Voices of society: the emergence of civil-society practices aiming to engage in the management of the COVID-19 pandemic in the Netherlands.

During the COVID-19 pandemic, public groups mobilised themselves in civil-society engagement practices (CSEPs) aiming to improve or suggest alternative epidemic management. This study explores the motivation to establish CSEPs and their perceived contributions to epidemic management, to gain insight whether integrating views of CSEPs could add value. A systematic online search was executed to identify CSEPs focused on COVID-19 management between January 2020 and January 2022 in the Netherlands. In order to create a comprehensible overview of the identified CSEPs, relevant characteristics were gathered and mapped, for example, local or national scope, subject of action and goals. A selection of CSEPs was interviewed between April and June 2022 to study their motivators to start the CSEPs and perceived contributions to management. The search resulted in the identification of 22 CSEPs, of which members of 14 CSEPs were interviewed. These members indicated several issues that motivated the start of their CSEP, namely; shortage of equipment, sense of solidarity, and a perceived lack of governmental action, lack of democratic values and lack in diversity of perspectives in epidemic management. All respondents believed to have contributed to policy or society, by influencing opinions, and occasionally by altering policy. However, respondents encountered obstacles in their attempts to contribute such as inability to establish contact with authorities, feeling unheard or undermined, and complications due to the interplay of political interests. In conclusion, CSEPs have fulfilled various roles such as providing alternative management policies, producing equipment, representing the needs of vulnerable populations, and supporting citizens and providing citizens with other viewpoints and information. The identified motivators to establish CSEPs in this study uncover room for improvements in policy. These insights, together with the identified perceived barriers of CSEPs, can be used to improve the connection between (future) epidemic management and public priorities and interests.

Polyethylene Glycol 3350 With Electrolytes Versus Polyethylene Glycol 4000 for Constipation: A Randomized, Controlled Trial.

OBJECTIVE: The long-term efficacy and safety of polyethylene glycol (PEG) in constipated children are unknown, and a head-to-head comparison of the different PEG formulations is lacking. We aimed to investigate noninferiority of PEG3350 with electrolytes (PEG3350 + E) compared to PEG4000 without electrolytes (PEG4000). METHODS: In this double-blind trial, children aged 0.5 to 16 years with constipation, defined as a defecation frequency of <3 times per week, were randomized to receive either PEG3350 + E or PEG4000. Primary outcomes were change in total sum score (TSS) at week 52 compared to baseline, and dose range determination. TSS was the sum of the severity of 5 constipation symptoms rated on a 4-point scale (0-3). Noninferiority margin was a difference in TSS of ≤1.5 based on a 95%-confidence interval [CI]. Treatment success was defined as a defecation frequency of ≥3 per week with <1 episode of fecal incontinence. RESULTS: Ninety-seven subjects were included, of whom 82 completed the study. Mean reduction in TSS was -3.81 (95% CI: -4.96 to -2.65) and -3.74 (95%CI: -5.08 to -2.40), for PEG3350 + E and PEG4000, respectively. Noninferiority criteria were not met (maximum difference between groups: -1.81 to 1.68). Daily sachet use was: 0 to 2 years: 0.4 to 2.3 and 0.9 to 2.1; 2 to 4 years: 0.1 to 3.5 and 1.2 to 3.2; 4 to 8 years: 1.1 to 2.8 and 0.7 to 3.8; 8 to 16 years 0.6 to 3.7 and 1.0 to 3.7, in PEG3350 + E and PEG4000, respectively. Treatment success after 52 weeks was achieved in 50% and 45% of children, respectively (P = 0.69). Rates of adverse events were similar between groups, and no drug-related serious adverse events occurred. CONCLUSIONS: Noninferiority regarding long-term constipation-related symptoms of PEG3350 + E compared to PEG4000 was not demonstrated. However, analysis of secondary outcomes suggests similar efficacy and safety of these agents.

Functional nonretentive fecal incontinence: do enemas help?

