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 for Children with Functional Constipation: A Pragmatic Randomized Controlled Trial in Primary Care.

OBJECTIVE: To determine the effectiveness of physiotherapy plus conventional treatment compared with conventional treatment alone for the treatment of functional constipation in children age 4-17 years in primary care. STUDY DESIGN: Pragmatic randomized controlled trial with 8 months follow-up. Primary care physicians recruited children diagnosed with functional constipation (n = 234), and pediatricians recruited newly referred children with a diagnosis of functional constipation (n = 11). Conventional treatment comprised toilet training, nutritional advice, and laxative prescribing, whereas physiotherapy focused on resolving dyssynergic defecation. The primary outcome was treatment success over 8 months, defined as the absence of functional constipation (Rome III criteria) without laxative use. Secondary outcomes included the absence of functional constipation irrespective of continuation of laxative use and global perceived treatment effect. RESULTS: Children were allocated to conventional treatment plus physiotherapy or conventional treatment alone (67 per group), mean (SD) age was 7.6 (3.5) years. Results of longitudinal analyses in the intention-to-treat population showed that the treatment success percentage was not statistically improved by adding physiotherapy to conventional treatment (adjusted relative risk [aRR] 0.80, 95% CI 0.44-1.30). At 4 months, fewer children receiving physiotherapy had treatment success (17%) than children receiving conventional treatment alone (28%), but this had equalized by 8 months (42% and 41%, respectively). The percentage of children without functional constipation, irrespective of continuation of laxative use, was not statistically different between groups over 8 months (aRR 1.12, 95% CI 0.82-1.34). Notably, parents reported significantly more global symptom improvement after physiotherapy than after conventional treatment (aRR 1.40; 95% CI 1.00-1.73). CONCLUSIONS: We find no evidence to recommend physiotherapy for all children with functional constipation in primary care. TRIAL REGISTRATION: Netherlands Trial Registry: NTR4797.

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.

Dientamoeba fragilis colonization is not associated with gastrointestinal symptoms in children at primary care level.

BACKGROUND: Dientamoeba fragilis is commonly identified in children in primary care and is suspected to cause gastrointestinal disease. OBJECTIVE: To determine the association between D. fragilis colonization and gastrointestinal symptoms in children. METHODS: We performed a cross-sectional study with children who presented in primary care with gastrointestinal symptoms. The associations between D. fragilis colonization and specific symptoms were explored by means of logistic regression analyses. Asymptomatic siblings of these cases were invited as control subjects for a case-control analysis, where we explored the association between D. fragilis and gastrointestinal symptoms with conditional logistic regression analysis. RESULTS: In the cross-sectional study, 107 children were included. Their median age was 9 years (interquartile range = 6-12) and 38 (35.5%) were boys. Colonization of D. fragilis was present in 59 children (55.1%). The absence of D. fragilis was associated with soft to watery stool [odds ratio (OR) = 0.29; 95% confidence interval (CI) = 0.10-0.85], chronic diarrhoea (OR = 0.42; 95% CI = 0.18-0.97) and fatigue (OR = 0.45; 95% CI = 0.20-0.99). The case-control analyses included 44 children in each group. Dientamoeba fragilis colonization was not observed more often in cases than in controls after adjustment for age and sex (OR = 1.02; 95% CI = 0.28-3.65). CONCLUSION: Dientamoeba fragilis is a common parasite in children with and without gastrointestinal symptoms. The anomalous finding of the association between the absence of D. fragilis with soft to watery stools, chronic diarrhoea and fatigue are inexplicable. Our study suggests that D. fragilis colonization does not increase the risk for gastrointestinal symptoms.

Evaluation of point-of-care test calprotectin and lactoferrin for inflammatory bowel disease among children with chronic gastrointestinal symptoms.

