hip fracture in older Taiwanese: benefits last for 1 year. J Gerontol A Biol Sci Med Sci 2008, 63: Cohen J: Statistical Power Analysis for the Behavioral Sciences, 2nd edn. Hillsdale, NJ: Lawrence Earlbaum Associates; Shyu YIL, Lu JR, Liang J: Evaluation of Medical Outcomes Study Short Form-36 Taiwan version in assessing elderly patients with hip fracture. Osteoporos Int 2004, 15: Were the recommendations made by the geriatric consultation followed? Was adherence to recommendations recorded? Response: Adherence to the geriatric consultation was obtained from clinical charts. The geriatrician s suggestions were generally followed except the use of anticoagulants for thromboembolic prophylaxis underutilization rates. This information has been provided in the intervention section. (p. 7) 4. The study population represents only 20% of the hip fracture population in the region. The authors should make a point of recognizing this fact. Response: This fact was added to the limitations section of the discussion (pp ). Minor Essential Revisions: 1. The second sentence in the second paragraph of the Background section should be 2

4 separated into two sentences. Response: Changed as suggested (p. 4). 2. What is a 'hemobag'? This should be clarified in the text. Response: Hemobag was a misspelling of hemovac, a device used for postoperative wound drainage. This information has been added in the text (p. 7). Reviewer 2: Faisal Mirza Reviewer's report: Major Compulsory Revisions: 1. Please provide data on the union rate of hip fractures treated with internal fixation. Response: Eighty-seven hip fractures were treated with internal fixation and followed-up for 1 year. Seven fractures failed to heal, and the union rate was 91%. However, only 80% of patients regained ambulatory ability (p. 13). 2. Please provide short statement on quality of arthroplasty. Response: Fifty-one hip fractures were treated with arthroplasty and followed-up for 1 year. However, 90% of patients regained ambulatory ability. Two patients hip prostheses were dislocated (2/51) and reduced with a closed technique (p. 13). 3. Both 1 and 2 can be provided in a short statement under first paragraph of results and reference Tidermark (2002). Response: We added the following sentences to the first paragraph of results: Eighty-seven hip fractures were treated with internal fixation and followed-up for 1 year. Seven fractures failed to heal, and the union rate was 91%. However, only 80% of patients regained ambulatory ability. Fifty-one hip fractures were treated with arthroplasty and followed-up for 1 year. However, 90% of patients regained ambulatory ability. Two patients hip prostheses were dislocated (2/51) and reduced with a closed technique [44]. (p. 13) 44. Tidermark J: Quality of Life and Femoral Neck Fractures. Stockholm, Sweden: Karolinska University Press; Please provide a statement as to how the forms were completed by the "illiterate" group; ie. translator, family member, research team. Considering that 8.8 were illiterate, this may pose a significant bias. Response: The following statement has been added to the procedure section: Due to the large proportion of illiterate participants (48%), data were collected during face-to-face interviews by research assistants reading the questionnaire aloud and recording participants responses. (p. 11) 5. Second sentence of second paragraph under Discussion must be revised - statement does not correlate with data and wording is confusing. Response: We revised the sentence, which now comes after a new section on needed-to-treat 3

5 numbers, as follows: These numbers are consistent with a prior report that the physical functioning dimension of hip-fractured elders was poorer after discharge than the mental/social dimensions of HRQOL [4]. Therefore, physical functioning might have a greater potential to be improved by treatment. (p. 15) 4. Shyu YIL, Chen MC, Liang J, Lu JFR, Wu CC, Su JY: Changes of quality of life among elderly patients with hip fracture in Taiwan. Osteoporos Int 2004, 15: Please provide a better rationale as to why cognitive impaired patients were excluded with reference to Feng (2010) and Samuelsson (2009). Mosely (2009) showed intensive rehab program improved outcomes better in those with cognitive impairment. Continue this in the discussion under weakness of the study. Response: We have explained the exclusion of elders