Background A small, non-blinded, RCT (randomised controlled trial) had reported that oral antibiotics reduced the incidence of mastitis in lactating women with  Staphylococcus aureus  ( S. aureus )- colonized cracked nipples. We aimed to replicate the study with a more rigorous design and adequate sample size.
Background
A small, non-blinded, RCT (randomised controlled trial) had reported that oral antibiotics reduced the incidence of mastitis in lactating women with  Staphylococcus aureus  ( S. aureus )- colonized cracked nipples. We aimed to replicate the study with a more rigorous design and adequate sample size.Staphylococcus aureusS. aureusMethods Our intention was to conduct a double-blind placebo-controlled trial to determine if an antibiotic (flucloxacillin) could prevent mastitis in lactating women with  S. aureus -colonized cracked nipples. We planned to recruit two groups of 133 women with  S. aureus- colonized cracked nipples.
Methods
Our intention was to conduct a double-blind placebo-controlled trial to determine if an antibiotic (flucloxacillin) could prevent mastitis in lactating women with  S. aureus -colonized cracked nipples. We planned to recruit two groups of 133 women with  S. aureus- colonized cracked nipples.S. aureusS. aureus-Results We spent over twelve months submitting applications to five hospital ethics committees and seven funding bodies, before commencing the trial. Recruitment to the trial was very slow and only ten women were randomized to the trial after twelve months, and therefore the trial was stopped early.
Results
We spent over twelve months submitting applications to five hospital ethics committees and seven funding bodies, before commencing the trial. Recruitment to the trial was very slow and only ten women were randomized to the trial after twelve months, and therefore the trial was stopped early.Conclusions In retrospect we should have conducted a feasibility study, which would have revealed the low number of women in these Melbourne hospitals (maternity wards and breastfeeding clinics) with damaged nipples. The appropriate use of antibiotics for breastfeeding women with cracked nipples still needs to be tested.
Conclusions
In retrospect we should have conducted a feasibility study, which would have revealed the low number of women in these Melbourne hospitals (maternity wards and breastfeeding clinics) with damaged nipples. The appropriate use of antibiotics for breastfeeding women with cracked nipples still needs to be tested.

Background Mastitis is a common problem for breastfeeding women [ 1 , 2 ]. Before planning a trial to reduce the number of lactating women who develop mastitis, we reviewed the literature to identify factors that may be associated with mastitis and to examine previous trials. A relatively small number of trials was identified which included mastitis as one of the outcome measures (see Table) [ 3 - 13 ]. Using historical controls, prophylactic topical penicillin ointment was found to be ineffective [ 3 ], while hand disinfectant at the mother's bedside appeared to reduce mastitis [ 7 ]. A Finnish study examined "breast massage" (which appears to be a variation of "nipple toughening") and found no impact of this practice on mastitis [ 10 ]. Table 1 Trials to prevent mastitis Author, date, country Subjects Aim Control(presence/absence/type) Intervention Sample size Outcome: mastitis Hesseltine et al 1948, USA[3] Patients at the Chicago Lying-In Hospital: July – Sept 1946 Does topical penicillin ointment on mother's nipples prevent mastitis? Historical controls: July 1933 to Dec 1946 Penicillin ointment (2,000 units per treatment) on nipples after feeds (6–8 weeks) Intervention 865; Controls 40,629 Intervention: 53 women with mastitis, 6.1%, and 18 with abscess, 2%; Control: 210 women with abscess, 0.51% Sasse 1973, Germany (in German)[4] Postnatal women in the Frauenclinik der Freien Universitat Berlin-Charlottenburg, 1967 Does an antibiotic spray to mother's nipples prevent mastitis? Historical controls Nabectin Puder Spray(neomycin and bacitracin) applied to nipples, plus hand disinfection for nurses and mothers before handling breasts. Intervention130; Controls100 Intervention: 7% mastitis by 2 months; Control: 23% Berger & Pusteria 1981 Switzerland[5] Postnatal women in the Women's Hospital, University of Berne(reported in 1962 [22]) Does nipple ointment prevent mastitis? One group used a nipple ointment without the active ingredient. Not a RCT. Six nipple ointments: (a) boric-acid Vaseline with Peruvian balsam, (a) 1,000 (a) 1.5% (b) chlortetracycline, (b) 1,000 (b) 0.7% (c) chlorquinadol ointment, (c) 1,000 (c) 0.4% (d) base of chlorquinadol ointment (without active ingredient), (d) 1,000 (d) 0.4% (e) calcium pantothenicum, (e) 2,000 (e) 0.8% (f) dihydrofolliculin benzoate and tyrothrycin (f) 1,500 (f) 0.5% Kovalev 1990, Russia (in Russian)[6] Does treating cracked nipples with laser therapy prevent mastitis? Unclear from abstract Laser treatment to damaged nipples 329 women with damaged nipples Intervention reduced mastitis from 18.6% to 3.7% Sytnik 1990, Russia [8] (in Russian)[8] Does bifidobacterium prevent mastitis? Unclear from abstract Bifidobacterium 160 women Mastitis reduced from 6.88% to 1.25% Peters and Flick-Fillies1991, Germany[7,23] Postnatal women in St Hildegardis Hospital, Mainz, 1989–1991 Does the use of bedside hand disinfectant prevent mastitis? Historical controls: 12 months (Sep 1989-Jun 1990, May-Jun 1991) Bed-side disinfectant dispensers: 12 months (Jul 1990-April 1991, Jul-Aug 1991) Intervention: 1095; Control 1230 Intervention 8 women, 0.65%; Control 32 women 2.9%; p <0.001 Waldenstrom and Nilsson 1994, Sweden[9] Women giving birth at South Hospital, Stockhom Is birth centre care beneficial for breastfeeding? Does it increase duration and reduce complications (including mastitis)? RCT Birth centre care compared to standard care Intervention 617; Control 613. Postal questionnaire 2 months postpartum. "Milk stasis" (fever and swelling, redness and tenderness in one of the breasts): Intervention 26%; Control 19% (p = 0.002). "Mastitis" (infective breast treated with antibiotics): Intervention 1%, Control < 1% (p = 0.07) Jonsson & Pulkkinen 1994, Finland[10] Women in South-West Finland Does antenatal / postnatal breast massage prevent mastitis? Concurrent controls. "Breast massage with the hands, a brush, a coarse towel or a sponge before and / or after delivery" Intervention 255, Control 400. Questionnaire 5–12 weeks postpartum at outpatient visit. Overall incidence of mastitis was 24%. No difference in incidence of mastitis (no details given). "This physical training of the nipples neither decreases or increases the frequency of mastitis" (p86) Evans et al 1995, Australia[11] Postnatal women at Flinders Medical Centre, Adelaide Does prolonged feeding on one breast per feed reduce breastfeeding complications, including mastitis? Historical controls: 5 months Advice to feed from one breast per feed and only offer the second breast if the baby still showed signs of hunger rather than standard care of both breasts at each feed: 5 months Intervention 150; Control 152 Telephone interview at 6 months postpartum: Intervention 15%; Control 18% Gunn et al 1998, Australia[12] Women giving birth in one metropolitan hospital and one rural hospital in Victoria, 1995 Does an early visit to a general practitioner reduce problems (including mastitis) compared to the standard six-week postnatal visit? RCT General practitioner visit at one week compared to standard six week visit Intervention 232; Control 243 Postal questionnaire at 3 months. Intervention 11.6%; Control 15.6% (Odds Ratio 0.71, 95%CI: 0.42, 1.20) Livingstone & Stringer, Canada[13] Women attending the Vancouver Breastfeeding Center with a cracked nipple and  S. aureus  positive culture. Are oral or topical antibiotics more effective in the treatment of  S. aureus -colonized cracked nipples than standard care? RCT (not blind to treatment group or outcome) 4 groups: Assessment at 7 days. Oral antibiotics: 1/19, 5%; Other groups: 16/65 (25%) (Fisher exact 0.1) (a) oral antibiotics (a) 19 (b) topical mupirocin (b) 25 (c) topical fusidic acid (c) 17 (d) standard care (d) 23 The authors of one trial were convinced that their intervention was effective, despite methodological difficulties [ 13 , 14 ]. Livingstone and Stringer conducted a randomised trial for women with cracked nipples with positive cultures for  Staphylococcus aureus  ( S. aureus) , in Canada[ 13 ]. They compared topical antibiotics, oral antibiotics and "optimal breastfeeding advice" and found better improvement in nipple healing in the women given oral antibiotics. In addition, they found 16 women out of 65 (25%) given non-systemic treatment developed mastitis within 7 days, compared to 1 of 19 women (5%) given systemic antibiotics (chi-square, p = 0.065) [not 0.005 as stated in their abstract]. The authors have concluded that cracked nipples colonized with  S. aureus  should be "treated aggressively with systemic antibiotics". However, the chi-square test used by the authors is inappropriate because one cell contains an expected value less than 5. Using Fisher's exact test, the p value is 0.10 [ 15 ]. As the Livingstone and Stringer trial had been published in a major lactation journal and was likely to be very influential in practice [ 13 ], it needs to be replicated in a more rigorous manner in order to assess the usefulness and safety of the intervention. Our intention was to replicate that study with an adequate sample size, rigorous definitions of nipple damage and mastitis, and double blinding of the intervention.
