Predictors and moderators of burden of care and emotional distress in first-episode psychosis caregivers: results from the GET UP pragmatic cluster randomised controlled trial.

AIMS: First-episode psychosis (FEP) is a major life event and can have an adverse impact on the diagnosed individual and their families. The importance of intervening early and providing optimal treatments is widely acknowledged. In comparison to patient groups, literature is scarce on identifying treatment predictors and moderators of caregiver outcomes. This study aimed to identify pre-treatment characteristics predicting and/or moderating carer outcomes, based on data from a multi-element psychosocial intervention to FEP patients and carers (GET-UP PIANO trial). METHODS: Carer demography, type of family relationship, patient contact hours, pre-treatment carer burden, patient perceptions of parental caregiving and expressed emotion (EE) were selected, a priori, as potential predictors/moderators of carer burden and emotional distress at 9 months post treatment. Outcomes were analysed separately in mixed-effects random regression models. RESULTS: Analyses were performed on 260 carers. Only patient perceptions of early maternal criticism predicted reports of lower carer burden at follow-up. However, multiple imputation analysis failed to confirm this result. For treatment moderators: higher levels of carer burden at baseline yielded greater reductions in carer emotional distress at follow-up in the experimental group compared with treatment as usual (TAU). Higher levels of perceived EE moderated greater reductions in carer reports of tension in experimental group, compared with TAU, at follow-up. In younger caregivers (<51 years old), there were greater reductions in levels of worry during the baseline to follow-up period, within the experimental group compared with TAU. CONCLUSION: The study failed to identify significant treatment predictors of FEP carer outcomes. However, our preliminary findings suggest that optimal treatment outcomes for carers at first episode might be moderated by younger carer age, and carers reporting higher baseline levels of burden, and where patients perceive higher levels of negative effect from caregivers.

[Authorisation procedures could be simpler]. / Toestemmingsprocedures kunnen eenvoudiger.

Increasing numbers of trials involving human subjects are being conducted at several centres simultaneously in the Netherlands. This multicentre research is, however, unnecessarily hampered by the major variation in procedures, processing times and costs of obtaining authorisation in each individual centre, even though it would not be difficult to streamline these essentially simple procedures and make them more transparent and cheaper.

Surveillance in patients with long-segment Barrett's oesophagus: a cost-effectiveness analysis.

OBJECTIVE: Surveillance is recommended for Barrett's oesophagus (BO) to detect early oesophageal adenocarcinoma (OAC). The aim of this study was to evaluate the cost-effectiveness of surveillance. DESIGN: We included 714 patients with long-segment BO in a multicentre prospective cohort study and used a multistate Markov model to calculate progression rates from no dysplasia (ND) to low-grade dysplasia (LGD), high-grade dysplasia (HGD) and OAC. Progression rates were incorporated in a decision-analytic model, including costs and quality of life data. We evaluated different surveillance intervals for ND and LGD, endoscopic mucosal resection (EMR), radiofrequency ablation (RFA) and oesophagectomy for HGD or early OAC and oesophagectomy for advanced OAC. The incremental cost-effectiveness ratio (ICER) was calculated in costs per quality-adjusted life-year (QALY). RESULTS: The annual progression rate was 2% for ND to LGD, 4% for LGD to HGD or early OAC and 25% for HGD or early OAC to advanced OAC. Surveillance every 5 or 4 years with RFA for HGD or early OAC and oesophagectomy for advanced OAC had ICERs of €5.283 and €62.619 per QALY for ND. Surveillance every five to one year had ICERs of €4.922, €30.067, €32.531, €41.499 and €75.601 per QALY for LGD. EMR prior to RFA was slightly more expensive, but important for tumour staging. CONCLUSIONS: Based on a Dutch healthcare perspective and assuming a willingness-to-pay threshold of €35.000 per QALY, surveillance with EMR and RFA for HGD or early OAC, and oesophagectomy for advanced OAC is cost-effective every 5 years for ND and every 3 years for LGD.

Optimal resource allocation in colonoscopy: timing of follow-up colonoscopies in relation to adenoma detection rates.

