Author's response to reviews

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1 Author's response to reviews Title: Effectiveness of alcohol-based hand disinfectants in a public administration: Impact on health and work performance related to acute respiratory symptoms and diarrhoea Authors: Nils-Olaf Hübner (nhuebner@uni-greifswald.de) Claudia Hübner (ch@bcv.org) Michel Wodny (wodny@biometrie.uni-greifswald.de) Günther Kampf (Guenter.Kampf@bode-chemie.de) Axel Kramer (kramer@uni-greifswald.de) Version: 2 Date: 11 May 2010 Author's response to reviews: see over

2 MS: Authors reply to reviewers comments Effectiveness of alcoholic hand disinfectants in a public administration: Impact on health and work performance related to acute respiratory symptoms and diarrhoea We thank the respected reviewers for their detailed assessment of our paper and their valuable comments. All reviewers also pointed out that several issues need some clarification. According to these suggestions, we have revised our manuscript and have included the requested changes. We feel that our manuscript has been strengthened by following the reviewers recommendations. Below, please find a point-by-point response to the reviewers comments. The revised manuscript was read and approved by all authors. We hope that the content of our revised paper meets the stringent quality criteria of the journal. Referee 1 Anna Bowen Reviewer's report: Major Compulsory Revisions 1. Several components of the methods should be clarified. o It appears that participants were randomized to treatment group after stratification by frequency of interpersonal contact and contact with archive materials, but the methods used for randomization aren t clear. - We have changed the text accordingly to describe the randomization procedure more clearly. Frankly, we used a stratified randomization procedure in which the six groups of participants (based on the pure-survey data) were split by half into intervention/control, randomly allocating the participants. o Two different hand rubs were used in this study. It would be helpful to state more clearly the criteria for using the Sterillium product (what types of underlying skin problems were used as criteria? Who assessed the skin conditions?), and to show the proportion of participants who received either type of product in the figure. - Skin conditions and hand hygiene behaviour were assessed as part of the monthly questionnaires. A change to Sterillium was performed in subjects who reported one

3 of the requested skin problems (increased dryness, redness, itching) with "strong". Sterillium is known to have a refatting effect (Kramer, A., T. Bernig and G. Kampf Clinical double-blind trial on the dermal tolerance and user acceptability of six alcohol-based hand disinfectants for hygienic hand disinfection. Journal of Hospital Infection 51: ).and is therefore recommended in these cases. During the trial, 10 subjects (15.6 %) switched to Sterilium. o The model of distribution of hand rub is not described. Presumably, participants received more than one allotment at the beginning of the study. - Personal contact with all participants was kept with all participants during the study. Hand rub was distributed as needed, participants were provided with a second bottle as reserve. How much product was distributed? - Application of product followed the standard procedure described in the DIN EN Participants were instructed to apply as much product as needed to ensure complete wetting of the hands (at least 3 ml or a palmful). We have changed the text accordingly. Were participants given identical supplies, or were they re-stocked as needed? - participants were re-stocked as needed and provided with a reserve flask to ensure continuity of use. Was product in desktop, wall-mounted, or pocket-sized containter? - Product was provided in 500 ml bottles for desktop use. To ensure minimum effort for use and prevent misuse by non-participants Was volume of product tracked in some way? - While product usage was not tracked per person, hand hygiene behaviour was monitored using the monthly questionnaire (paragraph added, and see above). The personal contact that was maintained with all participants ensured a good compliance over the whole duration of the trial. Were those who used more product generally healthier than those who used less?

4 - This is a very interesting question we had been happy to answer. But, due to the number of participants, a sub-group analysis would lack the power needed for a reliable statement. Were educational or reinforcing messages delivered at any time? What were they, when were they delivered, by whom? - Participants in the intervention group were instructed how to use the product at the start of the study (see methods section). As started above, personal contact that was maintained with all participants to ensure compliance over the whole duration of the trial. This contact included an educational aspect, but we did not use regular reinforcing or spammed the participant with reminders. How are the authors certain that the product was used only at work? - product was provided in 500 ml bottles for desktop use and participants instructed to leave them at work. While we got no final proof for that, we think it highly unlikely that the participants did take them home. o The authors state that close contact was maintained with all participants during the study, but this needs to be described in more detail (how often, what was done during these contacts, how did contact differ between control and intervention groups, etc.). - A more detailed description has been included in the text now. o The methods of accounting for illness and absenteeism are not clear to me. First, it appears that data collection instruments were self-administered, perhaps even by mail, on a monthly basis over the course of a year. Looking at tables 3 and 4, it seems that there are data for every participant (100% returned at least one survey during the study period), which seems remarkable for a self-administered survey. Is this true, and how were participants prompted if they did not initially return surveys? How often was this done? - We believe that the high compliance was based on the personal contact, the positive attitude of the participants to scientific work and the positive effect of the

