Behavioural and psychological patterns of patients with idiopathic pulmonary fibrosis: a prospective study.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive lung condition. Currently, care models predominantly focus on acute medical and pharmacological needs. As a step towards holistic care, the aim of this prospective study was to investigate the psychological and behavioural needs of IPF patients treated with pirfenidone from diagnosis until two years of follow-up. METHODS: The following variables were selected from the literature on patients' needs and the COM-B model, a theoretical model explaining behaviour: medication adherence, barriers to adherence, importance and intentions of medication adherence, anxiety, depression, health literacy, knowledge, reported side effects, adherence to sun protection recommendations, alcohol use, physical activity, quality of life and health status. Linear and generalised linear models for longitudinal data were used to evaluate the evolution since treatment initiation. RESULTS: We included 66 outpatients: 72.7% men, mean age of 70.3 years (range 50-87), predicted mean forced vital capacity of 85.8% (SD 17.4) and predicted mean diffusing capacity for monoxide of 56.9% (SD 15.7). The participants placed considerable importance on following the treatment recommendations. We noticed difficulties regarding health literacy, alcohol use, pirfenidone adherence (decline over time) and adherence to sun protection recommendations (early in follow-up care). There were low levels of physical activity (no effect of time), high body mass indices (decline over time) and moderate levels of depression and anxiety. CONCLUSION: When providing care to IPF patients, behavioural issues, health literacy and psychological well-being should be taken into consideration. There is a need to further explore interventions and care models to tackle these difficulties. Trial registration This study was registered in the ClinicalTrials.gov database (identifier NCT03567785) on May 9th, 2018.

Manual lymphatic drainage with or without fluoroscopy guidance did not substantially improve the effect of decongestive lymphatic therapy in people with breast cancer-related lymphoedema (EFforT-BCRL trial): a multicentre randomised trial.

QUESTIONS: When added to decongestive lymphatic therapy (DLT), what is the effect of fluoroscopy-guided manual lymphatic drainage (MLD) versus traditional MLD or placebo MLD for the treatment of breast cancer-related lymphoedema (BCRL)? DESIGN: Multicentre, three-arm, randomised controlled trial with concealed allocation, intention-to-treat analysis and blinding of assessors and participants. PARTICIPANTS: At five hospitals in Belgium, 194 participants with unilateral chronic BCRL were recruited. INTERVENTION: All participants received standard DLT (education, skin care, compression therapy and exercises). Participants were randomised to also receive fluoroscopy-guided MLD (n = 65), traditional MLD (n = 64) or placebo MLD (n = 65). Participants received 14 sessions of physiotherapy during the 3-week intensive phase and 17 sessions during the 6-month maintenance phase. Participants performed self-management on the other days. OUTCOME MEASURES: All outcomes were measured: at baseline; after the intensive phase; after 1, 3 and 6 months of maintenance phase; and after 6 months of follow-up. The primary outcomes were reduction in excess volume of the arm/hand and accumulation of excess volume at the shoulder/trunk, with the end of the intensive phase as the primary endpoint. Secondary outcomes included daily functioning, quality of life, erysipelas and satisfaction. RESULTS: Excess lymphoedema volume decreased after 3 weeks of intensive treatment in each group: 5.3 percentage points of percent excessive volume (representing a relative reduction of 23.3%) in the fluoroscopy-guided MLD group, 5.2% (relative reduction 20.9%) in the traditional MLD group and 5.4% (relative reduction 24.8%) in the placebo MLD group. The effect of fluoroscopy-guided MLD was very similar to traditional MLD (between-group difference 0.0 percentage points, 95% CI -2.0 to 2.1) and placebo MLD (-0.2 percentage points, 95% CI -2.1 to 1.8). Fluid accumulated at the shoulder/trunk in all groups. The average accumulation with fluoroscopy-guided MLD was negligibly less than with traditional MLD (-3.6 percentage points, 95% CI -6.4 to -0.8) and placebo MLD (-2.4 percentage points, 95% CI -5.2 to 0.4). The secondary outcomes also showed no clinically important between-group differences. CONCLUSION: In patients with chronic BCRL, MLD did not provide clinically important additional benefit when added to other components of DLT. REGISTRATION: NCT02609724.

Bupivacaine infiltration in children for postoperative analgesia after tonsillectomy: A randomised controlled trial.

