Outpatient interdisciplinary multimodal pain treatment programme for patients with chronic musculoskeletal pain: a longitudinal cohort study.

PURPOSE: To describe the outcomes of an interdisciplinary multimodal pain treatment (IMPT) for chronic musculoskeletal pain (CMP) patients up until 12 months post-treatment. MATERIALS AND METHODS: Data were gathered during routine clinical practice during a 3-year period (2019-2021) at six Dutch rehabilitation centres. Assessments included patient-reported outcome measures for multiple domains including disability, pain and fatigue. Longitudinal data were analysed using repeated-measures models and by quantifying responder rates. RESULTS: Included were 2309 patients with a mean age of 43.7 (SD 12.9) years, of which 73% female. All outcomes showed significant improvements at each timepoint. At discharge, large effect sizes were found for disability, average and worst pain, fatigue and health-related quality of life. Improvements were largely sustained at 12-months. Relatively large proportions of patients had clinically relevant improvements after treatment (pain-related disability: 60%; average pain: 52%; worst pain: 37.4%; work capacity: 50%; concentration: 50%; fatigue: 46%). Patients who received a treatment extension showed further improvements for all outcome measures, except average pain. CONCLUSIONS: At group level, all outcomes significantly improved with mainly large effect sizes. The results were mostly sustained. The proportion of patients showing clinically relevant improvements tends to be larger than previously reported for mixed CMP patients.

Chronic musculoskeletal pain can be very disabling and impacting participation and quality of life.Often several psychosocial factors contribute to the maintenance of pain and its evolving consequences.In this study, a 61 hours highly individualized interdisciplinary multimodal pain treatment resulted in significant improvements with moderate to very large effect sizes for all important domains like pain, fatigue, disability, work capacity, and quality of life.Care providers as well as health insurers should acknowledge the interdisciplinary multimodal pain programme as an effective treatment in their clinical decision making.

Abdominal pain in patients with inflammatory bowel disease in remission: A prospective study on contributing factors.

BACKGROUND: Abdominal pain is highly prevalent in patients with inflammatory bowel disease (IBD) in remission, but the aetiology is incompletely understood. AIM: To investigate the association of clinical, lifestyle and psychosocial factors with abdominal pain in patients with IBD in remission. METHODS: We performed a prospective multicentre study enrolling consecutive patients with IBD. Data were collected between 1 January 2020 and 1 July 2021, using myIBDcoach, an established remote monitoring platform for IBD. Chronic abdominal pain in IBD in remission (IBDremissionPain+) was defined as abdominal pain score ≥3 (0-10 NRS) on ≥1/3 of all assessments, combined with faecal calprotectin <150 µg/g in 90 days around periodic assessments. Disease activity, lifestyle and psychosocial factors were assessed every 1-3 months during 18 months. Using linear mixed models, the association of these factors with abdominal pain over time was analysed. RESULTS: We included 559 patients, of whom 429 (76.7%) remained in biochemical remission. Of these, 198 (46.2%) fulfilled the criteria for chronic abdominal pain. IBDremissionPain+ patients were characterised by female sex, younger age, higher BMI, and shorter disease duration. They reported more often or higher levels of stress, fatigue, depressive and anxiety symptoms, and life events (all p < 0.001). In the multivariable analysis, sex, disease entity, fatigue, depressive symptoms and life events were associated with abdominal pain over time (all p < 0.05). CONCLUSION: In this cohort of patients with IBD in remission, abdominal pain was common and associated with psychosocial factors. A more holistic treatment approach for patients with IBD suffering from abdominal pain may improve quality of care and subjective wellbeing.

It Is Smart to Set Treatment Goals, But Are Set Treatment Goals SMART? A Qualitative Assessment of Goals Described in the Assessment of the Burden of COPD Tool.

The Assessment of the Burden of COPD (ABC) tool facilitates shared decision-making and goal setting to develop a personalized care plan. In a previous trial (RCT), the ABC tool was found to have a significant effect on patients' Health-related Quality of Life (HRQoL). In this exploratory study we used data from the intervention group of the RCT to investigate if patients with health-related goals had an improved HRQoL compared to those without goals, and if the quality and types of goals differed for those who have a clinically meaningful improvement in HRQoL. We hypothesized that the quality and the type of the goal described in the ABC tool, relates to an improved HRQoL. We assessed the quality of the goals according to the Specificity, Measurability, Achievability, Relevance and Timeliness (SMART) criteria, and coded and counted each type of goal. We found that having a goal or not, did not differ significantly for those who had a clinically meaningful improved HRQoL versus those who had not, nor was the quality or type of goal significantly different. The most common types of goals were exercise more, smoke less, and improve weight. Based on the results, we speculate that when a clinically meaningful improvement in HRQoL is achieved, it is not related to a single component (i.e. goal setting as part of shared decision-making) but that the different components of the ABC tool (visualization of burden, shared decision making, utilization of tailored evidence based interventions, and regular monitoring of progress) may have a synergistic effect on disease cognition and/or behavior change. Noteworthy, the sample size was small while the calculated effect size was moderate, making it unlikely to find a significant effect.

