Planned hospital birth compared with planned home birth for pregnant women at low risk of complications.

BACKGROUND: Observational studies of increasingly better quality and in different settings suggest that planned hospital birth in many places does not reduce mortality and morbidity but increases the frequency of interventions and complications. Euro-Peristat (part of the European Union's Health Monitoring Programme) has raised concerns about iatrogenic effects of obstetric interventions, and the World Health Organization (WHO) has raised concern that the increasing medicalisation of childbirth tends to undermine women's own capability to give birth and negatively impacts their childbirth experience. This is an update of a Cochrane Review first published in 1998, and previously updated in 2012. OBJECTIVES: To compare the effects of planned hospital birth with planned home birth attended by a midwife or others with midwifery skills and backed up by a modern hospital system in case a transfer to hospital should turn out to be necessary. The primary focus is on women with an uncomplicated pregnancy and low risk of medical intervention during birth.  SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register (which includes trials from CENTRAL, MEDLINE, Embase, CINAHL, WHO ICTRP, and conference proceedings), ClinicalTrials.gov (16 July 2021), and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing planned hospital birth with planned home birth in low-risk women as described in the objectives. Cluster-randomised trials, quasi-randomised trials, and trials published only as an abstract were also eligible. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked the data for accuracy. We contacted study authors for additional information. We assessed the certainty of the evidence using the GRADE approach.  MAIN RESULTS: We included one trial involving 11 participants. This was a small feasibility study to show that well-informed women - contrary to common beliefs - were prepared to be randomised. This update did not identify any additional studies for inclusion, but excluded one study that had been awaiting assessment. The included study was at high risk of bias for three out of seven risk of bias domains. The trial did not report on five of the seven primary outcomes, and reported zero events for one primary outcome (caesarean section), and non-zero events for the remaining primary outcome (baby not breastfed). Maternal mortality, perinatal mortality (non-malformed), Apgar < 7 at 5 minutes, transfer to neonatal intensive care unit, and maternal satisfaction were not reported. The overall certainty of the evidence for the two reported primary outcomes was very low according to our GRADE assessment (downgraded two levels for high overall risk of bias (due to high risk of bias arising from lack of blinding, high risk of selective reporting and lack of ability to check for publication bias) and two levels for very serious imprecision (single study with few events)).   AUTHORS' CONCLUSIONS: This review shows that for selected, low-risk pregnant women, the evidence from randomised trials to support that planned hospital birth reduces maternal or perinatal mortality, morbidity, or any other critical outcome is uncertain. As the quality of evidence in favour of home birth from observational studies seems to be steadily increasing, it might be just as important to prepare a regularly updated systematic review including observational studies as described in the Cochrane Handbook for Systematic Reviews of Interventions as to attempt to set up new RCTs. As women and healthcare practitioners may be aware of evidence from observational studies, and as the International Federation of Gynecology and Obstetrics and the International Confederation of Midwives collaboratively conclude that there is strong evidence that out-of-hospital birth supported by a registered midwife is safe, equipoise may no longer exist, and randomised trials may now thus be considered unethical or hardly feasible.

SCI peer health coach influence on self-management with peers: a qualitative analysis.

STUDY DESIGN: A process evaluation of a clinical trial. OBJECTIVES: To describe the roles fulfilled by peer health coaches (PHCs) with spinal cord injury (SCI) during a randomized controlled trial research study called 'My Care My Call', a novel telephone-based, peer-led self-management intervention for adults with chronic SCI 1+ years after injury. SETTING: Connecticut and Greater Boston Area, MA, USA. METHODS: Directed content analysis was used to qualitatively examine information from 504 tele-coaching calls, conducted with 42 participants with SCI, by two trained SCI PHCs. Self-management was the focus of each 6-month PHC-peer relationship. PHCs documented how and when they used the communication tools (CTs) and information delivery strategies (IDSs) they developed for the intervention. Interaction data were coded and analyzed to determine PHC roles in relation to CT and IDS utilization and application. RESULTS: PHCs performed three principal roles: Role Model, Supporter, and Advisor. Role Model interactions included CTs and IDSs that allowed PHCs to share personal experiences of managing and living with an SCI, including sharing their opinions and advice when appropriate. As Supporters, PHCs used CTs and IDSs to build credible relationships based on dependability and reassuring encouragement. PHCs fulfilled the unique role of Advisor using CTs and IDSs to teach and strategize with peers about SCI self-management. CONCLUSION: The SCI PHC performs a powerful, flexible role in promoting SCI self-management among peers. Analysis of PHC roles can inform the design of peer-led interventions and highlights the importance for the provision of peer mentor training.

