Shared decision making with frail people with intellectual disabilities in the palliative phase: A process evaluation of the use of the In-Dialogue conversation aid in practice.

BACKGROUND: This study reports the process evaluation of the In-Dialogue conversation aid to facilitate shared decision-making with people with intellectual disabilities in the palliative phase. METHODS: Training for In-Dialogue was evaluated by 53 support staff members through questionnaires. The use of In-Dialogue in four residential care facilities for frail people with mild to severe intellectual disabilities was evaluated with semi-structured interviews with five relatives, nine support staff and three people with intellectual disabilities. RESULTS: Most participants considered the training helpful to apply shared decision-making. Sixty-three people with intellectual disabilities participated in In-Dialogue conversations. Almost all interviewees stated that these conversations provided additional insight into people's concerns and preferences. Involvement of people with profound intellectual disabilities and their relatives appeared to be challenging. CONCLUSION: Conversations about illness and the end of life appeared to be feasible with the In-Dialogue conversation aid and provided insight into people's experiences and preferences.

Meaning-making following loss among bereaved spouses during the COVID-19 pandemic (the CO-LIVE study).

This study investigates how individuals construe, understand, and make sense of experiences during the first wave of the COVID-19 pandemic. Seventeen semi-structured interviews were conducted with bereaved spouses focusing on meaning attribution to the death of their partner. The interviewees were lacking adequate information, personalized care, and physical or emotional proximity; these challenges complicated their experience of a meaningful death of their partner. Concomitantly, many interviewees appreciated the exchange of experiences with others and any last moments together with their partner. Bereaved spouses actively sought valuable moments, during and after bereavement, that contributed to the perceived meaning.

Development of an international core domain set for medium, large and giant congenital melanocytic naevi as a first step towards a core outcome set for clinical practice and research.

BACKGROUND: Medium, large and giant congenital melanocytic naevi (CMN) can impose a psychosocial burden on patients and families, and are associated with increased risk of developing melanoma or neurological symptoms. Lack of consensus on what outcomes to measure makes it difficult to advise patients and families about treatment and to set up best practice for CMN. OBJECTIVES: Fostering consensus among patient representatives and professionals, we aim to develop a core outcome set, defined as the minimum set of outcomes to measure and report in care and all clinical trials of a specific health condition. We focused on the 'what to measure' aspect, the so-called core domain set (CDS), following the COMET and CS-COUSIN guidelines. METHODS: We conducted a systematic review to identify outcomes reported in the literature. Focus groups with patient representatives identified patient-reported outcomes. All these outcomes were classified into domains. Through e-Delphi surveys, 144 stakeholders from 27 countries iteratively rated the importance of domains and outcomes. An online consensus meeting attended by seven patient representatives and seven professionals finalized the CDS. RESULTS: We reached consensus on six domains, four of which were applied to both care and research: 'quality of life', 'neoplasms', 'nervous system' and 'anatomy of skin'. 'Adverse events' was specific to care and 'pathology' to research. CONCLUSIONS: We have developed a CDS for medium-to-giant CMN. Its application in reporting care and research of CMN will facilitate treatment comparisons. The next step will be to reach consensus on the specific outcomes for each of the domains and what instruments should be used to measure these domains and outcomes.

Unraveling patients' readiness in advance care planning conversations: a qualitative study as part of the ACTION Study.