Background: Faecal calprotectin is considered to be a valid test for ruling out inflammatory bowel disease (IBD) in children with chronic gastrointestinal symptoms in specialist care. In contrast, faecal lactoferrin has higher specificity. The recent availability of both as point-of-care tests (POCTs) makes them attractive for use in primary care. Objective: To evaluate the test characteristics of calprotectin and lactoferrin POCTs for diagnosing IBD in symptomatic children. Methods: We defined two prospective cohorts of children with chronic gastrointestinal symptoms: (i) children presenting to primary care (primary care cohort); (ii) children referred for specialist care (referred cohort). Baseline POCT results were compared with the outcome of either endoscopic assessment or 12 months follow-up. Clinicians were blinded to the POCT results. Results: In the primary care cohort, none of the 114 children had IBD, and the calprotectin and lactoferrin POCTs had specificities of 0.95 (0.89-0.98) and 0.98 (0.93-0.99), respectively. In the referred cohort, 17 of the 90 children had IBD: the sensitivity of POCT calprotectin and POCT lactoferrin were both 0.94 (0.72-0.99); and the specificity was 0.93 (0.84-0.97) and 0.99 (0.92-1.00), respectively. The POCT calprotectin could reduce the referral rate by 76% and POCT lactoferrin by 81%, while missing one child with IBD (6%). Conclusion: A diagnostic test strategy in primary care using a simple POCT calprotectin or lactoferrin has the potential to reduce the need for referral for further diagnostic work-up in specialist care, with a low risk of missing a child with IBD.

Incidence and treatment of heavy menstrual bleeding in general practice.

Background: Heavy menstrual bleeding (HMB) is a common problem in women of reproductive age. In 2008, the Dutch guideline for general practitioners (GPs) was revised to recommend the levonorgestrel intrauterine system (LNG-IUS) as a first-choice treatment for HMB. However, GP prescribing practices have not been studied in depth. Objectives: To investigate the incidence and initial treatment of HMB in general practice, and to identify if there were changes in prescribing practices after the revision of the national guideline in 2008. Methods: Retrospective analysis of data from the Registration Network Groningen, the Netherlands. We selected data for prescriptions and referrals related to women consulting their GP for HMB between 2004 and 2013. We calculated the incidence rates and investigated potential trends in prescribing over time, with particular attention to the prescribing of LNG-IUS. Results: Over 10 years, 881 women consulted their GP for HMB, with a mean annual incidence of 9.3 per 1000 person years (95% confidence interval: 8.5-10.2). Most women received hormonal treatment (406/881; 46%) within three months of diagnosis, but many (387/881; 44%) received no medication. The LNG-IUS was prescribed for 2.4%, but there was no significant increase in the number of prescriptions over time. Conclusion: In this cohort, most women with HMB were treated with oral hormone therapy, and few received the LNG-IUS. If patients are to benefit from the LNG-IUS, further research is needed into the reasons for this lack of change in prescribing practices.

Diagnostic Accuracy of Fecal Calprotectin for Pediatric Inflammatory Bowel Disease in Primary Care: A Prospective Cohort Study.

PURPOSE: In specialist care, fecal calprotectin (FCal) is a commonly used noninvasive diagnostic test for ruling out inflammatory bowel disease (IBD) in children with chronic gastrointestinal symptoms. The aim of this study was to evaluate the diagnostic accuracy of FCal for IBD in symptomatic children in primary care. METHODS: We studied 2 prospective cohorts of children with chronic diarrhea, recurrent abdominal pain, or both: children initially seen in primary care (primary care cohort) and children referred to specialist care (referred cohort). FCal (index test) was measured at baseline and compared with 1 of the 2 reference standards for IBD: endoscopic assessment or 1-year follow-up. Physicians were blinded to FCal results, and values greater than 50 µg/g feces were considered positive. We determined specificity in the primary care cohort and sensitivity in the referred cohort. RESULTS: None of the 114 children in the primary care cohort ultimately received a diagnosis of IBD. The specificity of FCal in the primary care cohort was 0.87 (95% CI, 0.80-0.92). Among the 90 children in the referred cohort, 17 (19%) ultimately received a diagnosis of IBD. The sensitivity of FCal in the referred cohort was 0.99 (95% CI, 0.81-1.00). CONCLUSIONS: The findings of this study suggest that a positive FCal result in children with chronic gastrointestinal symptoms seen in primary care is not likely to be indicative of IBD. A negative FCal result is likely to be a true negative, which safely rules out IBD in children in whom a primary care physician considers referral to specialist care.

Avoid Endoscopy in Children With Suspected Inflammatory Bowel Disease Who Have Normal Calprotectin Levels.