Background
Mastitis is a common problem for breastfeeding women [ 1 , 2 ]. Before planning a trial to reduce the number of lactating women who develop mastitis, we reviewed the literature to identify factors that may be associated with mastitis and to examine previous trials. A relatively small number of trials was identified which included mastitis as one of the outcome measures (see Table) [ 3 - 13 ]. Using historical controls, prophylactic topical penicillin ointment was found to be ineffective [ 3 ], while hand disinfectant at the mother's bedside appeared to reduce mastitis [ 7 ]. A Finnish study examined "breast massage" (which appears to be a variation of "nipple toughening") and found no impact of this practice on mastitis [ 10 ].Trials to prevent mastitisAuthor, date, countrySubjectsAimControl(presence/absence/type)InterventionSample sizeOutcome: mastitisS. aureusS. aureusThe authors of one trial were convinced that their intervention was effective, despite methodological difficulties [ 13 , 14 ]. Livingstone and Stringer conducted a randomised trial for women with cracked nipples with positive cultures for  Staphylococcus aureus  ( S. aureus) , in Canada[ 13 ]. They compared topical antibiotics, oral antibiotics and "optimal breastfeeding advice" and found better improvement in nipple healing in the women given oral antibiotics. In addition, they found 16 women out of 65 (25%) given non-systemic treatment developed mastitis within 7 days, compared to 1 of 19 women (5%) given systemic antibiotics (chi-square, p = 0.065) [not 0.005 as stated in their abstract]. The authors have concluded that cracked nipples colonized with  S. aureus  should be "treated aggressively with systemic antibiotics". However, the chi-square test used by the authors is inappropriate because one cell contains an expected value less than 5. Using Fisher's exact test, the p value is 0.10 [ 15 ].Staphylococcus aureusS. aureus)S. aureusAs the Livingstone and Stringer trial had been published in a major lactation journal and was likely to be very influential in practice [ 13 ], it needs to be replicated in a more rigorous manner in order to assess the usefulness and safety of the intervention. Our intention was to replicate that study with an adequate sample size, rigorous definitions of nipple damage and mastitis, and double blinding of the intervention.Methods The aim of our study was to prevent mastitis in breastfeeding women with cracked nipples colonized with  S. aureus . A randomised controlled trial was conducted: participating women were randomized to receive a seven day course of either an oral antibiotic (flucloxacillin) or identical placebo capsules. A follow-up visit was arranged one week after recruitment for women with positive nipple culture for  S. aureus . Women with negative nipple culture were followed up by telephone at one week. All women received a final telephone interview at six weeks. The primary outcome was the incidence of mastitis in each group in the week following recruitment. In the study by Livingstone and Stringer [ 13 ] 30% of women with  S. aureus -colonized cracked nipples who received only breastfeeding advice developed mastitis within one week. In order to detect a 50% decrease in incidence, ie mastitis occurring in 15% of women receiving oral antibiotics, a sample size of 133 women in each group is required, with 95% confidence and 80% power. Sample size was calculated using Epi-Info 6. A previous study in Australia found that 62% (13/21) of cultures from breastfeeding women with cracked nipples were positive for  S. aureus  [ 16 ]. An earlier study by Livingstone and colleagues found that 54% of cracked nipples of mothers with infants younger than one month were positive for  S. aureus  (27/50) [ 17 ]. Assuming that 50% of cracked nipples are positive for  S. aureus , we would need 133 × 2 × 2 = 532 women with cracked nipples, to recruit two groups of 133 women with  S. aureus -colonized cracked nipples. To allow for loss to follow-up, it was planned to recruit 570 women. A review of the literature on the topic of nipple damage found a lack of consistency in assessment of nipple damage [ 18 ]. Many reports have not provided a clear description of the assessment process. Some of the more recent studies have provided a more detailed description, such as Brent et al's Nipple Attribute Score and Duffy et al's Nipple Trauma Index [ 19 , 20 ]. The Nipple Trauma Index used by Duffy and colleagues in Western Australia appeared to be useful, however a request for more information about this instrument was not successful (E. Duffy, email 28 February 2001) [ 20 ]. Our definitions of nipple damage are as follows: mild 1 or 2 mm wide; moderate 3–9 mm wide; severe: greater than 10 mm wide and / or yellow colour visible in crack. In addition to a clinical assessment, a more permanent record of nipple damage was created using digital photography. It was planned for the photographs to be reviewed independently by three lactation consultants, in order to allow a thorough assessment of nipple damage and changes over time, rather than relying on the clinical assessment alone. (As the trial ended prematurely, this did not take place). Furthermore, although the WHO defines mastitis as an inflammation of the breast [ 21 ], there is no generally agreed definition of mastitis for research purposes. The definition of mastitis used for this study was that a woman reported: • at least two breast symptoms (pain, redness, lump) and • at least one of fever or 'flu-like symptoms. Foreseen problems Multi-centred trial As we intended to recruit over 500 women we planned a multi-centred trial, involving a number of public and private maternity hospitals in inner Melbourne. All hospitals provide a breastfeeding clinic staffed with International Board Certified Lactation Consultants for women having breastfeeding difficulties following hospital discharge. The public hospitals, where women tend to have shorter hospital stays, also provide home visits by domiciliary midwives post discharge. It was foreseen that there would be replication in the requirements of the hospital ethics committees and logistical difficulties for one researcher (LA) to conduct the study on multiple sites. Each hospital had its own research ethics committee (or committees) and different forms to submit (at the time of this study). Approval was obtained from the Ethics Committees at La Trobe University (20/11/2000), Royal Women's Hospital (6/9/2000), Mercy Hospital for Women (12/2/2001), Frances Perry House (23/8/2001), Freemasons Maternity Hospital (15/3/2001) and Cabrini Private Hospital (24/04/02). One private hospital did not appear to have a procedure in place to deal with a research proposal. Negotiations continued with this hospital from late 2000 until mid-2002 when the hospital insisted that we sign a Sponsor Indemnity Form, which the university advised us against. The researcher visited the postnatal wards and breastfeeding clinics of these hospitals each day or second day and asked a senior member of the nursing staff if there were any breastfeeding women with damaged nipples in the ward. The staff member introduced the researcher to the woman in order to inform the woman about the study and invite her to participate in the trial. Also, the researcher asked the domiciliary midwives to inform women at home with a cracked nipple about the trial. If the woman were interested in the study, the midwife gave the researcher the woman's name and phone number. After a telephone discussion, the researcher would visit her at home to assess her eligibility. Thus, the researcher was visiting a number of hospitals on a daily basis and making home visits to potential participants and follow-up visits to participants one week after recruitment. Therefore, if the researcher was going to be unavailable one week, she could not recruit women the week prior (as she would not be able to follow them up). Funding All potential participants had a specimen collected from their nipple crack for culture and sensitivity. As this was collected for the purpose of research rather than clinical practice, it was necessary to seek funding for the cost of the microbiological assessment. We intended to recruit 570 women, therefore substantial funds were required. A number of applications (seven) were submitted to local, national and international funding bodies in 2001. A funding application to the Medical Research Foundation for Women and Babies for 2002 was successful (A$15,000). Delay between recruitment and randomization We recognized that there would be a delay between recruitment (when the initial data and nipple specimen were collected) and randomization (when the result was available). The Microbiology laboratory faxed the result to the researcher (or the researcher contacted the laboratory on weekends). However, the minimum time was 2 days for the laboratory to identify  S. aureus  and up to 6 days in one instance (mean 3.6). The delay meant that women would be at home when the results were available and the researcher was required to visit the participant at her home to deliver the capsules. In addition to the inconvenience, a small number of women had already developed mastitis by the time the researcher contacted her with the result. Unforeseen problems Production of placebo capsules It was expected that a local company specializing in the preparation of placebos for drug trials would prepare the identical capsules. A common practice is to cover the active capsule with a larger capsule; participants are unaware if their capsule contains the active capsule or an inert substance. However, when the company realized that the active capsule contained a penicillin-like drug they were unable to participate, as they do not have a license for penicillin. Finally, the pharmaceutical company, CSL Ltd, provided us with identical empty capsules as well as active flucloxacillin capsules. A pharmacy technician at the pharmacy department at the Royal Women's Hospital opened each capsule manually and inserted glucose powder. Randomisation was conducted in blocks of ten, stratified according to hospital. Ten bottles were prepared for each hospital prior to the trial commencing (further capsules were not needed). Participation Not all the women who were eligible for the trial were interested in taking part (see Figure  1 , ROBIn Trial Profile). Some women expressed a reluctance to take antibiotics, others were overwhelmed with the difficulties they were experiencing and preferred not to participate in a trial. The researchers had previously conducted studies involving breastfeeding women which had high rates of participation and had expected women to be more interested in taking part in a trial that aimed to prevent mastitis. We should have expected a lower participation rate as this study involved the possibility of taking a medication, in particular an antibiotic. Figure 1 ROBIn Trial Profile Less than anticipated incidence of cracked nipples A total of approximately 17,000 women give birth in these hospitals each year. We estimated that 80% of women start breastfeeding, 5% develop cracked nipple(s), 80% would be eligible and 95% would agree to participate, thus there would be 537 eligible women per year. We anticipated that we would recruit approximately ten women with cracked nipples per week. It would therefore take 57 weeks (57 × 10) to recruit the total sample. However, recruitment was slow, as very few women were identified with damaged nipples. Hospital staff made unsolicited remarks that nipple damage was seen much less frequently than in the past. Midwives have been trained to help women position the baby and attach the baby at the breast; women are reporting the presence of nipple pain and any nipple damage is usually identified at an early stage. In the past, women may have continued to breastfeed with poor attachment of the baby to the breast, resulting in more severe damage, whereas at the time of the study maternity staff were likely to suggest "resting" the damaged nipple and expressing the milk by hand or electric pump until the damage had healed.