BACKGROUND: Adenotonsillectomy is a frequently performed procedure in paediatric day-case surgery. Postoperative pain can be significant and standard analgesia protocols are often insufficient. OBJECTIVE: Our primary objective was to investigate if infiltration of the peritonsillar space with bupivacaine would reduce the need for postoperative opioids compared with pre-emptive intravenous tramadol. DESIGN: A double-blind, randomised controlled trial. SETTING: Ambulatory surgical day care centre, University Hospitals of Leuven, Belgium, from January 2012 to September 2016. PATIENTS: Two hundred children, between 4 and 10 years old, undergoing elective adenotonsillectomy were included in the study. INTERVENTION: Children were randomly allocated to receive either a bolus of 3 mg kg intravenous tramadol or infiltration of the tonsillar lodge with 5-ml bupivacaine 0.25%. Reasons for exclusion were American Society of Anesthesiologists classification greater than 2, allergies to the investigated products, psychomotor retardation, bleeding disorders and lack of proficiency in Flemish. MAIN OUTCOME MEASURES: The primary endpoint was the number of children in need of piritramide postoperatively. Secondary outcomes included the cumulative dose of postoperative piritramide, pain scores and the incidence of postoperative nausea and vomiting during the first 24 postoperative hours, time to discharge and adverse effects. RESULTS: The proportion of children in need of postoperative piritramide was significantly lower in the tramadol group than in children with peritonsillar infiltration (57 vs. 81%, P < 0.001). When in need of postoperative piritramide, the tramadol-group required a significantly lower dose (median [IQR] 0.7 [0.6 to 1] vs. 1 [0.6 to 1.5] mg, P < 0.007) and had lower pain scores during the first 60 min after surgery. There were no statistically significant differences in postoperative nausea and vomiting incidence, need for antiemetics or complications. CONCLUSION: Compared with peritonsillar infiltration, preemptive intravenous tramadol decreases the need for postoperative opioids after tonsillectomy in children without increasing the incidence of side effects. TRIAL REGISTRATION: EudraCT 2011-005467-25.

Dorsal penile nerve block for circumcision in pediatric patients: A prospective, observer-blinded, randomized controlled clinical trial for the comparison of ultrasound-guided vs landmark technique.

BACKGROUND AND AIMS: Circumcision is a frequently performed procedure in day case pediatric surgery. Dorsal penile nerve block has proven its effectiveness for the management of acute postoperative pain after circumcision. We investigated if the ultrasound-guided placement of a dorsal penile nerve block could reduce opioid requirement as compared to a landmark-based technique. METHODS: Three hundred and ten prepubertal children, aged between 52 weeks postconception and 11 years, were included in this prospective, observer-blinded, randomized controlled trial and received either a landmark- or an ultrasound-guided dorsal penile nerve block, using a caudal needle and injecting 0.1 mL/kg levobupivacaine 0.5% bilaterally. A single, experienced investigator performed all blocks. The primary endpoint was the number of patients in need of piritramide postoperatively as triggered by the Objective Pain Scale. Secondary outcome parameters included the cumulative dose of postoperatively administered opioids, the requirement to administer fentanyl intraoperatively, the need for paracetamol and ibuprofen during the first 24 postoperative hours, postoperative pain scores, the incidence of postoperative nausea and vomiting, the anesthesia induction time, and the time to discharge. RESULTS: The proportion of patients requiring postoperative piritramide did not differ significantly between both groups (Landmark: 38% vs Ultrasound: 47%, with a difference in proportion between both conditions (95% CI): 0.09 (0.2 to 0.02); P = .135). In addition, the cumulative doses of postoperative piritramide and intraoperative fentanyl, the postoperative need for paracetamol or ibuprofen, pain scores, the incidence of postoperative nausea and vomiting, and the time to discharge were not different either. However, the anesthesia induction time was significantly longer in the ultrasound-guided dorsal penile nerve block (median time [IQR]: Landmark: 11[9; 13] min vs Ultrasound: 13[11; 15] min, P < .001). CONCLUSION: Compared with the landmark-guided, the ultrasound-guided dorsal penile nerve block did not reduce the need for postoperative analgesia after circumcision in children, but was associated with an increase in the procedural time.

Influence on clinical parameters of depressomassage (part I): The effects of depressomassage on color and transepidermal water loss rate in burn scars: A pilot comparative controlled study.

