Reasons for not reaching or using web-based self-management applications, and the use and evaluation of Oncokompas among cancer survivors, in the context of a randomised controlled trial.

INTRODUCTION: The web-based self-management application Oncokompas was developed to support cancer survivors to monitor health-related quality of life and symptoms (Measure) and to provide tailored information (Learn) and supportive care options (Act). In a previously reported randomised controlled trial (RCT), 68% of 655 recruited survivors were eligible, and of those 45% participated in the RCT. Among participants of the RCT that were randomised to the intervention group, 52% used Oncokompas as intended. The aim of this study was to explore reasons for not participating in the RCT, and reasons for not using Oncokompas among non-users, and the use and evaluation of Oncokompas among users. METHODS: Reasons for not participating were assessed with a study-specific questionnaire among 243 survivors who declined participation. Usage was investigated among 320 participants randomised to the intervention group of the RCT via system data and a study-specific questionnaire that was assessed during the 1 week follow-up (T1) assessment. RESULTS: Main reasons for not participating were not interested in participation in scientific research (40%) and not interested in scientific research and Oncokompas (28%). Main reasons for not being interested in Oncokompas were wanting to leave the period of being ill behind (29%), no symptom burden (23%), or lacking internet skills (18%). Out of the 320 participants in the intervention group 167 (52%) used Oncokompas as intended. Among 72 non-users, main reasons for not using Oncokompas were no symptom burden (32%) or lack of time (26%). Among 248 survivors that activated their account, satisfaction and user-friendliness were rated with a 7 (scale 0-10). Within 3 (IQR 1-4) sessions, users selected 32 (IQR 6-37) topics. Main reasons for not using healthcare options in Act were that the information in Learn was already sufficient (44%) or no supportive care needs (32%). DISCUSSION: Main reasons for not reaching or using Oncokompas were no symptom burden, no supportive care needs, or lack of time. Users selected many cancer-generic and tumour-specific topics to address, indicating added value of the wide range of available topics.

Cost-utility of an eHealth application 'Oncokompas' that supports cancer survivors in self-management: results of a randomised controlled trial.

PURPOSE: The eHealth self-management application 'Oncokompas' was developed to support cancer survivors in monitoring health-related quality of life (HRQOL) and symptoms, and obtaining personalized feedback and options for supportive care. The aim of this study was to assess the cost-utility of Oncokompas compared with care as usual (CAU) among cancer survivors. METHODS: Survivors were randomly allocated to the intervention or control group. Direct (non-)medical, indirect non-medical costs, and HRQOL were measured at 3- and 6-month follow-up, using iMTA Medical Consumption and Productivity Costs and the EuroQol-5D questionnaires. Mean cumulative costs and quality-adjusted life-years (QALYs) were compared between both groups. RESULTS: In total, 625 survivors were randomized into intervention (n = 320) or control group (n = 305). Base case analysis showed that incremental costs from a societal perspective were - €163 (95% CI, - 665 to 326), and incremental QALYs were 0.0017 (95% CI, - 0.0121 to 0.0155) in the intervention group compared with those in the control group. The probability that, compared with CAU, Oncokompas is more effective was 60%, less costly 73%, and both more effective and less costly 47%. Sensitivity analyses showed that incremental costs vary between - €40 and €69, and incremental QALYs vary between - 0.0023 and - 0.0057. CONCLUSION: Oncokompas is likely to be equally effective on utilities, and not more expensive than CAU, and will therefore contribute to sustainable cancer survivorship care in a (cost-)effective manner. IMPLICATIONS FOR CANCER SURVIVORS: Oncokompas seems to improve HRQOL and reduces the burden of several tumour-specific symptoms, while costs from a societal perspective are similar to CAU.

The eHealth self-management application 'Oncokompas' that supports cancer survivors to improve health-related quality of life and reduce symptoms: which groups benefit most?