Moving beyond disrespect and abuse: addressing the structural dimensions of obstetric violence.

During recent decades, a growing and preoccupying excess of medical interventions during childbirth, even in physiological and uncomplicated births, together with a concerning spread of abusive and disrespectful practices towards women during childbirth across the world, have been reported. Despite research and policy-making to address these problems, changing childbirth practices has proved to be difficult. We argue that the excessive rates of medical interventions and disrespect towards women during childbirth should be analysed as a consequence of structural violence, and that the concept of obstetric violence, as it is being used in Latin American childbirth activism and legal documents, might prove to be a useful tool for addressing structural violence in maternity care such as high intervention rates, non-consented care, disrespect and other abusive practices.

The Pediatric Measure of Participation (PMoP) short forms.

STUDY DESIGN: Multi-center cross-sectional cohort study. OBJECTIVES: The objectives of this study were to develop and validate short forms (SFs) of participation for child- and parent-reported outcomes following spinal cord injury (SCI). SETTING: Three pediatric orthopedic hospitals in the United States. METHODS: The expert panel used calibration data from the pediatric computerized adaptive test (CAT) development study (convenience sample of 381 children and adolescents with SCI and 322 parents or caregivers) to select SF items. The panel selected items for two domains (participation self-relevant to what I want to do; participation friends-relevant to what my friends do), with parent and child versions for each domain. Psychometric analyses included group reliability, Cronbach's alpha, agreement (SFs and item banks), percent of sample with highest (ceiling) and lowest (floor) scores by level of lesion (paraplegia/tetraplegia), and test information function. RESULTS: Group reliability and Cronbach's alpha values are acceptable (0.74-0.92) and agreement (intraclass correlation coefficients for SFs and total item banks) is strong (0.89-0.95). Floor effects were minimal for people with tetraplegia and paraplegia (0-1.19%). Ceiling effects were minimal for people with tetraplegia (0-3.13%) and slightly higher, but acceptable, for people with paraplegia (8.06-14.02%). Test information function for the SFs was sufficiently high over the range of scores for the majority of the sample. CONCLUSION: Pediatric Measure of Participation (PMoP) SFs are acceptable for use when CATs are not feasible. SPONSORSHIP: The study was funded by the Shriners Hospitals for Children Research Grant 79142 (Mulcahey, PI) and the Boston ROC Grant 5R24HD065688-05 (Jette, PI).

Measuring activity limitation outcomes in youth with spinal cord injury.

STUDY DESIGN: A cross-sectional study. OBJECTIVES: The Pediatric Spinal Cord Injury Activity Measure (PEDI-SCI AM), which includes calibrated item banks (child and parent versions) for general mobility, daily routines, wheeled mobility and ambulation, can be administered using computerized adaptive tests (CATs) or short forms (SFs). The study objectives are as follows: (1) to examine the psychometric properties of the PEDI-SCI AM item banks and 10-item CATs; and (2) to develop and evaluate the psychometric properties of PEDI-SCI AM SFs. SETTING: US Shriners Hospitals for Children (California, Illinois and Pennsylvania). METHODS: Calibration data from a convenience sample of 381 children and adolescents with SCI and 322 parents or caregivers were used to examine PEDI-SCI AM item banks, 10-item CATs and SF scores. We calculated group reliability, internal consistency (Cronbach's alpha) and interclass coefficients (ICCs) to assess agreement between 10-item CATs, SFs and item banks. The percent of the sample with highest (ceiling) and lowest (floor) scores was also determined. An expert panel selected items for 14 SFs. RESULTS: PEDI-SCI item banks, 10-item CATs and SFs demonstrate acceptable group reliability (0.73-0.96) and internal consistency (0.77-0.98). ICC values show strong agreement with item banks for 10-item CATs (0.72-0.99) and SFs. Floor effects are minimal (<15%). Ceiling effects are minimal for children with tetraplegia but high in children with paraplegia for general mobility (13.41-26.05%) and daily activities (12.99-32.71%). CONCLUSIONS: The PEDI-SCI AM exhibited strong psychometric properties for children with tetraplegia. Replenishment of the general mobility and daily routine item banks is needed to reduce ceiling effects noted for youth with paraplegia.

