Anne Kjærgaard Danielsen

Patient education has a positive effect in patients with a stoma: a systematic review

A systematic review was performed to assess whether education of patients having stoma formation improves quality of life and whether it is cost effective.

The therapeutic or prophylactic effect of exogenous melatonin against depression and depressive symptoms: A systematic review and meta-analysis

Circadian- and sleep disturbances may be central for understanding the pathophysiology and treatment of depression. The effect of melatonin on depression/depressive symptoms has been investigated previously. This systematic review assesses the current evidence of a therapeutic- and prophylactic effect of melatonin in adult patients against depression or depressive symptoms. A search was performed in The Cochrane Library, PubMed, EMBASE and PsycINFO for published trials on November 14th 2013. Inclusion criteria were English language, RCTs or crossover trials. Our outcome was measurement of depression/depressive symptoms with a validated clinician-administered or self-rating questionnaire. PRISMA recommendations were followed and the Cochrane risk-of-bias tool used. Ten studies in 486 patients were included in the final qualitative synthesis and four studies, 148 patients, were included in two meta-analyses. Melatonin doses varied from 0.5-6 mg daily and the length of follow-up varied from 2 weeks to 3.5 years. Three studies were done on patients without depression at inclusion, two studies in patients with depression and five studies included a mixture. Six studies showed an improvement in depression scores in both the melatonin and placebo groups but there was no significant difference. One study showed a significant prophylactic effect and another found a significant treatment effect on depression with melatonin compared to placebo. The two meta-analyses did not show any significant effect of melatonin. No serious adverse events were reported. Although some studies were positive, there was no clear evidence of a therapeutic- or prophylactic effect of melatonin against depression or depressive symptoms.

Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial.

Objective: The objective was to study morbidity and mortality associated with early closure (8–13 days) of a temporary stoma compared with standard procedure (closure after > 12 weeks) after rectal resection for cancer. Background: A temporary ileostomy may reduce the risk of pelvic sepsis after anastomotic dehiscence. However, the temporary ileostomy is afflicted with complications and requires a second surgical procedure (closure) with its own complications. Early closure of the temporary ileostomy could reduce complications for rectal cancer patients. Methods: Early closure (8–13 days after stoma creation) of a temporary ileostomy was compared with late closure (>12 weeks) in a multicenter randomized controlled trial, EASY (www.clinicaltrials.gov, NCT01287637) including patients undergoing rectal resection for cancer. Patients with a temporary ileostomy without signs of postoperative complications were randomized to closure at 8 to 13 days or late closure (>12 weeks after index surgery). Clinical data were collected up to 12 months. Complications were registered according to the Clavien-Dindo Classification of Surgical Complications, and Comprehensive Complication Index was calculated. Results: The trial included 127 patients in eight Danish and Swedish surgical departments, and 112 patients were available for analysis. The mean number of complications after index surgery up to 12 months follow up was significantly lower in the intervention group (1.2) compared with the control group (2.9), P < 0.0001. Conclusions: It is safe to close a temporary ileostomy 8 to 13 days after rectal resection and anastomosis for rectal cancer in selected patients without clinical or radiological signs of anastomotic leakage.

Early closure of temporary ileostomy—the EASY trial: protocol for a randomised controlled trial

Objective The objective is to evaluate efficiency based on data on morbidity and mortality, health-related quality of life and healthcare-related costs after early reversal of temporary ileostomy after rectal resection for cancer compared with the standard procedure (late reversal). Background Reversal of a temporary ileostomy is generally associated with a low morbidity and mortality. However, ostomy reversal may cause complications requiring reoperation with subsequent major complications, in ranges from 0% to 7–9% and minor complications varying from 4–5% to 30%. Based on studies exploring and describing the time of closure in previous studies which are mostly of low quality, a recent review concluded that closing a temporary stoma within 2 weeks did not seem to be associated with an increase in morbidity and mortality. Design and methods Early closure of temporary ileostomy (EASY), a randomised controlled trial, is a prospective randomised controlled multicentre study which is performed within the framework of the Scandinavian Surgical Outcomes Research Group (http://www.ssorg.net/) and plans to include 200 patients from Danish and Swedish hospitals. The primary end-point of the study is the frequency of complications 0–12 months after surgery (the stoma creation operation). The secondary end-points of the study are (1) comparison of the total costs of the two groups at 6 and 12 months after surgery (stoma creation); (2) comparison of health-related quality of life in the two groups evaluated with the 36-item short-form and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29/CR30 at 3, 6 and 12 months after surgery (stoma creation); and (3) comparison of disease-specific quality of life in the two groups at 3, 6 and 12 months after surgery (stoma creation). Discussion The aim of the EASY trial is to evaluate the efficiency of early reversal of temporary ileostomy after surgery for rectal cancer versus late reversal. The EASY trial is expected to have a huge impact on patient safety as well as an improvement in patient-reported outcome. Clinical trials identifier NCT01287637.

Establishment of a regional Danish database for patients with a stoma

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.

