Establishment of a regional Danish database for patients with a stoma
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1 Original article doi: /codi Establishment of a regional Danish database for patients with a stoma A. K. Danielsen*, B. M. Christensen, J. Mortensen*, L. L. Voergaard, P. Herlufsen and L.Balleby *Department of Gastroenterology, Herlev, University of Copenhagen, Copenhagen, Denmark, Department of Surgery, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark, Department of Surgery, Hillerød, University of Copenhagen, Copenhagen, Denmark, Department of Surgery, Hvidovre, University of Copenhagen, Copenhagen, Denmark and Digestive Disease Centre, Bispebjerg, University of Copenhagen, Copenhagen, Denmark Received 19 May 2014; accepted 15 October 2014; Accepted Article online 23 November 2014 Abstract Aim To present the Danish Stoma Database Capital Region with clinical variables related to stoma creation including colostomy, ileostomy and urostomy. Method The stomatherapists in the Capital Region of Denmark developed a database covering patient identifiers, interventions, conditions, short-term outcome, long-term outcome and known major confounders. The completeness of data was validated against the Danish National Patient Register. Results In 2013, five hospitals included data from 1123 patients who were registered during the year. The types of stomas formed from 2007 to 2013 showed a variation reflecting the subspecialization and surgical techniques in the centres. Between 92 and 94% of patients agreed to participate in the standard programme aimed at handling of the stoma and more than 88% of patients having planned surgery had the stoma site marked pre-operatively. Conclusion The database is fully operational with high data completeness and with data about patients with a stoma from before surgery up to 12 months after surgery. The database provides a solid basis for professional learning, clinical research and benchmarking. Keywords Stoma creation, clinical database, stoma care nurses, enterostoma therapy, stoma nursing, quality development What does this paper add to the literature? The database provides clinicians and researchers with the first documented evidence on incidence and prevalence of stoma creation in the Capital Region of Denmark. It invites clinicians and researchers to apply for data access as part of the conduct of research. Introduction Correspondance to: A. K. Danielsen, Department of Gastroenterology, Herlev, University of Copenhagen, Herlev Ringvej 75, 2730 Herlev, Denmark. anne.k.danielsen@gmail.com A colostomy or ileostomy is constructed to divert the faecal flow in the treatment of intestinal disease [1]. A urostomy is created to divert the flow of urine. Any stoma may be associated with a decrease in quality of life [2,3]. It involves a major bodily change [4] leading to alteration in function and body image, with implications for spouses [5] and health costs [6]. Research in stoma creation seems to be focused on morbidity and mortality related to different surgical interventions and techniques [7]. Furthermore, researchers have explored quality of life [2,8], educational programmes aimed at patients with a stoma [9] and rehabilitation after stoma creation [10]. Several types of questions are linked to specific points such as the height of the stoma [11,12], reversal [13] and skin problems [14], but further research is also required for other clinically relevant issues [15]. This would provide a foundation for continuous quality management as the individual clinician could base his or her care on an evaluation of actual data [16]. Some questions regarding stomas may be answered using clinical databases that provide individual-level data [17]. So far research based on clinical databases seems to be absent, which may be due to difficulties in establishing the level of completeness and accuracy of the data [18]. There is currently no central clinical database holding data on individual patients after stoma creation. Such a database would facilitate research based on large samples, long follow-up periods, detailed data on the O27
2 A regional Danish database for patients with a stoma A. K. Danielsen et al. stoma and the handling of the stoma over time [19]. For this reason the stoma care nurses (SCNs) in the Capital Region of Denmark have established a database, the Danish Stoma Database Capital Region (fully operational in 2010), to include all patients undergoing stoma creation [20]. It now includes data from patients in five large university hospitals with a catchment area covering approximately 1.7 million inhabitants (2012). This paper describes the development of the database and its potential contribution to clinical management and research. Method The stimulus to form the database was the desire to improve the quality of clinical management and to benchmark operations and compare results between hospitals. An electronic database was set up and clinical data were registered from The aim was to include all patients having stoma surgery in the region. In 2010 all five hospitals in the region joined the project. In the same year the database obtained support from the Regional Board of Health Surgery, the quality council in the Capital Region, and was approved by the National Board of Health and the Danish Data Protection Agency [21]. A steering committee consisting of an SCN from each centre, a nurse manager