BACKGROUND: Oncokompas is a web-based self-management application that supports cancer survivors to monitor their health-related quality of life (HRQOL) and symptoms, and to obtain personalised feedback and tailored options for supportive care. In a large randomised controlled trial among survivors of head and neck cancer, colorectal cancer, and breast cancer and (non-)Hodgkin lymphoma, Oncokompas proved to improve HRQOL, and to reduce several tumour-specific symptoms. Effect sizes were however small, and no effect was observed on the primary outcome patient activation. Therefore, this study aims to explore which subgroups of cancer survivors may especially benefit from Oncokompas. MATERIALS AND METHODS: Cancer survivors (n = 625) were randomly assigned to the intervention group (access to Oncokompas, n = 320) or control group (6 months waiting list, n = 305). Outcome measures were HRQOL, tumour-specific symptoms, and patient activation. Potential moderators included socio-demographic (sex, age, marital status, education, employment), clinical (tumour type, stage, time since diagnosis, treatment modality, comorbidities), and personal factors (self-efficacy, personal control, health literacy, Internet use), and patient activation, mental adjustment to cancer, HRQOL, symptoms, and need for supportive care, measured at baseline. Linear mixed models were performed to investigate potential moderators. RESULTS: The intervention effect on HRQOL was the largest among cancer survivors with low to moderate self-efficacy, and among those with high personal control and those with high health literacy scores. Cancer survivors with higher baseline symptom scores benefitted more on head and neck (pain in the mouth, social eating, swallowing, coughing, trismus), and colorectal cancer (weight) specific symptoms. DISCUSSION: Oncokompas seems most effective in reducing symptoms in head and neck cancer and colorectal cancer survivors who report a higher burden of tumour-specific symptoms. Oncokompas seems most effective in improving HRQOL in cancer survivors with lower self-efficacy, and in cancer survivors with higher personal control, and higher health literacy.

Effectiveness of routine follow-up in the detection of contralateral breast cancer in young women with early breast cancer.

BACKGROUND: The purpose of the study was to determine the effectiveness of routine follow-up to detect contralateral breast cancer (CBC) in young women. METHODS: We used the data of the population-based Eindhoven Cancer Registry, which covers the southern part of the Netherlands. Between 1988 and 2005, 1451 women aged ≤ 40 years were treated for early-stage breast cancer with breast-conserving treatment or mastectomy. RESULTS: Of the 94 patients who developed CBC 17 had an in situ carcinoma. Fifty-seven CBCs (61%) were diagnosed more than 5 years after the primary tumour. Forty-two CBCs (45%) were detected during routine follow-up visits, while 52 (55%) presented between two visits. Of the CBC diagnosed between two visits, only 27 (60%) were visible on mammography. Of the invasive CBCs more than 25% was larger than 2 cm in diameter and in 34% positive axillary lymph nodes were found. CONCLUSIONS: These figures indicate that routine follow-up does not guarantee early detection of CBC in young women with breast cancer.

No difference between lowest and highest volume hospitals in outcome after colorectal cancer surgery in the southern Netherlands.

AIM: To investigate the quality of surgical colorectal cancer (CRC) care in the southern Netherlands by evaluating differences between the five hospitals with the lowest volume and the five hospitals with the highest volume. METHODS: Patients who underwent resection for primary CRC diagnosed between 2008 and 2011 in southern Netherlands were included (n = 5655). The five hospitals performing <130 resections/year were classified 'low volume'; the five hospitals performing ≥ 130 resections/year 'high volume'. Differences in surgical approach, circumferential resection margins (CRM), anastomotic leakage and 30-day mortality between hospital volumes were analysed using Chi(2) tests. Expected proportions anastomotic leakage and 30-day mortality were calculated using multivariable logistic regression. Crude 3-year survival was calculated using Kaplan-Meier curves. Cox regression was used to discriminate independent risk factors for death. RESULTS: 23% of patients with locally advanced rectal cancer (LARC) diagnosed in a low volume centre was referred to a high volume centre. Patients with colon cancer underwent less laparoscopic surgery and less urgent surgery in low compared to high volume hospitals (10% versus 32%, p < 0.0001, and 8% versus 11%, p = 0.003, respectively). For rectal cancer, rates of abdominoperineal resections versus low anterior resections, and CRM were not associated with hospital volume. Anastomotic leakage, 30-day mortality, and survival did not differ between hospital volumes. CONCLUSION: In southern Netherlands, low volume hospitals deliver similar high quality surgical CRC care as high volume hospitals in terms of CRM, anastomotic leakage and survival, also after adjustment for casemix. However, this excludes LARC since a substantial proportion was referred to high volume hospitals.

Laparoscopically assisted transhiatal resection for malignancies of the distal esophagus.