with severe cognitive impairment as follows: Although outcomes f cognitively impaired elders have been improved by intensive rehabilitation programs [25,26,27], this study included only participants with mild and moderate cognitive impairment. This decision was based on our reasoning that those with severe cognitive impairment (MMSE < 10) are disoriented to time, place, and persons, have lost their ability to learn due to severe memory deficit, and have difficulty following directions [28], which might require different protocols for the rehabilitation intervention. To avoid complicating the study design, we included only participants with mild and moderate cognitive impairment. (pp. 5-6) This exclusion criterion was also mentioned as a limitation of generalizability (pp ). 25. Feng L, Scherer SC, Tan BY, Chan G, Fong NP, Ng TP: Comorbid cognitive impairment and depression is a significant predictor of poor outcomes in hip fracture rehabilitation. Int Psychogeriatr 2010, 22: Moseley AM, Sherrington C, Lord SR, Barraclough E, St George RJ, Cameron ID: Mobility training after hip fracture: a randomised controlled trial. Age Ageing 2009, 38: Samuelsson B, Hedström MI, Ponzer S, Söderqvist A, Samnegård E, Thorngren K-G, Cederholm T, Sääf M, Dalen N: Gender differences and cognitive aspects on functional outcome after hip fracture - A 2 years' follow-up of 2,134 patients. Age Ageing 2009, 38: Perneczky R, Wagenpfeil S, Komossa K, Grimmer T, Diehl J, Kurz A: Mapping scores onto stages: mini-mental state examination and clinical dementia rating. Am J Geriatr Psychiatry 2006, 14: Provide a statement under Discussion and weaknesses of type of randomization used in this study (coin flip). State that group size and demographics were equal, however. Response: We added the following limitation: Third, despite the similar size and demographics of the experimental and control groups, our method of randomization (coin flip) might have resulted in a dynamic bias [52] and can be considered a weakness of this study. (p. 16) 52. Diaconis P, Holmes S, Montgomery R: Dynamical bias in the coin toss. SIAM Rev 2007, 49: Fourth line under 'Geriatric Consultation' under Methods, provide one brief sentence as to what "specific attention" implies and then under discussions, state how whether this impacted outcome. Also, provide a short flow diagram as to the standardized method employed by geriatrician for recommendations made. Response: The geriatric assessment was conducted for all subjects in the experimental group, and clinical suggestions were made for patients 80 years old, with high operative risk, poor 4

6 nutritional status, cognitive impairment or disorientation, or those with unstable comorbid conditions. (p. 7) We also added the following sentences to the Discussion: It is difficult to separate the treatment effects for different components of this intervention program. Nonetheless, the rehabilitation combined with the geriatric consultation s clinical suggestions for high-risk patients might have improved their mental and physical function [45]. This possibility is supported by improved outcomes after hip fracture i[0]n a systematic review of multidisciplinary interventions including geriatric evaluation and management [46]. (p. 14) A flow diagram has been attached as Figure Marcantonio ER, Flacker JM, Wright RJ, Resnick NM: Reducing delirium after hip fracture: a randomized trial. J Am Geriatr Soc 2001, 49: Halbert J, Crotty M, Whitehead C, Cameron I, Kurrle S, Graham S, Handoll H, Finnegan T, Jones T, Foley A, Shanahan M, the Hip Fracture Rehabilitation Trial Collaborative Group: Multi-disciplinary rehabilitation after hip fracture is associated with improved outcome: a systematic review. J Rehabil Med 2007, 39: Provide data on timing of surgery and elaborate under Discussion. Response: Timing of surgery did not differ significantly between the experimental and control groups. This information was provided in the results section (p. 13) and Table 1. We also added the following sentences to the discussion: Early surgery (within 48 hours of admission) after hip fracture was found in a systematic review of 52 studies to reduce hospital stay and possibly complications and mortality [50]. In our study 35% to 42.7% of subjects received surgery within 24 hours after fracture, close to a prior study [51]. Time between fracture and surgery did not differ significantly