BACKGROUND AND STUDY AIMS: The assessment of indications for follow-up colonoscopy may help to improve the allocation of available endoscopy resources. The aim of this study was to assess the timing of early follow-up colonoscopy and surveillance utilization in relation to adenoma detection rate (ADR) at follow-up. METHODS: An assessment of the timing and yield of follow-up colonoscopies was performed in patients with non-inflammatory bowel disease (IBD) in a Dutch multicenter study. The primary outcome was the number of patients with a prior (index) colonoscopy. The necessity for follow-up procedures was assessed using the ADR. RESULTS: Of 4800 consecutive patients undergoing a colonoscopy, 1249 non-IBD patients had undergone an index colonoscopy. Of these, follow-up procedures were performed within 1 year in 27 % (331/1249). Excluding incomplete colonoscopy, incomplete polypectomy, or poor bowel preparation on index, the ADR on early follow-up was 4 % for symptomatic and 26 % for asymptomatic patients. Among the asymptomatic patients with a follow-up colonoscopy at > 1 year (n = 463), an ADR of 23 % (108/463) was found. In 27 % of these patients, the observed surveillance intervals were in accordance with American Gastroenterological Association (AGA) surveillance recommendations; 60 % were classified as over-utilization and 13 % as under-utilization according to the AGA. Optimal utilization follow-up colonoscopies had higher ADRs on follow-up compared with over-utilized procedures (31 % vs. 17 %; P < 0.001). CONCLUSIONS: Follow-up colonoscopy in symptomatic patients within a year has limited value in terms of adenoma detection. A considerable proportion of surveillance colonoscopies are performed too early according to current guidelines, resulting in low detection rates. Both aspects can be targeted for optimal usage in endoscopic capacity.

Unit costs in population-based colorectal cancer screening using CT colonography performed in university hospitals in The Netherlands.

OBJECTIVES: Computed tomography (CT) colonography cost assumptions so far ranged from 346 to 594 per procedure, based on clinical CT reimbursement rates. The aim of our study was to estimate the costs in a screening situation. METHODS: Data were collected within an invitational population-based CRC screening trial (n = 2,920, age 50-75 years) with a dedicated CT-screening setting. Unit costs were calculated per action, per invitee and per participant (depending on adherence) and per individual with detected advanced neoplasia. Sensitivity analyses were performed, and alternative scenarios were considered. RESULTS: Of the invitees, 47.2 % were reminded, 38.8 % scheduled for an intake, 37.2 % scheduled for CT colonography, 33.6 % underwent CT colonography and 1.1 % needed a re-examination. Lesions ≥ 10 mm were detected in 2.9 % of the invitees. Invitation costs were Euro 5.57. Costs per CT colonography (intake to results) were Euro 144.00. Extra costs of communication of positive results were Euro 9.00. Average costs of invitational-based CT colonography screening were Euro 56.97 per invitee, Euro 169.40 per participant and Euro 2,772.51 per individual with detected advanced neoplasia. CONCLUSIONS: Dutch costs of CT-screening were substantially lower than the cost assumptions that were used in published cost-effectiveness analyses on CT colonography screening. This finding indicates that previous cost-effectiveness analyses should be updated, at least for the Dutch situation.

Management of precancerous conditions and lesions in the stomach (MAPS): guideline from the European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter Study Group (EHSG), European Society of Pathology (ESP), and the Sociedade Portuguesa de Endoscopia Digestiva (SPED).

Atrophic gastritis, intestinal metaplasia, and epithelial dysplasia of the stomach are common and are associated with an increased risk for gastric cancer. In the absence of guidelines, there is wide disparity in the management of patients with these premalignant conditions. The European Society of Gastrointestinal Endoscopy (ESGE), the European Helicobacter Study Group (EHSG), the European Society of Pathology (ESP) and the Sociedade Portuguesa de Endoscopia Digestiva (SPED) have therefore combined efforts to develop evidence-based guidelines on the management of patients with precancerous conditions and lesions of the stomach (termed MAPS). A multidisciplinary group of 63 experts from 24 countries developed these recommendations by means of repeat online voting and a meeting in June 2011 in Porto, Portugal. The recommendations emphasize the increased cancer risk in patients with gastric atrophy and metaplasia, and the need for adequate staging in the case of high grade dysplasia, and they focus on treatment and surveillance indications and methods.