In children with suspected inflammatory bowel disease, adding calprotectin stool testing to the screening strategy has been recommended to distinguish organic from nonorganic disease. In this cohort study with historical controls, we could not confirm that screening with stool calprotectin improves the diagnostic yield (ratio inflammatory bowel disease-positive endoscopies and total number of endoscopies); however, in patients with normal fecal calprotectin levels (<50 µg/g) endoscopic and histological abnormalities were not seen. We propose to refrain from endoscopy when stool calprotectin levels are normal.

Predictors of chronic abdominal pain affecting the well-being of children in primary care.

PURPOSE: Abdominal pain is a frequent symptom among children but is rarely associated with organic disease. Although it may persist for years, no factors have been identified that predict its prognosis. Our aim was to determine whether patient characteristics at initial consultation can predict chronic abdominal pain severe enough to influence the child's well-being at 1 year of follow-up. METHODS: We conducted this prospective cohort study in primary care, including consecutive children aged 4 to 17 years seen for abdominal pain by their family physician. Multivariate logistic regression analysis was used to identify prognostic factors that predicted chronic abdominal pain 1 year later. Discriminative ability of identified predictors was assessed using the area under the receiver operating characteristic curve and explained variance. RESULTS: The risk of having chronic abdominal pain at 1 year of follow-up was 37.1% in the cohort overall. Increasing age, waking up at night with pain, high levels of other somatic complaints, and chronic abdominal pain at baseline independently predicted chronic abdominal pain at 1 year. These predictors had a poor to moderate discriminative ability, however; the area under the receiver operating characteristic curve was only 0.69, and the predictors collectively explained only 14.3% of variance in the development of chronic abdominal pain. The absolute risk ranged from 19.4% among children having none of the predictors to 65.5% among children having 3 or 4 predictors. CONCLUSIONS: Chronic abdominal pain sufficient to affect well-being is common among children initially seen for abdominal pain by family physicians. Although the risk of this outcome increases with number of predictors, these predictors are of limited value in identifying children in whom pain will become chronic, suggesting that other, as yet unidentified factors play an important role.

Prognosis of abdominal pain in children in primary care--a prospective cohort study.

PURPOSE: Abdominal pain is a common complaint in children. Because few data exist on its natural history, we wanted to investigate the prognosis of abdominal pain in children in general practice. METHODS: In a prospective cohort study of children (aged 4 to 17 years) complaining of abdominal pain, follow-up was at 3, 6, 9, and 12 months using standardized questionnaires. The primary outcome measure was chronic abdominal pain: abdominal pain at least 1 time a month during at least 3 consecutive months that had an impact on daily activities. Prevalence, incidence, and duration of chronic abdominal pain were assessed. RESULTS: Three hundred five children (116 boys, 189 girls), with a median age of 7.8 years (interquartile range [IQR] = 5.7-10.5 years) were included. Chronic abdominal pain was present in 142 (46.6%) children at an initial visit to the primary care physician for this complaint. During follow-up, 78.7% fulfilled the criteria for chronic abdominal pain at 1 or more follow-up points. Among 163 children at risk for developing chronic abdominal pain, the cumulative incidence of chronic abdominal pain was 60.1% (95% CI, 52.1%-67.7%) and was higher in girls than in boys (RR = 1.23; 95% CI, 0.94-1.61). Median duration of abdominal pain was 7.5 months (IQR = 4.5-12.0 months). Children aged 10 to 17 years had the longest duration of abdominal pain (median = 9.0 months; IQR = 7.5-12.4 months). Children with symptoms of irritable bowel syndrome seemed to have a less favorable prognosis compared with children with symptoms of functional dyspepsia or functional abdominal pain. CONCLUSIONS: The presence and development of chronic abdominal pain is common and of long duration among children consulting in primary care for abdominal pain. These poor outcome data warrant follow-up.

Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding: a multicentre randomised controlled trial.