OBJECTIVE: To assess the current treatment of functional nonretentive fecal incontinence, which consists of education, toilet training, and positive motivation. STUDY DESIGN: Patients, age 6 years and older, referred for fecal incontinence (FI) and diagnosed with functional nonretentive fecal incontinence were eligible candidates. Seventy-one children (76% boys, median age 9.3 years) were randomized to receive conventional therapy (control group) or conventional therapy in addition to daily enemas during 2 weeks. Treatment success was defined as <2 episodes of FI/month without use of enemas. RESULTS: At intake, the median FI frequency was 6.1 per week, whereas the median defecation frequency was 7.0 per week. At the end of the treatment period, the median number of FI episodes was significantly decreased in both groups: from 7.0 (IQR 4.0-11.5) to 1.0 (IQR 0.5-2.0) in the intervention group and from 6.0 (IQR 4.0-10) to 2.0 (IQR 0.5-3.5) in the control group. No statistical difference was found between the groups at the end of the treatment period (P = .08) nor during additional follow-up (average success rate 17% for both groups, P = .99). CONCLUSION: Temporarily application of additional rectal enemas did not significantly improve treatment success compared with conventional therapy alone.

Long-term prognosis for childhood constipation: clinical outcomes in adulthood.

OBJECTIVES: This study examines long-term prognoses for children with constipation in adulthood and identifies prognostic factors associated with clinical outcomes. METHODS: In a Dutch tertiary hospital, children (5-18 years of age) who were diagnosed as having functional constipation were eligible for inclusion. After a 6-week treatment protocol, prospective follow-up evaluations were conducted at 6 and 12 months and annually thereafter. Good clinical outcomes were defined as > or =3 bowel movements per week for > or =4 weeks, with < or =2 fecal incontinence episodes per month, irrespective of laxative use. RESULTS: A total of 401 children (260 boys; median age: 8 years [interquartile range: 6-9 years]) were included, with a median follow-up period of 11 years (interquartile range: 9-13 years). The dropout rate during follow-up was 15%. Good clinical outcomes were achieved by 80% of patients at 16 years of age. Thereafter, this proportion remained constant at 75%. Poor clinical outcomes at adult age were associated with: older age at onset (odds ratio [OR]: 1.15 [95% confidence interval [CI]: 1.02-1.30]; P = .04), longer delay between onset and first visit to our outpatient clinic (OR: 1.24 [95% CI: 1.10-1.40]; P = .001), and lower defecation frequency at study entry (OR: 0.92 [95% CI: 0.84-1.00]; P = .03). CONCLUSIONS: One-fourth of children with functional constipation continued to experience symptoms at adult age. Certain risk factors for poor clinical outcomes in adulthood were identified. Referral to a specialized clinic should be considered at an early stage for children who are unresponsive to first-line treatment.

Magnetic resonance imaging of the lumbosacral spine in children with chronic constipation or non-retentive fecal incontinence: a prospective study.

OBJECTIVE: To determine the prevalence of lumbosacral spine (LSS) abnormalities in children with defecation disorders, intractable constipation, or non-retentive fecal incontinence (NRFI) and evaluate whether LSS abnormalities on magnetic resonance imaging (MRI) are clinically detected by neurologic examination. STUDY DESIGN: MRI of the LSS and complete neurologic examination by a pediatric neurologist blinded to the MRI results were performed in patients with intractable defecation disorders. RESULTS: Patients with intractable constipation (n = 130; 76 males; median age, 11 years; range, 6-18 years), and patients with NRFI (n = 28; 18 males; median age, 10 years; range, 7-15 years) participated. One occult spina bifida (OSB) and 3 terminal filum lipomas were found in patients with a normal neurologic examination. One patient had a terminal filum lipoma and neurologic complaints. Gluteal cleft deviation was found in 3 of 4 patients with LSS abnormalities. Neurosurgical treatment was not required in any patient during the 12-week follow-up. CONCLUSIONS: MRI showed LSS abnormalities in 3% of patients with defecation disorders and normal neurologic examination, all of whom reported symptom relief at the 12-week follow-up without neurosurgical intervention. Thus, whether or not LSS abnormalities play a role in defecation disorders remains unclear.

Rectal fecal impaction treatment in childhood constipation: enemas versus high doses oral PEG.

OBJECTIVE: We hypothesized that enemas and polyethylene glycol (PEG) would be equally effective in treating rectal fecal impaction (RFI) but enemas would be less well tolerated and colonic transit time (CTT) would improve during disimpaction. METHODS: Children (4-16 years) with functional constipation and RFI participated. One week before disimpaction, a rectal examination was performed, symptoms of constipation were recorded, and the first CTT measurement was started. If RFI was determined, then patients were assigned randomly to receive enemas once daily or PEG (1.5 g/kg per day) for 6 consecutive days. During this period, the second CTT measurement was started and a child's behavior questionnaire was administered. Successful rectal disimpaction, defecation and fecal incontinence frequencies, occurrence of abdominal pain and watery stools, CTTs (before and after disimpaction), and behavior scores were assessed. RESULTS: Ninety-five patients were eligible, of whom 90 participated (male, n = 60; mean age: 7.5 +/- 2.8 years). Forty-six patients received enemas and 44 PEG, with 5 dropouts in each group. Successful disimpaction was achieved with enemas (80%) and PEG (68%; P = .28). Fecal incontinence and watery stools were reported more frequently with PEG (P < .01), but defecation frequency (P = .64), abdominal pain (P = .33), and behavior scores were comparable between groups. CTT normalized equally (P = .85) in the 2 groups. CONCLUSION: Enemas and PEG were equally effective in treating RFI in children. Compared with enemas, PEG caused more fecal incontinence, with comparable behavior scores. The treatments should be considered equally as first-line therapy for RFI.

