The yield of routine laboratory examination in osteoporosis evaluation in primary care.

This study evaluated the yield of routine laboratory examination in a large population of older women in primary care. The prevalence of laboratory abnormalities was low and the clinical consequences in follow-up were limited. There was a weak association of laboratory abnormalities with osteoporosis but no association with vertebral fractures and recent fractures. PURPOSE: Most osteoporosis guidelines advice routine laboratory examination. We have investigated the yield of laboratory examinations in facture risk evaluation of elderly women in primary care. METHODS: We assessed the prevalence of laboratory abnormalities and their association with risk factors for fractures, recent fractures, low bone mineral density (BMD), and prevalent vertebral fracture in 8996 women ≥ 65 years of age participating in a primary care fracture risk screening study. In a sample of 2208 of these participants, we also evaluated the medical consequences in the medical records during a follow-up period of ≥ 1 year. RESULTS: Vitamin D deficiency (< 30 nmol/L) was present in 13% and insufficiency (< 50 nmol/L) in 43% of the study sample. The prevalence of other laboratory abnormalities (ESR, calcium, creatinine, FT4) was 4.6% in women with risk factors for fractures, 6.1% in women with low BMD (T-score ≤ - 2.5), 6.0% after a prevalent vertebral fracture, 5.2% after a recent fracture and 2.6% in the absence of important risk factors for fractures. Laboratory abnormalities other than vitamin D were associated with low BMD (OR 1.4, 95%CI 1.1-1.8) but not with prevalent vertebral fractures nor recent fractures. Low BMD was associated with renal failure (OR 2.0, 95%CI 1.3-3.4), vitamin D insufficiency (OR 1.2, 95%CI 1.0-1.3) and deficiency (OR 1.3, 95%CI 1.1-.5). In the follow-up period, 82% of the laboratory abnormalities did not result in a new diagnosis or treatment reported in the medical records. CONCLUSIONS: We identified a low prevalence of laboratory abnormalities in a primary care population of older women and the majority of these findings had no medical consequences.

Insomnia management in Dutch general practice: a routine care database study.

OBJECTIVE: To explore insomnia management in general practice, with a focus on sleep medication prescription. DESIGN: Descriptive analysis of anonymized routine general practice care data extracted from electronic medical records (EMRs), including demographics, free text annotations from sleep consultations and sleep medication prescriptions covering one year before up to two years after the registration of the International Classification for Primary Care (ICPC) code P06 'Sleep disturbance'. SETTING: Twenty-one general practices in an urban area of the Netherlands. PATIENTS: Adults (18-85 year) with a first sleep consultation with their GP. OUTCOMES: Documented non-pharmacological and sleep medication treatment. RESULTS: Of the 1,089 patients who consulted their general practitioner (GP) for sleep disturbance for the first time, about 50% had one more sleep consultation during the two years follow-up. Over two years including the first consultation, GPs documented a non-pharmacological intervention for 48.4% of the patients and prescribed sleep medication to 77.0%. 64.6% of the patients received a sleep medication prescription in the first consultation. Among patients receiving medication (N = 838); 59.6% received more than one prescription; 76.8% received one or more short-acting benzodiazepine receptor agonist (BZRA), 39.5% one or more unrecommended drugs and 14.7% >180 pills of BZRAs in two years. CONCLUSION: Although the guidelines advocate non-pharmacological treatment and warn against unwarranted sleep medication, it is still very common in Dutch general practice to prescribe medication, even at the first sleep consultation. Prescriptions frequently include unrecommended and off-label drugs or repeated BZRA prescriptions.

Short statementThere are concerns about the prescription rate and nature of sleep medication prescribed for patients with sleep disturbance. Analysis of routine care data can provide insights in general practitioners (GPs) management of insomnia.3 main statements GPs prescribed sleep medication in the first consultation to 64.6% of the patients who consulted them for sleep disturbance for the first time.Over two years including the first consultation, 48.4% of the patients received a (documented) non-pharmacological intervention, 77.0% a sleep medication prescription.Among patients receiving medication, the majority received short-acting benzodiazepine receptor agonists (BZRAs), but 39.5% (also) received an unrecommended drug.

Online vestibular rehabilitation for chronic vestibular syndrome: 36-month follow-up of a randomised controlled trial in general practice.