Access to patients' health records for drug therapy problem determination by pharmacists.

OBJECTIVES: To evaluate differences in the number and type of drug therapy problems (DTPs) identified by pharmacists with and without access to patients' primary care health records; determine the confidence level of pharmacists in their assessment of DTPs with and without access to health records; and determine the type of information pharmacists need to confirm their assessment. METHODS: The study design was an exploratory and comparative evaluation of comprehensive medication management assessments. Pharmacists initially completed patient assessments without access to the patient's primary care health record. Pharmacists documented the visit according to the standard of care and documented the assessment in a standardized study form. Pharmacists then reviewed the patient's primary care health record and documented a revised assessment in the standardized study form. The standardized form included sections about the number of DTPs, the classification of DTPs, the pharmacist's confidence level in identifying DTPs, and the information needed to increase the pharmacist's confidence level in identifying DTPs. RESULTS: Pharmacists evaluated 24 patients and identified 132 DTPs. After reviewing patients' primary care health records, 31 DTPs were deemed "false DTPs," 3 DTPs were recategorized, and 9 new DTPs were identified. Practitioner confidence levels in DTP determination improved after reviewing patients' primary care health records. The health information most frequently identified as desirable after the initial review was laboratory tests. CONCLUSION: Pharmacists identified more DTPs with lower confidence levels without access to patients' primary care health records. Fewer DTPs were deemed "confirmed DTPs" and confidence in the practitioners' assessments improved after review of the primary care health records. Access to primary care health records can help community pharmacists build an efficient and comprehensive medication management practice.

Access to patients' health records for drug therapy problem determination by pharmacists.

OBJECTIVES: To evaluate differences in the number and type of drug therapy problems (DTPs) identified by pharmacists with and without access to patients' primary care health records; determine the confidence level of pharmacists in their assessment of DTPs with and without access to health records; and determine the type of information pharmacists need to confirm their assessment. METHODS: The study design was an exploratory and comparative evaluation of comprehensive medication management assessments. Pharmacists initially completed patient assessments without access to the patient's primary care health record. Pharmacists documented the visit according to the standard of care and documented the assessment in a standardized study form. Pharmacists then reviewed the patient's primary care health record and documented a revised assessment in the standardized study form. The standardized form included sections about the number of DTPs, the classification of DTPs, the pharmacist's confidence level in identifying DTPs, and the information needed to increase the pharmacist's confidence level in identifying DTPs. RESULTS: Pharmacists evaluated 24 patients and identified 132 DTPs. After reviewing patients' primary care health records, 31 DTPs were deemed "false DTPs," 3 DTPs were recategorized, and 9 new DTPs were identified. Practitioner confidence levels in DTP determination improved after reviewing patients' primary care health records. The health information most frequently identified as desirable after the initial review was laboratory tests. CONCLUSION: Pharmacists identified more DTPs with lower confidence levels without access to patients' primary care health records. Fewer DTPs were deemed "confirmed DTPs" and confidence in the practitioners' assessments improved after review of the primary care health records. Access to primary care health records can help community pharmacists build an efficient and comprehensive medication management practice.

Quantification of Longitudinal Patient-Reported Burden of Adverse Drug Reactions Attributed to the Use of TNF-α Inhibitors in inflammatory rheumatic diseases: an observational prospective cohort study.

BACKGROUND: There is a lack of knowledge on patient perspectives on adverse drug reactions (ADRs) attributed to the use of biologics. The aim of this study is to quantify the burden over time of ADRs attributed to TNF-α inhibitors in patients with inflammatory rheumatic diseases (IRDs) and investigate whether the burden over time differs between different types of ADRs. RESEARCH DESIGN AND METHODS: Data were used from the Dutch Biologic Monitor (DBM), an observational prospective cohort study for patient-reported ADRs attributed to biologics. Patients with an IRD using a TNF-α inhibitor reporting an ADR, lasting for three consecutive questionnaires, were included. Questionnaires were sent every two months and burden was scored on a 5-point Likert-type scale. Burden scores were analyzed using linear mixed models. RESULTS: Data from 166 unique patients reporting 274 ADRs were included. The burden score decreased every month by 0.29 points (95% CI -0.34 - -0.24) on average on a 5-point Likert-type scale. The burden score for infections and infestations decreased significantly faster than the burden score for injection site reactions. CONCLUSIONS: Patient-reported burden of ADRs attributed to the use of a TNF-α inhibitor in patients with IRDs decreased significantly over time, especially for infections and infestations.