Additional value of a triggerlist as selection criterion in identifying patients at high risk of medication-related hospital admission: a retrospective cohort study.

BACKGROUND: Of all hospital admissions in older patients, 10-30% seem to be medication-related. However, medication-related admissions are often unidentified in clinical practice. To increase the identification of medication-related hospital admissions in older patients a triggerlist is published in the Dutch guideline for polypharmacy. AIM: To assess whether the triggerlist has value as selection criterion to identify patients at high risk of medication-related hospital admissions. METHOD: This retrospective cohort study was carried out in 100 older (≥ 60 years) patients with polypharmacy and having two triggers from the triggerlist. The admissions were assessed as either possibly or unlikely medication-related according to the Assessment Tool for identifying Hospital Admissions Related to Medications. RESULTS: Of all the admissions 48% were classified as possibly medication-related. Patients with a possible medication-related hospital admission were more likely to have an impaired renal function (p = 0.015), but no differences with regard to age, sex, comorbidity or number of medicines were found. CONCLUSION: The high prevalence of medication-related hospital admissions, suggests the triggerlist may have added value as selection criterion in a cohort of older patients with polypharmacy and can be used to improve the identification of a population at high risk of medication-related hospital admissions.

Battling the obesity epidemic with a school-based intervention: Long-term effects of a quasi-experimental study.

BACKGROUND: School-based health-promoting interventions are increasingly seen as an effective population strategy to improve health and prevent obesity. Evidence on the long-term effectiveness of school-based interventions is scarce. This study investigates the four-year effectiveness of the school-based Healthy Primary School of the Future (HPSF) intervention on children's body mass index z-score (BMIz), and on the secondary outcomes waist circumference (WC), dietary and physical activity (PA) behaviours. METHODS AND FINDINGS: This study has a quasi-experimental design with four intervention schools, i.e., two full HPSFs (focus: diet and PA), two partial HPSFs (focus: PA), and four control schools. Primary school children (aged 4-12 years) attending the eight participating schools were invited to enrol in the study between 2015 and 2019. Annual measurements consisted of children's anthropometry (weight, height and waist circumference), dietary behaviours (child- and parent-reported questionnaires) and PA levels (accelerometers). Between 2015 and 2019, 2236 children enrolled. The average exposure to the school condition was 2·66 (SD 1·33) years, and 900 participants were exposed for the full four years (40·3%). After four years of intervention, both full (estimated intervention effect (B = -0·17 (95%CI -0·27 to -0·08) p = 0·000) and partial HPSF (B = -0·16 (95%CI-0·25 to -0·06) p = 0·001) resulted in significant changes in children's BMIz compared to control schools. Likewise, WC changed in favour of both full and partial HPSFs. In full HPSFs, almost all dietary behaviours changed significantly in the short term. In the long term, only consumption of water and dairy remained significant compared to control schools. In both partial and full HPSFs, changes in PA behaviours were mostly absent. INTERPRETATION: This school-based health-promoting intervention is effective in bringing unfavourable changes in body composition to a halt in both the short and long term. It provides policy makers with robust evidence to sustainably implement these interventions in school-based routine.

Inadequate awareness of adherence to ARRIVE guidelines, regarding reporting quality of hernia models repaired with meshes: a systematic review.