Family interventions in early psychosis: specificity and effectiveness.

The first episode of psychosis frequently occurs during adolescence and early adulthood, and is associated with high levels of trauma, affective disturbance and suicide. The social networks of service users often decrease significantly following the first onset, although many will remain in close contact with some family members particularly during the early phases. However, the negative impact of psychosis on families and their relationship with the identified service user are well documented. Family intervention is a recommended and evidence-based treatment in later psychosis. In this paper, we review the literature on family interventions in early psychosis in the context of new evidence for its efficacy and its routine incorporation in early intervention services for psychosis.

Screening for colorectal cancer: comparison of perceived test burden of guaiac-based faecal occult blood test, faecal immunochemical test and flexible sigmoidoscopy.

BACKGROUND: Perceived burden of colorectal cancer (CRC) screening is an important determinant of participation in subsequent screening rounds and therefore crucial for the effectiveness of a screening programme. This study determined differences in perceived burden and willingness to return for a second screening round among participants of a randomised population-based trial comparing a guaiac-based faecal occult blood test (gFOBT), a faecal immunochemical test (FIT) and flexible sigmoidoscopy (FS) screening. METHODS: A representative sample of the Dutch population (aged 50-74years) was randomised to be invited for gFOBT, FIT and FS screening. A random sample of participants of each group was asked to complete a questionnaire about test burden and willingness to return for CRC screening. RESULTS: In total 402/481 (84%) gFOBT, 530/659 (80%) FIT and 852/1124 (76%) FS screenees returned the questionnaire. The test was reported as burdensome by 2.5% of gFOBT, 1.4% of FIT and 12.9% of FS screenees (comparing gFOBT versus FIT p=0.05; versus FS p<0.001). In total 94.1% of gFOBT, 94.0% of FIT and 83.8% of FS screenees were willing to attend successive screening rounds (comparing gFOBT versus FIT p=0.84; versus FS p<0.001). Women reported more burden during FS screening than men (18.2% versus 7.7%; p<0.001). CONCLUSIONS: FIT slightly outperforms gFOBT with a lower level of reported discomfort and overall burden. Both FOBTs are better accepted than FS screening. All three tests have a high level of acceptance, which may affect uptake of subsequent screening rounds and should be taken into consideration before implementing a CRC screening programme.

Cost comparison of gastrojejunostomy versus duodenal stent placement for malignant gastric outlet obstruction.

BACKGROUND: Gastrojejunostomy (GJJ) and stent placement are the most commonly used palliative treatments for malignant gastric outlet obstruction (GOO). In a recent randomized trial, stent placement was preferred in patients with a relatively short survival and GJJ in patients with a longer survival. As health economic aspects have only been studied in general terms, we estimated the cost of GJJ and that of stent placement in such patients. METHODS: In the SUSTENT study, patients were randomized to GJJ (n = 18) or stent placement (n = 21). Pancreatic cancer was the most common cause of GOO. We compared initial costs and costs during follow-up. For cost-effectiveness, the incremental cost-effectiveness ratio was calculated. RESULTS: Food intake improved more rapidly after stent placement than after GJJ, but long-term relief of obstructive symptoms was better after GJJ. More major complications (P = 0.02) occurred and more reinterventions were performed (P < 0.01) after stent placement than after GJJ. Initial costs were higher for GJJ compared to stent placement (euro8315 vs. euro4820, P < 0.001). We found no difference in follow-up costs. Total costs per patient were higher for GJJ compared to stent placement (euro12433 vs. euro8819, P = 0.049). The incremental cost-effectiveness ratio of GJJ compared to stent placement was euro164 per extra day with a gastric outlet obstruction scoring system (GOOSS) >or=2 adjusted for survival. CONCLUSIONS: Medical effects were better after GJJ, although GJJ had higher total costs. Since the cost difference between the two treatments was only small, cost should not play a predominant role when deciding on the type of treatment assigned to patients with malignant GOO (ISRCTN 06702358).

A cost-benefit analysis of endoscopy reporting methods: handwritten, dictated and computerized.

