The effect of offering a third-trimester routine ultrasound on pregnancy-specific anxiety and mother-to-infant bonding in low-risk women: A pragmatic cluster-randomized controlled trial.

BACKGROUND: Third-trimester routine ultrasounds are increasingly offered to monitor fetal growth. In addition to limited evidence for its clinical effectiveness, little is known about its importance for pregnancy-specific anxiety and mother-to-infant bonding. METHODS: 1275 low-risk women participated in a Dutch nationwide pragmatic cluster-randomized trial and answered questionnaires on pregnancy-specific anxiety (PRAQ-R) and prenatal mother-to-infant bonding (MAAS) before and after a third-trimester routine ultrasound was offered to the intervention group. Linear mixed model regression analyses were performed to examine the effect of offering a third-trimester routine ultrasound on pregnancy-specific anxiety and mother-to-infant bonding. In addition, we examined whether the effect depended on maternal background characteristics and level of satisfaction with the ultrasound procedure. RESULTS: We found no effect of offering a third-trimester routine ultrasound on pregnancy-specific anxiety and mother-to-infant bonding. However, interaction analyses showed that women with high levels of depressive symptoms at baseline and women who were very satisfied with the ultrasound procedure benefited somewhat more from offering a third-trimester routine ultrasound in terms of mother-to-infant bonding compared with women with low or no depressive symptoms, or less satisfied women. CONCLUSIONS: The relationship between offering a third-trimester routine ultrasound with pregnancy-specific anxiety and mother-to-infant bonding is limited. A beneficial effect only applies to some subgroups of women. This implies that, in terms of psychological outcomes, there are no counterarguments to implementing a third-trimester routine ultrasound. Strong evidence for offering all pregnant women a third-trimester routine ultrasound for psychological reasons, however, is lacking.

Development of an online personalized self-management intervention for men with uncomplicated LUTS.

AIMS: To develop an online platform to facilitate evidence-based self-management of lower urinary tract symptoms (LUTS) in men. METHODS: Using the PubMed database (search until January 2017) and relevant guidelines, we reviewed evidence for the self-management of LUTS and identified suitable components for the intervention. Next, we built an algorithm that provided individualized advice based on patient characteristics and symptoms for use on an online platform. Men with LUTS tested the usability of the intervention and provided feedback. Finally, we surveyed urologists and general practitioners to identify potential areas for improvement of the intervention. RESULTS: We identified nine self-help interventions from 48 eligible publications. These were as follows: information and education about LUTS, pelvic floor muscle training, bladder training, urethral milking, double voiding, caffeine management, alcohol management, fluid management, and exercise advice. The level of evidence for each item was low due to the paucity of research available. Six men with LUTS reported difficulties understanding and completing the frequency-volume chart online. The 158 surveyed physicians agreed (≥50% positive ratings) on the inclusion of seven advice items, but not for double voiding and fluid management. Respondents noted that some advice should be provided to all men with LUTS, while other advice should only be presented to certain groups. Some recommendations for additions were offered. CONCLUSIONS: Despite a lack of evidence for the self-management advice, physicians agreed with most of the included advice. The online platform needs further development. Therefore, adjustments will be made and we will assess its impact in future studies.

The impact of a mobile application-based treatment for urinary incontinence in adult women: Design of a mixed-methods randomized controlled trial in a primary care setting.

AIMS: We aim to assess whether a purpose-developed mobile application (app) is non-inferior regarding effectiveness and cost-effective when used to treat women with urinary incontinence (UI), as compared to care as usual in Dutch primary care. Additionally, we will explore the expectations and experiences of patients and care providers regarding app usage. METHODS: A mixed-methods study will be performed, combining a pragmatic, randomized-controlled, non-inferiority trial with an extensive process evaluation. Women aged ≥18 years, suffering from UI ≥ 2 times per week and with access to a smartphone or tablet are eligible to participate. The primary outcome will be the change in UI symptom scores at 4 months after randomization, as assessed by the International Consultation on Incontinence Modular Questionnaire UI Short Form. Secondary outcomes will be the change in UI symptom scores at 12 months, as well as the patient-reported global impression of improvement, quality of life, change in sexual functioning, UI episodes per day, and costs at 4 and 12 months. In parallel, we will perform an extensive process evaluation to assess the expectations and experiences of patients and care providers regarding app usage, making use of interviews, focus group sessions, and log data analysis. CONCLUSION: This study will assess both the effectiveness and cost-effectiveness of app-based treatment for UI. The combination with the process evaluation, which will be performed in parallel, should also give valuable insights into the contextual factors that influence the effectiveness of such a treatment.