BACKGROUND: Resection of the esophagus remains the only curative therapy for esophageal cancer. Conventional resections are right-side thoracotomy in combination with laparotomy, gastric tube creation, and the transhiatal approach according to Orringer. This study evaluated laparoscopically assisted transhiatal esophagus resection, which offers perfect visualization of the esophagus during mediastinal dissection without the necessity of a thoracotomy. METHODS: In this study, 25 laparoscopically assisted transhiatal esophagus resections were compared with a historical control group consisting of 20 open transhiatal esophagus resections. RESULTS: Nine laparoscopically assisted resections (36%) were converted to open procedures. The operating time was longer in the laparoscopically assisted group (300 vs 257 min; p < 0.05), but laparoscopically assisted esophagus resection was associated with less blood loss (600 vs 900 ml; p < 0.05) and shorter intensive care unit stay (1 vs 2 days; p < 0.05). There were no differences in morbidity, mortality, and hospital stay. During a shorter follow-up time for the laparoscopic group (17 vs 54 months), 11 patients (44%) in the laparoscopically assisted group and 10 (50%) patients in the open group had recurrence of the disease. CONCLUSIONS: Laparoscopically assisted transhiatal esophagus resection is a safe procedure with important advantages, as compared with the open procedure, such as less blood loss and shorter intensive care unit stay. At this point, the oncologic consequences are not clear.

Anesthesiological hazards during laparoscopic transhiatal esophageal resection: a case control study of the laparoscopic-assisted vs the conventional approach.

BACKGROUND: Interest for minimal invasive approach of esophagus resection is increasing. Today, a minimally invasive transhiatal esophagectomy is possible and is accepted widespread. Since cardiopulmonary changes during laparoscopic dissection of the mediastinum has not been studied yet we assessed the anesthesiological consequences of pneumothorax during laparoscopic mediastinal dissection. METHODS: In this case control study, 25 laparoscopically assisted transhiatal espohagus resections were compared with a control group consisting of 20 open transhiatal esophagus resections. Patient characteristics and intraoperative haemodynamic, respiratory, and ventilatory parameters were assessed. RESULTS: The laparoscopic assisted procedure was performed successfully in 12 of the 20 patients. The duration of the laparoscopic assisted procedure, compared to the open group was significantly longer (p<0.05). Intraoperative blood loss was significantly less in the laparoscopic group (p<0.05). Mediastinal dissection resulted in entry of the pleura in 84% of the open and 93% of the laparoscopic assisted procedure. Carbonedioxide pneumothorax resulted in increased end-tidal CO2)and airway pressure levels and decreased lung compliance. Airway pressure showed a significant difference between the groups (p<0.05). Hemodynamic parameters did not differ between groups significantly. There were no differences in postoperative cardiopulmonary complications. CONCLUSIONS: Laparoscopic assisted transhiatal esophagectomy is a safe procedure and has no increased risk of postoperative cardiopulmonary complications compared to thr conventional approach. The anesthesiologist and the surgeon must be aware of the potential risk of pleural injury to manage cardiopulmonary compromises and minimize complications.

Which children could benefit from additional diagnostic tools in case of suspected appendicitis?

BACKGROUND: New diagnostic tools such as ultrasound scan, computed tomography (CT) scan, and diagnostic laparoscopy, have become available for children with suspected appendicitis but should be reserved for equivocal cases. The aim of this study was to develop a scoring system to identify this subgroup of children. METHODS: Patients from 2 different periods (period 1, 99 consecutive children [group 1] and period 2, 62 consecutive children [group 2] with suspected appendicitis) were prospectively evaluated. Variables predicting appendicitis were obtained from group 1. By means of a regression analysis, a scoring system was created and applied to the patients of group 2. Missed appendicitis and negative appendectomy rates obtained by clinical practice were compared with the results that would have been accomplished based on the scoring system. Thereafter, the scoring system was externally validated in a group of children presented at another hospital (group 3, n = 114). RESULTS: The variables, leukocyte count > or = 10.10(9)/L (2 points); rebound tenderness (2 points); and temperature > or = 38 degrees C (1 point) correlated significantly with appendicitis. The scoring system was used to categorize patients into 3 groups: appendicitis unlikely, doubtful appendicitis, and suspected appendicitis. The specificity and sensitivity of the scoring system were, respectively, 85% and 89%. Applying the scoring system would lead to comparable negative appendectomy rates of 8% versus 6% using clinical judgement and a comparable number of performed laparoscopies (26% v 31%). However, it could lead to a lower missed appendicitis rate (1% v 6%) and a lower perforation rate (0% v 11%). External validation showed comparable performed laparoscopies (32%) and missed appendicitis (2%) rates but a higher negative appendectomy rate (19%), probably owing to a lower percentage of appendicitis in hospital (2, 47%) compared with hospital (1, 71%). CONCLUSIONS: Children can be observed if leukocyte count is less than 10.10(9)/L and rebound tenderness is absent; a diagnostic laparoscopy should be performed if one of these is present, and if both are present one could perform an appendectomy.