No role for increased rectal compliance in pediatric functional constipation.

BACKGROUND & AIMS: Increased rectal compliance has been proposed to contribute to pediatric functional constipation (FC). We evaluated the clinical relevance of increased rectal compliance and assessed whether regular use of enemas improves rectal compliance in children with FC. METHODS: A prospective longitudinal study was conducted on children (8-18 years old) with FC. Pressure-controlled rectal distensions were performed at baseline and at 1 year. Rectal compliance was categorized into 3 groups: normal, moderately increased, or severely increased. Patients were randomly assigned to groups given conventional therapy or rectal enemas and conventional therapy. Clinical success was defined as >or=3 spontaneous defecations per week and fecal incontinence <1 per week. RESULTS: Baseline measurements were performed in 101 children (11.0 +/- 2.1 years); rectal compliance was normal in 36%, moderately increased in 40%, and severely increased in 24%. Patients with severely increased rectal compliance had lower defecation frequency (P = .03), more fecal incontinence (P = .04), and more rectal fecal impaction (P < .001). After 1 year, success values were similar between groups: 42% normal, 41% moderately increased, and 40% with severely increased compliance. Barostat studies performed after 1 year in 80 children (37 conventional therapy and 43 rectal enemas in addition to conventional therapy) revealed that rectal compliance had not changed in either group and had not improved in successfully treated patients. CONCLUSIONS: Constipated children with severely increased rectal compliance have severe symptoms. However, increased rectal compliance is not related to treatment failure. Regular use of enemas to avoid rectal fecal impaction does not improve rectal compliance in pediatric FC.

A randomized controlled trial of enemas in combination with oral laxative therapy for children with chronic constipation.

BACKGROUND & AIMS: After 5 years of intensive oral laxative use, up to 30% of constipated children still have an unsuccessful outcome. Children refractory to oral laxatives might benefit from regular rectal evacuation by enemas. This randomized controlled trial compared the effects of additional treatment with rectal enemas (intervention) with conventional treatment alone (oral laxatives, control) in severely constipated children. METHODS: In a tertiary hospital in the Netherlands, 100 children, aged 8-18 years, with functional constipation for at least 2 years were randomly assigned to intervention or control groups. The control group received education, behavioral strategies, and oral laxatives. The intervention group was also given 3 rectal enemas/week, reduced by 1 enema/week every 3 months. Outcome measures were defecation and fecal incontinence frequency and overall success at 12, 26, 39, and 52 weeks. Overall success was defined as 3 or more defecations/week and less than 1 fecal incontinence episode/week, irrespective of laxative use. RESULTS: Defecation frequency normalized in both groups but was significantly higher in the intervention group compared with controls at 26 and 52 weeks (5.6 vs 3.9/week, P = .02, and 5.3 vs 3.9/week, P = .02, respectively). There were no significant differences between groups in reduction of fecal incontinence episodes (P = .49) and overall success rates (P = .67). After 1 year of treatment, the overall success rate was 47.1% in the intervention group versus 36.1% in the control group. CONCLUSIONS: There is no additional effect of enemas compared with oral laxatives alone as maintenance therapy for severely constipated children.

Health-related quality of life in young adults with symptoms of constipation continuing from childhood into adulthood.