BACKGROUND AND STUDY AIMS: Gastrointestinal endoscopy investigations are frequently requested by gastroenterologists, general practitioners and other physicians. In addition to the classic methods of report writing, several electronic endoscopic report systems are currently available. The aim of the study was to evaluate the costs of three different ways of producing reports; by hand, by dictation, or by computer. METHODS: Three methods of report writing were compared, with special attention to costs. The endoscopy process was analyzed, from arrival of the patient to sending the report to the referring doctor, and including production of endoscopic images or video, logging of used endoscopes and their disinfection, and storage costs for endoscopy data. RESULTS: During the first 5 years, the mean costs per procedure were Euro 4.78 for handwritten, Euro 6.39 for dictated and Euro 8.90 for computerized reports. Due to depreciation, after this initial period, the respective costs declined to Euro 4.37, Euro 5.20 and Euro 5.13, respectively. Despite high initial costs, a cost-benefit analysis already revealed a financial benefit from a computerized system after 3 years. CONCLUSIONS: The electronic production of an endoscopic report turned out to be the most expensive way of report writing during the first 5 years, due to high initial costs. After 5 years the costs of the different systems were comparable with each other. Cost-benefit analysis showed a positive financial benefit for computerized reports after 3 years.

Nurse-led follow-up of patients after oesophageal or gastric cardia cancer surgery: a randomised trial.

Between January 2004 and February 2006, 109 patients after intentionally curative surgery for oesophageal or gastric cardia cancer were randomised to standard follow-up of surgeons at the outpatient clinic (standard follow-up; n=55) or by regular home visits of a specialist nurse (nurse-led follow-up; n=54). Longitudinal data on generic (EuroQuol-5D, European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30) and disease-specific quality of life (EORTC QLQ-OES18), patient satisfaction and costs were collected at baseline and at 6 weeks and 4, 7 and 13 months afterwards. We found largely similar quality-of-life scores in the two follow-up groups over time. At 4 and 7 months, slightly more improvement on the EQ-VAS was noted in the nurse-led compared with the standard follow-up group (P=0.13 and 0.12, respectively). Small differences were also found in patient satisfaction between the two groups (P=0.14), with spouses being more satisfied with nurse-led follow-up (P=0.03). No differences were found in most medical outcomes. However, body weight of patients of the standard follow-up group deteriorated slightly (P=0.04), whereas body weight of patients of the nurse-led follow-up group remained stable. Medical costs were lower in the nurse-led follow-up group (2600 euro vs 3800 euro), however, due to the large variation between patients, this was not statistically significant (P=0.11). A cost effectiveness acceptability curve showed that the probability of being cost effective for costs per one point gain in general quality-of-life exceeded 90 and 75% after 4 and 13 months of follow-up, respectively. Nurse-led follow-up at home does not adversely affect quality of life or satisfaction of patients compared with standard follow-up by clinicians at the outpatient clinic. This type of care is very likely to be more cost effective than physician-led follow-up.

Gastro-oesophageal reflux, medical resource utilization and upper gastrointestinal endoscopy in patients at risk of oesophageal adenocarcinoma.

BACKGROUND: Early identification of patients at risk of oesophageal adenocarcinoma (OAC) might improve survival. AIM: To assess the medical resource utilization in the 3 years before OAC diagnosis as potential markers for early identification and intervention. METHODS: We identified 65 incident OAC within the Integrated Primary Care Information database. For comparison, we randomly selected 260 age- and gender-matched population controls. We abstracted the use of gastric acid inhibitors, general practitioner (GP) and specialist care, and gastroscopies in the 3 years before the detection of OAC. RESULTS: Approximately 20% of the cases used gastric acid inhibitors in the third and second year before OAC, which increased to almost 50% in the last year, compared to approximately 10% among controls. Only in the 6 months before OAC, the proportion of patients visiting a GP (97%) or specialist (41%) increased compared to controls. Of 13 gastroscopies performed in the 3 years, six (46%) were not suspect for a malignancy. CONCLUSIONS: Only a minority of all OAC patients used acid inhibitors before diagnosis. The use of medical care between cases and controls differed only in the final year before OAC diagnosis. Detection of early neoplastic changes proves to be difficult.