PURPOSE: Patients' readiness for advance care planning (ACP) is often considered a prerequisite for starting ACP conversations. Healthcare professionals' uncertainty about patients' readiness hampers the uptake of ACP in clinical practice. This study aims To determine how patients' readiness is expressed and develops throughout an ACP conversation. METHODS: A qualitative sub-study into the ACTION ACP conversations collected as part of the international Phase III multicenter cluster-randomized clinical trial. A purposeful sample was taken of ACP conversations of patients with advanced lung or colorectal cancer who participated in the ACTION study between May 2015 and December 2018 (n = 15). A content analysis of the ACP conversations was conducted. RESULTS: All patients (n = 15) expressed both signs of not being ready and of being ready. Signs of being ready included anticipating possible future scenarios or demonstrating an understanding of one's disease. Signs of not being ready included limiting one's perspective to the here and now or indicating a preference not to talk about an ACP topic. Signs of not being ready occurred more often when future-oriented topics were discussed. Despite showing signs of not being ready, patients were able to continue the conversation when a new topic was introduced. CONCLUSION: Healthcare professionals should be aware that patients do not have to be ready for all ACP topics to be able to participate in an ACP conversation. They should be sensitive to signs of not being ready and develop the ability to adapt the conversation accordingly.

Content analysis of Advance Directives completed by patients with advanced cancer as part of an Advance Care Planning intervention: insights gained from the ACTION trial.

PURPOSE: Writing an Advance Directive (AD) is often seen as a part of Advance Care Planning (ACP). ADs may include specific preferences regarding future care and treatment and information that provides a context for healthcare professionals and relatives in case they have to make decisions for the patient. The aim of this study was to get insight into the content of ADs as completed by patients with advanced cancer who participated in ACP conversations. METHODS: A mixed methods study involving content analysis and descriptive statistics was used to describe the content of completed My Preferences forms, an AD used in the intervention arm of the ACTION trial, testing the effectiveness of the ACTION Respecting Choices ACP intervention. RESULTS: In total, 33% of 442 patients who received the ACTION RC ACP intervention completed a My Preferences form. Document completion varied per country: 10.4% (United Kingdom), 20.6% (Denmark), 29.2% (Belgium), 41.7% (the Netherlands), 61.3% (Italy) and 63.9% (Slovenia). Content analysis showed that 'maintaining normal life' and 'experiencing meaningful relationships' were important for patients to live well. Fears and worries mainly concerned disease progression, pain or becoming dependent. Patients hoped for prolongation of life and to be looked after by healthcare professionals. Most patients preferred to be resuscitated and 44% of the patients expressed maximizing comfort as their goal of future care. Most patients preferred 'home' as final place of care. CONCLUSIONS: My Preferences forms provide some insights into patients' perspectives and preferences. However, understanding the reasoning behind preferences requires conversations with patients.

Shared decision-making with people with intellectual disabilities in the last phase of life: A scoping review.

BACKGROUND: Shared decision-making (SDM) is the process in which healthcare professionals and patients jointly discuss and decide which care and treatment policy is to be followed. The importance of SDM is increasingly being recognised across health settings, including palliative care. Little is known about SDM with people with intellectual disabilities (IDs) in the last phase of life. This review aimed to explore to which extent and in which way people with ID in the last phase of life are involved in decision-making about their care and treatment. METHOD: In this scoping review, we systematically searched in the Embase, Medline and PsycINFO databases for empirical studies on decision-making with people with ID in the last phase of life. RESULTS: Of a total of 281 identified titles and abstracts, 10 studies fulfilled the inclusion criteria. All focused on medical end-of-life decisions, such as foregoing life-sustaining treatment, do-not-attempt-resuscitation orders or palliative sedation. All studies emphasise the relevance of involving people with ID themselves, or at least their relatives, in making decisions at the end of life. Still, only two papers described processes of decision-making in which persons with ID actively participated. Furthermore, in only one paper, best practices and guidelines for decision-making in palliative care for people with ID were defined. CONCLUSION: Although the importance of involving people with ID in the decision-making process is emphasised, best practices or guidelines about what this should look like are lacking. We recommend developing aids that specifically support SDM with people with ID in the last phase of life.

Advance care planning: A systematic review about experiences of patients with a life-threatening or life-limiting illness.