BACKGROUND: Vestibular rehabilitation (VR) is the preferred treatment for chronic vestibular symptoms such as dizziness and vertigo. An internet-based programme was developed to increase uptake of VR. The authors have previously reported that internet-based VR resulted in a clinically relevant decrease of vestibular symptoms for up to 6 months, compared with usual care. AIM: To evaluate long-term outcomes of internet-based VR in patients with chronic vestibular syndrome. DESIGN AND SETTING: A randomised controlled trial was conducted in Dutch general practice involving 322 participants aged ≥50 years with chronic vestibular syndrome. Participants were randomised to stand-alone VR, blended VR (with physiotherapy support), and usual care. Usual care participants were allowed to cross over to stand-alone VR 6 months after randomisation. METHOD: Participants were approached 36 months after randomisation. The primary outcome was the presence of vestibular symptoms as measured by the vertigo symptom scale-short form (VSS-SF). Secondary outcomes were dizziness-related impairment, anxiety, depressive symptoms, and healthcare utilisation. RESULTS: At 36-month follow-up, 65% of participants filled in the VSS-SF. In the usual care group, 38% of participants had crossed over to VR at 6 months. There were no significant differences in vestibular symptoms between VR groups and usual care (mean difference = -0.8 points, 95% confidence interval [CI] = -2.8 to 1.2, for stand-alone VR; -0.3, 95% CI = -2.2 to 1.7, for blended VR). In VR groups, clinically relevant improvement compared with baseline was maintained over time. CONCLUSION: Internet-based VR provides a maintained improvement of vestibular symptoms for up to 36 months in patients with chronic vestibular syndrome.

Exploring maladaptive cognitions and behaviors as perpetuating factors in patients with persistent somatic symptoms: a longitudinal study.

OBJECTIVE: Maladaptive cognitions and behaviors may influence symptoms and impairment in patients with persistent somatic symptoms (PSS). Aims of this study were to examine: (i) whether maladaptive cognitions and behaviors are associated with symptom severity and functional health over time; (ii) if these associations are the result of changes within individuals over time or of differences between individuals; (iii) directions of changes within individuals over time. METHODS: Longitudinal data of a heterogeneous sample of patients with PSS were analyzed (n = 322 patients enrolled in the PROSPECTS cohort study). Cognitive and behavioral responses to symptoms (CBRQ), symptom severity (PHQ-15) and physical and mental functioning (RAND-36 PCS and MCS) were assessed seven times over a five-year period (0, 6 months, 1, 2, 3, 4, 5 year). Longitudinal mixed model and hybrid model analysis with and without time-lag were applied. RESULTS: Maladaptive cognitions and behaviors were associated with more severe symptoms and reduced physical and mental functioning over time. Both changes within individuals over time and differences between individuals were associated with higher symptom severity and reduced physical and mental functioning. The between-subject component was about twice the effect size of the within-subject component. Changes in several specific maladaptive cognitions and behaviors were associated with more severe symptoms and reduced physical and mental functioning later in time and vice versa. CONCLUSION: This study shows that maladaptive cognitions and behaviors are associated with symptom severity and reduced physical and mental functioning over time in patients with PSS.

Effectiveness of psychosomatic therapy for patients with persistent somatic symptoms: Results from the CORPUS randomised controlled trial in primary care.

OBJECTIVE: To evaluate the effectiveness of psychosomatic therapy versus care as usual in primary care for patients with persistent somatic symptoms (PSS). METHODS: We conducted a pragmatic, two-armed, randomised controlled trial among primary care patients with PSS in the Netherlands that included 39 general practices and 34 psychosomatic therapists. The intervention, psychosomatic therapy, consisted of 6-12 sessions delivered by specialised exercise- and physiotherapists. PRIMARY OUTCOME MEASURE: patient's level of functioning. SECONDARY OUTCOMES: severity of physical and psychosocial symptoms, health-related quality of life, health-related anxiety, illness behaviour and number of GP contacts. RESULTS: Compared to usual care (n = 85), the intervention group (n = 84) showed no improvement in patient's level of functioning (mean difference - 0.50 [95% CI -1.10 to 0.10]; p = .10), and improvement in health-related anxiety (mean difference - 1.93 [95% CI -3.81 to -0.04]; p = .045), over 12 months. At 5-month follow-up, we found improvement in physical functioning, somatisation, and health-related anxiety. The 12-month follow-up revealed no therapy effects. Subgroup analyses showed an overall effect in patient's level of functioning for the group with moderate PSS (mean difference - 0.91 [95% CI -1.78 to -0.03]; p = .042). In the year after the end of therapy, the number of GP contacts did not differ significantly between the two groups. CONCLUSION: We only found effects on some secondary outcome measures, and on our primary outcome measure especially in patients with moderate PSS, the psychosomatic therapy appears promising for further study. TRIAL REGISTRATION: the trial is registered in the Netherlands Trial Registry, https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7356 under ID NTR7356.