Multidisciplinary consensus on screening for, diagnosis and management of fetal growth restriction in the Netherlands.

BACKGROUND: Screening for, diagnosis and management of intrauterine growth restriction (IUGR) is often performed in multidisciplinary collaboration. However, variation in screening methods, diagnosis and management of IUGR may lead to confusion. In the Netherlands two monodisciplinary guidelines on IUGR do not fully align. To facilitate effective collaboration between different professionals in perinatal care, we undertook a Delphi study with uniform recommendations as our primary result, focusing on issues that are not aligned or for which specifications are lacking in the current guidelines. METHODS: We conducted a Delphi study in three rounds. A purposively sampled selection of 56 panellists participated: 27 representing midwife-led care and 29 obstetrician-led care. Consensus was defined as agreement between the professional groups on the same answer and among at least 70% of the panellists within groups. RESULTS: Per round 51 or 52 (91% - 93%) panellists responded. This has led to consensus on 27 issues, leading to four consensus based recommendations on screening for IUGR in midwife-led care and eight consensus based recommendations on diagnosis and eight on management in obstetrician-led care. The multidisciplinary project group decided on four additional recommendations as no consensus was reached by the panel. No recommendations could be made about induction of labour versus expectant monitoring, nor about the choice for a primary caesarean section. CONCLUSIONS: We reached consensus on recommendations for care for IUGR within a multidisciplinary panel. These will be implemented in a study on the effectiveness and cost-effectiveness of routine third trimester ultrasound for monitoring fetal growth. Research is needed to evaluate the effects of implementation of these recommendations on perinatal outcomes. TRIAL REGISTRATION: NTR4367 .

Effectiveness and cost-effectiveness of routine third trimester ultrasound screening for intrauterine growth restriction: study protocol of a nationwide stepped wedge cluster-randomized trial in The Netherlands (The IRIS Study).

BACKGROUND: Intrauterine growth retardation (IUGR) is a major risk factor for perinatal mortality and morbidity. Thus, there is a compelling need to introduce sensitive measures to detect IUGR fetuses. Routine third trimester ultrasonography is increasingly used to detect IUGR. However, we lack evidence for its clinical effectiveness and cost-effectiveness and information on ethical considerations of additional third trimester ultrasonography. This nationwide stepped wedge cluster-randomized trial examines the (cost-)effectiveness of routine third trimester ultrasonography in reducing severe adverse perinatal outcome through subsequent protocolized management. METHODS: For this trial, 15,000 women with a singleton pregnancy receiving care in 60 participating primary care midwifery practices will be included at 22 weeks of gestation. In the intervention (n = 7,500) and control group (n = 7,500) fetal growth will be monitored by serial fundal height assessments. All practices will start offering the control condition (ultrasonography based on medical indication). Every three months, 20 practices will be randomized to the intervention condition, i.e. apart from ultrasonography if indicated, two routine ultrasound examinations will be performed (at 28-30 weeks and 34-36 weeks). If IUGR is suspected, both groups will receive subsequent clinical management as described in the IRIS study protocol that will be developed before the start of the trial. The primary dichotomous clinical composite outcome is 'severe adverse perinatal outcome' up to 7 days after birth, including: perinatal death; Apgar score <4 at 5 minutes after birth; impaired consciousness; need for assisted ventilation for more than 24 h; asphyxia; septicemia; meningitis; bronchopulmonary dysplasia; intraventricular hemorrhage; cystic periventricular leukomalacia; neonatal seizures or necrotizing enterocolitis. For the economic evaluation, costs will be measured from a societal perspective. Quality of life will be measured using the EQ-5D-5 L to enable calculation of QALYs. Cost-effectiveness and cost-utility analyses will be performed. In a qualitative sub-study (using diary notes from 32 women for 9 months, at least 10 individual interviews and 2 focus group studies) we will explore ethical considerations of additional ultrasonography and how to deal with them. DISCUSSION: The results of this trial will assist healthcare providers and policymakers in making an evidence-based decision about whether or not introducing routine third trimester ultrasonography. TRIAL REGISTRATION: NTR4367 , 21 March 2014.