BACKGROUND: Advance care planning is seen as an important strategy to improve end-of-life communication and the quality of life of patients and their relatives. However, the frequency of advance care planning conversations in practice remains low. In-depth understanding of patients' experiences with advance care planning might provide clues to optimise its value to patients and improve implementation. AIM: To synthesise and describe the research findings on the experiences with advance care planning of patients with a life-threatening or life-limiting illness. DESIGN: A systematic literature review, using an iterative search strategy. A thematic synthesis was conducted and was supported by NVivo 11. DATA SOURCES: The search was performed in MEDLINE, Embase, PsycINFO and CINAHL on 7 November 2016. RESULTS: Of the 3555 articles found, 20 were included. We identified three themes in patients' experiences with advance care planning. 'Ambivalence' refers to patients simultaneously experiencing benefits from advance care planning as well as unpleasant feelings. 'Readiness' for advance care planning is a necessary prerequisite for taking up its benefits but can also be promoted by the process of advance care planning itself. 'Openness' refers to patients' need to feel comfortable in being open about their preferences for future care towards relevant others. CONCLUSION: Although participation in advance care planning can be accompanied by unpleasant feelings, many patients reported benefits of advance care planning as well. This suggests a need for advance care planning to be personalised in a form which is both feasible and relevant at moments suitable for the individual patient.

Association of change in physical activity and body weight with quality of life and mortality in colorectal cancer: a systematic review and meta-analysis.

PURPOSE: A systematic review and a meta-analysis were performed to assess the associations between change over time in physical activity and weight and quality of life and mortality in colorectal cancer patients. METHODS: The PubMed, Embase, and Cochrane Central Register of Controlled Trials databases were searched for English language articles published between January 1, 1990 and October 7, 2013. These articles reported results for changes in physical activity and body weight, assessed at pre- to post-diagnosis or at post-diagnosis only. A random effects model was used to analyze pooled quality of life and mortality estimates. RESULTS: Seven eligible studies were identified and analyzed. Increased physical activity was associated with higher overall quality of life scores (N = 3 studies; standardized mean difference (SMD) = 0.74, 95 % confidence interval (CI) = 0.66-0.82), reduced disease-specific mortality risk (hazard ratio (HRpooled) = 0.70, 95 % CI = 0.55-0.85), and reduced overall mortality (HRpooled = 0.75, CI = 0.62-0.87) (N = 2 studies). Weight gain was not associated with disease-specific (HRpooled = 1.02, CI = 0.84-1.20) or overall (HRpooled = 1.03, CI = 0.86-1.19) mortality (N = 3 studies). CONCLUSIONS: Increased physical activity was associated with improved quality of life, a reduced risk of colorectal cancer, and overall mortality rate. Given the paucity of the literature published on this topic, this finding should be interpreted with caution.

Meta-analysis shows clinically relevant and long-lasting deterioration in health-related quality of life after esophageal cancer surgery.

PURPOSE: The purpose of the study is to (1) estimate the direction, clinical relevance, and duration of health-related quality of life (HRQL) change in the first year following esophageal cancer surgery and (2) to assess the robustness of the estimates by subgroup and sensitivity analyses, and an exploration of publication bias. METHODS: A systematic literature search in MEDLINE, EMBASE, CINAHL, PsychINFO, and CENTRAL to identify randomized and non-randomized studies was performed. We compared the baseline HRQL data with 3-, 6-, 9-, or 12-month follow-ups to estimate the magnitude and duration of HRQL change. These estimates were then classified as trivial, small, medium, or large. Primary outcomes were role functioning, eating, and fatigue. Secondary outcomes were physical and social functioning, dysphagia, pain, and coughing problems. We conducted subgroup analysis for open surgery, open surgery preceded by neo-adjuvant therapy, and minimally invasive surgery. Sensitivity analyses assessed the influence of study design, transformation/imputation of the data, and HRQL questionnaire used. RESULTS: We included data from 15 studies to estimate the change in 28 HRQL outcomes after esophageal cancer surgery. The main analysis showed that patients' social functioning deteriorated. Symptoms of fatigue, pain, and coughing problems increased. These changes lasted for 9-12 months, although some symptoms persisted beyond the first year after surgery. For many other HRQL outcomes, estimates were only robust after subgroup or sensitivity analyses (e.g., role and physical functioning), or remained too heterogeneous to interpret (e.g., eating and dysphagia). CONCLUSIONS: Patients will experience a clinically relevant and long-lasting deterioration in HRQL after esophageal cancer surgery. However, for many HRQL outcomes, more and better quality evidence is needed.