Minimizing population health loss due to scarcity in OR capacity: validation of quality of life input.

OBJECTIVES: A previously developed decision model to prioritize surgical procedures in times of scarce surgical capacity used quality of life (QoL) primarily derived from experts in one center. These estimates are key input of the model, and might be more context-dependent than the other input parameters (age, survival). The aim of this study was to validate our model by replicating these QoL estimates. METHODS: The original study estimated QoL of patients in need of commonly performed procedures in live expert-panel meetings. This study replicated this procedure using a web-based Delphi approach in a different hospital. The new QoL scores were compared with the original scores using mixed effects linear regression. The ranking of surgical procedures based on combined QoL values from the validation and original study was compared to the ranking based solely on the original QoL values. RESULTS: The overall mean difference in QoL estimates between the validation study and the original study was - 0.11 (95% CI: -0.12 - -0.10). The model output (DALY/month delay) based on QoL data from both studies was similar to the model output based on the original data only: The Spearman's correlation coefficient between the ranking of all procedures before and after including the new QoL estimates was 0.988. DISCUSSION: Even though the new QoL estimates were systematically lower than the values from the original study, the ranking for urgency based on health loss per unit of time delay of procedures was consistent. This underscores the robustness and generalizability of the decision model for prioritization of surgical procedures.

Optimising personal continuity: a survey of GPs' and older patients' views.

BACKGROUND: Personal continuity - having a GP who knows their patients and keeps track of them - is an important dimension of continuity of care and is associated with lower mortality rates, higher quality of life, and reduced healthcare costs. In recent decades it has become more challenging for GPs to provide personal continuity owing to changes in society and health care. AIM: To investigate GPs' and older patients' views on personal continuity and how personal continuity can be improved. DESIGN & SETTING: Cross sectional survey study in The Netherlands. METHOD: A digital and postal survey was sent to 499 GPs and 1599 patients aged 65 years or older. Results were analysed using descriptive statistics for quantitative data and thematic analysis for open questions. RESULTS: In total, 249 GPs and 582 patients completed the surveys. A large majority of GPs (92-99%) and patients (91-98%) felt it was important for patients to see their own GP for life events or psychosocial issues. GPs and patients provided suggestions on how personal continuity can be improved. The thematic analysis of these suggestions identified nine themes: 1) personal connection, 2) GP accessibility and availability, 3) communication about (dis)continuity, 4) GP responsibility, 5) triage, 6) time for the patient, 7) actions by third parties, 8) team continuity, and 9) GP vocational training. CONCLUSION: Both GPs and older patients still place high value on personal continuity in the context of a changing society. GPs and patients provided a wide range of suggestions for improving personal continuity. The authors will use these suggestions to develop interventions for optimising personal continuity in general practice.

Off-label low dose amitriptyline for insomnia disorder: Patient-reported outcomes.

PURPOSE: Low dose amitriptyline is prescribed off-label to improve sleep maintenance in patients with insomnia disorder. Data on treatment outcomes are limited. We aimed to assess patient-reported treatment effect and side effects of low dose amitriptyline for insomnia in routine care data. METHODS: Cross-sectional study: Seven hundred fifty-two consecutive patients with insomnia disorder having sleep maintenance problems were treated in an outpatient sleep clinic with low dose amitriptyline (10-20 mg based on self-titration). Treatment was intended to improve sleep maintenance. Before the planned follow-up consultation (approximately 6 weeks after start treatment) patients completed an online treatment evaluation questionnaire. Treatment (dose, adherence), sleep, fatigue, satisfaction and side effects were assessed by multiple-choice questions with room for free-text elaboration. RESULTS: 53.7% of the patients reported to use amitriptyline up to 10 mg/day, 42.9% used a self-increased dose of mostly 20 mg/day, while 3.5% had discontinued treatment. 73.9% of the total study population reported improvement of sleep maintenance, 31.3% improved sleep onset, 35.2% improved daytime fatigue, and 45.8% reported to be (very) satisfied with treatment results. 66.1% reported at least one side effect. The reported side effects were generally the already known side effects of amitriptyline. CONCLUSION: These patient-reported outcomes support the clinical observations that low dose amitriptyline improves sleep maintenance on the short term and that it is generally well tolerated. This further justifies randomized controlled trials in patients with insomnia disorder and sleep maintenance problems to assess the effectiveness and safety of low dose amitriptyline on the short and long term.