PURPOSE: Research papers involving animal studies often display poor reporting standards, leading to lower study reproducibility. We aim to determine the difference in reporting animal studies regarding abdominal wall hernia repair with mesh placement, before and after the publication of ARRIVE-2010 (Animal Research: Reporting of In Vivo Experiments) guidelines. Furthermore, we aim to present the most up-to-date reporting quality using the updated ARRIVE-2020 as criteria. METHODS: All animal studies concerning hernia repair with meshes were systematically searched. Articles published in the 5 years leading up to the ARRIVE-2010 (pre-ARRIVE) and articles within the last 5 years until the updated ARRIVE 2.0 (post-ARRIVE) were compared for overall species and specific species separately. Articles published last year were evaluated for presenting fully reported (sub)items. RESULTS: The number of fully reported (sub)items per article was on average significantly higher for pre-ARRIVE than post-ARRIVE for overall species (mean (SD) = 14.0 (2.8) vs. 12.6 (2.5), P < 0.001). The same applies to rabbit (mean (SD) = 14.8 (2.6) vs. 12.6 (2.6), P = 0.001) and pig studies (mean (SD) = 14.5 (2.7) vs. 11.6 (2.6), P = 0.004), with no significance in rat studies (mean (SD) = 13.6 (2.9) vs. 12.9 (2.3), P = 0.076). Significance was found in several (sub)items between pre-ARRIVE and post-ARRIVE (n = 7, 3, 8, and 3 for overall species, rat, rabbit, and pig studies, respectively). CONCLUSION: General reporting quality of animal experiments has been improved markedly by ARRIVE guidelines. However, more improvements are required considering the arrival of ARRIVE 2.0 guidelines.

Mitral prolapsing volume is associated with increased cardiac dimensions in patients with mitral annular disjunction.

INTRODUCTION: In patients with mitral annular disjunction (MAD), it can be difficult to assess the severity of mitral regurgitation (MR), as they present with a prolapsing volume (i.e. volume resulting from mitral valve prolapse, blood volume shift) rather than a regurgitant jet. The influence of the mitral prolapsing volume (MPV) on cardiac dimensions is unknown. We hypothesised that the severity of MR is underestimated in these patients. Our aim was to measure MPV and to investigate its influence on cardiac dimensions in patients with MAD. METHODS: We retrospectively included 131 consecutive patients with MAD from our institution's echocardiographic database. Transthoracic echocardiography was used to assess MPV. Additionally, we established a control group of 617 consecutive patients with degenerative mitral valve disease and performed propensity score matching. RESULTS: Median MPV in the MAD group was 12 ml. MPV was an independent predictor for left ventricular end-diastolic (LVEDD) and end-systolic diameter (LVESD) and left atrial volume (all p < 0.001). In patients with large prolapsing volumes (> 15 ml), LVEDD (56 ± 6 mm vs 51 ± 6 mm, p < 0.001), LVESD [38 mm (34-41) vs 34 mm (31-39), p < 0.01] and left atrial volume [105 ml (86-159) vs 101 ml (66-123), p = 0.04] were significantly increased compared to matched patients with degenerative mitral valve disease and similarly assessed severity of MR. CONCLUSION: Due to a volume shift based on the MPV rather than an actual regurgitant jet, MR severity cannot be assessed adequately in MAD patients. Increased MPV induces ventricular and atrial enlargement. These findings warrant future studies to focus on MPV as an additional parameter for assessment of the severity of MR in MAD patients.

A patient decision aid for breast cancer patients deciding on their radiation treatment, no change in decisional conflict but better informed choices.

BACKGROUND AND PURPOSE: In selected breast cancer patients, radiation treatment (RT) lowers the recurrence risk, with minor or no improvement of survival. In these patients, the choice to undergo RT is considered a preference-sensitive decision. To facilitate shared decision-making (SDM) for this choice, a patient decision aid was made. We aimed to evaluate the effect of the PtDA on decisional conflict. MATERIAL AND METHODS: We performed a multi-center pre- and post-intervention study (BRASA-trial). The first 214 patients made a choice without support of the PtDA; the subsequent 189 patients received a link to the PtDA. The primary endpoint was decisional conflict; secondary endpoints were perceived SDM and knowledge on treatment options. Patients filled out questionnaires immediately after, and three months after their decision. Data were analyzed with multi-level regression analysis. RESULTS: After correcting for the difference in age and educational level, the mean (±SD) decisional conflict for the intervention group (27.3 ± 11.4) was similar to the control group (26.8 ± 11.4; difference = 0.86, 95 %CI 1.67,3.36) three months after their decision. This also applied to perceived SDM. Patients exposed to the PtDA pursued additional treatment less often (45% vs 56%, odds ratio 0.59, 95 %CI 0.37,0.95) and scored significantly higher on the knowledge test (7.4 ± 2.5 vs 6.1 ± 2.7, corrected difference = 1.0, 95 %CI 0.50,1.49). There was no significant increase in consultation time. CONCLUSIONS: Handing out the PtDA was not associated with improved scores in decisional conflict or perceived SDM, but it was associated with a choice for less additional treatment and better knowledge about the treatment options.

Cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (the BICAT-NL study): study design of a prospective multicenter randomised controlled trial.

BACKGROUND: Cataract surgery is one of the most frequently performed types of surgery. Most patients suffer from bilateral cataract and while cataract surgery of only one eye is effective in restoring functional vision, second-eye surgery leads to further improvements in health-related quality of life, and is cost-effective. At present, most patients undergo cataract surgery in both eyes on separate days as recommended in national guidelines, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves operating both eyes on the same day, but as separate procedures, known as immediately sequential bilateral cataract surgery (ISBCS). The aim of this study is to evaluate the effectiveness and costs of ISBCS compared to DSBCS, in order to test the hypothesis that ISBCS is non-inferior to DSBCS in terms of effectiveness and superior to ISBCS in terms of cost-effectiveness. METHODS/DESIGN: Multicenter non-inferiority randomised controlled clinical trial. Patients (18 years or older) with bilateral cataract and an indication for bilateral cataract surgery with an expected uncomplicated intraoperative and postoperative course are included in the study. Patients are randomly assigned to either ISBCS or DSBCS. The primary endpoint is the proportion of patients with a refractive outcome in the second eye within 1.0 dioptre from the target refraction, at 4 weeks after surgery. Secondary outcomes include corrected and uncorrected distance visual acuity, complications, patient reported outcomes (PROMs), cost-effectiveness, and budget impact. Follow-up visits are planned at 1 week after first-eye surgery and 4 weeks after second-eye surgery. At 3 months after first-eye surgery, the occurrence of complications is checked and patients fill in a final questionnaire. DISCUSSION: This study protocol describes the design of a multicenter non-inferiority randomised controlled trial. Current studies on ISBCS often lack information on safety regarding refractive outcomes. In addition, there is a lack of well-designed cost-effectiveness studies using established methods. The BICAT-NL study will provide more insight in refractive and cost-effectiveness outcomes for ISBCS compared to DSBCS. TRIAL REGISTRATION: This study was prospectively registered at Clinicaltrials.gov on January 17th 2018. (Identifier: NCT03400124 .

Comparison of coated meshes for intraperitoneal placement in animal studies: a systematic review and meta-analysis.

PURPOSE: Laparoscopic intraperitoneal onlay mesh in hernia repair can result in adhesions leading to intestinal obstruction and fistulation. The aim of this systematic review is to compare the effects of mesh coatings reducing the tissue-to-mesh adhesion in animal studies. METHODS: Pubmed and Embase were systematically searched. Animal experiments comparing intraperitoneally placed meshes with coatings were eligible for inclusion. Only studies with comparable follow-up, measurements, and species were included for data pooling and subsequent meta-analysis. RESULTS: A total of 131 articles met inclusion criteria, with four studies integrated into one comparison and five studies integrated into another comparison. Compared to uncoated polypropylene (PP) mesh, PP mesh coated with hyaluronic acid/carboxymethyl cellulose (HA/CMC) showed significantly reduced adhesion formation at follow-up of 4 weeks measured with adhesion score of extent (random effects model, mean difference,- 0.96, 95% CI - 1.32 to - 0.61, P < 0.001, I2 = 23%; fixed effects model, mean difference,- 0.94, 95% CI - 1.25 to - 0.63, P < 0.001, I2 = 23%). Compared to PP mesh, polyester mesh coated with collagen (PC mesh) showed no significant difference at follow-up of 4 weeks regarding percentage of adhesion-area on a mesh, using random effects model (mean difference - 11.69, 95% CI - 44.14 to 20.76, P = 0.48, I2 = 92%). However, this result differed using fixed effects model (mean difference - 25.55, 95% CI - 33.70 to - 7.40, P < 0.001, I2 = 92%). CONCLUSION: HA/CMC coating reduces adhesion formation to PP mesh effectively at a follow-up of 4 weeks, while the anti-adhesive properties of PC mesh are inclusive comparing all study data.

Medication in older patients reviewed multiple ways (MORE) study.

