A mixed-methods study to define Textbook Outcome for the treatment of patients with uncomplicated symptomatic gallstone disease with hospital variation analyses in Dutch trial data

Background: International consensus on the ideal outcome for treatment of uncomplicated symptomatic gallstone disease is absent. This mixed-method study defined a Textbook Outcome (TO) for this large group of patients. Methods: First, expert meetings were organised with stakeholders to design the survey and identify possible outcomes. To reach consensus, results from expert meetings were converted in a survey for clinicians and for patients. During the final expert meeting, clinicians and patients discussed survey outcomes and a definitive TO was formulated. Subsequently, TO-rate and hospital variation were analysed in Dutch hospital data from patients with uncomplicated gallstone disease. Results: First expert meetings returned 32 outcomes. Outcomes were distributed in a survey among 830 clinicians from 81 countries and 645 Dutch patients. Consensus-based TO was defined as no more biliary colic, no biliary and surgical complications, and the absence or reduction of abdominal pain. Analysis of individual patient data showed that TO was achieved in 64.2% (1002/1561). Adjusted-TO rates showed modest variation between hospitals (56.6-74.9%). Conclusion: TO for treatment of uncomplicated gallstone disease was defined as no more biliary colic, no biliary and surgical complications, and absence or reduction of abdominal pain.TO may optimise consistent outcome reporting in care and guidelines for treating uncomplicated gallstone disease

The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique

<p>Abstract</p> <p>Background</p> <p>Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain.</p> <p>Methods</p> <p>The TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia repair according to Lichtenstein or the transinguinal preperitoneal technique with soft mesh. All unilateral primary inguinal hernia patients eligible for operation who meet inclusion criteria will be invited to participate in this trial. The primary endpoint will be direct postoperative- and chronic pain. Secondary endpoints are operation time, postoperative complications, hospital stay, costs, return to daily activities (e.g. work) and recurrence. Both groups will be evaluated.</p> <p>Success rate of hernia repair and complications will be measured as safeguard for quality.</p> <p>To demonstrate that inguinal hernia repair according to the transinguinal preperitoneal (TIPP) technique reduces postoperative pain to <10%, with α = 0,05 and power 80%, a total sample size of 300 patients was calculated.</p> <p>Discussion</p> <p>The TULIP trial is aimed to show a reduction in postoperative chronic pain after anterior hernia repair according to the transinguinal preperitoneal (TIPP) technique, compared to Lichtenstein.</p> <p>In our hypothesis the TIPP technique reduces chronic pain compared to Lichtenstein.</p> <p>Trial registration</p> <p>ISRCTN 93798494</p

Sexual function and continence after ileo pouch anal anastomosis:a comparison between a meta-analysis and a questionnaire survey

Background and aims. Ileo pouch anal anastomosis (IPAA) is the standard restorative procedure for patients with ulcerative colitis and familial adenomatous polyposis, but its pros and cons have not been explored in depth. This study analyzed the long-term complications such as incontinence and sexual dysfunction after IPAA. Patients and methods. Netherlands Society for Crohn's disease and Ulcerative Colitis) A questionnaire on complications, sexual dysfunction, and continence was sent to all 137 members of the Netherlands Society for Crohn's disease and Ulcerative Colitis who had IPAA; the questionnaire was returned by 111. Results of the questionnaire were compared with those of a meta-analysis on pooled incidences of complications after IPAA, as previously performed and reported. Results. Pelvic sepsis was reported by 15.3% of respondents. The reported incidence of sexual dysfunction (19.8%), passive incontinence (23.4%), and soiling (39.3%) was significantly higher than that in the meta-analysis. Nevertheless, 90% of the population was satisfied with the results of the IPAA. Conclusion. This study underlines that the operation itself, freeing patients of their disease, provides the major satisfaction and improvement of quality of life, even when patients have pouch-related complications such as sexual dysfunction and some degree of fecal incontinence.</p

Sexual function and continence after ileo pouch anal anastomosis: a comparison between a meta-analysis and a questionnaire survey

Background and aims. Ileo pouch anal anastomosis (IPAA) is the standard restorative procedure for patients with ulcerative colitis and familial adenomatous polyposis, but its pros and cons have not been explored in depth. This study analyzed the long-term complications such as incontinence and sexual dysfunction after IPAA. Patients and methods. Netherlands Society for Crohn's disease and Ulcerative Colitis) A questionnaire on complications, sexual dysfunction, and continence was sent to all 137 members of the Netherlands Society for Crohn's disease and Ulcerative Colitis who had IPAA; the questionnaire was returned by 111. Results of the questionnaire were compared with those of a meta-analysis on pooled incidences of complications after IPAA, as previously performed and reported. Results. Pelvic sepsis was reported by 15.3% of respondents. The reported incidence of sexual dysfunction (19.8%), passive incontinence (23.4%), and soiling (39.3%) was significantly higher than that in the meta-analysis. Nevertheless, 90% of the population was satisfied with the results of the IPAA. Conclusion. This study underlines that the operation itself, freeing patients of their disease, provides the major satisfaction and improvement of quality of life, even when patients have pouch-related complications such as sexual dysfunction and some degree of fecal incontinence

A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial

Angelien Sieben,1 Hein AW van Onzenoort,2,3 Sandra van Dulmen,4&ndash;6 CJHM van Laarhoven,7 Sebastian JH Bredie81Department of Surgery, Division of Vascular Surgery, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands; 2Department of Clinical Pharmacy, Amphia Hospital, Breda, the Netherlands; 3Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Center+, Maastricht, the Netherlands; 4Department of Primary and Community Care, Radboud University Medical Center, Nijmegen, the Netherlands; 5NIVEL (Netherlands institute for health services research), Utrecht, the Netherlands; 6Faculty of Health and Social Sciences, University of South-Eastern Norway, Drammen, Norway; 7Department of General Surgery, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands; 8Department of General Internal Medicine, Division of Vascular Medicine, Radboud University Medical Center, Nijmegen, the NetherlandsBackground: Poor medication adherence is a limitation in the secondary prevention of cardiovascular diseases (CVDs) and leads to increased morbidity, mortality, and costs.Purpose: To examine the process and effect of a nurse-led, web-based intervention based on behavioral change strategies to improve medication adherence in patients with CVD.Patients and methods: In this single-center, prospective, controlled clinical trial, cardiovascular patients were assigned to usual care, usual care plus a personalized website, or usual care plus a personalized website and personal consultations. Primary outcome was the level of adherence to cardiovascular medication. Data collection occurred between October 2011 and January 2015.Results: In total, 419 patients were randomized. Just 77 patients logged on the website and half of the invited patients attended the group consultation. Due to the limited use of the website, we combined the results of usual care and the usual care plus website group in one group (usual care) and compared these with the results of the group which received the nurse intervention (intervention group). No significant difference in adherence between the usual care group and the intervention group was observed. The adherence level in the usual care group was 93%, compared to 89% in the intervention group (p=0.08). 29% (usual care) and 31% (intervention group) of the patients showed a low adherence according to the Modified Morisky Scale&reg; (p-value=0.94). The mean necessity concern differential was 3.8 with no differences between the two studied groups (mean 3.8 vs mean 3.9, p-value =0.86).Conclusion: Our intervention program did not show an effect. This could indicate that structured usual care provided to all cardiovascular patients already results in high medication adherence or that shortly after a cardiovascular event adherence is high. It could also indicate that the program did not have enough impact because there was not enough compliance with the intervention protocol.Trial registration: ID number NCT01449695, approved May 2011.Keywords: medication adherence, nurses, e-health, Health Belief Model, cardiovascula