A phenomenology of direct observation in residency: Is Miller's 'does' level observable?

INTRODUCTION: Guidelines on direct observation (DO) present DO as an assessment of Miller's 'does' level, that is, the learner's ability to function independently in clinical situations. The literature, however, indicates that residents may behave 'inauthentically' when observed. To minimise this 'observer effect', learners are encouraged to 'do what they would normally do' so that they can receive feedback on their actual work behaviour. Recent phenomenological research on patients' experiences with DO challenges this approach; patients needed-and caused-some participation of the observing supervisor. Although guidelines advise supervisors to minimise their presence, we are poorly informed on how some deliberate supervisor participation affects residents' experience in DO situations. Therefore, we investigated what residents essentially experienced in DO situations. METHODS: We performed an interpretive phenomenological interview study, including six general practice (GP) residents. We collected and analysed our data, using the four phenomenological lenses of lived body, lived space, lived time and lived relationship. We grouped our open codes by interpreting what they revealed about common structures of residents' pre-reflective experiences. RESULTS: Residents experienced the observing supervisor not just as an observer or assessor. They also experienced them as both a senior colleague and as the patient's familiar GP, which led to many additional interactions. When residents tried to act as if the supervisor was not there, they could feel insecure and handicapped because the supervisor was there, changing the situation. DISCUSSION: Our results indicate that the 'observer effect' is much more material than was previously understood. Consequently, observing residents' 'authentic' behaviour at Miller's 'does' level, as if the supervisor was not there, seems impossible and a misleading concept: misleading, because it may frustrate residents and cause supervisors to neglect patients' and residents' needs in DO situations. We suggest that one-way DO is better replaced by bi-directional DO in working-and-learning-together sessions.

Head-to-head comparison of somatic symptom scales: The Patient Health Questionnaire (PHQ-15) and the somatization scale of the Four-Dimensional Symptom Questionnaire (4DSQ-S).

OBJECTIVE: The goal of this study was to compare the 15-item Patient Health Questionnaire (PHQ-15) and the somatization subscale of the Four-Dimensional Symptoms Questionnaire (4DSQ-S) with respect to their latent structure and reliability, and to examine whether their scores are affected by age and gender, and whether the scales measure the same construct(s). METHODS: The study population consisted of individuals with a tendency to experience persistent somatic symptoms, recruited in multiple healthcare settings, who completed the PHQ-15 and 4DSQ-S concurrently. We analyzed the scales' latent factor structure using confirmatory factor analysis (CFA), the scales' reliability, and differential item functioning (DIF) due to age and gender. We performed a head-to-head comparison by fitting structural equation models of the questionnaires' factors. RESULTS: We included 234 participants. CFA showed that both questionnaires fitted a bifactor model with a general factor and four specific factors, three of which (labeled "musculoskeletal", "gastrointestinal", and "cardiopulmonary") were substantively similar. Both scales were essentially unidimensional. The reliability of the PHQ-15 and 4DSQ-S was equally high (omega 0.933 and 0.942, respectively). DIF-analysis showed minor DIF for age in one item of each questionnaire, with negligible impact on the scale score. Head-to-head comparison showed that the PHQ-15 and 4DSQ-S measured the same constructs. We present PHQ-15 - 4DSQ-S cross-walk tables. CONCLUSIONS: Both questionnaires mainly measure a single somatic symptom burden dimension of which all symptoms (covered by the questionnaires) are adequate indicators. They do so equally accurately and they behave the same across gender and age categories.

Lost in fragmentation - care coordination when somatic symptoms persist: a qualitative study of patients' experiences.