Background Polypharmacy in older patients can lead to potentially inappropriate prescribing. The risk of the latter calls for effective medication review to ensure proper medication usage and safety. Objective Provide insight on the similarities and differences of medication review done in multiple ways that may lead to future possibilities to optimize medication review. Setting This study was conducted in Zuyderland Medical Centre, the second largest teaching hospital in the Netherlands. Method This descriptive study compares the quantity and content of remarks identified by medication review performed by a geriatrician, outpatient pharmacist, and Clinical Decision Support System. The content of remarks is categorized in seven categories of possible pharmacotherapeutic problems: 'indication without medication', 'medication without indication', 'contra-indication/interaction/side-effect', 'dosage problem', 'double medication', 'incorrect medication' and 'therapeutic drug monitoring'. Main outcome measure Number and content of remarks on medication review. Results The Clinical Decision Support System (1.8 ± 0.8 vs. 0.9 ± 0.9, p < 0.001) and outpatient pharmacist (1.8 ± 0.8 vs. 0.9 ± 0.9, p = 0.045) both noted remarks in significantly more categories than the geriatricians. The Clinical Decision Support System provided more remarks on 'double medication', 'dosage problem' and 'contraindication/interaction/side effects' than the geriatrician (p < 0.050), while the geriatrician did on 'medication without indication' (p < 0.001). The Clinical Decision Support System noted significantly more remarks on 'contraindication/interaction/side effects' and 'therapeutic drug monitoring' than the outpatient pharmacist, whereas the outpatient pharmacist reported more on 'indication without medication' and 'medication without indication' than the Clinical Decision Support System (p ≤ 0.007). Conclusion Medication review performed by a geriatrician, outpatient pharmacist, and Clinical Decision Support System provides different insights and should be combined to create a more comprehensive report on medication profiles.

Meta-analysis of postoperative pain using non-sutured or sutured single-layer open mesh repair for inguinal hernia.

Background: Chronic postoperative pain occurs in up to 21·7 per cent of patients undergoing open inguinal hernia repair. Several mesh fixation techniques using glue or self-gripping meshes have been developed to reduce postoperative pain. The aim of this meta-analysis was to evaluate RCTs comparing adhesional/self-gripping and sutured single-layer open mesh fixations in the repair of inguinal herniation, with postoperative pain as endpoint. Methods: PubMed, Embase and Cochrane CENTRAL databases were searched systematically for RCTs according to the PRISMA guidelines; the study was registered at PROSPERO (CRD42017056373). Different fixation methods were analysed. The primary outcome, chronic pain, was defined as a postoperative visual analogue scale (VAS) score of at least 3 at 12 months. Secondary outcomes were mean VAS score at 1 week and at 1 month after surgery. Results: Twenty-three studies including 5190 patients were included in the meta-analysis. Adhesional (self-adhering or glued) or self-gripping fixation methods were associated with a significantly lower VAS score at 1 week (mean difference -0·49, 95 per cent c.i. -0·81 to -0·17; P = 0·003) and at 1 month (mean difference -0·31, -0·58 to -0·04; P = 0·02) after surgery than suture fixation, but the incidence of chronic pain after 12 months was similar in the two groups (odds ratio 0·70, 95 per cent c.i. 0·30 to 1·66). Differences in recurrences and complications between groups did not reach statistical significance. Conclusion: There was no difference in the incidence of chronic pain 12 months after different mesh repair fixation techniques despite significant reductions in short-term postoperative pain favouring a non-sutured technique. There were no differences in recurrence rates or in rates of other complications at 1 year.

Bariatric surgery in adolescents: a prospective randomized controlled trial comparing laparoscopic gastric banding to combined lifestyle interventions in adolescents with severe obesity (BASIC trial).

BACKGROUND: Obesity in children and adolescents is an increasing problem associated with multiple co-morbidities including metabolic and endocrine changes, cardiovascular abnormalities, and impaired quality of life. Combined lifestyle interventions are the current standard treatment for severe obesity in children. However, the medium- and long-term results of these interventions are relatively poor. Bariatric surgery shows substantial weight loss and health improvement in adults and retrospective studies in adolescents show similar outcomes. However, well-designed prospective studies in this young age group are rare. Our objectives are to determine whether combining surgery with lifestyle interventions in severely obese adolescents leads to a significant additional weight reduction compared to lifestyle interventions solely, and to assess its effect on obesity-associated co-morbidities in a prospective randomized controlled setting. METHODS: Patients aged 14-16 years with sex- and age-adjusted BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidity) and failure to achieve weight reduction > 5% during at least one year of combined lifestyle interventions are included in this trial. Randomization determines whether laparoscopic adjustable gastric banding will be added to combined lifestyle intervention throughout the trial period. Sixty children will be included in this trial. Follow-up visits are planned at 6 months, 1,2 and 3 years. Primary endpoints are percentage of total weight loss, and change of BMI. Secondary endpoints include body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, quality of life and changes in behaviour. DISCUSSION: This randomized controlled trial is designed to provide important information about the safety and efficacy of laparoscopic adjustable gastric banding treatment in severely obese adolescents with unsuccessful combined lifestyle interventions. The reversibility of this surgical procedure forms a strong argument to decide for gastric banding over other surgical procedures, since bariatric surgery in adolescents is still in its infancy. TRIAL REGISTRATION: The BASIC trial is registered in the register of ClinicalTrials.gov since July 2010, Identifier: NCT01172899.