Interpreting ethnic inequalities in healthcare consumption: a conceptual framework for research.

BACKGROUND: The increasing diversity of the Western-European population demands identification of potential ethnic healthcare inequities. We developed a framework that helps researchers in interpreting ethnic inequalities in healthcare consumption in equity terms. From this framework, we develop recommendations for the design of future studies. METHODS: The framework was developed by analysing three typical studies on ethnic inequalities in healthcare consumption with respect to the potential of interpreting their results as healthcare inequities. RESULTS: Analysing the effects of ethnic variations in healthcare consumption on health outcomes provides important clues about the presence of potential ethnic healthcare inequities. Interpretation of ethnic variations in healthcare consumption as potentially inequitable requires appropriate adjustment for medical need for healthcare, patient preferences and treatment adherence. Because of the central position of medical need, studies need to be disease-specific and based on standardized assessment of risk factors and disease characteristics. A longitudinal study design is necessary to prevent reverse causation. CONCLUSION: The framework shows that ethnic inequalities in healthcare consumption can be justified if healthcare received meets the need for healthcare in all groups and is in accordance with informed patient preferences. It also shows that ethnic equality in healthcare consumption may hide healthcare inequities. We recommend further research on ethnic healthcare inequities using multi-ethnic cohort designs combined with linkage to healthcare registries. We also recommend research to identify clinically relevant ethnic differences in disease profiles and optimization of treatment regimens.

Diagnostic testing for celiac disease among patients with abdominal symptoms: a systematic review.

CONTEXT: The symptoms and consequences of celiac disease usually resolve with a lifelong gluten-free diet. However, clinical presentation is variable and most patients presenting with abdominal symptoms in primary care will not have celiac disease and unnecessary diagnostic testing should be avoided. OBJECTIVE: To summarize evidence on the performance of diagnostic tests for identifying celiac disease in adults presenting with abdominal symptoms in primary care or similar settings. DATA SOURCES: A literature search via MEDLINE (beginning in January 1966) and EMBASE (beginning in January 1947) through December 2009 and a manual search of references for additional relevant studies. STUDY SELECTION: Diagnostic studies were selected if they had a cohort or nested case-control design, enrolled adults presenting with nonacute abdominal symptoms, the prevalence of celiac disease was 15% or less, and the tests used included gastrointestinal symptoms or serum antibody tests. DATA EXTRACTION: Quality assessment using the Quality Assessment of Diagnostic Accuracy Studies tool and data extraction were performed by 2 reviewers independently. Sensitivities and specificities were calculated for each study and pooled estimates were computed using bivariate analysis if there was clinical and statistical homogeneity. DATA SYNTHESIS: Sixteen studies were included in the review (N = 6085 patients). The performance of abdominal symptoms varied widely. The sensitivity of diarrhea, for example, ranged from 0.27 to 0.86 and specificity from 0.21 to 0.86. Pooled estimates for IgA antiendomysial antibodies (8 studies) were 0.90 (95% confidence interval [CI], 0.80-0.95) for sensitivity and 0.99 (95% CI, 0.98-1.00) for specificity (positive likelihood ratio [LR] of 171 and negative LR of 0.11). Pooled estimates for IgA antitissue transglutaminase antibodies (7 studies) were 0.89 (95% CI, 0.82-0.94) and 0.98 (95% CI, 0.95-0.99), respectively (positive LR of 37.7 and negative LR of 0.11). The IgA and IgG antigliadin antibodies showed variable results, especially for sensitivity (range, 0.46-0.87 and range, 0.25-0.93, respectively). One recent study using diamidated gliadin peptides showed good specificity (> or = 0.94), but evidence is limited in this target population. CONCLUSION: Among adult patients presenting with abdominal symptoms in primary care or other unselected populations, IgA antitissue transglutaminase antibodies and IgA antiendomysial antibodies have high sensitivity and specificity for diagnosing celiac disease.