Methods
The aim of our study was to prevent mastitis in breastfeeding women with cracked nipples colonized with  S. aureus . A randomised controlled trial was conducted: participating women were randomized to receive a seven day course of either an oral antibiotic (flucloxacillin) or identical placebo capsules. A follow-up visit was arranged one week after recruitment for women with positive nipple culture for  S. aureus . Women with negative nipple culture were followed up by telephone at one week. All women received a final telephone interview at six weeks.S. aureusS. aureusThe primary outcome was the incidence of mastitis in each group in the week following recruitment. In the study by Livingstone and Stringer [ 13 ] 30% of women with  S. aureus -colonized cracked nipples who received only breastfeeding advice developed mastitis within one week. In order to detect a 50% decrease in incidence, ie mastitis occurring in 15% of women receiving oral antibiotics, a sample size of 133 women in each group is required, with 95% confidence and 80% power. Sample size was calculated using Epi-Info 6.S. aureusA previous study in Australia found that 62% (13/21) of cultures from breastfeeding women with cracked nipples were positive for  S. aureus  [ 16 ]. An earlier study by Livingstone and colleagues found that 54% of cracked nipples of mothers with infants younger than one month were positive for  S. aureus  (27/50) [ 17 ]. Assuming that 50% of cracked nipples are positive for  S. aureus , we would need 133 × 2 × 2 = 532 women with cracked nipples, to recruit two groups of 133 women with  S. aureus -colonized cracked nipples. To allow for loss to follow-up, it was planned to recruit 570 women.S. aureusS. aureusS. aureusS. aureusA review of the literature on the topic of nipple damage found a lack of consistency in assessment of nipple damage [ 18 ]. Many reports have not provided a clear description of the assessment process. Some of the more recent studies have provided a more detailed description, such as Brent et al's Nipple Attribute Score and Duffy et al's Nipple Trauma Index [ 19 , 20 ]. The Nipple Trauma Index used by Duffy and colleagues in Western Australia appeared to be useful, however a request for more information about this instrument was not successful (E. Duffy, email 28 February 2001) [ 20 ].Our definitions of nipple damage are as follows: mild 1 or 2 mm wide; moderate 3–9 mm wide; severe: greater than 10 mm wide and / or yellow colour visible in crack. In addition to a clinical assessment, a more permanent record of nipple damage was created using digital photography. It was planned for the photographs to be reviewed independently by three lactation consultants, in order to allow a thorough assessment of nipple damage and changes over time, rather than relying on the clinical assessment alone. (As the trial ended prematurely, this did not take place).Furthermore, although the WHO defines mastitis as an inflammation of the breast [ 21 ], there is no generally agreed definition of mastitis for research purposes. The definition of mastitis used for this study was that a woman reported:• at least two breast symptoms (pain, redness, lump) and• at least one of fever or 'flu-like symptoms.Foreseen problems Multi-centred trial As we intended to recruit over 500 women we planned a multi-centred trial, involving a number of public and private maternity hospitals in inner Melbourne. All hospitals provide a breastfeeding clinic staffed with International Board Certified Lactation Consultants for women having breastfeeding difficulties following hospital discharge. The public hospitals, where women tend to have shorter hospital stays, also provide home visits by domiciliary midwives post discharge. It was foreseen that there would be replication in the requirements of the hospital ethics committees and logistical difficulties for one researcher (LA) to conduct the study on multiple sites. Each hospital had its own research ethics committee (or committees) and different forms to submit (at the time of this study). Approval was obtained from the Ethics Committees at La Trobe University (20/11/2000), Royal Women's Hospital (6/9/2000), Mercy Hospital for Women (12/2/2001), Frances Perry House (23/8/2001), Freemasons Maternity Hospital (15/3/2001) and Cabrini Private Hospital (24/04/02). One private hospital did not appear to have a procedure in place to deal with a research proposal. Negotiations continued with this hospital from late 2000 until mid-2002 when the hospital insisted that we sign a Sponsor Indemnity Form, which the university advised us against. The researcher visited the postnatal wards and breastfeeding clinics of these hospitals each day or second day and asked a senior member of the nursing staff if there were any breastfeeding women with damaged nipples in the ward. The staff member introduced the researcher to the woman in order to inform the woman about the study and invite her to participate in the trial. Also, the researcher asked the domiciliary midwives to inform women at home with a cracked nipple about the trial. If the woman were interested in the study, the midwife gave the researcher the woman's name and phone number. After a telephone discussion, the researcher would visit her at home to assess her eligibility. Thus, the researcher was visiting a number of hospitals on a daily basis and making home visits to potential participants and follow-up visits to participants one week after recruitment. Therefore, if the researcher was going to be unavailable one week, she could not recruit women the week prior (as she would not be able to follow them up). Funding All potential participants had a specimen collected from their nipple crack for culture and sensitivity. As this was collected for the purpose of research rather than clinical practice, it was necessary to seek funding for the cost of the microbiological assessment. We intended to recruit 570 women, therefore substantial funds were required. A number of applications (seven) were submitted to local, national and international funding bodies in 2001. A funding application to the Medical Research Foundation for Women and Babies for 2002 was successful (A$15,000). Delay between recruitment and randomization We recognized that there would be a delay between recruitment (when the initial data and nipple specimen were collected) and randomization (when the result was available). The Microbiology laboratory faxed the result to the researcher (or the researcher contacted the laboratory on weekends). However, the minimum time was 2 days for the laboratory to identify  S. aureus  and up to 6 days in one instance (mean 3.6). The delay meant that women would be at home when the results were available and the researcher was required to visit the participant at her home to deliver the capsules. In addition to the inconvenience, a small number of women had already developed mastitis by the time the researcher contacted her with the result.
Foreseen problems
Multi-centred trial As we intended to recruit over 500 women we planned a multi-centred trial, involving a number of public and private maternity hospitals in inner Melbourne. All hospitals provide a breastfeeding clinic staffed with International Board Certified Lactation Consultants for women having breastfeeding difficulties following hospital discharge. The public hospitals, where women tend to have shorter hospital stays, also provide home visits by domiciliary midwives post discharge. It was foreseen that there would be replication in the requirements of the hospital ethics committees and logistical difficulties for one researcher (LA) to conduct the study on multiple sites. Each hospital had its own research ethics committee (or committees) and different forms to submit (at the time of this study). Approval was obtained from the Ethics Committees at La Trobe University (20/11/2000), Royal Women's Hospital (6/9/2000), Mercy Hospital for Women (12/2/2001), Frances Perry House (23/8/2001), Freemasons Maternity Hospital (15/3/2001) and Cabrini Private Hospital (24/04/02). One private hospital did not appear to have a procedure in place to deal with a research proposal. Negotiations continued with this hospital from late 2000 until mid-2002 when the hospital insisted that we sign a Sponsor Indemnity Form, which the university advised us against. The researcher visited the postnatal wards and breastfeeding clinics of these hospitals each day or second day and asked a senior member of the nursing staff if there were any breastfeeding women with damaged nipples in the ward. The staff member introduced the researcher to the woman in order to inform the woman about the study and invite her to participate in the trial. Also, the researcher asked the domiciliary midwives to inform women at home with a cracked nipple about the trial. If the woman were interested in the study, the midwife gave the researcher the woman's name and phone number. After a telephone discussion, the researcher would visit her at home to assess her eligibility. Thus, the researcher was visiting a number of hospitals on a daily basis and making home visits to potential participants and follow-up visits to participants one week after recruitment. Therefore, if the researcher was going to be unavailable one week, she could not recruit women the week prior (as she would not be able to follow them up).
Multi-centred trial
As we intended to recruit over 500 women we planned a multi-centred trial, involving a number of public and private maternity hospitals in inner Melbourne. All hospitals provide a breastfeeding clinic staffed with International Board Certified Lactation Consultants for women having breastfeeding difficulties following hospital discharge. The public hospitals, where women tend to have shorter hospital stays, also provide home visits by domiciliary midwives post discharge. It was foreseen that there would be replication in the requirements of the hospital ethics committees and logistical difficulties for one researcher (LA) to conduct the study on multiple sites.Each hospital had its own research ethics committee (or committees) and different forms to submit (at the time of this study). Approval was obtained from the Ethics Committees at La Trobe University (20/11/2000), Royal Women's Hospital (6/9/2000), Mercy Hospital for Women (12/2/2001), Frances Perry House (23/8/2001), Freemasons Maternity Hospital (15/3/2001) and Cabrini Private Hospital (24/04/02). One private hospital did not appear to have a procedure in place to deal with a research proposal. Negotiations continued with this hospital from late 2000 until mid-2002 when the hospital insisted that we sign a Sponsor Indemnity Form, which the university advised us against.The researcher visited the postnatal wards and breastfeeding clinics of these hospitals each day or second day and asked a senior member of the nursing staff if there were any breastfeeding women with damaged nipples in the ward. The staff member introduced the researcher to the woman in order to inform the woman about the study and invite her to participate in the trial. Also, the researcher asked the domiciliary midwives to inform women at home with a cracked nipple about the trial. If the woman were interested in the study, the midwife gave the researcher the woman's name and phone number. After a telephone discussion, the researcher would visit her at home to assess her eligibility.Thus, the researcher was visiting a number of hospitals on a daily basis and making home visits to potential participants and follow-up visits to participants one week after recruitment. Therefore, if the researcher was going to be unavailable one week, she could not recruit women the week prior (as she would not be able to follow them up).Funding All potential participants had a specimen collected from their nipple crack for culture and sensitivity. As this was collected for the purpose of research rather than clinical practice, it was necessary to seek funding for the cost of the microbiological assessment. We intended to recruit 570 women, therefore substantial funds were required. A number of applications (seven) were submitted to local, national and international funding bodies in 2001. A funding application to the Medical Research Foundation for Women and Babies for 2002 was successful (A$15,000).
Funding
All potential participants had a specimen collected from their nipple crack for culture and sensitivity. As this was collected for the purpose of research rather than clinical practice, it was necessary to seek funding for the cost of the microbiological assessment. We intended to recruit 570 women, therefore substantial funds were required. A number of applications (seven) were submitted to local, national and international funding bodies in 2001. A funding application to the Medical Research Foundation for Women and Babies for 2002 was successful (A$15,000).Delay between recruitment and randomization We recognized that there would be a delay between recruitment (when the initial data and nipple specimen were collected) and randomization (when the result was available). The Microbiology laboratory faxed the result to the researcher (or the researcher contacted the laboratory on weekends). However, the minimum time was 2 days for the laboratory to identify  S. aureus  and up to 6 days in one instance (mean 3.6). The delay meant that women would be at home when the results were available and the researcher was required to visit the participant at her home to deliver the capsules. In addition to the inconvenience, a small number of women had already developed mastitis by the time the researcher contacted her with the result.