Optimizing decision-making among childcare staff on fever and common infections: cluster randomized controlled trial.

BACKGROUND: Children 0-4 years attending childcare are more prone to acquire infections than home-cared children. Childcare illness absenteeism due to fever is mostly driven by fear towards fever in childcare staff and parents. This may cause high childcare absenteeism, healthcare service use, and work absenteeism in parents. This study evaluates a multicomponent intervention targeting determinants of decision-making among childcare staff on illness absenteeism due to fever and common infections. METHODS: The multicomponent intervention was developed based on the Intervention Mapping approach and consisted of (i) an educational session, (ii) a decision tool, (iii) an information booklet and (iv) an online video. The intervention was evaluated in a cluster randomized controlled trial in Southern Netherlands. Nine centres received the intervention and nine provided childcare-as-usual. Primary outcome measure was the percentage of illness absenteeism on cluster level, defined as number of childcare days absent due to illness on total of registered childcare contract days in a 12-week period. Secondary outcome measures included intended behaviour, attitude, risk perception, knowledge and self-efficacy of childcare staff. Outcomes were analyzed using linear mixed models accounting for clustering. Knowledge was descriptively analysed. RESULTS: Overall illness absenteeism was comparable in intervention (2.95%) and control group (2.52%). Secondary outcomes showed significant improvements in intervention group regarding intended behaviour, two of three attitude dimensions. Knowledge increased compared with control but no differences regarding self-efficacy. CONCLUSION: The intervention was not effective in reducing illness absenteeism. However, the intervention improved determinants of decision-making such as intended behaviour, attitude, and knowledge on fever. TRIAL REGISTRATION: NTR6402 (registered on 21 April 2017).

Maternal quality of life in routine labor epidural analgesia versus labor analgesia on request: results of a randomized trial.

INTRODUCTION: The purpose of this study was to evaluate the changes in maternal quality of life (QOL) from pregnancy to 6 weeks after delivery between routine labor epidural analgesia (EA) and pain relief on maternal request only. METHODS: \Women delivering of a singleton in cephalic presentation beyond 36 + 0 weeks' gestation were randomly allocated to EA as a routine during labor (routine EA group), or to any kind of analgesia on request only (control group). The Short Form health survey (SF-36) was used to assess women's QOL before randomization, and 6 weeks postpartum. Data were analyzed according to the intention to treat principle. RESULTS: A total of 488 women were included, and antepartum as well as postpartum SF-36 questionnaires were filled in by 356 (73.0%) women, 176 (49.4%) in the routine EA group, and 180 (50.6%) in the control group. Changes from the QOL antepartum to the QOL 6 weeks postpartum were comparable between both groups, also in the subgroup of women in the control group who gave birth without any pain medication (n = 41, 22.8%). Maternal age and the incidence of adverse events related to EA, which were both higher in the routine EA group, had no influence on the changes in QOL. Differences in request for pain relief were comparable with other studies. CONCLUSION: Routine administration of EA during labor and pain relief on maternal request only are associated with comparable changes of women's QOL antepartum to 6 weeks postpartum.

The nocebo effect challenges the non-medical infliximab switch in practice.