between the experimental and control groups in our study. This might due timing of surgery depending largely on the time between hip fracture and admission, leaving little room for our intervention to intervene. Therefore, timing was treated in our study as a baseline characteristic, rather than an outcome variable. (pp ) 50. Khan SK, Kalra S, Khanna A, Thiruvengada MM, Parker MJ: Timing of surgery for hip fractures: a systematic review of 52 published studies involving 291,413 patients. Injury 2009, 40: Orosz GM, Magaziner J, Hannan EL, Morrison RS, Koval K, Gilbert M, McLaughlin M, Halm EA, Wang JJ, Litke A, Silberzweig SB, Siu AL: Association of timing of surgery for hip fracture and patient outcomes. JAMA 2004, 291: Under Methods section, Measurement (HRQOL), please discuss briefly in one statement responsiveness of SF36 to assess hip fracture outcomes - reference Tidermark (2003). Please add this reference to last line of same paragraph. Response: We added the following sentence: The responsiveness of the SF-36 to assess hip fracture outcomes has been established [4,36]. (p. 10) 4. Shyu YIL, Chen MC, Liang J, Lu JFR, Wu CC, Su JY: Changes of quality of life among elderly patients with hip fracture in Taiwan. Osteoporos Int 2004, 15: Tidermark J, Bergstrom G, Svensson O, Tornkvist H, Ponzer S: Responsiveness of the EuroQol (EQ 5-D) and the SF-36 in elderly patients with displaced femoral neck fractures. Qual Life Res 2003, 12: Under Conclusion, please add, "...without severe cognitive impairment..." after 5

7 "...persons..." in the first line. Response: Changed as suggested. (p. 17) 12. Under Background, please provide additional 1-2 sentences on the following study results - Crotty (2010), Tsauo (2005), Bryant (2009), Ryan (2006) and Huang (2005). This should cover additional studies not referenced on QOL outcomes intervention with hip fracture and Bryant (2005) will cover the appropriate use of outcome measures for hip fractures. Response: We added the following: Health-related quality of life (HRQOL) has been suggested as a measure for patients with hip fracture [16]. However, interventions to improve the HRQOL of elders with hip fracture have had inconsistent results. For example, elders HRQOL was reported to improve within 6 months of discharge after receiving discharge planning or home-based interventions [13,17,18]. On the other hand, HRQOL was reported to improve little or not at all in other interventional studies [12,19,20]. (p. 4) 12. Crotty M, Whitehead CH, Gray S, Finucane PM: Early discharge and home rehabilitation after hip fracture achieves functional improvements: a randomized controlled trial. Clin Rehabil 2002, 16: Binder EF, Brown M, Sinacore DR, Steger-May K, Yarasheski KE, Schechtman KB: Effects of extended outpatient rehabilitation after hip fracture: a randomized controlled trial. JAMA 2004, 292: Bryant DM, Sanders DW, Coles CP, Petrisor BA, Jeray KJ, Laflamme GY: Selection of outcome measures for patients with hip fracture. J Orthop Trauma 2009, 23: Huang TT, Liang SH: A randomized clinical trial of the effectiveness of a discharge planning intervention in hospitalized elders with hip fracture due to falling. J Clin Nurs 2005, 14: Tsauo JY, Leu WS, Chen YT, Yang RS: Effects on function and quality of life of postoperative home-based physical therapy for patients with hip fracture. Arch Phys Med Rehabil 2005, 86: Crotty M, Unroe K, Cameron ID, Miller M, Ramirez G, Couzner L: Rehabilitation interventions for improving physical and psychosocial functioning after hip fracture in older people. Cochrane Database Syst Rev 2010, (1):CD Ryan T, Enderby P, Rigby AS: A randomized controlled trial to evaluate intensity of community-based rehabilitation provision following stroke or hip fracture in old age. Clin Rehabil 2006, 20: State rationale why a hip-specific outcome score was not used and reference Bryant (2005). Response: In the methods section we added the following: To understand the impact of hip fracture on general health status, including physical symptoms, function, and emotional dimensions of health, rather than a specific aspect of health, a generic HRQOL measure was selected [16]. (p. 9). 16. Bryant DM, Sanders DW, Coles CP, Petrisor BA, Jeray KJ, Laflamme GY: Selection of outcome measures for patients with hip fracture. J Orthop Trauma 2009, 23: Minor Essential Revisions: 1. First sentence, Third paragraph of Background add the word "previous" after "...by our group in a..." Response: Changes were made accordingly. (p. 4) 2. Last line, Third paragraph of Background add ", as compared to controls," after "HRQOL" 6