BACKGROUND: GPs can play a central role in the care of patients with persistent somatic symptoms (PSS). To date, little is known about these patients' experiences relating to their coordination of care. AIM: To explore the experiences of patients with PSS relating to coordination of care - in particular by their GP - during their illness trajectory. DESIGN AND SETTING: This qualitative study was carried out from January to April 2019 in the Netherlands as part of a multicentre prospective cohort study on the course of PSS (PROSPECTS). METHOD: Thematic content analysis of 15 interviews. RESULTS: Three themes were identified: care fragmentation during the diagnostic trajectory; transition from the search for a cure to coping; and reframing to coping: GPs' role in facilitating supportive care. Patients experienced a lack of collaboration from healthcare workers during the diagnostic trajectory. Guidance by their GP in a process of shared decision making was positively valued by patients. Moving the focus from searching for a cure to coping with symptoms was described as a 'personal endeavour', made even more challenging by the ongoing uncertainty experienced by patients. When reframing to coping, the extent to which patients felt aligned with their GP played an important role in whether their supportive care request was met. CONCLUSION: Patients experienced difficulties when navigating the diagnostic trajectory and shifting to coping. The findings of this study underline the importance of collaboration between GPs and other healthcare professionals during the diagnostic trajectory. The authors recommend that GPs provide proactive guidance and are sensitive to patients who shift to coping by providing them with supportive care in a process of shared decision making.

Experiences of general practitioners explaining central sensitisation to patients with persistent physical symptoms: a focus group study.

OBJECTIVE: Patients with persistent physical symptoms (PPS) require an explanation that is acceptable and comprehensible to them. Central sensitisation (CS) is an explanatory model for PPS and chronic pain that has been broadly applied in the context of pain medicine, but, until recently, not by general practitioners (GPs). We explored how GPs used the CS model in their consultations with patients with PPS. DESIGN AND SETTING: A qualitative focus group study among GPs in the Netherlands. METHODS: We instructed 33 GPs on how to explain CS to patients with PPS. After 0.5-1.5 years of using the CS model, 26 GPs participated in focus groups and interviews to report and discuss their experiences with CS as an explanatory model. Audio recordings were transcribed and two researchers independently analysed the data. The text was coded, codes were organised into themes and discussed until consensus was reached. RESULTS: We identified eleven themes and grouped these into four categories.The GPs regarded the CS model as evidence-based, credible and giving recognition to the patient. On the other hand, they found explaining the CS model difficult and time-consuming. They tailored the CS model to their patients' needs and used multiple consultations to explain the model. The GPs reported that the use of the CS model seemed to improve the understanding and acceptance of the symptoms by the patients and seemed to reduce their need for more diagnostic tests. Furthermore, patients seemed to become more motivated to accept appropriate therapy. CONCLUSION: GPs reported that they were able to provide explanations with the CS model to their patients with PPS. They regarded the model as evidence-based, credible and giving recognition to the patient, but explaining it difficult and time-consuming.

Potentially traumatic events, social support and burden of persistent somatic symptoms: A longitudinal study.

OBJECTIVE: Psychological trauma is a well-known risk factor for the onset of persistent somatic symptoms (PSS). In contrast, little is known on the relation between potentially traumatic events (PTEs) and the severity of PSS, and on the protective effect of social support. We aimed to: (i) determine whether childhood, adulthood and recent PTEs are associated with burden of PSS over four years of follow-up; (ii) examine associations of multiple and cumulative (in childhood and adulthood) exposure to PTEs with burden of PSS; and (iii) determine whether social support modifies these associations. METHODS: Longitudinal data of 322 patients with PSS were analyzed. PTEs (Life Events Questionnaire) and social support (Social Support Scale) were assessed at baseline. Burden of PSS was measured in terms of symptom severity (PHQ-15) and physical functioning (RAND-36 PCS) at six repeated measurements over a four-year interval. Associations were analyzed using longitudinal mixed model analysis. RESULTS: Patients with multiple childhood PTEs reported higher burden of PSS over four-year time. Adulthood PTEs were associated with burden of PSS in patients with, but not in patients without childhood PTEs. Recent PTEs were not associated with burden over time. Social support did not modify any of the associations. CONCLUSIONS: PTEs are associated with higher burden of PSS over time, in addition to the well-known association with the onset of PSS. PTEs in early life and cumulative exposure to PTEs in childhood and adulthood are associated with higher burden over time in patients with PSS. Social support did not attenuate the associations.