Meta-analysis shows clinically relevant and long-lasting deterioration in health-related quality of life after esophageal cancer surgery.

PURPOSE: The purpose of the study is to (1) estimate the direction, clinical relevance, and duration of health-related quality-of-life (HRQL) change in the first year following esophageal cancer surgery and (2) to assess the robustness of the estimates by subgroup and sensitivity analyses, and an exploration of publication bias. METHODS: A systematic literature search in MEDLINE, EMBASE, CINAHL, PsychINFO, and CENTRAL to identify randomized and non-randomized studies was performed. We compared the baseline HRQL data with 3-, 6-, 9-, or 12-month follow-ups to estimate the magnitude and duration of HRQL change. These estimates were then classified as trivial, small, medium, or large. Primary outcomes were role functioning, eating, and fatigue. Secondary outcomes were physical and social functioning, dysphagia, pain, and coughing problems. We conducted subgroup analysis for open surgery, open surgery preceded by neoadjuvant therapy, and minimally invasive surgery. Sensitivity analyses assessed the influence of study design, transformation/imputation of the data, and HRQL questionnaire used. RESULTS: We included the data from 15 studies to estimate the change in 28 HRQL outcomes after esophageal cancer surgery. The main analysis showed that patients' social functioning deteriorated. Symptoms of fatigue, pain, and coughing problems increased. These changes lasted for 9-12 months, although some symptoms persisted beyond the first year after surgery. For many other HRQL outcomes, estimates were only robust after subgroup or sensitivity analyses (e.g., role and physical functioning), or remained too heterogeneous to interpret (e.g., eating and dysphagia). CONCLUSIONS: Patients will experience a clinically relevant and long-lasting deterioration in HRQL after esophageal cancer surgery. However, for many HRQL outcomes, more and better quality evidence is needed.

Predictors of HPV vaccination uptake: a longitudinal study among parents.

To assess among parents longitudinal predictors of human papillomavirus (HPV) vaccination uptake for their daughters, random samples of parents were identified via municipal services and sent baseline questionnaires in June 2009 and follow-up questionnaires in November 2011 after their uptake decision. Hierarchical logistic regression analysis was used to assess whether demographic characteristics, and affective and social cognitive factors, predicted uptake at follow-up. Response rates of the baseline and follow-up questionnaire were 29.8% (1762/5918) and 74.3% (793/1067), respectively. Uptake was predicted by a later (2011) versus earlier (2010) decision about uptake as HPV vaccination implementation [odds ratio (OR) 2.48; 95% confidence interval (CI) 1.11-5.52], anticipated regret about no uptake (OR 1.43; 95% CI 1.08-1.89) and intention (OR 2.61; 95% CI 1.47-4.61). There was an interaction between ambivalence and attitude (OR 1.68; 95% CI 1.14-2.47); parents with a positive attitude and a high ambivalence toward vaccination were more likely to have their daughter vaccinated than parents with a positive attitude and a low ambivalence. An informed choice about uptake (5/7 correct items) was made by 44%. In conclusion, uptake was predicted by intention, a later (2011) versus earlier (2010) decision and by anticipated regret about no uptake. Decisions regarding new vaccines are difficult to make, we recommend a well-balanced implementation process.

Patients' and urologists' preferences for prostate cancer treatment: a discrete choice experiment.