Quality assessment of ultrasonic foetal biometry during the IUGR Risk Selection (IRIS) trial: A cross sectional study.

OBJECTIVE: Intrauterine growth restriction is a major risk factor for perinatal morbidity and mortality. Ultrasonic foetal biometry is an important tool to monitor foetal growth. Therefore, the quality of these biometry scans is vital to achieve good diagnostic accuracy. We assessed the quality of foetal biometry during a nationwide trial and explored its association with sonographer's characteristics. METHODS: Four scans from every sonographer (n = 154), performed at 29 and 35 weeks gestational age were collected. Two assessors scored these scans according to a national audit system. A quality score ≥ 65% was considered 'adequate'. We compared the quality scores per scoring criterion (i.e. foetal head measurements, abdominal circumference and femur length with regard to magnification, correctness of the plane and calliper placement) and gestational age. We analysed the associations between characteristics of the sonographers and their scores. In a subsample of scans of 30 sonographers we determined the interrater agreement on the quality scores given by the two assessors independently. FINDINGS: The mean score was 81.3%. Thirteen sonographers (8.4%) failed to achieve 'adequate quality'. Scores for femur length (83.8%) were significantly higher than those for head (77.9%) and abdominal circumference (78.6%) (both P < 0.05). Scores for correctness of the plane (73.4%) were lower than those for magnification (81.2%) and calliper placement (85.7%) (both P < 0.05). Gestational age did not affect the quality scores. Only the number of scans performed in the previous year was positively associated with the scores (ß = 0.01; P < 0.05). The mean interrater difference in quality scoring was 11.1%, with 77.6% agreement on scans of 'adequate quality', but with no agreement on scans with 'insufficient quality'. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Most sonographers achieved an 'adequate quality' score. Highest quality scores were attained for femur length, lowest quality scores for the correct plane. The number of scans one performs is associated with the quality scores, yet the minimum number of scans to perform for guaranteed quality still needs to be determined. Further research is needed to develop a standardized method to assess and maintain good ultrasonic foetal biometry quality.

User Experiences and Preferences Regarding an App for the Treatment of Urinary Incontinence in Adult Women: Qualitative Study.

BACKGROUND: Although several apps are available to support the treatment of urinary incontinence (UI), little has been reported about the experiences and preferences of their users. OBJECTIVE: The objective of this study was to explore the experiences and preferences of women using a mobile app for the treatment of UI and to identify potential improvements to the app. We developed this app for three types of UI: stress UI, urgency UI, and mixed UI. METHODS: The participants in this qualitative study were women with self-reported stress UI, urgency UI, or mixed UI who used an app-based treatment to manage their condition for at least six weeks. Following the intervention, semistructured interviews were conducted to explore the participants' experiences and preferences regarding the app. All interviews were audio-recorded, transcribed verbatim, and analyzed separately by two researchers. RESULTS: Data saturation was reached after interviewing 9 women (aged 32-68 years) with stress UI (n=1, 11%), urgency UI (n=3, 33%), or mixed UI (n=5, 56%). Accessibility, awareness, usability, and adherence emerged as the main themes. On the one hand, participants appreciated that the app increased their accessibility to care, preserved their privacy, increased their awareness of therapeutic options, was easy to use and useful, and supported treatment adherence. On the other hand, some participants reported that they wanted more contact with a care provider, and others reported that using the app increased their awareness of symptoms. CONCLUSIONS: This qualitative study indicates that women appreciate app-based treatment for UI because it can lower barriers to treatment and increase both awareness and adherence to treatment. However, the app does not offer the ability of face-to-face contact and can lead to a greater focus on symptoms.