Detection of distant metastases in patients with oesophageal or gastric cardia cancer: a diagnostic decision analysis.

Computed tomography (CT) is presently a standard procedure for the detection of distant metastases in patients with oesophageal or gastric cardia cancer. We aimed to determine the additional diagnostic value of alternative staging investigations. We included 569 oesophageal or gastric cardia cancer patients who had undergone CT neck/thorax/abdomen, ultrasound (US) abdomen, US neck, endoscopic ultrasonography (EUS), and/or chest X-ray for staging. Sensitivity and specificity were first determined at an organ level (results of investigations, i.e., CT, US abdomen, US neck, EUS, and chest X-ray, per organ), and then at a patient level (results for combinations of investigations), considering that the detection of distant metastases is a contraindication to surgery. For this, we compared three strategies for each organ: CT alone, CT plus another investigation if CT was negative for metastases (one-positive scenario), and CT plus another investigation if CT was positive, but requiring that both were positive for a final positive result (two-positive scenario). In addition, costs, life expectancy and quality adjusted life years (QALYs) were compared between different diagnostic strategies. CT showed sensitivities for detecting metastases in celiac lymph nodes, liver and lung of 69, 73, and 90%, respectively, which was higher than the sensitivities of US abdomen (44% for celiac lymph nodes and 65% for liver metastases), EUS (38% for celiac lymph nodes), and chest X-ray (68% for lung metastases). In contrast, US neck showed a higher sensitivity for the detection of malignant supraclavicular lymph nodes than CT (85 vs 28%). At a patient level, sensitivity for detecting distant metastases was 66% and specificity was 95% if only CT was performed. A higher sensitivity (86%) was achieved when US neck was added to CT (one-positive scenario), at the same specificity (95%). This strategy resulted in lower costs compared to CT only, at an almost similar (quality adjusted) life expectancy. Slightly higher specificities (97-99%) were achieved if liver and/or lung metastases found on CT, were confirmed by US abdomen or chest X-ray, respectively (two-positive scenario). These strategies had only slightly higher QALYs, but substantially higher costs. The combination of CT neck/thorax/abdomen and US neck was most cost-effective for the detection of metastases in patients with oesophageal or gastric cardia cancer, whereas the performance of CT only had a lower sensitivity for metastases detection and higher costs. The role of EUS seems limited, which may be due to the low number of M1b celiac lymph nodes detected in this series. It remains to be determined whether the application of positron emission tomography will further increase sensitivities and specificities of metastases detection without jeopardising costs and QALYs.

Population screening for colorectal cancer: faeces, endoscopes or X-rays?

Colorectal carcinoma (CRC) is a common cancer and the second most common cause of death. The therapeutic costs for this disease will continue to rise due to an increasing incidence and the introduction of new chemotherapeutic modalities. Colorectal carcinoma is preceded by precursor lesions, which can be used as a target for early detection and therapy. Biennial population screening with faecal occult blood tests (FOBT) lowers CRC mortality with 14-18%. Five year screening with flexible sigmoidoscopy is a cost-effective alternative, which yields a higher preventive effect when similar participation rates are achieved. Screening colonoscopy has the advantage of examination of the complete colon but disadvantages are the high participant burden and the higher demand for endoscopic personnel and endoscopy units. Future screening modalities like faecal DNA markers and CT colonography are promising but need further improvement. In Europe, faecal occult blood testing and flexible sigmoidoscopy are currently the most suitable screening modalities for colorectal cancer screening.

The role of socio-economic status in the decision making on diagnosis and treatment of oesophageal cancer in The Netherlands.