OBJECTIVE: Depressomassage is a non-invasive massage technique using a mechanical suction device that is used in the treatment of traumatic or burn scars. Since color and transepidermal water loss (TEWL) are respectively the most important physical and physiological characteristic of hypertrophic scar formation, we wanted to investigate the effects of depressomassage on the recovery of color and TEWL in burn scars compared to the traditional physiotherapy. METHODS: In this pilot comparative controlled study a total 43 burn patients were included and allocated into 2 groups. All patients received standard physical therapy, and the test group received additional depressomassage during 6 months. Color was assessed using the POSAS questionnaire (for color, vascularity and pigmentation) and the Minolta Chromameter. TEWL was measured using DermaLab. RESULTS: Patients of both groups were evaluated at baseline, after 1, 3 and 6 months and after 1year. The evidence for a difference in evolution of color and TEWL between both groups in our study was minimal. CONCLUSIONS: In practice, precise indications to begin depressomassage have to be kept in mind. Perhaps other scar abnormalities such as decreased elasticity, increased thickness, excessive pain or itching could be sufficient reasons to begin depressomassage and should be assessed.

External Validation of the Prognostic Nomogram (COMPASS) for Patients with Peritoneal Carcinomatosis of Colorectal Cancer.

BACKGROUND: To optimize outcome, selection of patients for cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is critical. Recently, Simkens et al.7 evaluated the peritoneal surface disease severity score (PSDSS) and suggested a new prognostic nomogram, the colorectal peritoneal metastases prognostic surgical score (COMPASS) based on age, peritoneal carcinomatosis index score, locoregional lymph node status, and signet ring cell histology. This COMPASS nomogram had better discriminative ability according to the Harrell c-index than PSDSS (c = 0.72 vs. 0.62). This study aimed to validate the COMPASS nomogram externally. METHODS: Data were retrieved from a prospectively maintained database, and all patients who underwent surgery between May 2005 and May 2016 were included in the study. For each patient, the PSDSS and COMPASS were calculated and then divided into subgroups. The discriminative ability of both scores for overall survival were quantified using Harrell c indices. RESULTS: A total of 153 patients underwent CRS + HIPEC for peritoneal carcinomatosis (PC) of colorectal cancer. The median overall survival (OS) was 46 months, and the mean PSDSS was 7.8 ± 3.7. When the PSDSS was divided into subgroups, the c index was 0.67. The mean COMPASS was 55.5 ± 25.6. When the patients were divided into four groups according to cutpoints of Simkens et al.7 a c index of 0.72 was obtained, showing its significant superiority over the discriminative ability of the PSDSS (p = 0.016). CONCLUSION: External validation of the COMPASS confirms its moderate to good discriminative ability and its superiority over the PSDSS. Nevertheless, discrimination with the COMPASS score remains suboptimal, and further research on prognostic variables is essential for optimal patient selection.

The effect of orofacial myofunctional treatment in children with anterior open bite and tongue dysfunction: a pilot study.

OBJECTIVES: Insufficient attention is given in the literature to the early treatment of anterior open bite (AOB) subjects receiving orofacial myofunctional therapy (OMT), which aims to harmonize the orofacial functions. This prospective pilot study investigates the effects of OMT on tongue behaviour in children with AOB and a visceral swallowing pattern. MATERIALS AND METHODS: The study comprised of 22 children (11 boys, 11 girls; age range: 7.1-10.6 years). They were randomly assigned into OMT and non-OMT subjects. The randomization was stratified on the presence of a transversal crossbite. At baseline (T0), at the end of treatment (T1) and at 6 months after T1 (T2) maximum tongue elevation strength was measured with the IOPI system (IOPI MEDICAL LLC, Redmond, Washington, USA). Functional characteristics such as tongue posture at rest, swallowing pattern and articulation and the presence of an AOB were observed. RESULTS: OMT did significantly change tongue elevation strength, tongue posture at rest, and tongue position during swallowing of solid food. At T2 more OMT subjects had contact between the lower central incisors and their antagonists or palate (P = 0.036). More OMT subjects performed a physiological pattern of water swallowing than non-OMT children at T1 and T2, although the differences were not significant. Articulation of /s,l,n,d,t/ was not improved by OMT. No interaction between OMT and expansion was found for any of the parameters. CONCLUSION: OMT can positively influence tongue behaviour. However, further research is recommended to clarify the success of OMT as an adjunct to orthodontic treatment and to identify possible factors influencing the outcome.

The treatment of peritoneal carcinomatosis of colorectal cancer with complete cytoreductive surgery and hyperthermic intraperitoneal peroperative chemotherapy (HIPEC) with oxaliplatin: a Belgian multicentre prospective phase II clinical study.