Delay between recruitment and randomization
We recognized that there would be a delay between recruitment (when the initial data and nipple specimen were collected) and randomization (when the result was available). The Microbiology laboratory faxed the result to the researcher (or the researcher contacted the laboratory on weekends). However, the minimum time was 2 days for the laboratory to identify  S. aureus  and up to 6 days in one instance (mean 3.6).S. aureusThe delay meant that women would be at home when the results were available and the researcher was required to visit the participant at her home to deliver the capsules. In addition to the inconvenience, a small number of women had already developed mastitis by the time the researcher contacted her with the result.Unforeseen problems Production of placebo capsules It was expected that a local company specializing in the preparation of placebos for drug trials would prepare the identical capsules. A common practice is to cover the active capsule with a larger capsule; participants are unaware if their capsule contains the active capsule or an inert substance. However, when the company realized that the active capsule contained a penicillin-like drug they were unable to participate, as they do not have a license for penicillin. Finally, the pharmaceutical company, CSL Ltd, provided us with identical empty capsules as well as active flucloxacillin capsules. A pharmacy technician at the pharmacy department at the Royal Women's Hospital opened each capsule manually and inserted glucose powder. Randomisation was conducted in blocks of ten, stratified according to hospital. Ten bottles were prepared for each hospital prior to the trial commencing (further capsules were not needed). Participation Not all the women who were eligible for the trial were interested in taking part (see Figure  1 , ROBIn Trial Profile). Some women expressed a reluctance to take antibiotics, others were overwhelmed with the difficulties they were experiencing and preferred not to participate in a trial. The researchers had previously conducted studies involving breastfeeding women which had high rates of participation and had expected women to be more interested in taking part in a trial that aimed to prevent mastitis. We should have expected a lower participation rate as this study involved the possibility of taking a medication, in particular an antibiotic. Figure 1 ROBIn Trial Profile Less than anticipated incidence of cracked nipples A total of approximately 17,000 women give birth in these hospitals each year. We estimated that 80% of women start breastfeeding, 5% develop cracked nipple(s), 80% would be eligible and 95% would agree to participate, thus there would be 537 eligible women per year. We anticipated that we would recruit approximately ten women with cracked nipples per week. It would therefore take 57 weeks (57 × 10) to recruit the total sample. However, recruitment was slow, as very few women were identified with damaged nipples. Hospital staff made unsolicited remarks that nipple damage was seen much less frequently than in the past. Midwives have been trained to help women position the baby and attach the baby at the breast; women are reporting the presence of nipple pain and any nipple damage is usually identified at an early stage. In the past, women may have continued to breastfeed with poor attachment of the baby to the breast, resulting in more severe damage, whereas at the time of the study maternity staff were likely to suggest "resting" the damaged nipple and expressing the milk by hand or electric pump until the damage had healed.
Unforeseen problems
Production of placebo capsules It was expected that a local company specializing in the preparation of placebos for drug trials would prepare the identical capsules. A common practice is to cover the active capsule with a larger capsule; participants are unaware if their capsule contains the active capsule or an inert substance. However, when the company realized that the active capsule contained a penicillin-like drug they were unable to participate, as they do not have a license for penicillin. Finally, the pharmaceutical company, CSL Ltd, provided us with identical empty capsules as well as active flucloxacillin capsules. A pharmacy technician at the pharmacy department at the Royal Women's Hospital opened each capsule manually and inserted glucose powder. Randomisation was conducted in blocks of ten, stratified according to hospital. Ten bottles were prepared for each hospital prior to the trial commencing (further capsules were not needed).
Production of placebo capsules
It was expected that a local company specializing in the preparation of placebos for drug trials would prepare the identical capsules. A common practice is to cover the active capsule with a larger capsule; participants are unaware if their capsule contains the active capsule or an inert substance. However, when the company realized that the active capsule contained a penicillin-like drug they were unable to participate, as they do not have a license for penicillin. Finally, the pharmaceutical company, CSL Ltd, provided us with identical empty capsules as well as active flucloxacillin capsules. A pharmacy technician at the pharmacy department at the Royal Women's Hospital opened each capsule manually and inserted glucose powder. Randomisation was conducted in blocks of ten, stratified according to hospital. Ten bottles were prepared for each hospital prior to the trial commencing (further capsules were not needed).Participation Not all the women who were eligible for the trial were interested in taking part (see Figure  1 , ROBIn Trial Profile). Some women expressed a reluctance to take antibiotics, others were overwhelmed with the difficulties they were experiencing and preferred not to participate in a trial. The researchers had previously conducted studies involving breastfeeding women which had high rates of participation and had expected women to be more interested in taking part in a trial that aimed to prevent mastitis. We should have expected a lower participation rate as this study involved the possibility of taking a medication, in particular an antibiotic. Figure 1 ROBIn Trial Profile
Participation
Not all the women who were eligible for the trial were interested in taking part (see Figure  1 , ROBIn Trial Profile). Some women expressed a reluctance to take antibiotics, others were overwhelmed with the difficulties they were experiencing and preferred not to participate in a trial. The researchers had previously conducted studies involving breastfeeding women which had high rates of participation and had expected women to be more interested in taking part in a trial that aimed to prevent mastitis. We should have expected a lower participation rate as this study involved the possibility of taking a medication, in particular an antibiotic.Less than anticipated incidence of cracked nipples A total of approximately 17,000 women give birth in these hospitals each year. We estimated that 80% of women start breastfeeding, 5% develop cracked nipple(s), 80% would be eligible and 95% would agree to participate, thus there would be 537 eligible women per year. We anticipated that we would recruit approximately ten women with cracked nipples per week. It would therefore take 57 weeks (57 × 10) to recruit the total sample. However, recruitment was slow, as very few women were identified with damaged nipples. Hospital staff made unsolicited remarks that nipple damage was seen much less frequently than in the past. Midwives have been trained to help women position the baby and attach the baby at the breast; women are reporting the presence of nipple pain and any nipple damage is usually identified at an early stage. In the past, women may have continued to breastfeed with poor attachment of the baby to the breast, resulting in more severe damage, whereas at the time of the study maternity staff were likely to suggest "resting" the damaged nipple and expressing the milk by hand or electric pump until the damage had healed.
Less than anticipated incidence of cracked nipples
A total of approximately 17,000 women give birth in these hospitals each year. We estimated that 80% of women start breastfeeding, 5% develop cracked nipple(s), 80% would be eligible and 95% would agree to participate, thus there would be 537 eligible women per year. We anticipated that we would recruit approximately ten women with cracked nipples per week. It would therefore take 57 weeks (57 × 10) to recruit the total sample.However, recruitment was slow, as very few women were identified with damaged nipples. Hospital staff made unsolicited remarks that nipple damage was seen much less frequently than in the past. Midwives have been trained to help women position the baby and attach the baby at the breast; women are reporting the presence of nipple pain and any nipple damage is usually identified at an early stage. In the past, women may have continued to breastfeed with poor attachment of the baby to the breast, resulting in more severe damage, whereas at the time of the study maternity staff were likely to suggest "resting" the damaged nipple and expressing the milk by hand or electric pump until the damage had healed.Results Recruitment began at two hospitals in November 2001, two others in February 2002 and a fifth hospital in June 2002. Recruitment was slow as few women had damaged nipples. During the months of the trial, the rate of recruitment decreased rather than increased. Additionally, the flucloxacillin supplied by CSL were labeled to use before the end of November 2002. Therefore it was decided to stop recruiting, once a twelve-month recruiting period had elapsed. The trial stopped recruiting on the 14 th  November 2002. Of the 158 women referred to the study as possible participants, 48 women were eligible (ie they had a cracked nipple, were not allergic to penicillin, did not have concurrent "nipple thrush" and had adequate English). Twenty-six of these women refused (10 not interested, 9 didn't want to take antibiotics, 7 other reason given). Therefore, 22 were potentially eligible in that they had at least one cracked nipple and consented to take part in the trial if the results of the nipple swab confirmed  S. aureus . Thirteen of the nipple cultures were positive and ten women were randomized to receive flucloxacillin (n = 5) or placebo capsules (n = 5). Two women had already developed mastitis prior to receiving the results and the third woman had developed a rash and did not want to take the capsules. All women were followed-up at one week and six weeks. Of the ten women in the RCT, one woman in the placebo group developed mastitis (not in the first week of the trial, baby was 32 days old, 28 days after randomization). Three women reported that they had not taken the capsules. When the study was unblinded it showed that all three were in the placebo group.
