Title: Basic geriatric assessment does not predict in-hospital mortality after PEG placement

Transcription

1 Author's response to reviews Title: Basic geriatric assessment does not predict in-hospital mortality after PEG placement Authors: Christine Smoliner Dorothee Volkert Anke Wittrich Cornel C Sieber (Cornel.Sieber@klinikum-nuernberg.de) Rainer Wirth (rainer.wirth@hospital-borken.de) Version: 3 Date: 18 July 2012 Author's response to reviews: see over

2 St. Marien-Hospital Borken GmbH Borken/Westf. Klinik für Geriatrie Chefarzt PD Dr. med. Rainer Wirth St. Marien-Hospital-Borken GmbH Am Boltenhof Borken Telefon: / Telefax: / Borken, 18th of July 2012 Point to point letter Dear Sir or Madam, with this point-to-point letter we would like to address the editorial and reviewers comments. We reviewed the tables according to the additional editorial requirements and found them to adhere to the journals standards e.g. citing our tables in order, not using merged cells. We did not use any range but a confidence interval on page 18 and hope this is feasible. Before we start to answer the reviewer s remarks separately we would like to comment on two points that have been raised by both. 1. First we would like to point out that this manuscript is based on the retrospective analysis of a database extract of the Gemidas - Geriatric Minimum Data Set, which is an instrument of voluntary quality assurance of geriatric hospital units in Germany. The Gemidas database is designed to assess a variety of components of the geriatric assessment. Obligatory items are e.g. main diagnosis, procedures, functional status (self care capacity, ability to walk, mental status) and place of discharge after hospital stay. Additional data can be voluntarily provided, however those components are usually filled out sparsely with low numbers, which makes it difficult to use them in analysis. Some of the items asked for by the reviewers e.g. depression were therefore not retrieved. Even though additional information such as inflammatory markers, swallowing function, polypharmacy would have been of interest in this study, they are not part of the Gemidas database. 2. Secondly we reshaped the diagnosis groups to give a more logic grouping. In the first version we had formed 6 diagnosis groups: 1=malnutrition, 2=miscellaneous, 3=musculoskeletal disease, 4=Parkinson, 5=pneumonia, 6=stroke. In the rearrangement we included in group 5 diseases that are potentially accompanied by

3 swallowing disorders or such as: parkinson s disease (n=44), amyotrophic lateral sclerosis (n=4), dysphagia of unknown cause (n=24) and dementia (n=26). In a regression analysis the regrouping did not show any effect. Age and gender remained with significant influence in the model, as did diagnosis groups miscellaneous and pneumonia. Patients in group 5 with potentially altered swallowing function did not have an increased risk for in-hospital mortality. Below we address the reviewers remarks, answers are marked blue. Reviewer #1: This is a large retrospective database study of PEG insertion and outcomes. The investigators have made some novel observations about cognitive status prior to insertion. I would like to make a few suggestions 1. Reference 8 is incomplete could this be expanded accordingly J Postgrad Med Jan-Mar;51(1):23-8; discussion Percutaneous endoscopic gastrostomy: 30-day mortality trends and risk factors. Thank you for the attentive reading. We completed the reference. 2. The authors discuss issues regarding dementia and gastrostomy insertion but have not mentioned 2 key papers. Could these be cited and discussed for a more comprehensive picture. Sanders DS, Carter MJ, D'Silva J, James G, Bolton RP, Bardhan KD. Survival analysis in percutaneous endoscopic gastrostomy: a worse outcome in patients with dementia. Am J Gastroenterol 2000;95: N Engl J Med Oct 15;361(16): The clinical course of advanced dementia. Mitchell SL, Teno JM, Kiely DK, Shaffer ML, Jones RN, Prigerson HG, Volicer L, Givens JL, Hamel MB. We added Mitchell and Sanders et al. papers on page 10, line 225 in the discussion section. 3. I think in the introduction the authors have not provided a full list of previously recognised factors which may be associated with a worse PEG outcome. To this effect I have enclosed a review article and recent paper which provide relevant references that should be mentioned (for example, CRP and swallowing abnormality). Equally he authors did not collect this information and this has to be mentioned as a limitation in the discussion. According to your suggestion we completed the list of risk factors, please see page 4, line 68. Unfortunately the review article on swallowing function as a risk factor was not provided. As mentioned above it was not possible to collect data on inflammatory parameters or swallowing difficulties. We added this in the limitations section on page 11, line The authors need to clarify miscellaneous. I am concerned that suggesting that this category has a risk factor does not help the clinician as we don t know what that means could they expand 5. Where do common PEG groups like head injury, Road Traffic accident or horse injury (with cerebral damage), Motor Neurone Disease or Multiple Sclerosis sit in their classification. The grouping does not lend itself to an