and a surgeon was appointed to take care of strategic issues related to the database. Daily operations were handled by a data manager from the Regional Centre for Information, Medical Technology and Telephony covering maintenance and technical support. Patient completeness of the database was tested by comparing data for a full month on patients having stoma formation at any of the collaborating hospitals. During this period the SCNs traced and reviewed the description of the operation in the medical case notes from all patients undergoing stoma creation. Surgical codes were collected as required by the Danish National Patient Register, a national organization that follows the activity of individual hospitals in Denmark. The national entries are based on individual contacts and include diagnosis, surgical treatment and length of stay, and are presumed to be of high standard with a high rate of data completeness [20]. Based on past experience, however, the SCNs decided not to rely entirely on the surgical codes being correct. They therefore routinely checked all surgical patients operated on the previous day to ensure that every patient with a stoma was registered regardless of whether they were transferred to the intensive care unit or to another hospital shortly after surgery. This showed that 25 different surgical codes were used when documenting stoma creation. In some patients it was not possible to find any entered surgical code for stoma creation and these cases could be registered with seven different surgical codes. Thus stoma creation could only be identified by reviewing the description of the surgical intervention in the operation note. The database was held in a secure web site and only SCNs were able to enter it using a personal password (Fig. 1). After stoma creation all patients were entered using their unique Danish social security number, used for all contact with the Danish Health System. Data were entered before surgery, and postoperatively as follows: 3 ( 1 day), 10 ( 2 days), 30 ( 3 days), 90 ( 10 days), 182 ( 10 days) and 356 ( 10 days) days after surgery (Fig. 2). The choice of variables was based on studies in the literature, and those that were identified were assumed to be important components for good quality care covering all areas of stoma care. They included 19 perioperative and 15 postoperative items covering patient details, the intervention, short-term outcome and longterm outcome [18]. The framework for quality assurance was based on the dynamic standard system [22] developed for the local implementation of clinical audit and benchmarking. As part of an ongoing process related to data quality, the SCNs validated their observations daily if possible and at least at monthly meetings. Marking of the stoma site preoperatively was of great importance for patients subsequent management of the stoma. The optimal positioning was agreed partly from information in the literature but mostly by consensus of the participating SCNs. Results The five hospitals covered five stoma outpatient clinics staffed by 12 SCNs. In 2013, 1123 patients were entered on the database, a considerable increase from the figure of 335 entered in 2007 (Table 1). Extrapolating these numbers to the whole of Denmark would indicate a national annual incidence of stoma formation of 4000 and a prevalence of between and people living with any kind of stoma [21]. The registration of patients was found to be nearly 100% when entries on the database were reconciled with the review of the medical case notes. Between 2007 and 2013, 6277 patients had been entered. Comparing 2007 with 2013 for age and gender, approximately a third of the patients were under the age of 60 years (1050 men and 1186 women out of a total of 6277 for the whole period). There was an equal distribution regarding gender, although the data from 2012 to 2013 suggest a decrease in women (568 in 2012 and 480 in 2013). Over the whole period from O28
3 A. K. Danielsen et al. A regional Danish database for patients with a stoma Figure 1 Screenshot of the secure web site showing the personal page of every patient entered in the database up to 2013 there was a trend towards a higher proportion of female patients, when looking at patients aged over 80 years, and the gender ratio was 57.5% women/42.5% men among 851 patients. The type of stoma created in the centres varied as a reflection of specialization in the centres to include urostomy (388), ileostomy (2891), jejunostomy (131), sigmoideostomy (2431), transversostomy (399) and ureterocutaneostomy (36) (data were missing from only one patient) (Fig. 3). There was considerable variation in the proportion of patients having a temporary or permanent stoma (Table 2). After stoma creation, patients are invited to participate in a standard program aimed at handling the stoma and learning to live with a stoma, and between 6% and 8% of the total number of patients did not participate in 2010 and Stoma marking was fully documented from 2010 when all the centres had joined the collaboration. In 2013 this had been carried out in 88 95% of all patients having elective surgery. In contrast patients having emergency surgery were only marked in 35 78% of cases (Table 3). Discussion This is the first report of a database containing information on the incidence and prevalence of stoma formation in the Capital Region of Denmark. The variable data from the first years of the database probably reflect differences in case mix and the restructuring of the entire secondary regional health care sector which took place at that time. The five centres did not all join the collaboration until 2010, and this was the main reason why the database was not systematically used as an instrument to guide quality development and benchmarking before Quality assurance and the development of nursing have drawn heavily on a framework called the dynamic standard setting system [23], a model which provided principles for exploring, evaluating and developing O29