5 product use (in the intervention group). Participants were asked to return surveys within one week after each month. They were reminded to do so if they didn t returned surveys within one week. 5 subjects didn t returned at least one evaluable survey. and were excluded from the analysis. Second, were the surveys prospective (for example, at the beginning of each month, participants received a calendar on which to record illnesses and absences) or retrospective (eg, they were asked to recall all at once the total days with various symptoms, and total days of absence)? - The participants got the questionnaire at the beginning, and asked to return them at the end of each month. We therefore used a kind of mix between pro- and retrospective approach: participants knew that they would have to report symptoms at the end of each month, but were not forced to record them day-by-day. We believe that daily prospective recording by using a calendar is an excellent idea to improve data quality, but on the other hand would have reduced compliance and response rate. Third, the definition of illness episode is very unclear to me. In the methods section, it looks as though any day with a recorded symptom was counted as an illness episode for that symptom, regardless of number of days with that symptom during the month (in other words, no one could have more than one episode of sore throat or diarrhea in a month). Is this correct? - Yes, there was no distinction made on the number of episodes within a month, or, in other words, one month was the maximum resolution of our trail. We included in our illness-episode-analysis only the statement if the symptom occurred in the month or not. Could this be clarified in the text? - We have changed the text accordingly. Related to this issue, the paper focuses in part on differences in numbers of episodes of illness. The definition of episode of illness and the data presented in table 3 don t seem to harmonize. Table 3 seems to be looking at any report of a particular

6 symptom across the entire study period for each individual (since the n s in the table always sum to the N in the study group except for influenza, in which case I don t understand the figures presented in the table). This metric might be useful (how many people were affected at any time by particular symptoms), but it is not the same as the number of episodes of illness, and does not account for repeated illnesses within an individual. This needs to be clarified. - In fact, definition of an illness episode is tricky. Hand hygiene can lower the number of individual episodes, but should have a smaller (if any) effect on the duration of one episode. Therefore we wanted to use a definition that has been described by other author in the field (e.g. see White et al. or Morton et al.). Fifth, it isn t clear whether participants could report more than one symptom per day (for example, if someone had a cold with a sore throat and cough, would this count as a day with each of these symptoms, or was only one symptom allowed per day? This could have implications for the global testing. - Every symptom was asked separately, so that the participant could declare more than one symptom per day. This point had been heavily discussed when we designed the study. Naturally, symptoms would sometimes not occur separately but as bundles. After reviewing the other available data on the field and the method used by other autors, we decided the way described. Finally, what case definitions were given to participants for each of the syndromes? For example, were they told to record influenza only if given such diagnosis by a physician, or after assessing themselves for a pre-defined set of symptoms? Similarly, was fever subjective or objective? - Definitions of symptoms were given to the participants as part of the individual information at the beginning of the study. While most symptoms are quite selfexplanatory, influenza and pneumonia are specific diagnoses that were asked state when confirmed by professional diagnosis only. Similarly, (self-) diagnosis of fever required objective measurement with a thermometer. 2. If I have understood correctly that what the authors called an episode of illness is actually any experience of that symptom by an individual during the study period, then the relevant sections of the discussion need to be adjusted to reflect this.

7 - We agree that this point needed some clarification. We have changed the text accordingly. 3. In the methods section, the authors state that a survey about adherence to hand hygiene recommendations was administered, but the results are not presented. This would be interesting, and one could imagine some potentially useful analyses of reported use vs. outcomes. Also, in the final paragraph, the authors state that they have shown that hand disinfection was maintained through the study, but there are no data to support this conclusion. - Detailed monthly data on compliance and attitude towards hand hygiene as well as possible skin problems were recorded and have been published as presentations and a book (references have been updated). These data were not included in the manuscript fully (because we felt they would have been beyond the scope of it). As reaction to the respected referee s comments, we have added an additional paragrahaph on compliance in the results section, updated the references and will publish the data not shown in this article in a second one shortly to make access easier for the respected Non-German speaking colleagues. 4. The paper focuses heavily on costs of illness among workers and cost-effective prevention programs, but does not ever provide an estimate of the costs of lost or less-productive work due to illness. Similarly, the authors do not provide information about the costs of providing hand rub (and educational messages, if any were delivered) to the study participants. Thus, it is not possible to estimate the costeffectiveness of this sort of program. - We agree with the respected reviewer, that more precise data on cost would improve the paper and would moreover help to argue hand hygiene programmes. We have changed the introduction accordingly. Nonetheless, economical data on this field, especially on on-the-job-productivity-loss, is still sparse. Similarly, cost for hand hygiene programmes are influenced by many factors. General proof of costeffectiveness is therefore beyond the scope of this paper. We have therefore changed the discussion accordingly. 5. The finding of identical % of days absent due to colds between groups, despite twice as many episodes (again, I believe there are problems with how this is

