Dan Med Bull
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Randomized Controlled Trial Multicenter Study
Pain and convalescence following laparoscopic ventral hernia repair.
Severe pain is usual after laparoscopic ventral hernia repair (LVHR). Mesh fixation with titanium tacks may play a key role in the development of acute and chronic pain and alternative fixation methods should therefore be investigated. This PhD thesis was based on three studies and aimed too: 1) assess the intensity and impact of postoperative pain by detailed patient-reported description of pain and convalescence after LVHR (Study I), 2) evaluate the feasibility of fibrin sealant (FS) for mesh fixation in an experimental pig model (Study II), and 3) investigate FS vs. tacks for mesh fixation in LVHR in a randomised, double-blinded, clinical controlled study with acute postoperative pain as the primary outcome (Study III). ⋯ It is now documented, that the simple application of fibrin glue instead of titanium tacks for mesh fixation in LVHR of defects < 5 cm significantly reduced acute pain, discomfort and the period of convalescence. Long-term follow-up will show the value of FS fixation in terms of chronic pain and recurrence. As FS potentially may solve many of the outcome problems associated with LVHR, future studies should include larger hernia defects including large incisional hernias, as the operative technique may be different.
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Although patient-centred communication has provided a focus point in health care for many years, patient surveys continuously reveal serious communication problems as experienced by patients, due to poor communication. Likewise, poor inter-collegial communication can cause problems for both health care staff and patients. So, knowing that patient-centred communication and good inter-collegial communication is for the benefit of both health professionals and patients, the relevance of improving health care professionals' communication skills and investigating the effect on both professionals and patients is beyond doubt. ⋯ The study has shown that a communication skills training course can improve health care professionals' self-efficacy in communication with both patients and colleagues and also improve inter-collegial communication. The focus group interviews showed that the most essential experiences of change were more confident communication with patients and colleagues and an increased patient-centredness. Furthermore, the study has shown a significant increase in patient satisfaction concerning information, continuity and care after the training course for health care professionals.
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Percutaneous dilatational tracheostomy is a common procedure in intensive care. This guideline from the Danish Society of Intensive Care Medicine (DSIT) and the Danish Society of Anesthesiology and Intensive Care Medicine (DASAIM) describes indications and contraindications, timing, complications compared to surgical tracheostomy, anaesthesia and technique, decannulation strategy, as well as training and education.
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The clinical epidemiological studies included in this thesis fall into three parts. The first part includes studies on birth outcome in women with ulcerative colitis. The second part includes pharmacoepidemiological studies on birth outcome after anti-inflammatory drug therapy in pregnancy, including patients with ulcerative colitis and Crohn's disease. ⋯ Some residual confounding by disease activity may have been left in the analyses of preterm birth. In Crohn's disease women with disease activity during pregnancy our data suggest: 1) A significantly increased relative risk of preterm birth in women with the highest degree of disease activity during pregnancy. 2) Disease activity does not seem to increase the risk of low birth weight, intrauterine growth retardation or congenital abnormalities. This study is the first epidemiological study of the risk of adverse birth outcomes in Crohn's disease women with disease activity during pregnancy, compared to women with no activity during pregnancy, and in which confounders have been taken into consideration. Exceeding the studies included in my previous PhD thesis, this thesis provides new evidence on the following subjects: i) the risk of selected congenital abnormalities in children of women with ulcerative colitis, ii) pharmacoepidemiological studies on the risk of adverse birth outcome after maternal azathioprine/6-mercaptopurine exposure in pregnancy, and the risk of congenital abnormalities in children fathered by men treated with azathioprine/6-mercaptopurine before conception, iii) the risk of adverse birth outcome in women with Crohn's disease according to type of anti-inflammatory drug treatment in pregnancy (sulfasalazine/5-aminosalicylic acid, steroids or azathioprine/6-mercaptopurine), and iv) the impact of disease activity in women with Crohn's disease on adverse birth outcome. We learned from the studies in this thesis that the traditional way of reporting birth outcome in women with chronic inflammatory bowel disease, i.e. without having valid information on the type of underlying disease, concurrent therapeutic drug treatment and disease activity, is of limited value. The studies show that the risk of specific adverse birth outcome in women with ulcerative colitis and Crohn's disease depends on several factors including the time of birth in relation the début of disease, the type of underlying disease (ulcerative colitis or Crohn's disease), the type of anti-inflammatory drug treatment during pregnancy, and the degree of disease activity during pregnancy. At the same time one also has to realize that the existing evidence is still limited, especially in the field of reproductive safety after therapeutic drug treatment during pregnancy and possible effects of preconceptional therapeutic drug exposure.
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The main aim of the thesis was to evaluate the impact of modern treatment strategies on disease activity and disease course in patients with rheumatoid arthritis (RA), and to identify predictors for treatment response. Two different treatment strategies were investigated: (A) Aggressive, conventional treatment aiming at achieving inflammatory control in patients with recent-onset RA and (B) Treatment with tumour necrosis factor alpha (TNFα) inhibitors in patients with RA, who had an incomplete response to conventional treatment. (A) was studied in a randomized, placebo-controlled clinical trial (CIMESTRA), whereas (B) was investigated in an observational, nationwide cohort study (the DANBIO database). The main findings were: 1. ⋯ TNFα inhibitors were efficacious in clinical practice in the treatment of RA patients that had failed conventional treatment. Differences between the TNFα inhibitors regarding efficacy and drug adherence were found. Predictors of disease course and treatment response were identified.