4 understanding of risk within different sub-groups. Please could they expand and I think provide a new classification for their study. We would like to answer questions 4 and 5 together. First, in our geriatric patient population traumatic injuries such as head injury during traffic accident or horse injury did not occur. As mentioned above we regrouped our diagnosis groups. In the discussion section we extenuated our paragraph regarding the risk in the respective diagnosis groups. Please see page 9, line 205. Reviewer #2: MAJOR COMPULSORY REVISIONS 1. There must be some mention of advanced directives, and how this may affect the selection of candidates for PEG tube placement. Certainly advanced directives may have an influence on patient selection for PEGplacement, we introduced this on page 11, line "Miscellaneous" is a major category for the patients in this study, and is not helpful in characterizing the patients in this study. I'm surprised that cancer was not one of the major diagnoses considered among the baseline characteristics for this study. I would suggest that "Miscellaneous" be broken down into smaller categories. The group miscellaneous includes patients with following main diagnoses: cancer (n=20), epilepsy (n=20), infection (n=36), gastrointestinal diseases, COPD, skin diseases, periphery arterial diseases, etc. Patient numbers in the respective subgroups were too small to use them for statistical analysis, which is why we decided to form bigger groups with the most common diagnoses. We rearranged groups as mentioned above. 3. Many of the patients in this study had a prior stroke. There is no mention of results of swallowing evaluations for this patients. The results of swallowing screening and assessment are no component of the Gemidasdatabase. However, we formed a new group apart from stroke that now contains patients with diseases with potential effect on swallowing function. MINOR ESSENTIAL REVISIONS 1. "Pneumonia" was one of the major comorbidities. However, it is not clear what percentage of these cases were caused by aspiration. Pneumonia was recorded as main diagnosis in 6.2% cases, whereof 2,8% were categorized as aspiration pneumonia. We included this in the results section on page 7, line "Depression" often contributes to decreased appetite, and is common in patients after a stroke. How common was "Depression" among the patients in this study? It is true that depression is a common secondary diagnosis in stroke. However, as depression screening is not a mandatory part of the Gemidas database it was not included in analysis. 3. More recent studies suggest that the MMSE is an inferior screening tool compared with the SLUMS or Montreal Cognitive Assessment (MOCA). In the Discussion, I think it is important to mention the use of the MMSE as a limitation for this study.

5 The MMSE has limitations in differentiating between mild to moderate dysfunctions of cognitive status. Also, like every other assessment it is of limited use in patients with dysphasia. However, it is the instrument of choice in the Gemidas-database. We included our comment on page 11, line 241. DISCRETIONARY REVISIONS 1. Medications can often be a contributing factor to decreased appetite and indirectly, poor nutritional status. How many of these patients were on 10 or more medications (i.e. how prevalent was polypharmacy)? Indeed polypharmacy is a risk factor for malnutrition, especially in the elderly. Unfortunately, number of drugs is not an item that is recorded within the Gemidas database. 2. Chronic kidney disease can also be a contributing factor to decreased appetite and indirectly, poor nutritional status. How many of these patients had stage III or greater chronic kidney disease? This again is true, but unfortunately this information was not provided in our database.