Cost-effectiveness of physiotherapy in childhood functional constipation: a randomized controlled trial in primary care.

OBJECTIVE: Health care expenditures for children with functional constipation (FC) are high, while conservative management is successful in only 50% of the children. The aim is to evaluate whether adding physiotherapy to conventional treatment (CT) is a cost-effective strategy in the management of children with FC aged 4-18 years in primary care. METHODS: A cost-effectiveness analysis was performed alongside a randomized controlled trial (RCT) with 8-month follow-up. Costs were assessed from a societal perspective, effectiveness included both the primary outcome (treatment success defined as the absence of FC and no laxative use) and the secondary outcome (absence of FC irrespective of laxative use). Uncertainty was assessed by bootstrapping and cost-effectiveness acceptability curves (CEACs) were displayed. RESULTS: One hundred and thirty-four children were randomized. The incremental cost-effectiveness ratio (ICER) for one additional successfully treated child in the physiotherapy group compared with the CT group was €24,060 (95% confidence interval [CI] €-16,275 to €31,390) and for the secondary outcome €1,221 (95% CI €-12,905 to €10,956). Subgroup analyses showed that for children with chronic laxative use the ICER was €2,134 (95% CI -24,975 to 17,192) and €571 (95% CI 11 to 3,566), respectively. At a value of €1,000, the CEAC showed a probability of 0.53 of cost-effectiveness for the primary outcome, and 0.90 for the secondary outcome. CONCLUSIONS: Physiotherapy added to CT as first-line treatment for all children with FC is not cost-effective compared with CT alone. Future studies should consider the cost-effectiveness of physiotherapy added to CT in children with chronic laxative use. TRIAL REGISTRATION: The RCT is registered in the Netherlands Trial Register (NTR4797), on the 8th of September 2014. The first child was enrolled on the 2nd of December 2014. https://www.trialregister.nl/trial/4654.

Physiotherapy plus conventional treatment versus conventional treatment only in the treatment of functional constipation in children: design of a randomized controlled trial and cost-effectiveness study in primary care.

BACKGROUND: Our aim was to design a study to evaluate the effectiveness and cost-effectiveness of adding physiotherapy to conventional treatment for children with functional constipation in primary care. Physiotherapy is focusing on improving the coordination between the pelvic floor and abdominal musculature during bowel movement, while conventional treatment is mainly focusing on symptomatic relief of symptoms, therefore, we expect the effects of physiotherapy will be more sustainable than the effects of conventional treatment. In this paper we describe the final study design and how the design was adapted, to overcome recruitment problems. METHODS: We designed a randomized controlled trial of children aged 4-17 years with functional constipation diagnosed by a general practitioner or pediatrician. Children in the intervention group received physiotherapy plus conventional treatment, and those in the control group received conventional treatment only. Follow-up measurements took place at 4 and 8 months. The primary outcome was treatment success defined according to the Rome-III criteria as the absence of functional constipation, with no laxative use. Secondary outcomes were absence of functional constipation irrespective of laxative use, quality of life, global perceived effect, and costs. Children were recruited from September 2014 to February 2017. Initially, we aimed to include children with recent symptom onset. However, in the first phase of enrollment we were confronted with an unforeseen recruitment problem: many children and their parents refused randomization because physiotherapy was considered too burdensome for the stage of disease. Therefore, we decided to also include children with a longer duration of symptoms. In total 134 children were included. DISCUSSION: The target number of participants is achieved. Therefore, the results may change thinking about the management of functional constipation in children. TRAIL REGISTRATION: Netherlands Trial Register ( NTR4797 ), registered 8 September 2014.

Effectiveness and cost-effectiveness of pessary treatment compared with pelvic floor muscle training in older women with pelvic organ prolapse: 2-year follow-up of a randomized controlled trial in primary care.