Results
Recruitment began at two hospitals in November 2001, two others in February 2002 and a fifth hospital in June 2002. Recruitment was slow as few women had damaged nipples. During the months of the trial, the rate of recruitment decreased rather than increased. Additionally, the flucloxacillin supplied by CSL were labeled to use before the end of November 2002. Therefore it was decided to stop recruiting, once a twelve-month recruiting period had elapsed. The trial stopped recruiting on the 14 th  November 2002.Of the 158 women referred to the study as possible participants, 48 women were eligible (ie they had a cracked nipple, were not allergic to penicillin, did not have concurrent "nipple thrush" and had adequate English). Twenty-six of these women refused (10 not interested, 9 didn't want to take antibiotics, 7 other reason given). Therefore, 22 were potentially eligible in that they had at least one cracked nipple and consented to take part in the trial if the results of the nipple swab confirmed  S. aureus . Thirteen of the nipple cultures were positive and ten women were randomized to receive flucloxacillin (n = 5) or placebo capsules (n = 5). Two women had already developed mastitis prior to receiving the results and the third woman had developed a rash and did not want to take the capsules. All women were followed-up at one week and six weeks. Of the ten women in the RCT, one woman in the placebo group developed mastitis (not in the first week of the trial, baby was 32 days old, 28 days after randomization). Three women reported that they had not taken the capsules. When the study was unblinded it showed that all three were in the placebo group.S. aureusDiscussion This trial experienced a number of problems, both foreseen and unforeseen. In the trial conducted by Livingstone and Stringer, there is no mention of women refusing to participate in the study or not taking the treatment they were allocated [ 13 ]. It is not reported if any woman developed mastitis in the period between collection of the swab, the clinician receiving the result and the woman being given her allocated treatment regime – indeed the paper does not state that women had to return to the breastfeeding clinic for this. Possibly, women attending a breastfeeding clinic are more likely to comply with treatment regimes than women who are invited to participate in a trial. We thought the estimate of 5% of breastfeeding women developing a cracked nipple was a conservative estimate. For example, in Western Australia, Duffy et al had found that 6% of women in their intervention group had cracked nipples, compared to 69% in their control group [ 20 ]. However, on visiting the postnatal wards and breastfeeding clinics in inner Melbourne, it was not unusual to find that the staff were unable to identify any women with damaged nipples. And of the women who were assessed, more than half did not have a cracked nipple. Therefore, nipple damage appears to be uncommon in breastfeeding women in Melbourne.
Discussion
This trial experienced a number of problems, both foreseen and unforeseen. In the trial conducted by Livingstone and Stringer, there is no mention of women refusing to participate in the study or not taking the treatment they were allocated [ 13 ]. It is not reported if any woman developed mastitis in the period between collection of the swab, the clinician receiving the result and the woman being given her allocated treatment regime – indeed the paper does not state that women had to return to the breastfeeding clinic for this. Possibly, women attending a breastfeeding clinic are more likely to comply with treatment regimes than women who are invited to participate in a trial.We thought the estimate of 5% of breastfeeding women developing a cracked nipple was a conservative estimate. For example, in Western Australia, Duffy et al had found that 6% of women in their intervention group had cracked nipples, compared to 69% in their control group [ 20 ]. However, on visiting the postnatal wards and breastfeeding clinics in inner Melbourne, it was not unusual to find that the staff were unable to identify any women with damaged nipples. And of the women who were assessed, more than half did not have a cracked nipple. Therefore, nipple damage appears to be uncommon in breastfeeding women in Melbourne.Conclusions In retrospect, we should have conducted a pilot or feasibility study before commencing the trial. The appropriate use of antibiotics for breastfeeding women with cracked nipples still needs to be tested. We hope our experience will be useful for others planning trials of mastitis or nipple damage.
Conclusions
In retrospect, we should have conducted a pilot or feasibility study before commencing the trial. The appropriate use of antibiotics for breastfeeding women with cracked nipples still needs to be tested. We hope our experience will be useful for others planning trials of mastitis or nipple damage.Competing interests None declared.
Competing interests
None declared.Authors' contributions All authors contributed to the design of the trial, LA reviewed the literature, conducted the trial, and wrote the first draft of the paper. All authors approved the final draft of the paper.
Authors' contributions
All authors contributed to the design of the trial, LA reviewed the literature, conducted the trial, and wrote the first draft of the paper. All authors approved the final draft of the paper.Pre-publication history The pre-publication history for this paper can be accessed here:
Pre-publication history
The pre-publication history for this paper can be accessed here:


Background Most hospitals keep and update their paper-based medical records after introducing an electronic medical record or a hospital information system (HIS). This case report describes a HIS in a hospital where the paper-based medical records are scanned and eliminated. To evaluate the HIS comprehensively, the perspectives of medical secretaries and nurses are described as well as that of physicians.
Background
Most hospitals keep and update their paper-based medical records after introducing an electronic medical record or a hospital information system (HIS). This case report describes a HIS in a hospital where the paper-based medical records are scanned and eliminated. To evaluate the HIS comprehensively, the perspectives of medical secretaries and nurses are described as well as that of physicians.Methods We have used questionnaires and interviews to assess and compare frequency of use of the HIS for essential tasks, task performance and user satisfaction among medical secretaries, nurses and physicians.
Methods
We have used questionnaires and interviews to assess and compare frequency of use of the HIS for essential tasks, task performance and user satisfaction among medical secretaries, nurses and physicians.Results The medical secretaries use the HIS much more than the nurses and the physicians, and they consider that the electronic HIS greatly has simplified their work. The work of nurses and physicians has also become simplified, but they find less satisfaction with the system, particularly with the use of scanned document images.
Results
The medical secretaries use the HIS much more than the nurses and the physicians, and they consider that the electronic HIS greatly has simplified their work. The work of nurses and physicians has also become simplified, but they find less satisfaction with the system, particularly with the use of scanned document images.Conclusions Although the basis for reference is limited, the results support the assertion that replacing the paper-based medical record primarily benefits the medical secretaries, and to a lesser degree the nurses and the physicians. The varying results in the different employee groups emphasize the need for a multidisciplinary approach when evaluating a HIS.
Conclusions
Although the basis for reference is limited, the results support the assertion that replacing the paper-based medical record primarily benefits the medical secretaries, and to a lesser degree the nurses and the physicians. The varying results in the different employee groups emphasize the need for a multidisciplinary approach when evaluating a HIS.

Background Hospital information systems (HIS) and Electronic Medical Records (EMRs) are considered prerequisites for the efficient delivery of high quality health care in hospitals. However, a large number of legal and practical constraints influence on the design and introduction of such systems [ 1 ]. Hence, many EMR implementation projects do not aim at introducing the EMR and eliminating the paper-based counterpart in one step [ 2 ]. As a start, the EMR is introduced along with its paper-based counterpart, and both are kept updated. In such environments, health care workers have to deal with a hybrid electronic and paper-based solution. This probably limits the use of EMR [ 2 ]. Furthermore, errors are prone to develop due to cumbersome maintenance of the medical record information in dual storage media [ 3 ]. In Norway and in other countries, most hospital EMR projects have not passed beyond this phase [ 1 ] Aust-Agder Hospital is the first hospital in Norway to eliminate the paper-based medical record, using a widespread [ 2 ] and commercially available HIS in combination with scanning technology. In a recent report, we have evaluated the EMR part of the HIS in this hospital [ 4 ], discussing the views of the physicians only. However, to get a more complete picture of the impact of the system, its use by employees other than physicians needs to be evaluated. Both medical secretaries and nurses are important users of a HIS, utilizing both the EMR and the administrative part of the system. The medical secretaries work as transcriptionists, receptionists and coordinators of patient logistics and communication, and the nurses have their own documentation and administrative routines. The elimination of the paper-based medical records is a radical change in the work routines in the hospital organization. To assess the impact of this change on the organization, the EMR system may be described from the perspectives of three important employee groups separately. In this report, we have used questionnaires and interviews to assess how often medical secretaries, nurses and physicians use the HIS system for essential tasks, how easily these tasks are performed using the system, and how satisfied the hospital employees are with it.