BACKGROUND: Children with functional constipation report impaired Health-related Quality of Life (HRQoL) in relation to physical complaints and long duration of symptoms. In about one third of children with constipation, symptoms continue into adulthood. Knowledge on HRQoL in adults with constipation persisting from childhood is lacking. OBJECTIVES: To assess HRQoL in adults with constipation from early childhood in comparison to that of their peers. Furthermore to gain insight into the specific social consequences related to continuing symptoms of constipation and/or fecal incontinence at adult age. METHODS: One HRQoL questionnaire and one self-developed questionnaire focusing on specific consequences of symptoms of constipation continuing into adulthood were administrated to 182 adults with a history of childhood constipation. Successful clinical outcome was defined as a defecation frequency three or more times per week with less than two episodes of fecal incontinence per month, irrespective of laxative use. HRQoL of both adults with unsuccessful and successful clinical outcome were compared to a control group of 361 peers from the general Dutch population. RESULTS: No differences in HRQoL were found between the whole study population and healthy peers, nor between adults with successful clinical outcome (n = 139) and the control group. Adults with an unsuccessful clinical outcome (n = 43) reported significantly lower HRQoL compared to the control group with respect to scores on bodily pain (mean +/- SD 77.4 +/- 19.6 versus 85.7 +/- 19.5, p = 0.01) and general health (67.6 +/- 18.8 versus 74.0 +/- 18.1, p = 0.04). Adults with an unsuccessful clinical outcome reported difficulties with social contact and intimacy (20% and 12.5%, respectively), related to their current symptoms. Current therapy in these adults was more often self-administered treatment (e.g. diet modifications) (60.4%) than laxatives (20.9%). CONCLUSION: Overall, young adults with constipation in childhood report a good quality of life, as HRQoL of adults with successful clinical outcome was comparable to that of their peers. However, when childhood constipation continues into adulthood, it influences HRQoL negatively with social consequences in 20% of these adults.

Health related quality of life in children with constipation-associated fecal incontinence.

OBJECTIVES: With a disease-specific questionnaire, this study aimed to evaluate health-related quality of life (HRQoL) in children with constipation in association with clinical characteristics. STUDY DESIGN: Children with constipation-associated fecal incontinence (n = 114), 8 to 18 years, filled out the Defecation Disorder List at a Dutch tertiary hospital. Correlations and linear regression analysis between clinical characteristics and scores on emotional and social functioning were calculated. Specific concerns of children were described by individual item scores of these domains. RESULTS: Higher frequency of fecal incontinence episodes was associated with lower emotional and social functioning. Linear regression analysis showed a significant association between social functioning and fecal incontinence, but the variance of the model was low (adjusted R(2)= 0.08). Between 70% to 80% of children were concerned about experiencing fecal incontinence unnoticeably and the attendant social consequences. Children did not report having fewer friends and participated well in social events. CONCLUSION: Lower HRQoL regarding disease-specific emotional and social functioning was reported in children with frequent episodes of constipation-associated fecal incontinence. However, other nonspecified factors may also influence HRQoL of these children. Most children reported relatively more emotional concerns than social consequences.

Behavioral therapy for childhood constipation: a randomized, controlled trial.

OBJECTIVE: It has been suggested that the addition of behavioral interventions to laxative therapy improves continence in children with functional fecal incontinence associated with constipation. Our aim was to evaluate the clinical effectiveness of behavioral therapy with laxatives compared with conventional treatment in treating functional constipation in childhood. PATIENTS AND METHODS: In this randomized, controlled trial conducted in a tertiary hospital in The Netherlands, 134 children aged 4 to 18 years with functional constipation were randomly assigned to 22 weeks (12 visits) of either behavioral therapy or conventional treatment. Primary outcomes were defecation frequency, fecal incontinence frequency, and success rate. Success was defined as defecation frequency of > or = 3 times per week and fecal incontinence frequency of < or = 1 times per 2 weeks irrespective of laxative use. Secondary outcomes were stool-withholding behavior and behavior problems. Outcomes were evaluated at the end of treatment and at 6-months follow-up. All of the analyses were done by intention to treat. RESULTS: Defecation frequency was significantly higher for conventional treatment. Fecal incontinence frequency showed no difference between treatments. After 22 weeks, success rates did not differ between conventional treatment and behavioral therapy (respectively, 62.3% and 51.5%), nor did it differ at 6 months of follow-up (respectively, 57.3% and 42.3%). The proportion of children withholding stools was not different between interventions. At follow-up, the proportion of children with behavior problems was significantly smaller for behavioral therapy (11.7% vs 29.2%). CONCLUSION: Behavioral therapy with laxatives has no advantage over conventional treatment in treating childhood constipation. However, when behavior problems are present, behavioral therapy or referral to mental health services should be considered.

The clinical effect of a new infant formula in term infants with constipation: a double-blind, randomized cross-over trial.