BACKGROUND: Patients' preferences are important for shared decision making. Therefore, we investigated patients' and urologists' preferences for treatment alternatives for early prostate cancer (PC). METHODS: A discrete choice experiment was conducted among 150 patients who were waiting for their biopsy results, and 150 urologists. Regression analysis was used to determine patients' and urologists' stated preferences using scenarios based on PC treatment modality (radiotherapy, surgery, and active surveillance (AS)), and risks of urinary incontinence and erectile dysfunction. RESULTS: The response rate was 110 out of 150 (73%) for patients and 50 out of 150 (33%) for urologists. Risk of urinary incontinence was an important determinant of both patients' and urologists' stated preferences for PC treatment (P<0.05). Treatment modality also influenced patients' stated preferences (P<0.05), whereas the risk of erectile dysfunction due to radiotherapy was mainly important to urologists (P<0.05). Both patients and urologists preferred AS to radical treatment, with the exception of patients with anxious/depressed feelings who preferred radical treatment to AS. CONCLUSION: Although patients and urologists generally may prefer similar treatments for PC, they showed different trade-offs between various specific treatment aspects. This implies that urologists need to be aware of potential differences compared with the patient's perspective on treatment decisions in shared decision making on PC treatment.

Quality of life in Dutch women with lichen sclerosus.

BACKGROUND: Lichen sclerosus (LS) is a chronic inflammatory skin disease. Earlier studies have shown an impaired health-related quality of life (HRQoL), but more extensive research including generic questionnaires has not been reported. OBJECTIVES: To investigate, in a cross-sectional study, the HRQoL of a sample of Dutch women with LS; to compare the resulting HRQoL data with that available from other skin diseases and the general Dutch population; to explore factors that may influence the HRQoL. METHODS: Female members of the Dutch LS Foundation and Support Group filled out three questionnaires electronically: the Skindex-29, the SF-12 and the EQ-5D visual analogue scale (VAS). We distinguished Skindex-29 scores into groups with 'little' (score 0-24), 'mild' (25-31), 'moderate' (32-43) and 'severe' (44-100) impact on HRQoL. We compared differences using the Mann-Whitney U-test and the Kruskal-Wallis test, and correlations using Spearman's rank correlation coefficient. RESULTS: A total of 262 women with LS were included. The average diagnostic delay was 4·9 (SD 7·1) years. Patients had a mean total Skindex-29 score of 38·4 (0-100, SD 17·2). Domain scores for symptoms, emotions and functioning were 46·8 (SD 19·0), 38·2 (SD 20·2) and 33·6 (SD 19·3), respectively. The SF-12 showed average PCS-12 (physical component) and MCS-12 (mental component) scores of 47·7 and 48·5, respectively. For the Dutch population these scores were 49·3 and 52·3. The mean EQ-5D VAS score was 74·1 (SD 15·4). CONCLUSIONS: There is a considerable delay in diagnosis for female Dutch patients with LS. The Skindex-29 domain scores showed a moderately impaired HRQoL. Women with LS reported a lower generic HRQoL than the average female Dutch population.

Quality of life in participants of a CRC screening program.

BACKGROUND: Little is known about the effect of participating in a colorectal cancer (CRC) screening programme on quality of life (QOL), neither for participants with a negative nor for those with a positive test result. These findings, however, are important to evaluate the impact of CRC screening. METHODS: Participants from CRC screening trials were sent a questionnaire, which included validated measures on generic health-related QOL, generic anxiety and screen-specific anxiety. Both faecal immunochemical test (FIT) and flexible sigmoidoscopy (FS) participants, either with negative or positive test results, were addressed. RESULTS: The response rate was 73% (1289 out of 1772) for FIT and 78% (536 out of 689) for FS participants, with mean ages varying from 63-66 years. Positive FIT participants had worse physical (PCS-12, 47.1 vs 48.3, P=0.02), but equal mental QOL scores (MCS-12, 51.1 vs 51.6, P=0.26). Positive and negative FS participants had similar QOL scores. Both FIT and FS participants with a positive test result reported more screen-specific anxiety than negative FIT and FS participants. Positive and negative FS participants had similar generic anxiety scores. CONCLUSION: Our findings indicate that the burden of participating in CRC screening may be limited. Conducting a prospective study to confirm these results is recommended.