8 defined) and number of people reporting ever being absent due to colds, as well as increased % of days absent due to fever and cough among the intervention participants despite reportedly decreased numbers of days ill due to these conditions, was striking. This could be highlighted and discussed further, perhaps in the context of the surveillance methods used in the study. - We agree that there seems to be a mismatch between the number of episodes and the number of days absent at first glance. Because this was partly due to rounding, we have changed the table to show results in more detail. Still, we agree with the reviewer, that there the number of number of episodes and the number of days of work do not correlate. This supports our view, that the number of episodes and the number of days of work, as well as the number of day ill and absent are independent outcomes. As shown in table 6, differences for days of work were small and far from being statistically significant. While our results imply, that hand disinfection should reduce the number of days off work in a large sample, our trial lacked the power to show this effect and the differences in table 6 are found by chance. We have updated the discussion to make this clear in the manuscript, too. Monthly recall is probably far from ideal, and at least in studies of diarrheal disease, even weekly recall appears to have problems with validity. - We agree that a more frequent recall would enhance data quality, but, as said above, monthly recording has been shown by many authors in the field to be a good balance between reliability and feasibility. Minor Essential Revisions 1. There are a number of small linguistic issues, such as incorrect use of English terms or misspellings. o Use of the term alcoholic hand disinfectant is a bit odd and not entirely correct. Perhaps this could be replaced with alcohol-based hand disinfectant throughout. o Data is plural.

9 o Methods section, third paragraph: al should be replaced with at and colleges should be replaced with colleagues. o Results section, Pre-study survey sub-section: reference to regularly sport exercise could be replaced with exercise frequency in the text and regularly participate in sport exercises in table 2. Simiarly, way to work could be replaced with means of transportation to work or something similar. o Table is misspelled in table It seems as though there should be a row for 0 children when assessing baseline differences in table When ORs and 95% confidence intervals are first introduced in the results section, 95% CI should probably be written out and an abbreviation of such inserted into the bracketed results throughout that section. 4. I don t understand the n s for healthy persons in the influenza row of table 3. I suspect these figures are in error. - As suspected, this was a typo that has now been corrected. 5. The column headers in tables 3 and 4 are also a bit confusing. In table 3, yes and no would seem more intuitive than healthy and ill. Similarly, in table 4, adding another layer of column headers to read absent with columns for yes and no beneath that would be much clearer than trying to decipher what it means to be healthy and yet possibly have a cold or other symptom.

10 - We changed it as the author suggested. 6. It would be nice to include the % of total possible follow-up surveys the authors were able to collect, which by my calculation is about 79%. - We agree and have changed the text accordingly. 79,46 % of total possible followup surveys were able to collect. 7. Discussion, paragraph 4: I don t understand the first sentence and suspect others would also benefit from rephrasing. - The sentence has been changed accordingly. 8. There are some spelling and punctuation errors in the references (48, 51, 52). Reference 55 seems incomplete. - typos have been corrected The study described in this manuscript looks at an under-evaluated setting for hygiene interventions, namely, workplace hygiene promotion. Although the current draft of the manuscript could use some methodological clarifications, it appears as though the authors have obtained some interesting results that could broadly benefit workers and employers. - We thank the respected reviewer for her in-depth assessment of our manuscript and her helpful comments. Discretionary Revisions 1. Statistical Analysis section, second paragraph: the section beginning with Frankly, the L-statistic through the end of that paragraph could be deleted entirely or just replaced with the reference they cite at the end of the paragraph. - We thank the respected reviewer for her comment, but would argue that nonparametric statistics are not as well known in the medical community as their parametric counterparts. We therefore think that a more detailed description could be convenient for the some readers and help to establish these methods even better. 2. Methods section, second paragraph: does the hand cream have any antimicrobial properties? How were participants instructed to use it?