8 Response: Changes were made accordingly (p. 5). 3. Under sample size discussion, correct alpha=0.05 instead of 0.50 (I assume this was a typo). Also, reference the outcome score used to determine effect size and reference prior work (Shyu 2005?). Response: Changes were made accordingly. (p. 6) 4. State expected dropout as a percentage under same paragraph as 3. Response: Changes were made accordingly. (p. 6) 5. Under Methods and heading Pre-fracture self-care ability, add ", suggesting high consistency." after "CBI was 0.87" Response: Changes were made accordingly. (p. 10) 6. First line, Second paragraph of Discussion, add "be" after "benefits appeared to..." Response: Changes were made accordingly. (p. 15) 7. Figures 2 and 3, place p-value in parentheses to match wording of manuscript. Response: Changes were made accordingly in Figures 3 and 4 (original Figures 2 and 3). Reviewer 3: Dianne Bryant 1. Methods section (second para; 5th line): alpha error should be 0.05 not 0.50 Response: Changed as suggested. (p. 6) 2. Methods section (first para; 2nd line): the eligibility criteria states that to be eligible patients had to be able to perform full range of motion (ROM) against gravity and against some or full resistance...is this prior to hip fracture or post? How was this determined? In the same sentence, it states that the patients had to have a pre-fracture CBI >70 - please describe how this was obtained (I believe it is stated later on that this was retrospective but it should be clarified here). Has anyone shown that a retrospective CBI is valid? If so, please include a reference. Response: We added the following explanation: Muscle power of the unaffected limb at admission (post hip fracture) was assessed by a trained research nurse. The pre-fracture CBI score was obtained from participants and/or carers by the research nurse. Using the Barthel Index to retrospectively assess pre-fracture physical functioning has been suggested by the UK National Health Service [24]. (p. 5) 3. I would have liked to have seen more help provided to the reader in terms of interpreting the results. Could the authors provide the MID for the SF-domains? The 7

9 authors provide statistical comparison of their data but do not comment on whether the observed differences are clinically important. Could they comment on Number Needed to Treat at their primary endpoint? Response: We added the following: The clinical significance of these differences in HRQOL outcomes can be assessed [0]by the minimally important difference (MID), which indicates the smallest difference in score for the domain of interest that patients perceive as beneficial and mandating a change in the patient s management. A MID of 5 is suggested for the SF-36 [47,48]. The differences in BP, VT, and GH scores between the experimental and control groups at different time points were all greater than 7, indicating indicate clinical significance. In particular, the differences in PH and RP scores at many time points were close to or greater than 20, indicating the magnitude of the intervention s positive effect. (p. 15) For Number needed to treat, we added the following to the discussion: To further assess the proportion of patients whose SF-36 summary score improved by 5 units from baseline to any time point during the 12-month period, we calculated the number needed to treat (NTT) [49] to achieve, on average, 1 patient with improved HRQOL for each scale. We found that the NTT for PH = 7.0, RE = 4.1, BP = 13.0, VT = 11.8, and GH = 6.4, SF = 7.0, RP = 13.2, and MH = (p. 15) 47. Bjorner JB, Wallenstein GV, Martin MC, Lin P, Blaisdell-Gross B, Tak Piech C, Mody SH: Interpreting score differences in the SF-36 Vitality scale: using clinical conditions and functional outcomes to define the minimally important difference. Curr Med Res Opin 2007, 23: Walters SJ: Sample size and power estimation for studies with health related quality of life outcomes: A comparison of four methods using the SF-36. Health and Quality of Life Outcomes 2004, 2: Wyrwich KW, Bullinger M, Aaronson N, Hays RD, Patrick DL, Symonds T: Estimating clinically significant differences in quality of life outcomes. Qual Life Res 