Benchmarking patient experiences in colonoscopy using the Global Rating Scale.

INTRODUCTION: The Global Rating Scale (GRS) is a quality assurance program that was developed in England to assess patient-centered care in endoscopy. The aim of the current study was to evaluate patient experiences of colonoscopy using the GRS in order to compare different departments and to provide benchmarks. The study also evaluated factors associated with patient satisfaction. METHODS: A GRS questionnaire was used both before and after the procedure in outpatients undergoing colonoscopy. The questionnaire assessed the processes associated with the colonoscopy, from making the appointment up until discharge. Mean values and ranges of 12 endoscopy departments were calculated together with P values in order to assess heterogeneity. RESULTS: In total, 1904 pre-procedure and 1532 (80 %) post-procedure questionnaires were returned from 12 endoscopy departments. The mean time patients had to wait for their procedure was 4.3 weeks (range 3.1 - 5.8 weeks), and 54 % (range 35 - 64 %; P < 0.001) reported being given a choice of appointment dates/times. Discomfort during colonoscopy was reported by 20 % (range 8 - 40 %; P < 0.001). Recovery room privacy was satisfactory for 76 % of patients (range 66 - 90 %; P < 0.05). The majority of patients reported being sufficiently informed about what to do in case of problems after discharge (79 %, range 43 - 98 %; P < 0.001), and 85 % of individuals stated that they would be willing to repeat the colonoscopy procedure (range 72 - 92 %; P < 0.001). Factors associated with a decreased willingness to return were the burdensome bowel preparation (odds ratio [OR] = 0.25; P < 0.001), "rushing staff" attitude (OR = 0.57; P < 0.05), low acceptance of the procedure (OR = 0.42; P < 0.01), and more discomfort than expected (OR = 0.54; P < 0.05). CONCLUSION: Overall patient experiences with colonoscopy were satisfactory, but they also showed considerable variation. This study shows that use of a GRS patient questionnaire is feasible in the Dutch endoscopy setting for the assessment of patient experience. The significant variability between endoscopy units can be used to benchmark services and enable shortcomings to be identified.

Having a Pap smear, quality of life before and after cervical screening: a questionnaire study.

OBJECTIVE: To assess the health-related quality of life (HRQoL) impact of cervical cancer screening in women with normal test results. DESIGN: Questionnaire study. SETTING: Maastricht, the Netherlands. POPULATION: A cohort of 789 women were followed from screening invitation until after the receipt of screening results. A female age-matched reference group (n=567) was included. METHODS: Questionnaires were sent to the home address of the women before screening, after screening, and again with the screening results. MAIN OUTCOME MEASURES: Generic HRQoL (SF-12, EQ-5D), generic anxiety (STAI-6), screen-specific anxiety (PCQ), and potential symptoms and feelings related to the smear-taking procedure. RESULTS: A total of 60% of screening participants completed questionnaire 1(n=924): 803 of these women granted permission to access their files; 789 of these 803 women had normal test results (Pap 1), and were included in the analyses. Generic HRQoL (SF-12, EQ-5D) and anxiety (STAI-6) scores were similar in the study and reference groups. Before screening, after screening, and also after the receipt of test results, screening participants reported less screen-specific anxiety (PCQ, P<0.001) than the reference group (n=567), with differences indicating clinical relevance. 19% of screening participants were bothered by feelings of shame, pain, inconvenience, or nervousness during smear taking, and 8 and 5% of women experienced lower abdominal pain, vaginal bleeding, discharge, or urinary problems for 2-3 and 4-7 days, respectively, following the Pap smear. CONCLUSION: The reduced levels of screen-specific anxiety in screening participants, possibly indicating reassurance, are worthwhile addressing in more depth. We conclude that although considerable numbers of women reported unpleasant effects, there were no adverse HRQoL consequences of cervical screening in women with normal test results.