BACKGROUND: In clinical practice, non-medical switching of biological medication may provoke nocebo effects due to unexplained deterioration of therapeutic benefits. Indication extrapolation, idiosyncratic reactions, and interchangeability remain challenged in clinical practice after biosimilar approval by the European Medicines Agency. The principle of "first do no harm" may be challenged in a patient when switching from originator to biosimilar biological. AIM: To describe the 1-year results of a pragmatic study on infliximab biosimilar implementation in immune-mediated inflammatory disease patients on the basis of shared decision-making under effectiveness and safety monitoring. METHODS: Inflammatory bowel disease and rheumatology patients on infliximab originator were converted to infliximab biosimilar after providing informed consent. Nocebo response patients were monitored after switch back to originator. Linear mixed models were used to analyze continuous endpoints on effectiveness and laboratory outcomes to determine significance (P ≤ 0.05) of change over time after switching. RESULTS: After inviting 146 patients, a group of 125 patients enrolled in the project over time, respectively, 73 Crohn's disease, 28 ulcerative colitis, nine rheumatoid arthritis, ten psoriatic arthritis, and five ankylosing spondylitis patients. No statistically significant changes in effectiveness and safety were observed in any of the indications after a median of 4 infusions in 9 months of study. An overall nocebo response of 12.8% was found among the patients during a minimal observation period of 6 months after the transition to biosimilar infliximab. The overall nocebo response rate did not differ between the studied indications. CONCLUSIONS: In inflammatory bowel disease and rheumatological patients, similar effectiveness and safety were demonstrated on the transition into infliximab biosimilar. In our series, patient empowerment and registration of treatment outcomes delineated biosimilar transition, an approach that hypothetically could reduce nocebo response rates which are relevant to account for regarding biosimilar implementation.

The use of an electronic clinical rule to discontinue chronically used benzodiazepines and related Z drugs.

PURPOSE: The chronic use of benzodiazepines and benzodiazepine-related drugs (BZ/Z) in older people is common and not without risks. The objective of this study was to evaluate whether the implementation of a clinical rule promotes the discontinuation of chronically used BZ/Z for insomnia. METHODS: A clinical rule, generating an alert in case of chronic BZ/Z use, was created and applied to the nursing home (NH) setting. The clinical rule was a one-off intervention, and alerts did not occur over time. Reports of the generated alerts were digitally sent to NH physicians with the advice to phase out and eventually stop the BZ/Z. In cases where the advice was adopted, a follow-up period of 4 months on the use of BZ/Z was taken into account in order to determine whether the clinical rule alert led to a successful discontinuation of BZ/Z. RESULTS: In all, 808 NH patients were screened. In 161 (19.1%) of the patients, BZ/Z use resulted in a clinical rule alert. From these, the advice to phase out and stop the BZ/Z was adopted for 27 patients (16.8%). Reasons for not following the advice consisted of an unsuccessful attempt in the past (38 patients), patients family and/or patient resistance (37 patients), the non-continuous use of BZ/Z (32 patients) and indication still present (27 patients). Of the 12 NH physicians, seven adopted the advice. CONCLUSIONS: The success rate of a clinical rule for discontinuation of chronically used BZ/Z for insomnia was low, as reported in the present study. Actions should be taken to help caregivers, patients and family members understand the importance of limiting BZ/Z use to achieve higher discontinuation rates.

Well-being of nursing staff on specialized units for older patients with combined care needs.

WHAT IS ALREADY KNOWN ABOUT THE SUBJECT: Working in long-term care is seen as a stressful, physically and mentally demanding occupation, and thus, nursing staff are at risk for work and stress-related diseases. In older patients, psychiatric illnesses often occur in combination with physical illnesses, requiring nursing care that is specific to these combined care needs. The impact of caring for these patients on the mental well-being of nurses is unknown. WHAT THIS PAPER ADDS TO EXISTING KNOWLEDGE: Nursing staff working on specialized units for patients with combined care needs experience high levels of self-efficacy in combination with strong feelings of self-rated competence. Although levels of burnout are relatively low, mental healthcare nursing staff is more at risk for burnout when working in specialized settings for patients with combined care needs than nursing home staff working in specialized settings for these patients. Nursing staff characteristics, such as years of working experience and age, seem more important in relation to staff well-being than patient characteristics in specialized settings for combined care needs. WHAT ARE THE IMPLICATIONS FOR PRACTICE: Staff well-being might benefit from specializing care, so that patients with similar care needs are placed together and care is focused. The presence of specialized care units for older patients with combined care needs can allow for both targeted and focused allocation of nursing staff to these units and provision of specific training. ABSTRACT: Introduction In older patients, psychiatric illnesses frequently exist in tandem with physical illnesses, requiring nursing care that is specific to these combined care needs. The impact of caring for these patients on the mental well-being of nursing staff is unknown. AIM: To investigate whether care characteristics of patients with combined care needs are related to the mental well-being of nursing staff. METHOD: Well-being of nursing staff was studied within a larger exploratory observational cross-sectional study that examined the differences and similarities of specialized combined care units in Dutch mental healthcare and nursing home settings. RESULTS: Nursing staff across settings, with more than 5 years of work experience, felt competent in caring for patients with combined care needs. No significant effects of care characteristics of patients with combined care needs on the work-related well-being of nursing staff were shown. Both mental health nursing staff and older employees, however, were found to be more at risk for burnout. IMPLICATIONS/CONCLUSION: Staff well-being might benefit from placing patients with combined care needs together, so care is focused. The presence of specialized care units can allow for both targeted and focused allocation of nursing staff to these units and provision of specific training.