OBJECTIVE: We investigated the effectiveness and cost-effectiveness of pessary treatment compared with pelvic floor muscle training (PFMT) in women with pelvic organ prolapse over a 2-year period. METHODS: Randomized controlled trial with women (≥55 y) with symptomatic pelvic organ prolapse, identified by screening. Participants were recruited from 20 primary care practices (October 2009-December 2012). Primary outcome was the difference in change of pelvic floor symptoms (PFDI-20 score) between groups over 24 months. Secondary outcomes included prolapse, urinary, and anorectal symptoms; quality of life; costs; sexual functioning; prolapse stage; pelvic floor muscle function; and participants' perceived symptom improvement. RESULTS: There was a nonsignificant difference in the primary outcome between pessary treatment (n = 82) and PFMT (n = 80) with a mean difference of -3.7 points (95% CI, -12.8 to 5.3; P = 0.42) in favor of pessary treatment. A significantly greater improvement in the prolapse symptom score was, however, seen with pessary treatment (mean difference -3.2 points [95% CI, -6.3 to -0.0; P = 0.05]). Direct medical costs over the 2-year study were $309 and $437 per person for pessary treatment and PFMT, respectively. CONCLUSIONS: In older women with symptomatic prolapse, there was no significant difference between pessary treatment and PFMT in reducing pelvic floor symptoms, but specific prolapse-related symptoms did improve more with pessary treatment. Pessary treatment was preferable in the cost-effectiveness analysis. When counseling women for prolapse treatment it should, however, be taken into account that pessary fitting fails in a considerable portion of women and that pessary treatment was associated with more side effects compared with PFMT.

Prevalence, characteristics, and management of childhood functional abdominal pain in general practice.

OBJECTIVE: To (i) describe the proportion of children presenting with abdominal pain diagnosed by the GP as functional abdominal pain (GPFAP); (ii) evaluate the association between patient and disease characteristics and GPFAP; (iii) describe diagnostic management by the GP in children presenting with abdominal pain, and (iv) evaluate whether children with GPFAP fulfill diagnostic criteria for functional abdominal pain (FAP) as described in current literature: chronic abdominal pain (CAP) and the Rome III criteria (PRC-III) for abdominal pain-related functional gastrointestinal disorders (FGID). DESIGN: Cross-sectional study. SETTING: General practices in the Netherlands. SUBJECTS: 305 children aged 4-17 years consulting for abdominal pain. MAIN OUTCOME MEASURES: GPFAP, CAP, FGIDs. RESULTS: 89.2% of children were diagnosed with GPFAP. Headaches and bloating were positively associated with GPFAP whereas fever and > 3 red flag symptoms were inversely associated. Additional diagnostic tests were performed in 26.8% of children. Less than 50% of all children with GPFAP fulfilled criteria for CAP and FGIDs; in 47.9% of patients the duration of symptoms at presentation was less than three months. CONCLUSIONS: In almost 90% of children included in this study the GP suspected no organic cause for the abdominal pain. GPs diagnose FAP in children without alarm symptoms and order diagnostic testing in one out of four children presenting with abdominal pain. No difference was found in GPs' management between children with a diagnosis of GPFAP and other diagnoses. Only about half of the children with a GP diagnosis of FAP fulfilled time-criteria of FAP as defined in the literature.

Childhood nonspecific abdominal pain in family practice: incidence, associated factors, and management.

PURPOSE: Nonspecific abdominal pain (NSAP) is a common complaint in childhood. In specialist care, childhood NSAP is considered to be a complex and time-consuming problem, and parents are hard to reassure. Little is known about NSAP in family practice, but the impression is that family physicians consider it to be a benign syndrome needing little more than reassurance. This discrepancy calls for a better understanding of NSAP in family practice. METHODS: Data were obtained from the Second Dutch National Survey of General Practice (2001). Using registration data of 91 family practices, we identified children aged 4 to 17 years with NSAP. We calculated the incidence, and we studied factors associated with childhood NSAP, referrals, and prescriptions. RESULTS: The incidence of NSAP was 25.0 (95% confidence interval [CI], 23.7-26.3) per 1,000 person years. Most children (92.7%) with newly diagnosed NSAP (N = 1,480) consulted their doctor for this condition once or twice. Factors independently associated with NSAP were female sex (odds ratio [OR] = 1.4; 95% CI, 1.3-1.5), nongastrointestinal-nonspecific somatic symptoms (OR = 1.3; 95% CI, 1.1-1.5), and health care use (OR = 1.04; 95% CI, 1.03-1.05). When NSAP was diagnosed at the first visit, 3% of the patients were referred to specialist care, and 1% received additional testing. Family physicians prescribed medication in 21.3% of the visits for NSAP. CONCLUSIONS: Childhood NSAP is a common problem in family practice. Most patients visit their doctor once or twice for this problem. Family physicians use little additional testing and make few referrals in their management of childhood NSAP. Despite the lack of evidence for effectiveness, family physicians commonly prescribe medication for NSAP.