Background
Hospital information systems (HIS) and Electronic Medical Records (EMRs) are considered prerequisites for the efficient delivery of high quality health care in hospitals. However, a large number of legal and practical constraints influence on the design and introduction of such systems [ 1 ]. Hence, many EMR implementation projects do not aim at introducing the EMR and eliminating the paper-based counterpart in one step [ 2 ]. As a start, the EMR is introduced along with its paper-based counterpart, and both are kept updated. In such environments, health care workers have to deal with a hybrid electronic and paper-based solution. This probably limits the use of EMR [ 2 ]. Furthermore, errors are prone to develop due to cumbersome maintenance of the medical record information in dual storage media [ 3 ]. In Norway and in other countries, most hospital EMR projects have not passed beyond this phase [ 1 ]Aust-Agder Hospital is the first hospital in Norway to eliminate the paper-based medical record, using a widespread [ 2 ] and commercially available HIS in combination with scanning technology. In a recent report, we have evaluated the EMR part of the HIS in this hospital [ 4 ], discussing the views of the physicians only. However, to get a more complete picture of the impact of the system, its use by employees other than physicians needs to be evaluated. Both medical secretaries and nurses are important users of a HIS, utilizing both the EMR and the administrative part of the system. The medical secretaries work as transcriptionists, receptionists and coordinators of patient logistics and communication, and the nurses have their own documentation and administrative routines. The elimination of the paper-based medical records is a radical change in the work routines in the hospital organization. To assess the impact of this change on the organization, the EMR system may be described from the perspectives of three important employee groups separately. In this report, we have used questionnaires and interviews to assess how often medical secretaries, nurses and physicians use the HIS system for essential tasks, how easily these tasks are performed using the system, and how satisfied the hospital employees are with it.Methods The hospital The investigation was performed in a 410-bed community hospital in Aust-Agder county, Norway. The hospital serves a population of 102,000, caring for 18,600 inpatients and 74,000 outpatients per year (1998). The patients are admitted by primary care physicians external to the hospital and followed up by the hospital physicians. The hospital comprises of departments for psychiatry, general surgery, internal medicine, orthopaedics, gynecology, ear, nose and throat and ophthalmology. Well funded, and with a strong commitment by the hospital administration, the hospital staff began implementation of DIPS 2000 ®  , a commercially available combined EMR and hospital administrative system in March 2000. In April 2001, all except the psychiatric department started to scan documents. From this date, all new patient data was channeled into the EMR in these departments, either as electronic text and data or as scanned documents. The HIS was available in 1100 terminals throughout the hospital, except for the inpatients' rooms. The transition to HIS was administered by a project group, which had been recruited from the hospital staff. The group worked in conjunction with the IT department and the HIS vendor, and was also responsible for communicating with and training the users. The group regularly held series of mandatory hands-on training classes adapted to each profession (3–8 h in total). However, a substantial proportion of the users never attended the classes, particularly the physicians. To reach these users, a task force of medical secretaries was trained and employed during the first month after implementation of the HIS for ambulant training in the wards. Further support was provided by a network of super users (the most experienced users) among the ward staff. The EMR The patient data in the EMR part of the HIS is either stored as searchable text and numbers or as document images. The former, called "regular electronic data", essentially consists of the chronological, text-based medical record integrated with lab data in numerical form and textual radiology reports (fig  1 ). The latter is divided by structure into two categories, as follows: Upon admittance or consultation, the documents in the old paper-based medical records are scanned into the system as digital images in TIFF format. Each image contains all the sheets of one main section of the paper-based record, and hence corresponds to a whole document group (groups A-J in fig  1 ). These images are called "scanned multiple documents". Upon patient discharge, various paper sheets accumulated during the stay (e.g. the medical treatment form, printouts from diagnostic devices) are scanned, dated and labeled by document type singularly (fig  1 ). The resulting images are called "scanned single documents". In summary, the patient data is stored as regular electronic data, scanned multiple documents and scanned single documents. They all appear in the hierarchical list in the "medical record explorer" window (fig  2 ), but are treated separately in this paper, due to their difference in structure, indexation and functionality. The user interface of the HIS system is identical to all types of users, although medical secretaries, nurses and physicians often utilize different parts of system. The survey A questionnaire previously used in a national survey of hospital physicians [ 2 ] was modified for this study. The original questionnaire contained sections regarding frequency of use of an EMR system or HIS for specified tasks, user satisfaction with the system as a whole [ 5 ] as well as detailed aspects of it [ 6 ], and availability of computers. To make the questionnaire applicable to medical secretaries and nurses, new versions of the section regarding frequency of use of the HIS were developed. In collaboration with the authors, 3–6 representatives from the medical secretaries and the nurses identified work tasks for the questionnaire each in two 2-hour group sessions, using recently developed detailed work-flow charts as templates (not shown). The identified tasks were then reduced to 23 and 19 tasks supported by the HIS, respectively (see appendix A). The questionnaire was reviewed in similar sessions by representatives from the physicians. As a result, one new task was added to the physicians' questionnaire, and four tasks not supported by the HIS were removed. For all professions, a new section was added, containing questions about ease of performing each task using the system. The survey was conducted during February–April 2002, and 85 medical secretaries, 235 nurses and 80 physicians in the medical, surgical and other somatic wards received the questionnaire. Of these, 79 medical secretaries (93%), 172 nurses (73%) and 70 physicians (88%) responded, giving a total response rate of 81% (321/400). We used Teleform™ for data acquisition and SPSS 11.0 for Windows™ for statistical analysis. In addition to the survey, one of the authors interviewed 8–12 representatives of each profession for 0.5–2 hours. Comments on advantages and disadvantages of the system in all relevant work tasks were noted and summarized
Methods
The hospital The investigation was performed in a 410-bed community hospital in Aust-Agder county, Norway. The hospital serves a population of 102,000, caring for 18,600 inpatients and 74,000 outpatients per year (1998). The patients are admitted by primary care physicians external to the hospital and followed up by the hospital physicians. The hospital comprises of departments for psychiatry, general surgery, internal medicine, orthopaedics, gynecology, ear, nose and throat and ophthalmology. Well funded, and with a strong commitment by the hospital administration, the hospital staff began implementation of DIPS 2000 ®  , a commercially available combined EMR and hospital administrative system in March 2000. In April 2001, all except the psychiatric department started to scan documents. From this date, all new patient data was channeled into the EMR in these departments, either as electronic text and data or as scanned documents. The HIS was available in 1100 terminals throughout the hospital, except for the inpatients' rooms. The transition to HIS was administered by a project group, which had been recruited from the hospital staff. The group worked in conjunction with the IT department and the HIS vendor, and was also responsible for communicating with and training the users. The group regularly held series of mandatory hands-on training classes adapted to each profession (3–8 h in total). However, a substantial proportion of the users never attended the classes, particularly the physicians. To reach these users, a task force of medical secretaries was trained and employed during the first month after implementation of the HIS for ambulant training in the wards. Further support was provided by a network of super users (the most experienced users) among the ward staff.
The hospital
The investigation was performed in a 410-bed community hospital in Aust-Agder county, Norway. The hospital serves a population of 102,000, caring for 18,600 inpatients and 74,000 outpatients per year (1998). The patients are admitted by primary care physicians external to the hospital and followed up by the hospital physicians. The hospital comprises of departments for psychiatry, general surgery, internal medicine, orthopaedics, gynecology, ear, nose and throat and ophthalmology. Well funded, and with a strong commitment by the hospital administration, the hospital staff began implementation of DIPS 2000 ®  , a commercially available combined EMR and hospital administrative system in March 2000. In April 2001, all except the psychiatric department started to scan documents. From this date, all new patient data was channeled into the EMR in these departments, either as electronic text and data or as scanned documents. The HIS was available in 1100 terminals throughout the hospital, except for the inpatients' rooms. The transition to HIS was administered by a project group, which had been recruited from the hospital staff. The group worked in conjunction with the IT department and the HIS vendor, and was also responsible for communicating with and training the users. The group regularly held series of mandatory hands-on training classes adapted to each profession (3–8 h in total). However, a substantial proportion of the users never attended the classes, particularly the physicians. To reach these users, a task force of medical secretaries was trained and employed during the first month after implementation of the HIS for ambulant training in the wards. Further support was provided by a network of super users (the most experienced users) among the ward staff.The EMR The patient data in the EMR part of the HIS is either stored as searchable text and numbers or as document images. The former, called "regular electronic data", essentially consists of the chronological, text-based medical record integrated with lab data in numerical form and textual radiology reports (fig  1 ). The latter is divided by structure into two categories, as follows: Upon admittance or consultation, the documents in the old paper-based medical records are scanned into the system as digital images in TIFF format. Each image contains all the sheets of one main section of the paper-based record, and hence corresponds to a whole document group (groups A-J in fig  1 ). These images are called "scanned multiple documents". Upon patient discharge, various paper sheets accumulated during the stay (e.g. the medical treatment form, printouts from diagnostic devices) are scanned, dated and labeled by document type singularly (fig  1 ). The resulting images are called "scanned single documents". In summary, the patient data is stored as regular electronic data, scanned multiple documents and scanned single documents. They all appear in the hierarchical list in the "medical record explorer" window (fig  2 ), but are treated separately in this paper, due to their difference in structure, indexation and functionality. The user interface of the HIS system is identical to all types of users, although medical secretaries, nurses and physicians often utilize different parts of system.
The EMR
The patient data in the EMR part of the HIS is either stored as searchable text and numbers or as document images. The former, called "regular electronic data", essentially consists of the chronological, text-based medical record integrated with lab data in numerical form and textual radiology reports (fig  1 ). The latter is divided by structure into two categories, as follows: Upon admittance or consultation, the documents in the old paper-based medical records are scanned into the system as digital images in TIFF format. Each image contains all the sheets of one main section of the paper-based record, and hence corresponds to a whole document group (groups A-J in fig  1 ). These images are called "scanned multiple documents". Upon patient discharge, various paper sheets accumulated during the stay (e.g. the medical treatment form, printouts from diagnostic devices) are scanned, dated and labeled by document type singularly (fig  1 ). The resulting images are called "scanned single documents". In summary, the patient data is stored as regular electronic data, scanned multiple documents and scanned single documents. They all appear in the hierarchical list in the "medical record explorer" window (fig  2 ), but are treated separately in this paper, due to their difference in structure, indexation and functionality. The user interface of the HIS system is identical to all types of users, although medical secretaries, nurses and physicians often utilize different parts of system.The survey A questionnaire previously used in a national survey of hospital physicians [ 2 ] was modified for this study. The original questionnaire contained sections regarding frequency of use of an EMR system or HIS for specified tasks, user satisfaction with the system as a whole [ 5 ] as well as detailed aspects of it [ 6 ], and availability of computers. To make the questionnaire applicable to medical secretaries and nurses, new versions of the section regarding frequency of use of the HIS were developed. In collaboration with the authors, 3–6 representatives from the medical secretaries and the nurses identified work tasks for the questionnaire each in two 2-hour group sessions, using recently developed detailed work-flow charts as templates (not shown). The identified tasks were then reduced to 23 and 19 tasks supported by the HIS, respectively (see appendix A). The questionnaire was reviewed in similar sessions by representatives from the physicians. As a result, one new task was added to the physicians' questionnaire, and four tasks not supported by the HIS were removed. For all professions, a new section was added, containing questions about ease of performing each task using the system. The survey was conducted during February–April 2002, and 85 medical secretaries, 235 nurses and 80 physicians in the medical, surgical and other somatic wards received the questionnaire. Of these, 79 medical secretaries (93%), 172 nurses (73%) and 70 physicians (88%) responded, giving a total response rate of 81% (321/400). We used Teleform™ for data acquisition and SPSS 11.0 for Windows™ for statistical analysis. In addition to the survey, one of the authors interviewed 8–12 representatives of each profession for 0.5–2 hours. Comments on advantages and disadvantages of the system in all relevant work tasks were noted and summarized