Patients' Attitudes Towards Deprescribing Alpha-Blockers and Their Willingness to Participate in a Discontinuation Trial.

OBJECTIVE: The objective of this study was to gain insights into the attitudes of men with lower urinary tract symptoms towards deprescribing alpha-blockers and to assess their willingness to participate in a planned discontinuation trial. METHODS: This was a cross-sectional questionnaire study. Men aged 30 years and older with lower urinary tract symptoms, who were first prescribed an alpha-blocker in 2015 or 2016, were selected from a population-based prescription database. We recorded lower urinary tract symptom severity (e.g., International Prostate Symptom Score and Overactive Bladder questionnaire) and patient characteristics (e.g., comorbidity and polypharmacy). The linguistically validated Dutch version of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire was also used, to which we added ten specific questions on attitudes towards the deprescribing of alpha-blockers. Information about a future discontinuation trial on alpha-blockers was then provided and participants were asked to indicate if they would participate. We explored the explanatory factors for the willingness to participate by logistic regression analyses. RESULTS: Of the 1380 patients in the database, 421 were using an alpha-blocker, and 195 completed the questionnaire. Of these, 16 men were excluded because of indwelling catheter use or unknown indication. The mean age of the 179 participants was 69.4 (standard deviation 9.2) years. Most men were satisfied with their current therapy, but almost all (93%) were willing to stop the medicine at the request of a doctor. Therefore, most men (61%) were willing to participate in the proposed alpha-blocker discontinuation trial. Willingness to stop therapy was affected by patients' perceptions of the appropriateness of alpha-blocker therapy and concerns about stopping that therapy. CONCLUSIONS: Although men who use alpha-blockers are generally satisfied with their current therapy, most will participate in a discontinuation trial.

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.

Effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes in low risk pregnancy (the IRIS study): nationwide, pragmatic, multicentre, stepped wedge cluster randomised trial.

OBJECTIVES: To investigate the effectiveness of routine ultrasonography in the third trimester in reducing adverse perinatal outcomes in low risk pregnancies compared with usual care and the effect of this policy on maternal outcomes and obstetric interventions. DESIGN: Pragmatic, multicentre, stepped wedge cluster randomised trial. SETTING: 60 midwifery practices in the Netherlands. PARTICIPANTS: 13 046 women aged 16 years or older with a low risk singleton pregnancy. INTERVENTIONS: 60 midwifery practices offered usual care (serial fundal height measurements with clinically indicated ultrasonography). After 3, 7, and 10 months, a third of the practices were randomised to the intervention strategy. As well as receiving usual care, women in the intervention strategy were offered two routine biometry scans at 28-30 and 34-36 weeks' gestation. The same multidisciplinary protocol for detecting and managing fetal growth restriction was used in both strategies. MAIN OUTCOME MEASURES: The primary outcome measure was a composite of severe adverse perinatal outcomes: perinatal death, Apgar score <4, impaired consciousness, asphyxia, seizures, assisted ventilation, septicaemia, meningitis, bronchopulmonary dysplasia, intraventricular haemorrhage, periventricular leucomalacia, or necrotising enterocolitis. Secondary outcomes were two composite measures of severe maternal morbidity, and spontaneous labour and birth. RESULTS: Between 1 February 2015 and 29 February 2016, 60 midwifery practices enrolled 13 520 women in mid-pregnancy (mean 22.8 (SD 2.4) weeks' gestation). 13 046 women (intervention n=7067, usual care n=5979) with data based on the national Dutch perinatal registry or hospital records were included in the analyses. Small for gestational age at birth was significantly more often detected in the intervention group than in the usual care group (179 of 556 (32%) v 78 of 407 (19%), P<0.001). The incidence of severe adverse perinatal outcomes was 1.7% (n=118) for the intervention strategy and 1.8% (n=106) for usual care. After adjustment for confounders, the difference between the groups was not significant (odds ratio 0.88, 95% confidence interval 0.70 to 1.20). The intervention strategy showed a higher incidence of induction of labour (1.16, 1.04 to 1.30) and a lower incidence of augmentation of labour (0.78, 0.71 to 0.85). Maternal outcomes and other obstetric interventions did not differ between the strategies. CONCLUSION: In low risk pregnancies, routine ultrasonography in the third trimester along with clinically indicated ultrasonography was associated with higher antenatal detection of small for gestational age fetuses but not with a reduced incidence of severe adverse perinatal outcomes compared with usual care alone. The findings do not support routine ultrasonography in the third trimester for low risk pregnancies. TRIAL REGISTRATION: Netherlands Trial Register NTR4367.