4 A regional Danish database for patients with a stoma A. K. Danielsen et al. Perioperative period* POD**3, POD10, POD30 POD90, POD180, POD365 Modus of Operation Type of Operation Diagnosis Preoperative interview Type of stoma Preoperative stoma siting Primary fashionering Temporary or permanent Discharge interview Level of education in stomacare Height Weight Early complications: Ischaemic necrosis Mucocutaneos separation Retraction Fistula Skin disorder Prolapse Late complications: Stenosis Prolapse Peristomal bulge Skin disorder Retraction Fistula Patient course during hospitalization until after discharge from hospital *Only once during the perioperative period **POD = Post-Operative Day Figure 2 Data entry in the different phases of patients journeys from hospitalization to 1 year after stoma creation. Table 1 Stoma formation in the Capital Region of Denmark by centre and year of surgery. Centre Bispebjerg Herlev Hilleroed Hvidovre Rigshospitalet Total patient care. The implementation of the model for quality development was inspired by the approach taken by the Danish Colorectal Cancer Group when founding its database in 1994 [22]. The database, in line with its original intention, is used by SCNs to discuss results and propose means of improving quality of care. For example, the database makes it possible to identify problems related to the educational programme and to resolve them, thereby enhancing peer-learning processes. Stoma marking is known to have an immense impact on patients postoperative quality of life [24] and the database showed evidence of an increase in the adoption of this practice, certainly for elective surgery. There is some evidence of improvement in patients having emergency surgery. The differences seen regarding emergency surgery probably reflect different local protocols related to who actually did the stoma marking (the ward nurse or the stomatherapist). Some emergency patients were not hospitalized in a surgical ward with nurses trained to do the procedure. Regarding the decrease from 2012 to 2013 in female patients undergoing stoma creation, it was discussed and the authors found no apparent link to structure or organization, and therefore this decrease could be coincidental. The completeness of data demonstrated a rate of reporting of nearly 100%, and when compared with the Danish National Patient Register there were a higher number of patients in the database, even though the National Register is regarded as having a high level of O30
5 A. K. Danielsen et al. A regional Danish database for patients with a stoma 1200 Types of stomas operated from 2007 to 2013* in the differrent collaborating centres Number of patients Urostomy lleostomy Jejunostomy Sigmoideostomy Transversostomy Ureterocutaneostomy 0 Bispebjerg Herlev Hilleroed Hvidovre Rigshospitalet Figure 3 Types of stoma created from 2007 to Table 2 Number of patients having a permanent (P) or temporary (T) stoma between 2007 and P T P T P T P T P T P T P T Bispebjerg Herlev Hilleroed Hvidovre Rigshospitalet Total Table 3 Number (percentage in brackets) of patients undergoing elective or emergency surgery who had the stoma marked preoperatively* Bispebjerg Elective 86 (96%) 67 (94%) 96 (96%) 77 (96%) Emergency 43 (72%) 40 (78%) 71 (88%) 53 (77%) Herlev Elective 132 (85%) 150 (90%) 180 (92%) 178 (95%) Emergency 34 (25%) 33 (25%) 54 (46%) 35 (38%) Hilleroed Elective 63 (90%) 77 (93%) 82 (94%) 98 (91%) Emergency 21 (44%) 24 (42%) 45 (64%) 26 (52%) Hvidovre Elective 135 (95%) 155 (86%) 141 (93%) 143 (88%) Emergency 49 (49%) 84 (51%) 84 (54%) 79 (62%) Rigshospitalet Elective 123 (91%) 102 (92%) 115 (86%) 120 (90%) Emergency 46 (48%) 36 (39%) 33 (39%) 25 (35%) *In quality improvement the rate of achievement is based on calculation of the actual number of observations, and missing data are not included [by the equation (n yes 9 100)/(n yes + n no )]. completeness [20]. The SCNs themselves register their own patients on the database and trace patients on the surgical lists on a daily basis and collaboration between SCNs is likely to be a major factor underlying the validity and completeness of the database. The variables included are relevant to professionals, but so far patientreported outcomes have not been included [25]. Including information from patients is of great importance [10], and currently a group of SCNs has been established to explore this matter. Clearly such a data- O31