Optimising decision making on illness absenteeism due to fever and common infections within childcare centres: development of a multicomponent intervention and study protocol of a cluster randomised controlled trial.

BACKGROUND: Evidence has shown that children 0-4 year-old attending childcare are prone to acquire infections compared to children cared for at home, with fever being the most common symptom. Illness absenteeism due to fever and common infections is substantial and mostly driven by unrealistic concerns and negative attitude towards fever of both childcare staff and parents, resulting in illness absenteeism from childcare, work absenteeism among parents and healthcare service use. The objective of this study is to optimise decision making among childcare staff on illness absenteeism due to fever and common infections in childcare. Underlying determinants of behavioural change were targeted by means of a multicomponent intervention. METHODS: A multicomponent intervention was developed to improve decision making, using the stepwise approach of Intervention Mapping, and in close collaboration with stakeholders and experts. The intervention consisted of 1) a two-hour educational session on fever among childcare staff; 2) an online video for childcare staff and parents emphasising key information of the educational session; 3) a decision tool for childcare staff and parents in the format of a traffic light system to estimate the severity of illness and corresponding advices for childcare staff and parents; 4) an information booklet regarding childhood fever, common infections, and self-management strategies for childcare staff and parents. The multicomponent intervention will be evaluated in a cluster randomised trial with a 12-week follow-up period and absenteeism due to illness (defined as the percentage of childcare days absent due to illness on the total of childcare days during a 12-week period) as primary outcome measure. Secondary outcome measures are: incidence rate and duration of illness episodes, knowledge, attitude, self-efficacy, and risk perception on fever and common infections of childcare staff and parents, healthcare service use in general and paracetamol use, and work absenteeism of parents. DISCUSSION: This study aims to develop a multicomponent intervention and to evaluate to what extent illness absenteeism due to fever and common infections can be affected by implementing a multicomponent intervention addressing decision making and underlying determinants among childcare staff and parents of children attending daycare. TRIAL REGISTRATION: NTR6402 (registered on 21-apr-2017).

Systematic review of the influence of chemotherapy-associated liver injury on outcome after partial hepatectomy for colorectal liver metastases.

BACKGROUND: The impact of chemotherapy-associated liver injury (CALI) on postoperative outcome in patients undergoing partial hepatectomy for colorectal liver metastases (CRLM) remains controversial. The objective of this study was to clarify the effect of CALI (sinusoidal dilatation (SD), steatosis and steatohepatitis) on postoperative morbidity and mortality by investigating a large data set from multiple international centres. METHODS: PubMed and Embase were searched for studies published between 1 January 2004 and 31 December 2013 with keywords 'chemotherapy', 'liver resection', 'outcome' and 'colorectal metastases' to identify potential collaborating centres. Univariable and multivariable analyses were performed using binary logistic regression models, with results presented as odds ratios (ORs) with 95 per cent confidence intervals. RESULTS: A consolidated database comprising 788 patients who underwent hepatectomy for CRLM in eight centres was obtained. In multivariable analyses, severe SD was associated with increased major morbidity (Dindo-Clavien grade III-V; OR 1·73, 95 per cent c.i. 1·02 to 2·95; P = 0·043). Severe steatosis was associated with decreased liver surgery-specific complications (OR 0·52, 95 per cent c.i. 0·27 to 1·00; P = 0·049), whereas steatohepatitis was linked to an increase in these complications (OR 2·08, 1·18 to 3·66; P = 0·012). Subgroup analysis showed that lobular inflammation was the sole component associated with increased overall morbidity (OR 2·22, 1·48 to 3·34; P = 0·001) and liver surgery-specific complications (OR 3·35, 2·11 to 5·32; P < 0·001). Finally, oxaliplatin treatment was linked to severe SD (OR 2·74, 1·67 to 4·49; P < 0·001). CONCLUSION: An increase in postoperative major morbidity and liver surgery-specific complications was observed after partial hepatectomy in patients with severe SD and steatohepatitis. Postoperative liver failure occurred more often in patients with severe SD.