11 - The cream is a water-in-oil emulsion for hand care and no antibacterial properties. Participants were provided with a copy of the recommendations of the manufacturer for usage. 3. Discussion, paragraph 3: local epidemiology of these conditions is mentioned but no references are provided; these could be added. - references have been added as requested Referee 2: Alyssa Schultz Reviewer's report: This is an interesting study and points to a simple, but apparently effective, way to reduce illness and absence days in the workplace. We thank the respected reviewer for her positive statement. I. Major Compulsory Revisions 1. The randomization procedure is not clear. According to the paper, participants were randomized to control or intervention based on frequency of customer contact and work with paper documents. How exactly? Were they matched, so that workers with high customer contact were evenly placed in intervention and control groups? If so, that is not randomization. The results for Table 1 explain this a bit more but it requires better explanation in the methods. - The text has been changed accordingly, please see comments to reviewer 1, too. 2. The discussion would be greatly improved if the authors included a paragraph or two about the practical implications of their research. What should employers do? Should physicians recommend that all individuals use hand cleaner on a routine basis? - We thank the respected reviewer that she feels that our study would allow such a extensive conclusion. As we see our trail as a first pilot study in a particular setting, we would be cautious to go that far as to recommend the general use of alcoholbased hand rub based on our results alone. We have added some lines to show the questions that further studies should focus to allow a final statement.

12 II. Minor Essential Revisions 1. On page 3 in the introduction, the sentence saying that "hand disinfection in medical facilities has been demonstrated and proven" should be revised to remove the words "and proven". It is sufficient to say that it has been demonsrated a number of times. 2. On page 4, the word "invention" should be "intervention". 3. On page 4, the sentence saying "Related to literature..." might be revised to say "Based on the existing literature..." 4. On page 5, the word "colleges" should be "colleagues" 5. On page 5, the word "Cooperation" should be "Corporation" and the reference for Microsoft should be Redmond, WA, USA. 6. The difference between illness and absence is not well defined in the methods. 7. I applaud the researchers for employing the use of non-parametric statistics for their analysis of illness days which violate the normal distribution assumption. However, they should cite the Puri and Sen studies (1969 and 1985) when introducing this statistic in the methods section. - Again, we thank the respected reviewer for her favourable statement and included the references as requested. 8. Why are there <10 months of data per person available (1230 person-months for 129 participants over one year)? Missing forms for some months, perhaps?

13 - Every returned survey was counted as one person month. Not all participants returned every month their survey. Only persons (5/134) who did not returned at least one survey were excluded from the analysis. We clarified this in the text 9. The sentence on page 7 that says "As expected, an over proportional number of participants..." is awkward. I think the authors mean to say that the population from which this sample was drawn has a larger percentage of females than males. What matters in this study is that men are over represented in the control group compared to the intervention group. - We omitted this sentence. The differences in the distribution of women and men between the groups are random. 10. On page 9 it says that "significantly less days...". It is better to say "significantly fewer days...". This phrase was also used in the abstract. Referee 3: maryanne mcguckin Reviewer's report: This is a well designed study, well written with excellent review of literature. It provides support on the importance of HH in the non clinical setting. The outcomes of illness verus non illness and the degree of illness are important. - We thank the respected reviewer for her favourable assessment. The authors have identified the fact that the sample size in relation to recruiting is small. Given that, I would consider it important to this pulbication to include an indirect measurement for HH since observatin cannot be done. This would be to report on the amount of product used by each group. - please see below Major Compulsory Revision: The amount of product used by each group should b added. If data on illness is correct and in fact there was less illness in intevention group and we believe this is due to better adherence to HH then one would expect to find a greater use of product

14 in that group. This can simplying be determeined by the amount of product distributed to each group. - We absolutely agree with the reviewer, that adherence to hand hygiene is crucial to achieve the desired preventive effect. Administrative officers, who did already apply hand disinfection, were not considered for participation. Participants in the control group were not provided with hand rub and asked not to use it while in the study. While product usage in the intervention group was not tracked per person, hand hygiene behaviour was monitored using the monthly questionnaire (see above, paragraph in result section added). The personal contact that was maintained with all participants ensured a good compliance over the whole duration of the trial. A subgroup analysis to assess the relationship between the frequency of hand hygiene and symptoms would be very interesting, but due to the number of participants, would lack the power needed for a reliable statement.

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