Implications of removing a normal appendix.

BACKGROUND: The diagnosis of acute appendicitis remains difficult and therefore 15-30% of the removed appendices appear to be normal. The aim of this study was to investigate morbidity, mortality and costs of removing a normal appendix in patients with suspected appendicitis. PATIENTS AND METHODS: Retrospective study of patients who underwent a negative appendectomy for suspected appendicitis in the period 1991-1999 with a median follow-up of 4.4 years. Patients who underwent an elective appendectomy or appendectomy for other reasons were excluded. RESULTS: In 285 patients (70% women, 30% men) a normal appendix was removed. In 192 (67%) patients a muscle-splitting incision was performed, in 6 (2%) a median laparotomy, and in 51 (18%) the normal appendix was removed by laparoscopy. In 36 patients (13%) a diagnostic laparoscopy was converted to a muscle-splitting incision. Complications occurred in 16 (6%) patients, in 5 (2%) a re-operation was needed. The mean hospital stay was 4.4 (SE 2.8) days, in case of complications 7.4 (SE 4.2) days. The mean extra hospital costs of a negative appendectomy were EUR 2712. CONCLUSION: The removal of a normal appendix has considerable complications and costs. In an attempt to prevent these costs, extra diagnostic tools should be considered. Expensive diagnostic tools such as diagnostic laparoscopy should be used selectively in order not to further increase costs.

Implications of removing a normal appendix.

BACKGROUND: The diagnosis of acute appendicitis remains difficult, and therefore 15-30% of the removed appendices appear to be normal. The aim of this study is to investigate the morbidity, mortality and costs of removing a normal appendix in patients with suspected appendicitis. PATIENTS AND METHODS: A retrospective study was performed on patients who underwent a negative appendectomy for suspected appendicitis in the period 1991-1999 with a median follow-up of 4.4 years. Patients who underwent an elective appendectomy or appendectomy for other reasons were excluded. RESULTS: In 285 patients (70% women, 30% men) a normal appendix was removed. In 192 (67%) patients a muscle-splitting incision was performed, in 6 (2%) a median laparotomy, and in 51 (18%) the normal appendix was removed by laparoscopy. In 36 patients (13%) a diagnostic laparoscopy was converted to a muscle-splitting incision. Complications occurred in 16 (6%) patients, in 5 (2%) a reoperation was needed. The mean hospital stay was 4.4 (SE 2.8) days, in case of complication 7.4 (SE 4.2) days. The mean extra hospital costs of a negative appendectomy were EUR 2,712. CONCLUSION: The removal of a normal appendix has considerable complications and costs. In an attempt to prevent these costs, extra diagnostic tools should be considered. Expensive diagnostic tools as diagnostic laparoscopy should be used selectively in order to not further exceed costs.

A normal appendix found during diagnostic laparoscopy should not be removed.

BACKGROUND: Diagnostic laparoscopy has been introduced as a new diagnostic tool for suspected appendicitis. While the normal appendix used to be removed routinely, laparoscopy allows us to leave a normal looking appendix in place. This latter strategy is, however, not generally accepted. The long-term results of not removing a normal looking appendix were evaluated. METHODS: This was a prospective evaluation of 109 diagnostic laparoscopies for suspected appendicitis in which a normal looking appendix was left in place. After a median follow-up of 4.4 years a telephone questionnaire was performed. RESULTS: There were no false-negative laparoscopies. In 65 patients (60 per cent) another diagnosis was obtained (group 1). In 44 patients (40 per cent) no diagnosis was obtained (group 2). After a median interval of 8 months, 15 patients presented to the emergency department for symptoms possibly involving the appendix, during the median follow-up of 4.4 years. This resulted in readmission of nine patients, of whom eight were reoperated. In only one patient (1 per cent) was a histologically proven appendicitis found and the appendix removed. Some 105 patients were eligible for follow-up. Of the 100 patients interviewed (95 per cent), nine patients (9 per cent) (six in group 1 and three in group 2) still had recurrent pain in the right lower abdominal quadrant. There were no differences between patients with or without another diagnosis obtained during preceding laparoscopy. CONCLUSION: It is safe to leave a normal looking appendix in place when a diagnostic laparoscopy for suspected appendicitis is performed, even if another diagnosis cannot be found at laparoscopy.