The burden of adverse drug reactions reported by patients in the Dutch ADR monitor: a proof of concept.

BACKGROUND: We aimed to describe the burden of adverse drug reactions (ADRs) reported by patients participating in the Dutch ADR Monitor using a multifactorial burden measurement instrument. METHODS: The Dutch ADR Monitor is a cohort event monitoring system that collects information on ADR experiences, including burden. This study includes the initial data (November 2022 until May 2023). Patients were asked if experienced ADRs impacted 7 domains of burden: appearance, medical treatment, daily life, fatigue, physical consequences, mental consequences and the course of ADRs. Burden was scored from 0 to 10 on impacted domains. The distributions of these burden scores were demonstrated in Likert plots. The burden between persistent and recurrent ADRs was compared. RESULTS: 92 patients reported 199 ADRs. Impact on the domains fatigue and daily life were experienced most frequently, except for skin and subcutaneous tissue ADRs, where impact on appearance and mental consequences were experienced most frequently. Fatigue was considered the most burdensome domain. No difference in burden was found between persistent (median = 7, IQR = 4) and recurrent ADRs (median = 6, IQR = 4, p = 0.59). CONCLUSIONS: This is the first study investigating burden of ADRs on 7 domains in patients with chronic diseases. Impact on the domain fatigue was considered most burdensome.

Patients with skin and subcutaneous ADRs experienced impact on appearance and mental consequences most often, but found impact on fatigue most burdensome.For most reported ADRs, patients scored the highest burden on the domain fatigue and thus found impact on this domain to be the most burdensome.Patients with skin and subcutaneous ADRs experienced impact on appearance and mental consequences most often, but found impact on fatigue most burdensome.

A pilot study of a telehealth intervention for persons with spinal cord dysfunction.

STUDY DESIGN: Single-blind randomized controlled trial of 6 months' duration. OBJECTIVES: To evaluate the efficacy of a novel telehealth intervention, 'CareCall', on reducing pressure ulcers and depression and enhancing the use of appropriate health care. SETTING: General community, Massachusetts and Connecticut, United States METHODS: 'CareCall' is an automated, interactive voice response system that combines patient education, cognitive behavioral interventions, screening and referrals, with alerts to a nurse telerehabilitation coordinator for direct non-emergent phone follow up. Participants consisted of a convenience sample of 142 persons with multiple sclerosis or spinal cord injury using a wheelchair >6 h per day. The intervention group received CareCall (n=71) The control group received usual care (n=71). The main outcome measures were: The pressure ulcer scale for healing tool, Patient Health Questionnaire-9 depression scale, Cornell Services Index and Craig Hospital Inventory of Environmental Factors-Short Form Question 5. RESULTS: CareCall achieved a reduction in presence of pressure ulcers at 6 months in women (P<0.0001). Among those with baseline depression, CareCall reduced 6-month severity of depression, adjusting for age and gender (P<0.047). CareCall did not have a significant impact on health-care utilization (OR=1.8, P=0.07), but did significantly improve participants' report of health-care availability (OR=2.03, P<0.04). CONCLUSION: This is the first study to demonstrate the efficacy of a largely automated telehealth intervention for adults with spinal cord dysfunction. Future research needs to replicate this study in a larger, multisite trial.

Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient's Perspective.

INTRODUCTION: There is a need for more extensive information about adverse drug reactions (ADRs) for patients than currently available, including information on the course of ADRs. Aspects characterising the course of ADRs from the patient perspective have not been identified before. OBJECTIVE: We aimed to develop a framework based on common themes in the course of ADRs identified from patient descriptions in patient-reported ADRs. METHODS: In this qualitative study, patient descriptions of the course of patient-reported ADRs were analysed by a thematic analysis with an inductive approach using three different existing datasets containing patient-reported ADRs. Two datasets included patient-reported ADRs from cohort event monitoring of biologics and direct oral anticoagulants and one dataset included spontaneous reports from patients concerning medication for lower urinary tract symptoms. A conceptual framework was developed from the identified main themes and subthemes. RESULTS: Patient-reported data concerning 3888 ADRs were analysed. Six main themes with multiple subthemes were identified from patient descriptions of the course of ADRs. Four themes were descriptive: frequency of an ADR episode, duration of an ADR episode, moment or period of ADR occurrence, and development in the intensity of the ADR. Two themes concerned factors influencing the course of ADRs: triggering factors and improving factors. CONCLUSIONS: The presented framework illustrates that patients describe extensive details on the course and timeframe of ADRs. The identified themes provide a basis for improving the systematic data collection of more extensive details about ADRs from patients as a first step towards the provision of more comprehensive ADR information to patients.