2005, 14: Related to comment 3 - I would have liked to have seen some discussion about the magnitude of the positive effect of the intervention related to the cost of applying this intervention. It seems like a 'large' intervention, involving the time and coordination of many experts - thus, for policy makers, it would be important to be able to easily interpret the magnitude of the results as they will have an idea of the cost of implementation. The authors might also list the lack of a formal evaluation of cost-to-benefit as a limitation or direction for future research. Response: In the discussion, we added the following: The estimated cost added by the intervention program added to current routine care was $ 438 USD. The cost-effectiveness of this interdisciplinary program will be reported in detail in a separate paper. (p. 17) 5. The title should reflect the findings of the study - perhaps, "Providing an interdisciplinary intervention for older Taiwanese patients following surgery for hip fracture improves health-related quality of life" Response: The title was changed accordingly. Reviewer 4: Paul Zalzal Discretionary Revisions: 1. Consider reporting on mortality between the two groups. Not necessarily as a secondary outcome but to insure no difference. 8

10 Response: The experimental and control groups did not differ significantly in 1-year mortality (experimental vs control = 5% vs 7.2%, p = 0.54). (p. 13 and Table 1) 2. In the abstract, consider giving an age range for the study group rather than referring to it as older patients with hip fracture. Response: The age range years was added to the abstract. Minor Essential Revisions: 1. Page 5, Methods, inclusion criteria able to perform full range of motion against gravity. Does this mean they can do this after surgery? In my experience, it takes several weeks if ever to achieve full range of motion. Rather than saying full range of motion, a range should be defined. Response: The inclusion criteria were revised to able to perform active movement against gravity and some resistance or full resistance (p. 5) and Muscle power of the unaffected limb at admission (post hip fracture) was assessed by a trained research nurse. (p. 5) 2. Page 5, Methods, The sample was recruited and followed... Were patients recruited pre op or post op? If pre op, then the inclusion criteria of full ROM does not make sense because no one with a hip fracture could meet this criteria. Were the patients randomized pre op or post op? Response: To clarify the pre-operative assessment, we added the following: Muscle power of the unaffected limb at admission (post hip fracture) was assessed by a trained research nurse. (p. 5) To clarify that patients were randomized pre-op, we added Those who agreed to participate were randomly assigned right away (before surgery) to either an experimental or control group by the flip of a coin. (p. 11) 3. Page 6, Routine care (control group) treated with hip arthroplasty Is this a total hip or hemiarthroplasty should be clarified. Response: Hemiarthroplasty, as clarified in the text. (p. 6) 4. What is the weight bearing status of the patients post op. Are they all weight bear as tolerated? This should be clarified. Were the two groups similar with respect to weight bear status. Response: Patients are encouraged to ambulate with protected weight bearing for 3 months. Using a walker and touching the ground lightly are recommended (p. 7). The two groups were similar in weight bearing status. They were encouraged to ambulate with protected weight bearing for 3 months. (p. 7, 13) 5. Page 8, paragraph 2, During the in-home period, rehabilitation was delivered during 4 nurse visits for the first, and 4... This and the following sentence are very unclear. The two sentences need to be re-written. Response: These two sentences have been revised. During the first month, in-home rehabilitation was delivered by nurses once per week. During the second and third months, 9

11 in-home rehabilitation was delivered by nurses once every 2 weeks. (p. 9) 6. Page 12, first line, baseline characteristics BMI should be included here. Was the average BMI for both groups similar? Response: We added the following: The experimental and control groups did not differ significantly in baseline characteristics (i.e., BMI [body mass index], and ). (experimental vs. control = vs , p = 0.22) (p. 13 and Table 1) 10