In the United States (USA), a correlation has been demonstrated between socio-economic status (SES) of patients on the one hand, and tumour histology, stage of the disease and treatment modality of various cancer types on the other hand. It is unknown whether such correlations are also involved in patients with oesophageal cancer in The Netherlands. Between 1994 and 2003, 888 oesophageal cancer patients were included in a prospective database with findings on the diagnostic work-up and treatment of oesophageal cancer. Socio-economic status of patients was defined as the average net yearly income. Linear-by-linear association testing revealed that oesophageal adenocarcinoma was more frequently observed in patients with higher SES and squamous cell carcinoma in patients with lower SES (P=0.02). Multivariable logistic regression analysis showed no correlation between SES and staging procedures and preoperative TNM stage. The adjusted odds ratio (OR) for stent placement was 0.82 (95% CI 0.71-0.95), indicating that with an increase in SES by 1200 [euro], the likelihood that a stent was placed declined by 18%. Patients with a higher SES more frequently underwent resection or were treated with chemotherapy (OR: 1.15; 95% CI 1.01-1.32 and OR: 1.16; 95% CI 1.02-1.32, respectively). Socio-economic factors are involved in oesophageal cancer in The Netherlands, as patients with a higher SES are more likely to have an adenocarcinoma and patients with a lower SES a squamous cell carcinoma. Moreover, the correlations between SES and different treatment modalities suggest that both patient and doctor determinants contribute to the decision on the most optimal treatment modality in patients with oesophageal cancer.

[Chronic diarrhoea: the importance of an accurate medical history]. / Chronische diarree; het belang van de anamnese.

Four patients, two women aged 29 and 42 years and two men aged 45 and 34 years, with longstanding complaints of (watery) diarrhoea were referred for a second opinion after extensive and costly analysis, including numerous examinations. An accurate medical history revealed deviant food patterns with abundant intake of coffee and sugar or sugar-containing products like cola or sweeteners in all four patients. Coffee (and caffeine) has a stimulating effect on both intestinal motility and net secretion, possibly leading to diarrhoea. Over-consumption of sugars and sweeteners (sometimes added to medication) can also cause osmotic diarrhoea. In all four patients, dietary advice was sufficient to resolve the diarrhoea, thus emphasizing once more the importance of an accurate and complete medical history.

Video capsule endoscopy: procedure, indications and diagnostic yield.

Video capsule endoscopy (VCE) is a new noninvasive imaging technique for the complete small bowel. It provides good to excellent visualisation of the mucosa of the small bowel and has a high diagnostic yield in selected patients with gastrointestinal blood loss of suspected small bowel origin and in patients with Crohn's disease. In comparison with small bowel X-ray and push enteroscopy, diagnostic yield appears to be superior. Although VCE is becoming increasingly popular, good studies on its clinical implications and application are only just emerging. In this paper we review the possibilities and limitations of clinical application of VCE.

Expressed emotion at first-episode psychosis: investigating a carer appraisal model.

BACKGROUND: Even at the first episode of psychosis, high expressed emotion (EE) characterises over half of patient-carer relationships. This study compared a carer appraisal model of EE with the ability of illness factors to predict EE at the first episode. AIMS: To investigate the utility of a carer appraisal model of EE in first-episode psychosis. METHOD: We compared high- and low-EE carers of people who had first-episode psychosis (n=46). RESULTS: High EE in carers was associated with higher avoidant coping, higher subjective burden and lower perceived patient interpersonal functioning. Patient illness factors and carers' distress levels were not associated with EE. CONCLUSIONS: Even at the first episode, carers' psychological appraisal, not patient illness factors, is influential in determining high EE. Carers' appraisal of their situation should be a primary target to lower or prevent high EE in early intervention for psychosis.

An exploratory randomised controlled trial of a support programme for carers of patients with a psychosis.

BACKGROUND: Despite an acknowledgement of the impact of serious mental disorders on informal caregivers, we still know little about how to best help them. The aim of the study was to evaluate the effectiveness of a two-phased carers' intervention comprising family sessions followed by relatives' groups. This intervention was designed to be of 'intermediate' intensity, that is,one lying between brief educational programmes and long-term family psychoeducational treatments. METHODS: An exploratory randomised controlled trial was conducted comparing the experimental support programme with 'standard' care. All carers of patients with a psychotic disorder from a defined population were approached. Outcome measures were based on a 'stress-appraisal-coping' model of caregiving. RESULTS: Despite concerted attempts to engage carers, only 42% participated in the study. The carers' programme did not offer any significant advantage on any of the outcome measures: psychological morbidity, negative appraisal, coping or social support. The severity of caregiving difficulties decreased over the study period for the group as a whole. CONCLUSIONS: There is still uncertainty about the most effective interventions for carers. Meeting 'needs' may not improve caregiver distress.