BACKGROUND: Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, which saves costs, but has considerable failure rates. As an alternative, endometrial ablation is also very effective, but this treatment has to be performed by a gynaecologist. Due to lack of direct comparison of LNG-IUS with endometrial ablation, there is no evidence based preferred advice for the use of one of these treatment possibilities. METHOD/DESIGN: A multicenter randomised controlled trial, organised in a network infrastructure in the Netherlands in which general practitioners and gynaecologists collaborate. DISCUSSON: This study, considering both effectiveness and cost effectiveness of LNG-IUS versus endometrial ablation may well improve care for women with heavy menstrual bleeding. TRIAL REGISTRATION: Dutch trial register, number NTR2984.

Challenges in diagnostic accuracy studies in primary care: the fecal calprotectin example.

BACKGROUND: Low disease prevalence and lack of uniform reference standards in primary care induce methodological challenges for investigating the diagnostic accuracy of a test. We present a study design that copes with these methodological challenges and discuss the methodological implications of our choices, using a quality assessment tool for diagnostic accuracy studies (QUADAS-2). DESIGN: The study investigates the diagnostic value of fecal calprotectin for detecting inflammatory bowel disease in children presenting with chronic gastrointestinal symptoms in primary care. It is a prospective cohort study including two cohorts of children: one cohort will be recruited in primary care and the other in secondary/tertiary care. Test results of fecal calprotectin will be compared to one of the two reference standards for inflammatory bowel disease: endoscopy with histopathological examination of mucosal biopsies or assessment of clinical symptoms at 1-year follow-up. DISCUSSION: According to QUADAS-2 the use of two reference standards and the recruitment of patients in two populations may cause differential verification bias and spectrum bias, respectively. The clinical relevance of this potential bias and methods to adjust for this are presented. This study illustrates the importance of awareness of the different kinds of bias that result from choices in the design phase of a diagnostic study in a low prevalence setting. This approach is exemplary for other diagnostic research in primary care.

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.

The course of mental health problems in children presenting with abdominal pain in general practice.

OBJECTIVE: To investigate the course of mental health problems in children presenting to general practice with abdominal pain and to evaluate the extent to which abdominal pain characteristics during follow-up predict the presence of mental health problems at 12 months' follow-up. DESIGN: A prospective cohort study with one-year follow-up. SETTING: 53 general practices in the Netherlands, between May 2004 and March 2006. SUBJECTS: 281 children aged 4-17 years. MAIN OUTCOME MEASURES: The presence of a depressive problem, an anxiety problem, and multiple non-specific somatic symptoms at follow-up and odds ratios of duration, frequency, and severity of abdominal pain with these mental health problems at follow-up. RESULTS: A depressive problem persisted in 24/74 children (32.9%; 95% CI 22.3-44.9%), an anxiety problem in 13/43 (30.2%; 95% CI 17.2-46.1%) and the presence of multiple non-specific somatic symptoms in 75/170 children (44.1%; 95% CI 36.7-51.6%). None of the abdominal pain characteristics predicted a depressive or an anxiety problem at 12 months' follow-up. More moments of moderate to severe abdominal pain predicted the presence of multiple non-specific somatic symptoms at follow-up. CONCLUSIONS: In one-third of the children presenting to general practice for abdominal pain, anxiety and depressive problems persist during one year of follow-up. Characteristics of the abdominal pain during the follow-up period do not predict anxiety or depressive problems after one-year follow-up. We recommend following over time children seen in primary care with abdominal pain.

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.

Prognostic factors for persistence of chronic abdominal pain in children.

OBJECTIVES: The aim of the study was to identify prognostic factors for the persistence of chronic abdominal pain (CAP) in children. MATERIALS AND METHODS: For this systematic review, MEDLINE, EMBASE, and PsycINFO were searched up to June 2008 for prospective follow-up studies of pediatric CAP as defined by the criteria of Apley, von Baeyer, or the Rome committee. The outcome measure of interest was persistence of CAP. Persistent CAP was considered only when the abdominal pain of children with CAP persisted during follow-up at the same level of frequency and severity. For each study the risk for bias was assessed. The evidence for prognostic factors was summarized according to a best-evidence synthesis. RESULTS: Eight studies, which examined 17 prognostic factors, were included. Moderate evidence was found that having a parent with gastrointestinal symptoms predicts the persistence of CAP. Strong evidence was found for no association between female sex and the duration of CAP, and moderate evidence that the severity of abdominal pain does not predict persistence of CAP. There is conflicting evidence as to whether psychological factors prevent, or have no relation with, persistence of CAP. CONCLUSIONS: Because there are few prognostic follow-up studies on pediatric CAP, the evidence for prognostic factors is limited. Physicians should ask about parental gastrointestinal problems because this is a risk factor for persistence of CAP in children. The hypothesis that psychological factors of the child predict persistence of CAP is not supported by evidence from the follow-up studies.