BACKGROUND: Up to 25% of patients with metastatic colorectal cancer (CRC) present with peritoneal carcinomatosis (PC) as the only site of metastases. Complete cytoreductive surgery (CCRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC) aims for locoregional disease control and long-term survival. Oxaliplatin is effective for treating advanced CRC. This study assesses the safety and efficacy of CCRS with HIPEC with oxaliplatin for patients with PC of CRC. METHODS: A Belgian prospective multicenter registry was performed to monitor perioperative morbidity and assess mortality, disease-free survival (DFS), and overall survival (OS). RESULTS: Forty-eight consecutive patients underwent CCRS (R0/1) with HIPEC (male/female ratio 17/31, median age 60 years, range 24-76 years). Median PC index was 11 (range 1-22). Median operation time was 460 (range 125-840) min, with a median blood loss of 475 (range 2-6,000) ml. Thirty-day mortality was 0%. Complication rate (any grade) was 52.1%. Anastomotic leakage occurred in 10.4% of patients, bleeding in 6.3%, and bowel perforation in 2.1%. Median hospital stay was 20 (range 5-65) days. At median follow-up of 22.7 (range 3.2-55.7) months, OS was 97.9% [95% confidence interval (CI) 86.1-99.7] at 1 year and 88.7% (95% CI 73.6-95.4) at 2 years. DFS at 1 year was 65.8% (95% CI 52.3-76.2) and 45.5% (95% CI 34.3-55.9) at 2 years. Median time until recurrence was 19.8 months (95% CI 12-upper limit not defined). Only after dichotomizing PC index was a significant difference in OS found between low and high PC index. CONCLUSIONS: CCRS followed by HIPEC with oxaliplatin for PC from CRC can be implemented with acceptable morbidity. Long-term DFS and OS can be achieved in selected patients.

Impact of interval between neoadjuvant chemoradiotherapy and TME for locally advanced rectal cancer on pathologic response and oncologic outcome.

BACKGROUND: The interval between neoadjuvant chemoradiotherapy and surgery for rectal cancer has arbitrarily been set at 6-8 weeks. However, tumor regression is variable. This study aimed to evaluate whether the interval between neoadjuvant therapy and surgery had an impact on pathologic response and on surgical and oncologic outcome. METHODS: A total of 356 consecutive patients with clinical stage II and III rectal adenocarcinoma were identified. Median age was 63 years, and 65 % were men. All patients received neoadjuvant chemoradiotherapy (45 Gy) with a continuous infusion of 5-fluorouracil. Data on neoadjuvant-surgery interval, type of surgery, pathology, postoperative complications, length of hospital stay, disease recurrence, and survival were reviewed. Patients were divided into two groups according to the interval between neoadjuvant therapy and surgery: ≤ 7 weeks (short interval, n = 201) and >7 weeks (long interval, n = 155). RESULTS: The complete pathologic response rate was 21 %. It was significantly higher after a longer interval (28 %) than after a shorter interval (16 %, p = 0.006). A longer interval did not affect morbidity or length of hospital stay. After a median follow-up of 4.9 years, the 5-year cancer-specific survival rate was 83 % in the short-interval group versus 91 % in the long-interval group (p = 0.046), and the free-from-recurrence rate was 73 versus 83 %, respectively (p = 0.026). CONCLUSIONS: In this retrospective analysis, there seems to be an association between a longer interval after neoadjuvant chemoradiotherapy and complete pathologic response without affecting postoperative morbidity and length of hospital stay, and with no detrimental effect on oncologic outcome.

The effects of electrical stimulation or an electrolytic lesion in the mediodorsal thalamus of the rat on survival, body weight, food intake and running activity in the activity-based anorexia model.

The glucose metabolism in the mediodorsal thalamus (MD) is increased in rats in the activity-based anorexia (ABA) model. In patients, electrical stimulation in hyperactive brain regions reduced symptoms in e.g. major depressive disorder and cluster headache. In two blinded randomised controlled experiments, we therefore examined the effects of high-frequency electrical stimulation and an electrolytic lesion in the MD in a validated rat model for anorexia nervosa. The ABA model was successfully replicated in all our experiments, with a reduction in body weight, food intake, and survival time and an increase in running activity. In a first experiment, we evaluated the effect of electrical stimulation or a curative lesion in the MD on survival, body weight, food intake and locomotor activity in ABA rats. Electrical MD stimulation or an electrolytic MD lesion did not improve the symptoms of rats in the ABA model, compared to control groups. In a second experiment, we investigated the effect of a preventive electrolytic lesion in the MD on rats in the ABA model. Although there was no significant improvement of survival, body weight and food intake, locomotor activity was significantly reduced in the lesion group compared to the control group. Apart from this positive effect on running activity, we found no convincing evidence for the suitability of the MD as a neuromodulation target for anorexia nervosa patients.