Cost-Effectiveness of Routine Third Trimester Ultrasound Screening for Fetal Growth Restriction Compared to Care as Usual in Low-Risk Pregnancies: A Pragmatic Nationwide Stepped-Wedge Cluster-Randomized Trial in The Netherlands (the IRIS Study).

Routine third trimester ultrasonography is increasingly used to screen for fetal growth restriction. However, evidence regarding its cost-effectiveness is lacking. We aimed to evaluate the cost-effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes compared to usual care (selective ultrasonography). An economic evaluation alongside a stepped-wedge cluster-randomized trial was conducted. Via 60 midwifery practices 12,974 Dutch women aged ≥16 years with low-risk pregnancies were enrolled at 22.8 (SD = 2.4) weeks' gestation. All practices provided usual care. At 3, 7, and 10 months a third of the practices were randomized to the intervention strategy providing routine ultrasonography at 28-30 and 34-36 weeks' gestation and usual care. The primary clinical outcome was a dichotomous composite measure of 12 severe adverse perinatal outcomes (SAPO) up to one week postpartum. Information on perinatal care and societal costs was derived from Netherlands Perinatal Registry, hospital records and a survey. Cost-effectiveness analyses revealed no significant differences in SAPO and healthcare and societal costs between the intervention strategy (n = 7026) and usual care (n = 5948). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was never higher than 0.6 for all possible ceiling ratios. Adding routine third trimester ultrasonography to usual care is not cost-effective in reducing SAPO.

Perceived working mechanisms of psychosomatic therapy in patients with persistent somatic symptoms in primary care: a qualitative study.

OBJECTIVES: To explore the perceived working mechanisms of psychosomatic therapy according to patients with persistent somatic symptoms (PSS) and their psychosomatic therapists. DESIGN: Qualitative study using semistructured face-to-face interviews and focus groups. All interviews were audiorecorded, transcribed verbatim and analysed, by two researchers independently, based on the thematic analysis. SETTING: Alongside a randomised controlled trial to establish the (cost-)effectiveness of psychosomatic therapy in patients with PSS in primary care, we conducted a process evaluation with a qualitative study. Patients were recruited in general practice in three regions in the Netherlands. PARTICIPANTS: Interviews were conducted with twenty patients with PSS who received psychosomatic therapy and 25 psychosomatic therapists. In addition, two focus groups were conducted with six and seven psychosomatic therapists, respectively. INTERVENTION: Psychosomatic therapy, delivered by specialised exercise and physical therapists, is a multimodal and tailored treatment based on the biopsychosocial model. OUTCOME MEASURES: Experiences, opinions and views from patients' and therapists' perspective on psychosomatic therapy were identified. RESULTS: A total of 37 interviews with patients, 25 interviews and two focus groups with therapists were analysed. Three main themes emerged from the data of the patients: (1) continuous alternation of psychosocial conversations and body-oriented exercises; (2) awareness of body-mind connection and (3) good relationship with therapist. Four main themes emerged from the data of the therapists (1) building rapport; (2) continuously searching for common ground; (3) making patients aware of the interaction between body and mind; and (4) continuous alternation between exploration and treatment. CONCLUSION: According to patients as well as therapists, the continuous alternation of psychosocial conversations and body-oriented exercises to provide awareness of the interaction between body and mind are the perceived working mechanism of psychosomatic therapy. Therapeutic alliance and finding common ground between patient and therapist are prerequisites for the success of psychosomatic therapy. TRIAL REGISTRATION NUMBER: NL7157 (NTR7356).

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.

Optimising personal continuity for older patients in general practice: a study protocol for a cluster randomised stepped wedge pragmatic trial.