Lumbar supports to prevent recurrent low back pain among home care workers: a randomized trial.

BACKGROUND: People use lumbar supports to prevent low back pain. Secondary analyses from primary preventive studies suggest benefit among workers with previous low back pain, but definitive studies on the effectiveness of supports for the secondary prevention of low back pain are lacking. OBJECTIVE: To determine the effectiveness of lumbar supports in the secondary prevention of low back pain. DESIGN: Randomized, controlled trial. SETTING: Home care organization in the Netherlands. PATIENTS: 360 home care workers with self-reported history of low back pain. INTERVENTION: Short course on healthy working methods, with or without patient-directed use of 1 of 4 types of lumbar support. MEASUREMENTS: Primary outcomes were the number of days of low back pain and sick leave over 12 months. Secondary outcomes were the average severity of low back pain and function (Quebec Back Pain Disability scale) in the previous week. RESULTS: Over 12 months, participants in the lumbar support group reported an average of -52.7 days (CI, -59.6 to -45.1 days) fewer days with low back pain than participants who received only the short course. However, the total sick days in the lumbar support group did not decrease (-5 days [CI, -21.1 to 6.8 days]). Small but statistically significant differences in pain intensity and function favored lumbar support. LIMITATIONS: Study participants were unblinded, and a substantial amount of missing data required imputation. Objective data on sick days due to low back pain were not available. CONCLUSION: Adding patient-directed use of lumbar supports to a short course on healthy working methods may reduce the number of days when low back pain occurs, but not overall work absenteeism, among home care workers with previous low back pain. Further study of lumbar supports is warranted.

Prediction of an unfavourable course of low back pain in general practice: comparison of four instruments.

BACKGROUND: Several instruments can be used to identify patients with an unfavourable course of low back pain in general practice. However, it is unclear which instrument is the predictor of outcome. AIM: To compare the predictive performance (that is, calibration and discrimination) of risk estimation by GPs with assessments using the Orebro Musculoskeletal Pain Screening Questionnaire, the Low Back Pain Perception Scale (LBPPS), and a prediction rule developed for this purpose. DESIGN OF STUDY: A prospective cohort study with 1-year follow-up. SETTING: General practice in The Netherlands. METHOD: The outcome 'unfavourable course of low back pain' was defined as having no clinically important improvement at minimally 50% of the measurements at 6, 13, 26, and 52 weeks. Logistic regression analyses were used to study associations between potential predictors and outcome. RESULTS: In total, 60 GPs recruited 314 patients to the study (16 patients were excluded from analysis due to missing data on the course of low back pain). Over a third of patients (112/298) showed an unfavourable course of low back pain on follow-up. Risk estimation by GPs, the Orebro questionnaire, the LBPPS, and the prediction rule had discriminative ability (area under the curve) of 0.59 (95% CI [confidence intervals] = 0.52 to 0.66); 0.61 (95% CI = 0.54 to 0.67); 0.59 (95% CI = 0.52 to 0.66); and 0.75 (95% CI = 0.69 to 0.81) respectively. The prediction rule included history of low back pain, self-perceived risk to develop chronic low back pain, no solicitous responses of the patient's partner (as reported by the patient), frequent walking at work, and 'pain catastrophising'. CONCLUSION: Although the prediction rule performed best with regard to calibration and discrimination, it needs to be externally validated. Risk estimation by GPs performs as well as other instruments and, at present, seems to be the best available option.

Why is a treatment aimed at psychosocial factors not effective in patients with (sub)acute low back pain?