First-time adverse drug reactions, survival analysis, and the share of adverse drug reactions in treatment discontinuation in real-world rheumatoid arthritis patients: a comparison of first-time treatment with adalimumab and etanercept.

BACKGROUND: This study aims to compare nature and frequency of adverse drug reactions (ADRs), time to first ADR, drug survival, and the share of ADRs in treatment discontinuation of first-time treatment with adalimumab (ADA) and etanercept (ETN) in real-world RA patients. RESEARCH DESIGN AND METHODS: Retrospective, single-center cohort study including naïve patients treated between January 2003-April 2020. Time to first ADR and drug survival of first-time treatment were studied using Kaplan-Meier and Cox-regression models up to 10 years, with 2- and 5-year post-hoc sensitivity analysis. Nature and frequencies of first-time ADRs and causes of treatment discontinuation were assessed. RESULTS: In total, 416 patients (ADA: 255, ETN: 161, 4865 patient years) were included, of which 92 (22.1%) experienced ADR(s) (ADA: 59, 23.1%; ETN: 33, 20.4%). Adjusted for age, gender and concomitant conventional DMARD use, ADA was more likely to be discontinued than ETN up to 2-, 5- and 10-year follow-up (adjusted HRs 1.63; 1.62; 1.59 (all p<0.001)). ADRs were the second reason of treatment discontinuation (ADA 20.7%, ETN 21.4%). CONCLUSIONS: Despite seemingly different nature and frequencies, ADRs are the second reason of treatment discontinuation for both bDMARDs. Furthermore, 2-, 5-, and 10-year drug survival is longer for ETN compared to ADA.

Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor.

BACKGROUND: Fatigue is a common problem in immune-mediated inflammatory disease (IMID) patients, significantly impacting their quality of life. OBJECTIVES: In this study, we describe the pattern and characteristics of fatigue as a patient-reported adverse drug reaction (ADR) of biologics, and compared patient and treatment characteristics with patients reporting other ADRs or no ADRs. METHODS: In this cohort event monitoring study, the description and characteristics of fatigue reported as a possible ADR in the Dutch Biologic Monitor were assessed and analysed for commonly recurring themes or patterns. Baseline and treatment characteristics of patients with fatigue and patients reporting other ADRs or no ADRs were compared. RESULTS: Of 1382 participating patients, 108 patients (8%) reported fatigue as an ADR of a biologic. Almost half of these patients (50 patients, 46%) described episodes of fatigue during or shortly after biologic injection, which often recurred following subsequent injections. Patients with fatigue were significantly younger than patients with other ADRs or patients without ADRs (median age for patients with fatigue, 52 years; median age for patients with other ADRs, 56 years; and median age for patients without ADRs, 58 years); significantly more often smoked (25% vs. 16% and 15%); used infliximab (22% vs. 9% and 13%), rituximab (9% vs. 3% and 1%) or vedolizumab (6% vs. 2% and 1%); and significantly more often had Crohn's disease (28% vs. 13% and 13%) and other comorbidities (31% vs. 20% and 15%). Patients with fatigue significantly less frequently used etanercept (12% vs. 29% and 34%) or had rheumatoid arthritis (30% vs. 45% and 43%). CONCLUSIONS: IMID patients may experience fatigue as a postdosing effect of biologics.

Disease-specific ADRs of TNF-α inhibitors as reported by patients with inflammatory rheumatic diseases: a registry-based prospective multicenter cohort study.