BACKGROUND: Continuity of care, in particular personal continuity, is a core principle of general practice and is associated with many benefits such as a better patient-provider relationship and lower mortality. However, personal continuity is under pressure due to changes in society and healthcare. This affects older patients more than younger patients. As the number of older patients will double the coming decades, an intervention to optimise personal continuity for this group is highly warranted. METHODS: Following the UK Medical Research Council framework for complex Interventions, we will develop and evaluate an intervention to optimise personal continuity for older patients in general practice. In phase 0, we will perform a literature study to provide the theoretical basis for the intervention. In phase I we will define the components of the intervention by performing surveys and focus groups among patients, general practitioners, practice assistants and practice nurses, concluded by a Delphi study among members of our group. In phase II, we will test and finalise the intervention with input from a pilot study in two general practices. In phase III, we will perform a stepped wedge cluster randomised pragmatic trial. The primary outcome measure is continuity of care from the patients' perspective, measured by the Nijmegen Continuity Questionnaire. Secondary outcome measures are level of implementation, barriers and facilitators for implementation, acceptability and feasibility of the intervention. In phase IV, we will establish the conditions for large-scale implementation. DISCUSSION: This is the first study to investigate an intervention for improving personal continuity for older patients in general practice. If proven effective, our intervention will enable General practitioners to improve the quality of care for their increasing population of older patients. The pragmatic design of the study will enable evaluation in real-life conditions, facilitating future implementation. TRIAL REGISTRATION NUMBER: Netherlands Trial Register, trial NL8132 . Registered 2 November 2019.

Tests for central sensitization in general practice: a Delphi study.

INTRODUCTION: Central sensitization (CS) may explain the persistence of symptoms in patients with chronic pain and persistent physical symptoms (PPS). There is a need for assessing CS in the consultation room. In a recently published systematic review, we made an inventory of tests for CS. In this study we aimed to assess which tests might have added value, might be feasible and thus be suitable for use in general practice. METHODS: We conducted a Delphi study consisting of two e-mail rounds to reach consensus among experts in chronic pain and PPS. We invited 40 national and international experts on chronic pain and PPS, 27 agreed to participate. We selected 12 tests from our systematic review and additional searches; panellists added three more tests in the first round. We asked the panellists, both clinicians and researchers, to rate these 15 tests on technical feasibility for use in general practice, added value and to provide an overall judgement for suitability in general practice. RESULTS: In two rounds the panellists reached consensus on 14 of the 15 tests: three were included, eleven excluded. Included were the Central Sensitization Inventory (CSI), pressure pain thresholds (PPTs) and monofilaments. No consensus was reached on the Sensory Hypersensitivity Scale. CONCLUSION: In a Delphi study among an international panel of experts, three tests for measuring CS were considered to be suitable for use in general practice: the Central Sensitization Inventory (CSI), pressure pain thresholds (PPTs) and monofilaments.

Effectiveness of low-dose amitriptyline and mirtazapine for insomnia disorder: study protocol of a randomised, double-blind, placebo-controlled trial in general practice (the DREAMING study).

INTRODUCTION: For over more than a decade, low-dose amitriptyline and mirtazapine are prescribed off-label for insomnia. However, placebo-controlled evidence on these antidepressants for insomnia is still lacking. Therefore, the present trial aims to assess the effectiveness of low-dose amitriptyline (10-20 mg/day) and mirtazapine (7.5-15 mg/day) in patients with insomnia disorder with difficulty maintaining sleep or early-morning awakening problems in general practice. METHODS AND ANALYSIS: The Drug REdiscovery: low-dose Amitriptyline and Mirtazapine for INsomnia disorder in General practice (DREAMING) study is a randomised, double-blind, placebo-controlled trial in about 50 general practices. Adults (18-85 years) with insomnia disorder (Diagnostic and Statistical Manual of Mental Disorders-5) who ask their general practitioner (GP) for sleep medication when non-pharmacological treatment is deemed not effective, are eligible. EXCLUSION CRITERIA: isolated sleep initiation problem, contraindications for or drug-drug interactions with either amitriptyline or mirtazapine. Participants (n=156) will be randomly assigned to three parallel treatment groups of 16-week treatment with either amitriptyline (one or two tablets of 10 mg/day) or mirtazapine (one or two tablets of 7.5 mg/day) or placebo (one or two tablets) alongside usual GP care. All participants start and end with single dose, but dose can be doubled following GP consultation in week 3. Questionnaire assessments will be conducted at baseline, week 6, 12, 20 and 52. The primary study outcome is self-reported insomnia severity at 6 weeks, measured with the Insomnia Severity Index (ISI) in an intention to treat analysis. Secondary outcomes include subjective sleep quality quantified by sleep indices, daytime functioning and symptoms, safety and treatment evaluation and other sleep care consumption. ETHICS AND DISSEMINATION: The Medical Ethics Committee of the VU Medical Centre Amsterdam approved this trial. The results of this trial will be published in peer-reviewed scientific journals and presented at relevant academic conferences and to key stakeholders. TRIAL REGISTRATION NUMBER: NTR7449.