Psychosocial factors have been shown to play an important role in the development of chronic low back pain (LBP). In our recently completed cluster-randomized trial we found, however, no evidence of an effect of our minimal intervention strategy (MIS) aimed at psychosocial factors, over usual care (UC) in patients with (sub)acute LBP. To explore the reasons why, this paper presents an evaluation of the processes presumably underlying the effectiveness of MIS. General practitioner (GP) attitude was evaluated by the Pain Attitudes and Beliefs Scale and two additional questions. GP behaviour was evaluated by analysing treatment registration forms and patients' responses to items regarding treatment content. Patients also scored items on satisfaction and compliance. Modification of psychosocial measures was evaluated by analysing changes after 6 and 52 weeks on the Fear Avoidance and Beliefs Questionnaire, the Coping Strategies Questionnaire and the 4-Dimensional Symptom Questionnaire. A total of 60 GPs and 314 patients participated in the study. GPs in the MIS-group adopted a less biomedical orientated attitude than in the UC-group, but were only moderately successful in identification of psychosocial factors. Treatment contents as perceived by the patient and patient satisfaction differed significantly between both groups. Changes on psychosocial measures, however, did not differ between groups. The suboptimal identification of psychosocial factors in the MIS-group and the absence of a relevant impact on psychosocial factors may explain why MIS was not more effective than UC.

[Irritable bowel syndrome: criteria and clinical view]. / Prikkelbaredarmsyndroom: criteria én klinische blik.

The syndrome diagnosis 'irritable bowel syndrome' (IBS) is often made on the basis of exclusion, but the question is how many diagnostic tests should be performed in order to establish this diagnosis with a degree of confidence. We present the diagnostic value of various IBS criteria for excluding IBS, based on a systematic review. The potential of the various criteria for distinguishing IBS from organic disease is extremely variable and disappointing. Patients fulfilling IBS criteria have, however, a lower risk of organic disease than patients with abdominal symptoms who do not fulfil the criteria. The same holds true for the diagnostic performance of individual alerting symptoms. These seem to be present frequently in IBS patients in whom there is no underlying organic bowel condition. An organic condition cannot be accurately excluded on the basis of symptom criteria. However, the low prior risk of organic conditions among patients who consult a primary care doctor and who meet IBS criteria argues against exhaustive diagnostic evaluation.

Measuring practitioner/therapist effects in randomised trials of low back pain and neck pain interventions in primary care settings.

In psychological health treatment studies it has been shown that differences between therapists account for some of the non-specific effect of treatment but this phenomenon has not so far systematically been investigated in musculoskeletal disorders. In this study we evaluated and compared the size and potential influence of the 'practitioner effect' (or 'therapist effect') in three randomised treatment trials of low back pain and neck pain patients in primary care. We calculated the proportion of variance in outcomes attributable to differences across practitioners, i.e. the practitioner-variance partition coefficient (p-vpc). As measures of outcome, we focused on self-reported disability as the primary outcome, but we also investigated assessed psychological outcomes. The p-vpc for the disability measures ranged from 2.6% to 7.1% across trials and time points (post treatment and follow up). Estimates differed between treatment subgroups within trials; being highest in treatment subgroups assigned to psychosocial-based interventions. A 'practitioner effect' does exist and is more pronounced in treatments involving greater psychosocial emphasis. This has implications for both practice and research in this clinical area. It highlights the importance of patient-practitioner interactions, and the need to address practitioner effects in designing and analysing outcome studies in low back pain and neck pain in primary care.

Value of symptoms and additional diagnostic tests for colorectal cancer in primary care: systematic review and meta-analysis.