BACKGROUND: The extent to which adverse drug reactions (ADRs) of biologics differ per immune-mediated inflammatory disease (IMID), and the relevance of tailoring ADR information per IMID is not fully investigated. We aimed to compare patient-reported ADRs attributed to adalimumab and etanercept between different inflammatory rheumatic diseases (IRDs). RESEARCH DESIGN AND METHODS: ADR reports from IRD patients were extracted from the Dutch Biologic Monitor. ADR frequencies were compared using Fischer-Freeman-Halton exact test and the influence of covariates was assessed using binomial logistic regression.A total, of 729 participants were included, of which 354 participants reported 887 unique ADRs. ADR frequencies were not significantly different between the IRDs. Rheumatoid arthritis and ankylosing spondylitis including axial spondyloarthritis patients had an increased risk of ADRs related to 'Respiratory, thoracic and mediastinal disorders' and as compared to psoriatic arthritis patients. Etanercept use, combination therapy with methotrexate and/or corticosteroids, and age also influenced the risk of reporting specific ADRs. CONCLUSIONS: There were no differences in frequencies and nature of patient-reported ADRs attributed to adalimumab and etanercept between different IRDs. However, more research is needed to align patients' and health-care professionals' perspectives to improve knowledge on disease-specific ADRs.

Sex differences in adverse drug reactions from Adalimumab and etanercept in patients with inflammatory rheumatic diseases.

BACKGROUND: We examine sex differences in relation to the nature, frequency, and burden of patient-reported adverse drug reactions (ADRs) in patients with inflammatory rheumatic diseases. RESEARCH DESIGN AND METHODS: Rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis patients using etanercept or adalimumab from the Dutch Biologic Monitor were sent bimonthly questionnaires concerning experienced ADRs. Sex differences in the proportion and nature of reported ADRs were assessed. Additionally, 5-point Likert-type scales reported for the burden of ADRs, were compared between sexes. RESULTS: In total 748 consecutive patients were included (59% female). From the women 55% reported ≥1 ADR, which was significantly higher than 38% of the men that reported ≥1 ADR (p < 0.001). A total of 882 ADRs were reported comprising 264 distinct ADRs. The nature of the reported ADRs differed significantly between both sexes (p = 0.02). Women in particular reported more injection site reactions than men. The burden of ADRs was similar between sexes. CONCLUSIONS: Sex differences in the frequency and nature of ADRs, but not in ADR burden, exist during treatment with adalimumab and etanercept in patients with inflammatory rheumatic diseases. This should be taken into consideration when investigating and reporting results on ADRs and when counseling patients in daily clinical practice.

Planned hospital birth versus planned home birth.

BACKGROUND: Observational studies of increasingly better quality and in different settings suggest that planned home birth in many places can be as safe as planned hospital birth and with less intervention and fewer complications. This is an update of a Cochrane review first published in 1998. OBJECTIVES: To assess the effects of planned hospital birth compared with planned home birth in selected low-risk women, assisted by an experienced midwife with collaborative medical back up in case transfer should be necessary. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 March 2012) and contacted editors and authors involved with possible trials. SELECTION CRITERIA: Randomised controlled trials comparing planned hospital birth with planned home birth in low-risk women as described in the objectives. DATA COLLECTION AND ANALYSIS: The two review authors as independently as possible assessed trial quality and extracted data. We contacted study authors for additional information. MAIN RESULTS: Two trials met the inclusion criteria but only one trial involving 11 women provided some outcome data and was included. The evidence from this trial was of moderate quality and too small to allow conclusions to be drawn. AUTHORS' CONCLUSIONS: There is no strong evidence from randomised trials to favour either planned hospital birth or planned home birth for low-risk pregnant women. However, the trials show that women living in areas where they are not well informed about home birth may welcome ethically well-designed trials that would ensure an informed choice. As the quality of evidence in favour of home birth from observational studies seems to be steadily increasing, it might be as important to prepare a regularly updated systematic review including observational studies as described in the Cochrane Handbook for Systematic Reviews of Interventions as to attempt to set up new randomised controlled trials.

Neuropsychiatric adverse drug reactions associated with low dose methotrexate in rheumatoid arthritis patients.

BACKGROUND: Neuropsychiatric adverse drug reactions (NPADRs) are not commonly associated with low dose methotrexate (LDMTX) in patients with rheumatoid arthritis (RA). RESEARCH DESIGN AND METHODS: In this case series assessment, we described the nature and frequency of NPADRs with LDMTX in the Dutch DREAM-RA registry, including causality of NPADRs, the impact on further LDMTX treatment and the impact on patient reported Health Related Quality of Life (HRQoL). RESULTS: A total of 71 NPADRs (frequency 6.8%) associated with LDMTX were captured in the DREAM-RA registry. NPADRs were registered for 62 (5.9%) out of 1048 patients with 10.9 NPADRs per 1000 patient years. Headache, dizziness and depression were most frequently reported. The causality was considered probable for 67 NPADRs (94.4%) and definite for 1 NPADR (1.4%). NPADRs led to LDMTX withdrawal in 34 cases (47.9%) and was not restarted in 16 cases (47.1%). Median mental HRQoL was significantly decreased around the occurrence of the NPADR and remained significantly lower after the event. Median physical HRQoL was not significantly affected. CONCLUSIONS: Knowledge on the nature, frequency and impact of the demonstrated NPADRs during LDMTX therapy will enhance attention toward these potential ADRs allowing better risk assessment and communication to patients.