[Screening for child abuse at emergency rooms is useful]. / Screening kindermishandeling op SEH toch nuttig.

In the Netherlands screening of child abuse is obligatory at emergency departments. In spite of the modest detection rate, in our opinion there is sufficient evidence and reason to continue screening.

The measurement properties of the five-item International Index of Erectile Function (IIEF-5): a Dutch validation study.

Erectile dysfunction (ED), affecting men worldwide, is associated with worse mental health. The severity of ED as well as the effect of its treatment can be assessed using valid self-reported outcome measures. A widely used measure is the International Index of Erectile Function short form (IIEF-5) which is not yet validated in Dutch. The objective of this study was to translate the IIEF-5 into Dutch and to investigate its reliability and validity to provide a useful evaluation tool. The IIEF-5 was translated into Dutch following standardized forward-backward procedures. To conduct this observational study, men with symptoms of ED completed the Dutch IIEF-5 at inclusion, 1 week later, and 6 months after inclusion. A population-based sample (reference group) completed the IIEF-5 once. The quality domains reliability and validity were addressed by testing the measurement properties internal consistency, reliability, measurement error, and content validity. Data of 82 patients and 253 reference group participants were analyzed. Internal consistency was adequate with Cronbach's alpha of 0.94 in both patient and reference group. In patients, the test-retest reliability was adequate with an intra-class correlation coefficient for agreement of 0.88. A floor effect was present in the patient group (42%), though not in the reference group (3%). There was no ceiling effect in patients (0%), while this was present in the reference group (17%). Analysis of responsiveness was not possible due to the limited number of patients receiving treatment. The Dutch IIEF-5 is a reliable and valid measure to determine severity of symptoms of ED. This evaluation tool is valuable for clinical use and interpreting results across international clinical studies. The context of a patient's sexual life is, however, indispensable and should be taken into account.

A cluster-randomised trial of screening for language disorders in toddlers.

OBJECTIVE: To assess the screening performance of a specific language-screening instrument at 18 and 24 months of age and to assess its effect on the early detection and prognosis of language delay. DESIGN: Child health care physicians were randomised to the intervention group, in which specific language screening was conducted twice (at age 18 months and 24 months), or to the control group (usual care). The specific screening instrument consisted of a uniform set of questions for the parents and test elements for the child, with scaled scores to assess responses. SETTING: Child health care in the Netherlands and referral of screen-positive children. SUBJECTS: 5734 children in the intervention group and 4621 in the control group. MAIN OUTCOME MEASURES: Test characteristics and disorders at 24 months, and confirmed diagnoses of a language disorder before 36 months in both groups. Gold standard based on reports of parents, specialists and expert panel. Prognosis estimated from two diagnostic language development performance scores at 36 months (in questionnaire). RESULTS: In the intervention group, 3147 of the 5734 children (55%) were screened with the specific screening instrument and 73 of the screened children (2.3%) were screen-positive. Of the screen-positive children, 41 (55%) had confirmed language delay (diagnostic assessment and/or reported treatment). The estimated sensitivity of the test ranged between 24-52% depending on the severity of language disorders. The prevalence of language disorders in three-year olds was estimated to be 2.4-5.3%. In the intervention group, 1.25-2 times more children with language delay had been diagnosed before 36 months. The assessment of language development at 36 months showed no statistically significant differences between the intervention and the control groups. CONCLUSIONS: The inclusion of a specific language-screening instrument in child health centre activities resulted in the earlier detection of children with language delay. Short-term health benefits could not be demonstrated. Large-scale introduction cannot be recommended on the basis of this information alone.