6 A regional Danish database for patients with a stoma A. K. Danielsen et al. base has the potential to be useful for research. However, the distinction between aiming for improvement in quality of care and research is often small, since highquality management should be based on data validated by research. The database could be relevant when designing any form of clinical study. The limitations of the database are primarily related to its regional nature, and expansion to a national level would improve the data by reducing the effect of any regional differences, which for a country like Denmark with only has 5.6 million inhabitants may be present. It is not yet known whether there will be missing data when examining the long-term outcome. So far, unfortunately, we have not had access to all the data at 12 months and we acknowledge that this is a difficulty when working with real-time data. This implies that we do actually not know much about the completeness of follow-up data in the longer term. In conclusion, the database provides a basis for professional learning, systematic assessment of the quality of care and benchmarking within the collaborating colorectal and urological departments. Researchers focusing on patients with a stoma may now gain access to data that were formerly not possible to obtain. Acknowledgements We thank all the SCNs who have included and registered patient data in the database. Source of funding The study was initiated by the authors and has not received any external funding. Authorship and contributions Study conception and design: all authors. Acquisition of data: all authors. Analysis and interpretation of data: AKD, LB. Writing manuscript: all authors. Conflicts of interest The authors declare no conflicts of interest. References 1 Montedori A, Cirocchi R, Farinella E, Sciannameo F, Abraha I. Covering ileo- or colostomy in anterior resection for rectal carcinoma. Cochrane Database Syst Rev 2010; (5): CD Sprangers MA, Taal BG, Aaronson NK, te Velde A. Quality of life in colorectal cancer. Stoma vs. nonstoma patients. Dis Colon Rectum 1995; 38: Danielsen AK. Life after stoma creation. Dan Med J 2013; 60: B Thorpe G, McArthur M, Richardson B. Bodily change following faecal stoma formation: qualitative interpretive synthesis. J Adv Nurs 2009; 65: Danielsen AK, Burcharth J, Rosenberg J. Spouses of patients with a stoma lack information and support and are restricted in their social and sexual life: a systematic review. Int J Colorectal Dis 2013; 28: Koperna T. Cost-effectiveness of defunctioning stomas in low anterior resections for rectal cancer: a call for benchmarking. Arch Surg 2003; 138: Gooszen AW, Geelkerken RH, Hermans J, Lagaay MB, Gooszen HG. Quality of life with a temporary stoma: ileostomy vs. colostomy. Dis Colon Rectum 2000; 43: Nugent KP, Daniels P, Stewart B, Patankar R, Johnson CD. Quality of life in stoma patients. Dis Colon Rectum 1999; 42: Danielsen AK, Burcharth J, Rosenberg J. Patient education has a positive effect in patients with a stoma: a systematic review. Colorectal Dis 2013; 15: e Carlsson E, Berndtsson I, Hallen A-M, Lindholm E, Persson E. Concerns and quality of life before surgery and during the recovery period in patients with rectal cancer and an ostomy. J Wound Ostomy Continence Nurs 2010; 37: Persson E, Berndtsson I, Carlsson E, Hallen A-M, Lindholm E. Stoma-related complications and stoma size - a 2-year follow up. Colorectal Dis 2010; 12: Cottam J, Richards K, Hasted A, Blackman A. Results of a nationwide prospective audit of stoma complications within 3 weeks of surgery. Colorectal Dis 2007; 9: Roig JV, Cantos M, Balciscueta Z, Uribe N, Espinosa J, Rosello V, et al. Hartmann s operation: how often is it reversed and at what cost? A multicentre study Colorectal Dis 2011; 13: e Herlufsen P, Olsen AG, Carlsen B, Nybaek H, Karlsmark T, Laursen TN, et al. Stoma care. Study of peristomal skin disorders in patients with permanent stomas. Br J Nurs 2006; 15: Wille-Jørgensen P, Meisner S. Just another stoma - why have we not improved? Colorectal Dis 2010; 12: Lundin J, Lundin M, Isola J, Joensuu H. A web-based system for individualised survival estimation in breast cancer. BMJ 2003; 326: Black N, Barker M, Payne M. Cross sectional survey of multicentre clinical databases in the United Kingdom. BMJ 2004; 328: Black N, Payne M. Directory of clinical databases: improving and promoting their use. Qual Saf Health Care 2003; 12: O32
7 A. K. Danielsen et al. A regional Danish database for patients with a stoma 19 Bay-Nielsen M, Kehlet H. Establishment of a national Danish hernia database: preliminary report. Hernia 1999; 3: Wille-Jørgensen P. Data completeness can be optimized in clinical databases. Dan Med Bull 2011; 58: A Balleby L, Andersen BD, Schmidt DS, Christensen BM. The Danish Stoma Data Base Capital Region[Stomidatabasen i Region Hovedstaden] pp Danish Colorectal Cancer Group (DCCG). Available at Accessed August 25, Morrell C, Harve G, Kitson A. Practitioner-based quality improvement: a review of the Royal College of Nursing s dynamic standard setting system. Qual Health Care 1997; 6: Person B, Ifargan R, Lachter J, Duek SD, Kluger Y, Assalia A. The impact of preoperative stoma site marking on the incidence of complications, quality of life, and patient s independence. Dis Colon Rectum 2012; 55: Dawson J, Doll H, Fitzpatrick R, Jenkinson C, Carr AJ. The routine use of patient reported outcome measures in healthcare settings. BMJ 2010; 340: c186. Supporting Information Additional Supporting Information may be found in the online version of this article: Text box S1. The registration of data is based on basic variables and follow-up variables. Text box S2. Presenting the variable related to an indicator on stoma marking as an example of one of the variables in the database. O33
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