The survey
A questionnaire previously used in a national survey of hospital physicians [ 2 ] was modified for this study. The original questionnaire contained sections regarding frequency of use of an EMR system or HIS for specified tasks, user satisfaction with the system as a whole [ 5 ] as well as detailed aspects of it [ 6 ], and availability of computers. To make the questionnaire applicable to medical secretaries and nurses, new versions of the section regarding frequency of use of the HIS were developed. In collaboration with the authors, 3–6 representatives from the medical secretaries and the nurses identified work tasks for the questionnaire each in two 2-hour group sessions, using recently developed detailed work-flow charts as templates (not shown). The identified tasks were then reduced to 23 and 19 tasks supported by the HIS, respectively (see appendix A). The questionnaire was reviewed in similar sessions by representatives from the physicians. As a result, one new task was added to the physicians' questionnaire, and four tasks not supported by the HIS were removed. For all professions, a new section was added, containing questions about ease of performing each task using the system.The survey was conducted during February–April 2002, and 85 medical secretaries, 235 nurses and 80 physicians in the medical, surgical and other somatic wards received the questionnaire. Of these, 79 medical secretaries (93%), 172 nurses (73%) and 70 physicians (88%) responded, giving a total response rate of 81% (321/400). We used Teleform™ for data acquisition and SPSS 11.0 for Windows™ for statistical analysis.In addition to the survey, one of the authors interviewed 8–12 representatives of each profession for 0.5–2 hours. Comments on advantages and disadvantages of the system in all relevant work tasks were noted and summarizedResults The medical secretaries used the HIS routinely for most of their tasks defined in the questionnaire. This stands in contrast to the nurses and the physicians (fig  3 ). The number of tasks with a median response of "always or almost always" was highest for the medical secretaries (15 out of 23 tasks, 65%), and lowest for the nurses (4 out of 19 tasks, 21%). The medical secretaries reported that all of the defined tasks were performed more easily than before the HIS was introduced (i.e. median response for ease of performing the task was "increased" or "significantly increased", in 23 out of 23 tasks, fig  4 ). In comparison, the number of tasks more easily performed was much lower for the nurses and the physicians (respectively 9 [47%] and 7 [37%] out of 19 individual tasks). The medical secretaries were much more satisfied with the use of the HIS than the nurses and physicians, both when assessing the detailed aspects of it and the system as a whole. The detailed aspects of the HIS was assessed in twelve questions related to the factors content, accuracy, format, user friendliness and timeliness [ 6 ]. The parts of the HIS that contained scanned document images and regular electronic data were assessed separately. The medical secretaries were equally satisfied with both parts of the HIS (fig  5 ). This stands in contrast to nurses and in particular the physicians, who were less satisfied, particularly with the part containing the scanned document images. The difference between the professions was significant in all factors regarding the scanned document images (ANOVA p < 0.001), and in all factors except accuracy regarding the regular electronic data (fig  5 , (ANOVA p = 0.001 to 0.04, p = 0.07 for factor 'accuracy'). In addition to the detailed aspects, the user satisfaction with the HIS as a whole was assessed (fig  6 ). The medical secretaries gave significantly more positive responses than the nurses and the physicians in all of the five questions in this section (Kruskall-Wallis p = 0.05 in question 2, p < 0.001 in the remaining four questions). However, the majority of each profession gave positive answers in all of these questions. To summarize all results regarding user satisfaction, the system seems to be well adapted to the work of medical secretaries but leave nurses and physicians less satisfied. Partly explaining the differences in user satisfaction, the physicians reported more frequent problems related to availability of the HIS than the medical secretaries and the nurses (fig  7 , Kruskall-Wallis p < 0.001 in all questions). The most frequently reported problems among the physicians occurred daily or weekly, and consisted of various software and hardware-related problems, the system working too slowly, and lack of computers where the clinical work was being done. Such problems were not frequently reported among the medical secretaries, except problems with the systems working too slowly (42% daily or weekly, 32/77). In the interviews, the perceived advantages and disadvantages of the HIS were discussed. Both nurses and physicians in the medical ward found that patient data were more accessible when stored electronically than when stored on paper, in particular regarding lab test data. However, the nurses were still using pen and paper when documenting their activities. The medical secretaries found that generation, handling, fetching and delivery of paper documents and logistics of paper-based patient records had diminished dramatically. The generation of written text had become considerably easier. On the other hand, the scanning process had become an additional burden and was considered time consuming. Overall, handling of paper documents was considered additional work whenever the documents appeared.
Results
The medical secretaries used the HIS routinely for most of their tasks defined in the questionnaire. This stands in contrast to the nurses and the physicians (fig  3 ). The number of tasks with a median response of "always or almost always" was highest for the medical secretaries (15 out of 23 tasks, 65%), and lowest for the nurses (4 out of 19 tasks, 21%).The medical secretaries reported that all of the defined tasks were performed more easily than before the HIS was introduced (i.e. median response for ease of performing the task was "increased" or "significantly increased", in 23 out of 23 tasks, fig  4 ). In comparison, the number of tasks more easily performed was much lower for the nurses and the physicians (respectively 9 [47%] and 7 [37%] out of 19 individual tasks).The medical secretaries were much more satisfied with the use of the HIS than the nurses and physicians, both when assessing the detailed aspects of it and the system as a whole. The detailed aspects of the HIS was assessed in twelve questions related to the factors content, accuracy, format, user friendliness and timeliness [ 6 ]. The parts of the HIS that contained scanned document images and regular electronic data were assessed separately. The medical secretaries were equally satisfied with both parts of the HIS (fig  5 ). This stands in contrast to nurses and in particular the physicians, who were less satisfied, particularly with the part containing the scanned document images. The difference between the professions was significant in all factors regarding the scanned document images (ANOVA p < 0.001), and in all factors except accuracy regarding the regular electronic data (fig  5 , (ANOVA p = 0.001 to 0.04, p = 0.07 for factor 'accuracy').In addition to the detailed aspects, the user satisfaction with the HIS as a whole was assessed (fig  6 ). The medical secretaries gave significantly more positive responses than the nurses and the physicians in all of the five questions in this section (Kruskall-Wallis p = 0.05 in question 2, p < 0.001 in the remaining four questions). However, the majority of each profession gave positive answers in all of these questions. To summarize all results regarding user satisfaction, the system seems to be well adapted to the work of medical secretaries but leave nurses and physicians less satisfied.Partly explaining the differences in user satisfaction, the physicians reported more frequent problems related to availability of the HIS than the medical secretaries and the nurses (fig  7 , Kruskall-Wallis p < 0.001 in all questions). The most frequently reported problems among the physicians occurred daily or weekly, and consisted of various software and hardware-related problems, the system working too slowly, and lack of computers where the clinical work was being done. Such problems were not frequently reported among the medical secretaries, except problems with the systems working too slowly (42% daily or weekly, 32/77).In the interviews, the perceived advantages and disadvantages of the HIS were discussed. Both nurses and physicians in the medical ward found that patient data were more accessible when stored electronically than when stored on paper, in particular regarding lab test data. However, the nurses were still using pen and paper when documenting their activities. The medical secretaries found that generation, handling, fetching and delivery of paper documents and logistics of paper-based patient records had diminished dramatically. The generation of written text had become considerably easier. On the other hand, the scanning process had become an additional burden and was considered time consuming. Overall, handling of paper documents was considered additional work whenever the documents appeared.Discussion In this hospital, we have found that the medical secretaries use the HIS more extensively for their tasks than the nurses and the physicians. Also, they are much more satisfied with the HIS. Medical secretaries reported that they use the HIS routinely for most of the tasks defined in the questionnaire (fig  3 ). A simple explanation is that their tasks generally are smaller in scope and have a smaller and more easily defined range of needed information types than that of the nurses and physicians (See appendix A). Hence, the medical secretaries' tasks should be more easily supported by computers than the nurses' and the physicians' tasks. The particular inefficiencies of certain paper-based routines (e.g. regarding task 6, 15, 18 and 19) readily demonstrates the usefulness of computer support [ 7 ]. Unlike the work of nurses and physicians, the work of medical secretaries is stationary, avoiding the difficulties in providing an efficient mobile work environment. In addition, each medical secretary typically is assigned a computer, while nurses and physicians usually have to share a limited number of them (fig  7 , question C). Another possible reason for the difference in usage pattern could be difference in computer literacy. However, the usage patterns were not consistent with the limited differences found in self-reported computer literacy (data not shown), and the amount of in-house training of medical secretaries and physicians was principally equal. The medical secretaries reported that all of the tasks in their questionnaire are more easily performed (fig  4 ). The results from the interviews identify the elimination of the paper-based medical record as a major contributor to this, as several manual paper routines have disappeared (e.g. searching for a lost paper-based medial record or sorting the contents of a medical record) or are replaced by more efficient computer functions (e.g. transferring new lab data to doctors for review). Furthermore, having the administrative functions integrated with the EMR means that a substantial selection of structured demographic, clinical and administrative data is concurrently available to the users of the HIS. This makes several tasks more efficient for the medical secretaries (e.g. sending standard letters to patients in waiting lists). The results are supported by the fact that the number of medical secretaries in the hospital has been reduced by 15 since the onset of the HIS project (Bjørn Engum, personal communication Sept 2003). Not surprisingly, the medical secretaries were more satisfied with the system than the nurses and the physicians (figs  3  and  4 ). This agrees with the results of Sittig [ 8 ] and Lee [ 9 ], who both found that user satisfaction was strongest correlated to questions regarding how easily the work was done. On the other hand, when comparing the user satisfaction scores to the reference data of Doll & Torkzadeh [ 6 ], the median user satisfaction score of the medical secretaries lies between the 20 th  and 30 th  percentile of the reference data set. This suggests that there is room for improvement of the EMR system regarding the medical secretaries as well as the others. Unlike the nurses and the physicians, the medical secretaries were equally satisfied with the scanned document images as that of the regular electronic medical record. The most likely reason is that the document images are not very often used by the medical secretaries, particularly the document images scanned in sections (data not shown). The disadvantages of the document images, for instance that they can not be searched, therefore seem to affect the user satisfaction of nurses and physicians to a stronger degree than that of the medical secretaries. The use of the HIS by medical secretaries, nurses and physicians may to some degree be compared at a task-by-task level when the tasks are equally worded. In these tasks, work roles seem to explain the differences. For instance, the tasks "Reviewing the patient's problems" (tasks 1) and "Seek out specific information from patient records" (task 2) appeared in all questionnaires. Of all the respondents, only the physicians had a significant proportion finding that these tasks were more difficult to perform than before (figure  4 ). A possible reason is that the physicians, in order to perform these tasks as they saw fit for their work role, more often needed to search the scanned document images extensively. When examining the task "Order clinical biochemical laboratory analyses" (task 6 for nurses, task 7 for physicians), the nurses both use the HIS more frequently for this task and find the task more easily to perform than the physicians. However, many Norwegian physicians find that order entry is a task better performed by others [ 10 ], reducing the motivation for learning the new system. This way, understanding work roles in the given context appears necessary to interpret the results. A secondary finding in this study was that the physicians reported frequent computer-related problems, much more frequent than that of medical secretaries and nurses (fig  7 ). This may be due to escalated demands on computing power, system stability and availability. Without the paper-based medical record, the EMR is taken into full use and the real demands of supporting the physicians' information processing are revealed. The high reported frequency of computer-related problems may partly explain the overall lower user satisfaction of the physicians, as well as the relatively high proportion of physicians finding certain tasks more difficult to perform (task 1 and 2, fig  4 ). An observational study could elaborate on these relationships, focusing on what kinds of computer problems are the least tolerable to the physicians. Limitations of the study In the questionnaire, we do not know how often each task is carried out (using the HIS or not) or how long it takes, which means that demanding tasks might be outnumbered by the less demanding ones. Furthermore, the list of tasks supported in some way by the system may not be complete, and the list does not cover the full range of conceivable tasks suited for support by any given HIS. However, given that the tasks defined for each group cover important parts of their information-related work, a cautious comparison of general patterns of use between groups of hospital employees is possible.