BACKGROUND: Nutrilon Omneo (new formula; NF) contains high concentration of sn-2 palmitic acid, a mixture of prebiotic oligosaccharides and partially hydrolyzed whey protein. It is hypothesized that NF positively affects stool characteristics in constipated infants. METHODS: Thirty-eight constipated infants, aged 3-20 weeks, were included and randomized to NF (n = 20) or a standard formula (SF; n = 18) in period 1 and crossed-over after 3 weeks to treatment period 2. Constipation was defined by at least one of the following symptoms: 1) defecation frequency < 3/week; 2) painful defecation; 3) abdominal or rectal palpable mass. RESULTS: Period 1 was completed by 35 infants. A significant increase in defecation frequency (NF: 3.5 pre versus 5.6/week post treatment; SF 3.6 pre versus 4.9/week post treatment) was found in both groups, but was not significantly different between the two formulas (p = 0.36). Improvement of hard stool consistency to soft stool consistency was found more often with NF than SF, but did not reach statistical significance (90% versus 50%; RR, 1.8; 95% CI, 0.9-3.5; p = 0.14). No difference was found in painful defecation or the presence of an abdominal or rectal mass between the two groups. Twenty-four infants completed period 2. Only stool consistency was significantly different between the two formulas (17% had soft stools on NF and hard stools on SF; no infants had soft stools on SF and hard stools on NF, McNemar test p = 0.046). CONCLUSION: The addition of a high concentration sn-2 palmitic acid, prebiotic oligosaccharides and partially hydrolyzed whey protein resulted in a strong tendency of softer stools in constipated infants, but not in a difference in defecation frequency. Formula transition to NF may be considered as treatment in constipated infants with hard stools.

Functional nonretentive fecal incontinence in children.

Fecal incontinence, the loss of feces in the underwear after age 4 years, is a frustrating phenomenon for children and their parents. It is difficult to treat, presenting as a single symptom without any organic cause or signs of constipation. This review addresses the definition of functional nonretentive fecal incontinence and provides an overview of its epidemiology, pathophysiology, clinical features, diagnostic work-up and prognosis.

The value of the abdominal radiograph in children with functional gastrointestinal disorders.

Functional gastrointestinal disorder is a common problem in childhood. The symptoms vary from a relative mild gastrointestinal problem such as abdominal pain or infrequent defecation to severe problems with fecal impaction and fecal incontinence. The aim of this review is to describe and evaluate the value of the different existing methods to assess fecal loading on an abdominal radiograph with or without the use of radio-opaque markers in the diagnosis of functional abdominal pain, functional constipation and functional non-retentive fecal incontinence. In our opinion, the abdominal radiograph has limited value in the diagnostic work-up of children with functional gastrointestinal disorders.

No indications for altered essential fatty acid metabolism in two murine models for cystic fibrosis.

A deficiency of essential fatty acids (EFA) is frequently described in cystic fibrosis (CF), but whether this is a primary consequence of altered EFA metabolism or a secondary phenomenon is unclear. It was suggested that defective long-chain polyunsaturated fatty acid (LCPUFA) synthesis contributes to the CF phenotype. To establish whether cystic fibrosis transmembrane conductance regulator (CFTR) dysfunction affects LCPUFA synthesis, we quantified EFA metabolism in cftr-/-CAM and cftr+/+CAM mice. Effects of intestinal phenotype, diet, age, and genetic background on EFA status were evaluated in cftr-/-CAM mice, DeltaF508/DeltaF508 mice, and littermate controls. EFA metabolism was measured by 13C stable isotope methodology in vivo. EFA status was determined by gas chromatography in tissues of cftr-/-CAM mice, DeltaF508/DeltaF508 mice, littermate controls, and C57Bl/6 wild types fed chow or liquid diet. After enteral administration of [13C]EFA, arachidonic acid (AA) and docosahexaenoic acid (DHA) were equally 13C-enriched in cftr-/-CAM and cftr+/+CAM mice, indicating similar EFA elongation/desaturation rates. LA, ALA, AA, and DHA concentrations were equal in pancreas, lung, and jejunum of chow-fed cftr-/-CAM and DeltaF508/DeltaF508 mice and controls. LCPUFA levels were also equal in liquid diet-weaned cftr-/-CAM mice and littermate controls, but consistently higher than in age- and diet-matched C57Bl/6 wild types. We conclude that cftr-/-CAM mice adequately absorb and metabolize EFA, indicating that CFTR dysfunction does not impair LCPUFA synthesis. A membrane EFA imbalance is not inextricably linked to the CF genotype. EFA status in murine CF models is strongly determined by genetic background.