Discontinuation of alpha-blocker therapy in men with lower urinary tract symptoms: a systematic review and meta-analysis.

OBJECTIVES: We aimed to synthesise the available data for the effect of stopping alpha-blocker therapy among men with lower urinary tract symptoms. The focus was on symptom, uroflowmetry and quality of life outcomes, but we also reviewed the adverse events (AEs) and the number of patients who restarted therapy. DATA SOURCES: We searched MEDLINE/PubMed, EMBASE/Ovid and The Cochrane Central Register of Controlled Trials from inception to May 2018. ELIGIBILITY CRITERIA: We selected studies regardless of study design in which men were treated with an alpha-blocker for at least 3 months and in which the effects of alpha-blocker discontinuation were subsequently studied. Only controlled trials were used for the primary objective. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data and assessed the risk of bias for the controlled studies only using the Cochrane Collaboration's tool for assessing risk of bias. Data were pooled using random-effects meta-analyses. RESULTS: We identified 10 studies (1081 participants) assessing the primary objective. Six studies (733 participants) assessed differences in AEs between continuation and discontinuation, and six studies (501 participants) reported the numbers of subjects that restarted treatment after discontinuation. No studies in primary care were identified. After discontinuing monotherapy, symptom scores increased and peak flow rates decreased at 3 and 6 months, but not at 12 months; however, neither parameter changed when alpha-blockers were stopped during combination therapy. Small differences in post-void residual volumes and quality of life scores were considered clinically irrelevant. We also found that 0%-49% of patients restarted after stopping alpha-blocker therapy and that AEs did not increase with discontinuation. CONCLUSIONS: Discontinuing alpha-blocker monotherapy leads to a worsening compared with continuing therapy. Discontinuing the alpha-blocker after combination therapy had no significant effects on outcomes in either the short or long term. Discontinuation may be appropriate for the frail, elderly or those with concomitant illness or polypharmacy. However, studies in primary care are lacking. PROSPERO REGISTRATION NUMBER: CRD42016032648.

Is the hymen a suitable cut-off point for clinically relevant pelvic organ prolapse?

OBJECTIVES: The primary objective was to evaluate the ability of different anatomic cut-off points, as established in specialist urogynecology populations, to identify clinically relevant prolapse in a population of postmenopausal women with pelvic floor symptoms recruited from primary care. STUDY DESIGN: Cross-sectional study among 890 women (≥55 years) screened for pelvic floor symptoms. MAIN OUTCOME MEASURES: The Pelvic Floor Distress Inventory 20 was used to measure symptoms, and the Pelvic Organ Prolapse Quantification (POP-Q) system was used to assess prolapse. Areas under the curves, sensitivity, and specificity were calculated for the hymen as a cut-off point for symptomatic prolapse of the anterior and posterior vaginal wall. For the apical compartment, a cut-off point of -5cm relative to the hymen was used. RESULTS: Vaginal bulging was the only symptom reported more often with increasing POP-Q stages. Areas under the curves (95% confidence intervals) to discriminate between women with and without vaginal bulging symptoms were 0.66 (0.61-0.72), 0.56 (0.50-0.63), and 0.61 (0.55-0.66) for the anterior (Ba), posterior (Bp) and apical (C) compartment, respectively. When the hymen was used as the cut-off point, Ba had a sensitivity of 38.1% and a specificity of 82.4%, and Bp had a sensitivity of 13.3% and a specificity of 96.5%. For C, the cut-off point of -5cm relative to the hymen had a sensitivity of 37.9% and a specificity of 73.1%. CONCLUSIONS: The anatomic cut-off points for clinically relevant prolapse established in the specialist urogynecology population cannot adequately identify symptomatic prolapse in a population of postmenopausal women with pelvic floor symptoms recruited from primary care.