Selective use of diagnostic laparoscopy in patients with suspected appendicitis.

BACKGROUND: Diagnostic laparoscopy has been introduced as a new diagnostic tool for patients with acute appendicitis. We performed diagnostic laparoscopy when the clinical diagnosis of appendicitis was in doubt. The aims of this study were to evaluate this strategy and to analyze the efficacy of diagnostic laparoscopy in patients with suspected appendicitis. PATIENTS AND METHODS: All patients referred to our hospital with suspected appendicitis during the period 1994-1997 were evaluated prospectively. The clinical diagnosis was determined by the surgeon or resident on call based on the patient's history, physical examination, and leukocyte count. The patients were divided into three groups: group 1: appendicitis not likely. These patients were observed for 24 h or discharged. When they showed signs of appendicitis in 24 h, they were transferred to either group 2 or 3; group 2: doubt concerning diagnosis. These patients underwent diagnostic laparoscopy, and appendectomy was performed if indicated; group 3: In these patients the diagnosis appendicitis was felt to be certain. They were treated by primary appendectomy by an open procedure. In this study, 1,050 patients, 531 women (51%), 389 men (37%), and 130 children (12%) <11 yrs, were evaluated. RESULTS: Altogether, 377 diagnostic laparoscopies were performed, leaving 109 healthy-looking appendices in place. This reduced the negative appendectomy rate from 25% to 14% in all surgically managed patients. The negative appendectomy rate for the women in group 2 was reduced from 49% to 14%, and for the men from 22% to 11%, so it also seemed worthwhile to perform diagnostic laparoscopy in men. Because the appendix sana was left in place in only three children, the benefit from laparoscopy is relatively small for children. In 48% of these patients a second diagnosis was obtained, most of them gynecologic in nature. There were no false-negative laparoscopies and no complications resulting from the laparoscopic procedure. CONCLUSIONS: Diagnostic laparoscopy is a safe procedure that reduced the appendix sana rate without increasing the total number of operations. It is a useful method for obtaining other, mostly gynecologic, diagnoses. To further reduce the appendix sana rate, better criteria for laparoscopic assessment of the appendix are needed.

Stratification for elective laparoscopic cholecystectomy.

BACKGROUND: In a former retrospective study in our clinic, an improvement in patient care was observed after the introduction of laparoscopic cholecystectomy. The aim of this study was to verify whether this improvement could be maintained or even be further improved. METHODS: Retrospective evaluation of all patients who underwent an elective cholecystectomy due to symptomatic cholelithiasis. We compared the results of 1992, the year of the introduction of laparoscopic cholecystectomy with 1993, the year that laparoscopic cholecystectomy became standard procedure. Also we compared specialized with general surgeons. RESULTS: In comparison with 1992 more elective cholecystectomies were performed in 1993 (162 vs 211). In 1993 there were more primary laparoscopic procedures (86 vs 93%) but due to an increase in conversion rate in 1993 (2.5 vs 10%) the overall number of open procedures remained comparable (17 vs 16%). In 1993 there was an increase in cholecystectomies by general surgeons (56 vs 72%). The general surgeons almost doubled their conversion rate in 1993 (6 vs 13%) while that of the specialized surgeons remained comparable (0 vs 2%). Morbidity and mortality remained comparable between 1992 and 1993 and between specialized and general surgeons. CONCLUSIONS: The quality of patient care has not significantly been altered. An improvement could be made if more laparoscopic operations were performed by specialized surgeons, but this would negatively interfere with the working methods of a general hospital. Therefore we suggest stratification: Certain patients, as high-risk patients, preferably should be operated on by specialized surgeons, while routine operations could be performed by general surgeons.

Lesions of the suprachiasmatic nucleus do not disturb sexual orientation of the adult male rat.

An enlarged suprachiasmatic nucleus (SCN) has been found earlier in a group of homosexual men, as compared to heterosexual controls. In order to assess a possible relationship between the SCN and sexual orientation, the present study was undertaken to investigate whether the rat SCN might play a role with respect to the expression of sexual orientation. Sexual orientation was measured in partner preference tests as the percentage of time spent in the vicinity of sexually active male and female incentives, that were separated from the experimental animal by a wire mesh. The results show that established patterns of sexual orientation towards female incentives by the adult male rat are not influenced by SCN-lesions. Disturbances in circadian rhythmicity of activity in SCN-lesioned animals did not affect this conclusion.