Translation of Questionnaires Measuring Health Related Quality of Life Is Not Standardized: A Literature Based Research Study

Introduction There is growing awareness of the need to explore patient reported outcomes in clinical trials. In the Scandinavian Surgical Outcomes Research Group we are conducting several clinical trials in cooperation between Danish and Swedish surgical researchers, and we use questionnaires aimed at patients from both countries. In relation to this and similar international cooperation, the validity and reliability of translated questionnaires are central aspects. Main Objectives The purpose of this study was to explore which methodological measures were used in studies reporting translation of questionnaires. Furthermore, we wanted to make some methodological suggestions for clinical researchers who are faced with having to translate a questionnaire. Material and Methods We designed a research study based on a survey of the literature and extracted data from published studies reporting the methodological process when translating questionnaires on health related quality of life for different diseases. Results We retrieved 187 studies and out of theses we included 52 studies. The psychometric properties of the translated versions were validated using different tests. The focus was on internal validity (96%), reliability (67%) criterion validity (81%), and construct validity (62%). For internal validity Cronbachs alpha was used in 94% of the studies. Conclusions This study shows that there seems to be a consensus regarding the translation process (especially for internal validity) although most researchers did not use a translation guide. Moreover, we recommended that clinical researchers should consider three steps covering the process of translation, the qualitative validation as well as the quantitative validation.

A feeling of flow: exploring junior scientists' experiences with dictation of scientific articles.

BackgroundScience involves publishing results, but many scientists do not master this. We introduced dictation as a method of producing a manuscript draft, participating in writing teams and attending a writing retreat to junior scientists in our department. This study aimed to explore the scientists’ experiences with this process.MethodsFour focus group interviews were conducted and comprised all participating scientists (n = 14). Each transcript was transcribed verbatim and coded independently by two interviewers. The coding structure was discussed until consensus and from this the emergent themes were identified.ResultsParticipants were 7 PhD students, 5 scholarship students and 2 clinical research nurses. Three main themes were identified: ‘Preparing and then letting go’ indicated that dictating worked best when properly prepared. ‘The big dictation machine’ described benefits of writing teams when junior scientists got feedback on both content and structure of their papers. ‘Barriers to and drivers for participation’ described flow-like states that participants experienced during the dictation.ConclusionsMotivation and a high level of preparation were pivotal to be able to dictate a full article in one day. The descriptions of flow-like states seemed analogous to the theoretical model of flow which is interesting, as flow is usually deemed a state reserved to skilled experts. Our findings suggest that other academic groups might benefit from using the concept including dictation of manuscripts to encourage participants’ confidence in their writing skills.

Perception of Fatigue Among Surgeons During Night Shifts

It is well known that sleep deprivation induces fatigue and that fatigue induces impaired cognition. Studies have demonstrated that long work hours, restricted sleep, time pressure and high demands may cause impaired performance in physicians. Some studies have shown through laparoscopic simulation that surgeons, when deprived of sleep, take longer to perform the procedure, make more unnecessary movements with their instruments and significantly more mistakes. Surgeons with an opportunity for sleep of less than 6 hours on the previous on-call night shift had an 83% increase in risk of postoperative complications when working the following day.

Constipation is casting a shadow over everyday life – a systematic review on older people's experience of living with constipation

AIMS AND OBJECTIVES To explore and summarise best evidence of how constipation affects the daily living of older people from their own perspective. Furthermore, to assess how interventions aimed at treating constipation in older people affect patient-reported outcome such as quality of life. BACKGROUND Constipation is a common and overlooked problem with an impact on everyday life, especially among older people. Older people seem to have individual preconceptions on constipation which can influence the strategies used to prevent and treat constipation. DESIGN A systematic review, integrating findings from both qualitative and quantitative studies. METHOD Systematic searches were carried out in PubMed, CINAHL, PsycINFO and EMBASE on the 31st of July 2014. A search strategy was constructed with key concepts identified using PICO to identify quantitative studies and PIC(o) to identify qualitative studies. Search terms included constipation, elderly, aged, elderly people, aged people, quality of life, patient experience, patient perspective, meaning, emotion, psychological. Reference lists were searched manually. RESULTS A total of nine studies were included in the review, five quantitative and four qualitative. Three main themes crystallised from the results of the included studies: bodily experiences, everyday life shadowed by constipation and adverse psychological effects. CONCLUSION Constipation among older people was connected to subjective and comprehensive experiences. It had a negative impact on physical and mental well-being as well as the social life of older people. The review also showed that older people had individual and personal strategies, based on their own beliefs. RELEVANCE TO CLINICAL PRACTICE Healthcare professionals need to be aware of the experiences of living with constipation as well as the range of strategies used by patients to prevent and treat constipation. The patient perspective on constipation needs to be integrated in the strategies and actions carried out by healthcare professionals.

Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial)

A temporary ileostomy may reduce symptoms from anastomotic leakage after rectal cancer resection. Earlier results of the EASY trial showed that early closure of the temporary ileostomy was associated with significantly fewer postoperative complications. The aim of the present study was to compare health‐related quality of life (HRQOL) following early versus late closure of a temporary ileostomy.