OBJECTIVE: To summarise available evidence on diagnostic tests that might help primary care physicians to identify patients with an increased risk for colorectal cancer among those consulting for non-acute lower abdominal symptoms. DATA SOURCES: PubMed, Embase, and reference screening. Study eligibility criteria Studies were selected if the design was a diagnostic study; the patients were adults consulting because of non-acute lower abdominal symptoms; tests included signs, symptoms, blood tests, or faecal tests. Study appraisal and synthesis methods Two reviewers independently assessed quality with a modified version of the QUADAS tool and extracted data. We present diagnostic two by two tables and pooled estimates of sensitivity and specificity. We refrained from pooling when there was considerable clinical or statistical heterogeneity. RESULTS: 47 primary diagnostic studies were included. Sensitivity was consistently high for age >or=50 (range 0.81-0.96, median 0.91), a referral guideline (0.80-0.94, 0.92), and immunochemical faeces tests (0.70-1.00, 0.95). Of these, only specificity of the faeces tests was good. Specificity was consistently high for family history (0.75-0.98, 0.91), weight loss (0.72-0.96, 0.89), and iron deficiency anaemia (0.83-0.95, 0.92), but all tests lacked sensitivity. None of these six tests was (sufficiently) studied in primary care. CONCLUSIONS: Although combinations of symptom and results of immunochemical faeces tests showed good diagnostic performance for colorectal cancer, evidence from primary care is lacking. High quality studies on their role in the diagnostic investigation of colorectal cancer in primary care are urgently needed.

Psychosocial interventions for low back pain in primary care: lessons learned from recent trials.

STUDY DESIGN: Workshop discussion and literature overview. OBJECTIVE: To give an overview of the main lessons learnt from recent trials on the effectiveness of psychosocial interventions for back pain in primary care. SUMMARY OF BACKGROUND DATA: Recently, there has been a move to provide early psychosocial interventions in primary care to prevent chronic back pain. The results of most of the randomized trials, however, show only small differences between the psychosocial intervention and active control treatments in function or other outcome measures. METHODS: During Low Back Pain Forum 2006 in Amsterdam 3 subgroups debated possible explanations for these "negative" findings, focusing on (1) patient selection, (2) the intervention, or (3) assessment. These discussions were illustrated with evidence from the literature and with data from 2 randomized trials. RESULTS: The workshop participants highlighted the importance of better targeting psychosocial interventions at those who are at high risk of chronic back pain, and are likely to respond to treatment. Interventions should focus on modifiable prognostic factors, and address somatic, psychological, and social aspects of the pain problem. The general consensus was that, depending on the complexity of the condition, primary care providers can be involved in the psychosocial management of back pain, but should be adequately trained. Competencies of care providers and adherence to treatment protocols should be investigated in a process evaluation. Finally, although trials have included relevant instruments to measure back pain and disability, patient assessment might be improved by measuring other factors that may mediate or modify the effects of treatment. CONCLUSION: Despite the publication of recent "negative" results of psychosocial interventions for back pain, workshop participants remained optimistic about the importance of this line of research. Suggestions are given for a refocused research agenda on the effectiveness of psychosocial interventions for back pain in primary care.

Do psychological factors predict outcome in both low-back pain and shoulder pain?

BACKGROUND AND OBJECTIVE: Psychological factors are assumed to predict persistent or recurrent musculoskeletal pain. The influence of psychological factors in patients with low-back pain (LBP) or shoulder pain was explored to study whether there is similarity regarding the factors that predict persisting pain and disability. METHODS: Patients presenting in primary care with a new episode of shoulder pain or non-specific (sub)acute low back pain (LBP) were enrolled in a prospective study. In both patient groups, pain catastrophising, distress, somatisation and fear-avoidance beliefs were measured at baseline. Primary outcome measures at 3 months were (1) persistent symptoms, and (2) <30% reduction in functional disability. Multivariate logistic regression analysis was used to study the associations between psychological factors and outcome. RESULTS: A total of 587 patients with shoulder pain and 171 patients with LBP were enrolled in the study. In patients with shoulder pain, most associations of psychological factors with outcome were weak and not significant. Only in patients with longer symptom duration at baseline (>or=3 months) were higher scores on catastrophising significantly associated with persistent symptoms (p = 0.04). In patients with LBP, psychological factors were more strongly associated with poor outcome, although most associations were not significant. CONCLUSION: Psychological factors, with the exception of fear-avoidance beliefs, are more strongly associated with persistent pain and disability in patients with LBP than in those with shoulder pain. This seems to indicate that in a primary care population the influence of psychological factors on outcome may vary across patients with different types of pain.