Discussion
In this hospital, we have found that the medical secretaries use the HIS more extensively for their tasks than the nurses and the physicians. Also, they are much more satisfied with the HIS.Medical secretaries reported that they use the HIS routinely for most of the tasks defined in the questionnaire (fig  3 ). A simple explanation is that their tasks generally are smaller in scope and have a smaller and more easily defined range of needed information types than that of the nurses and physicians (See appendix A). Hence, the medical secretaries' tasks should be more easily supported by computers than the nurses' and the physicians' tasks. The particular inefficiencies of certain paper-based routines (e.g. regarding task 6, 15, 18 and 19) readily demonstrates the usefulness of computer support [ 7 ]. Unlike the work of nurses and physicians, the work of medical secretaries is stationary, avoiding the difficulties in providing an efficient mobile work environment. In addition, each medical secretary typically is assigned a computer, while nurses and physicians usually have to share a limited number of them (fig  7 , question C). Another possible reason for the difference in usage pattern could be difference in computer literacy. However, the usage patterns were not consistent with the limited differences found in self-reported computer literacy (data not shown), and the amount of in-house training of medical secretaries and physicians was principally equal.The medical secretaries reported that all of the tasks in their questionnaire are more easily performed (fig  4 ). The results from the interviews identify the elimination of the paper-based medical record as a major contributor to this, as several manual paper routines have disappeared (e.g. searching for a lost paper-based medial record or sorting the contents of a medical record) or are replaced by more efficient computer functions (e.g. transferring new lab data to doctors for review). Furthermore, having the administrative functions integrated with the EMR means that a substantial selection of structured demographic, clinical and administrative data is concurrently available to the users of the HIS. This makes several tasks more efficient for the medical secretaries (e.g. sending standard letters to patients in waiting lists). The results are supported by the fact that the number of medical secretaries in the hospital has been reduced by 15 since the onset of the HIS project (Bjørn Engum, personal communication Sept 2003).Not surprisingly, the medical secretaries were more satisfied with the system than the nurses and the physicians (figs  3  and  4 ). This agrees with the results of Sittig [ 8 ] and Lee [ 9 ], who both found that user satisfaction was strongest correlated to questions regarding how easily the work was done. On the other hand, when comparing the user satisfaction scores to the reference data of Doll & Torkzadeh [ 6 ], the median user satisfaction score of the medical secretaries lies between the 20 th  and 30 th  percentile of the reference data set. This suggests that there is room for improvement of the EMR system regarding the medical secretaries as well as the others. Unlike the nurses and the physicians, the medical secretaries were equally satisfied with the scanned document images as that of the regular electronic medical record. The most likely reason is that the document images are not very often used by the medical secretaries, particularly the document images scanned in sections (data not shown). The disadvantages of the document images, for instance that they can not be searched, therefore seem to affect the user satisfaction of nurses and physicians to a stronger degree than that of the medical secretaries.The use of the HIS by medical secretaries, nurses and physicians may to some degree be compared at a task-by-task level when the tasks are equally worded. In these tasks, work roles seem to explain the differences. For instance, the tasks "Reviewing the patient's problems" (tasks 1) and "Seek out specific information from patient records" (task 2) appeared in all questionnaires. Of all the respondents, only the physicians had a significant proportion finding that these tasks were more difficult to perform than before (figure  4 ). A possible reason is that the physicians, in order to perform these tasks as they saw fit for their work role, more often needed to search the scanned document images extensively. When examining the task "Order clinical biochemical laboratory analyses" (task 6 for nurses, task 7 for physicians), the nurses both use the HIS more frequently for this task and find the task more easily to perform than the physicians. However, many Norwegian physicians find that order entry is a task better performed by others [ 10 ], reducing the motivation for learning the new system. This way, understanding work roles in the given context appears necessary to interpret the results.A secondary finding in this study was that the physicians reported frequent computer-related problems, much more frequent than that of medical secretaries and nurses (fig  7 ). This may be due to escalated demands on computing power, system stability and availability. Without the paper-based medical record, the EMR is taken into full use and the real demands of supporting the physicians' information processing are revealed. The high reported frequency of computer-related problems may partly explain the overall lower user satisfaction of the physicians, as well as the relatively high proportion of physicians finding certain tasks more difficult to perform (task 1 and 2, fig  4 ). An observational study could elaborate on these relationships, focusing on what kinds of computer problems are the least tolerable to the physicians.Limitations of the study In the questionnaire, we do not know how often each task is carried out (using the HIS or not) or how long it takes, which means that demanding tasks might be outnumbered by the less demanding ones. Furthermore, the list of tasks supported in some way by the system may not be complete, and the list does not cover the full range of conceivable tasks suited for support by any given HIS. However, given that the tasks defined for each group cover important parts of their information-related work, a cautious comparison of general patterns of use between groups of hospital employees is possible.
Limitations of the study
In the questionnaire, we do not know how often each task is carried out (using the HIS or not) or how long it takes, which means that demanding tasks might be outnumbered by the less demanding ones. Furthermore, the list of tasks supported in some way by the system may not be complete, and the list does not cover the full range of conceivable tasks suited for support by any given HIS. However, given that the tasks defined for each group cover important parts of their information-related work, a cautious comparison of general patterns of use between groups of hospital employees is possible.Conclusion Evaluation of a HIS in a hospital that has eliminated the paper-based medical record reveals considerable differences in user satisfaction and reported use of the system among medical secretaries, nurses and physicians. Although the basis for reference is limited, the results seem to support the claim that replacing the paper-based medical record primarily benefits the medical secretaries, and to a lesser degree the nurses and the physicians. Inspired by Aust-Agder Hospital, two of 22 other Norwegian hospitals using the same system (as of Aug 2002) are about to eliminate the paper-based medical record, making a future comparison between hospitals possible. When assessing the effects of a HIS on a hospital organization by asking users, the multidisciplinary nature of health care provision should be reflected in the selection of hospital employees that participate in the evaluation.
Conclusion
Evaluation of a HIS in a hospital that has eliminated the paper-based medical record reveals considerable differences in user satisfaction and reported use of the system among medical secretaries, nurses and physicians. Although the basis for reference is limited, the results seem to support the claim that replacing the paper-based medical record primarily benefits the medical secretaries, and to a lesser degree the nurses and the physicians. Inspired by Aust-Agder Hospital, two of 22 other Norwegian hospitals using the same system (as of Aug 2002) are about to eliminate the paper-based medical record, making a future comparison between hospitals possible. When assessing the effects of a HIS on a hospital organization by asking users, the multidisciplinary nature of health care provision should be reflected in the selection of hospital employees that participate in the evaluation.Competing interests The authors declare that they have no competing interests.
Competing interests
The authors declare that they have no competing interests.Authors' contributions HL, THK and AF planned the investigation. HL and THK developed the questionnaires for the medical secretaries and nurses. THK organized the administration of the questionnaires, and HL scanned and analysed the data. HL, THK and AF wrote the manuscript jointly.
Authors' contributions
HL, THK and AF planned the investigation. HL and THK developed the questionnaires for the medical secretaries and nurses. THK organized the administration of the questionnaires, and HL scanned and analysed the data. HL, THK and AF wrote the manuscript jointly.Pre-publication history The pre-publication history for this paper can be accessed here:
Pre-publication history
The pre-publication history for this paper can be accessed here:Supplementary Material Additional File 1 Appendix A: Task lists  The three lists of tasks as they appear in the questionnaire developed for the medical secretaries, nurses and physicians, respectively. Click here for file Additional File 2 An English translation of the questionnaire used for the physicians in the survey. It is meant for review purposes. Click here for file
Supplementary Material
Additional File 1
Appendix A: Task lists  The three lists of tasks as they appear in the questionnaire developed for the medical secretaries, nurses and physicians, respectively.Appendix A: Task listsClick here for fileAdditional File 2
An English translation of the questionnaire used for the physicians in the survey. It is meant for review purposes.Click here for file