Discrepancy between patient- and healthcare provider-reported adverse drug reactions in inflammatory bowel disease patients on biological therapy.

BACKGROUND: Only limited data is available on the extent and burden of adverse drug reactions (ADRs) to biological therapy in inflammatory bowel disease (IBD) patients in daily practice, especially from a patient's perspective. OBJECTIVE: The aim of this study was to systematically assess patient-reported ADRs during biological therapy in IBD patients and compare these with healthcare provider (HCP)-reported ADRs. METHODS: This multicentre, prospective, event monitoring study enrolled IBD patients on biological therapy. Patients completed bimonthly comprehensive web-based questionnaires regarding description of biological induced ADRs, follow-up of previous ADRs and experienced burden of the ADR using a five-point Likert scale. The relationship between patient-reported ADRs and biological therapy was assessed. HCP-reported ADRs were extracted from the electronic healthcare records. RESULTS: In total, 182 patients (female 51%, mean age 42.2 [standard deviation 14.2] years, Crohn's disease 77%) were included and completed 728 questionnaires. At baseline, 60% of patients used infliximab, 30% adalimumab, 9% vedolizumab and 1% ustekinumab. Fifty percent of participants reported at least one ADR with a total of 239 unique ADRs. Fatigue (n = 26) and headache (n = 20) resulted in the highest burden and a correlation in time with the administration of the biological was described in 56% and 85% respectively. Out of 239 ADRs, 115 were considered biological-related. HCPs reported 119 ADRs. Agreement between patient-reported ADRs and HCP-reported ADRs was only 13%. CONCLUSION: IBD patients often report ADRs during biological therapy. We observed an important significant difference between the type and frequency of patient-reported ADRs versus HCP-reported ADRs, leading to an underestimation of more subjective ADRs and patients' ADR-related burden.

Gastrointestinal Adverse Drug Reaction Profile of Etanercept: Real-world Data From Patients and Healthcare Professionals.

OBJECTIVE: We aimed to describe the nature and frequency of gastrointestinal adverse drug reactions (GI-ADRs) of etanercept (ETN) using patient-reported and healthcare professional (HCP)-registered data and compared this frequency with the GI-ADR frequency of the widely used tumor necrosis factor-α inhibitor adalimumab (ADA). METHODS: Reported GI-ADRs of ETN for rheumatic diseases were collected from the Dutch Biologic Monitor and DREAM registries. We described the clinical course of GI-ADRs and compared the frequency with ADA in both data sources using Fisher exact test. RESULTS: Out of 416 patients using ETN for inflammatory rheumatic diseases in the Dutch Biologic Monitor, 25 (6%) patients reported 36 GI-ADRs. In the DREAM registries 11 GI-ADRs were registered for 9 patients (2.3%), out of 399 patients using ETN, with an incidence of 7.1 per 1000 patient-years. Most GI-ADRs consisted of diarrhea, nausea, and abdominal pain. GI-ADRs led to ETN discontinuation in 1 patient (4%) and dose adjustment in 4 (16%) in the Dutch Biologic Monitor. Eight GI-ADRs (73%) led to ETN discontinuation in the DREAM registries. The frequency of GI-ADRs of ETN did not significantly differ from GI-ADRs of ADA in both data sources (Dutch Biologic Monitor: ETN 8.7% vs ADA 5.3%, P = 0.07; DREAM: ETN 2.8% vs ADA 4.7%, P = 0.16). CONCLUSION: Most GI-ADRs associated with ETN concerned gastrointestinal symptoms. These ADRs may lead to dose adjustment or ETN discontinuation. The frequency of ETN-associated GI-ADRs was comparable to the frequency of ADA-associated GI-ADRs. Knowledge about these previously unknown ADRs can facilitate early recognition and improve patient communication.