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Background: Psychological distress is highly prevalent among university students and can contribute to poor academic performance and drop-out. Help-seeking has increased in recent years, contributing to growing interest in employing internet-delivered psychological treatments to support the mental health of university students. However, few large-scale “real-world” effectiveness trials have been conducted in routine care settings for this population. Aim: The aim of the current study was to examine the acceptability and effectiveness of a brief, five-week internet-delivered cognitive behavioural therapy (iCBT) intervention for anxiety and depression when delivered as part of routine care by a university counselling service in New Zealand. Design: A large, prospective, single-group Phase IV clinical trial. Method: Students (N = 1044) engaging with the university counselling service between 2018 and 2023 were provided the option to receive the intervention based on their needs and preferences. Students completed standardised measures of depression and anxiety severity at pre-treatment, each week of the intervention, and post-treatment. A subsample (n = 405) also completed these at 3-month follow-up. Results: Over a 5-year period, 839 students participated in the intervention. Significant reductions in symptoms of depression (% reduction = 35%, Hedges' g = 0.56) and anxiety (% reduction = 36%, Hedges' g = 0.73) were observed, alongside high levels of satisfaction (> 60%). Symptom deterioration was observed in

Objective: Health anxiety, also known as hypochondriasis, is a common psychiatric disorder which leads to considerable distress and is associated with high societal costs. Internet-based cognitive behavioural therapy (ICBT) for health anxiety has demonstrated efficacy in randomized controlled trials (RCTs), but there is limited knowledge regarding its effectiveness in real-world settings. This study aimed to evaluate the clinical effectiveness of guided ICBT for health anxiety in routine psychiatric care, including symptom change, treatment adherence, and potential negative effects. Additionally, we explored predictors of treatment adherence. Method: A longitudinal cohort study of 447 patients enrolled in 12 weeks of ICBT for health anxiety between 2018 and 2020 in an outpatient psychiatric clinic specializing in ICBT. Primary outcome measure was the 14-item Short Health Anxiety Inventory (SHAI-14) and a within-group design with repeated measures was utilized for the primary analysis. Results: Participants showed significant improvements from pre- to post-treatment (d = 1.61). At post-treatment, 60 % (95 % CI 58–62) demonstrated statistically reliable change (RCI), and 44 % (95 % CI 42–46) were in remission. On average, participants completed 7 (SD = 4) out of 12 treatment modules. For each additional completed module, the mean reduction was 0.31 (95 % CI 0.10 to 0.54) points on the SHAI-14. Conclusions: Guided ICBT for health anxiety can be effective when delivered within the context of routine psychiatric care. The study suggests that effect sizes are comparable with those in RCTs and higher treatment adherence is associated with better outcomes in health anxiety. ICBT could be used to increase availability to effective therapy for health anxiety.

Abstract Objectives: This paper examines factors that enabled successful integration of testing for sexually transmissible infections into routine care in Aboriginal Community Controlled Health Services. Methods: This paper reports analysis of qualitative interview data recorded with 19 purposively sampled key informants in New South Wales, Australia, representing six Aboriginal Community Controlled Health Services and five government health bodies supporting those services. The analysis explicitly adopted a strengths‐based approach. Results: Participants reported a strong belief that routine screening overcomes shame and increases engagement with sexual health screening. Incorporating sexual health screening into general medical consultations increases the capture of asymptomatic cases. The Medicare Benefits Schedule 715 Adult Health Check was highlighted as an ideal lever for effective integration into routine care. Conclusion: Integration of testing for sexually transmissible infections into routine care is widely perceived as best practice by senior stakeholders in Aboriginal healthcare in NSW. Findings support continued work to optimise the MBS 715 as a lever to increase testing. Implications for public health: Identifying accessible strategies to increase testing for sexually transmissible infections in Aboriginal Community Controlled Health Services can reduce disparities in notifications affecting Aboriginal young people.

Background: Burn injuries can cause significant mortality and morbidity. This study aimed to evaluate the efficiency of topical recombinant human erythropoietin (rhEPO) on enhancing burn wound healing., Methods: In this randomized double-blind controlled clinical trial, we enrolled 40 participants aged 18 years and older who were referred to a burn center during the first 24 h of burning. The participants with no concurrent comorbidities had superficial and deep second-degree burns, no respiratory burns, no face and perineum burns, no keloid formation, or a healed, fully epithelialized, hypertrophic burn scar. Topical rhEPO or nitrofurazone/Vitamin A was administered every other day, and the patients were scheduled for follow-up visits to receive wound cleansing, debridement, and dressing changes. Burn wound healing response to treatment was measured as the study main outcome., Results: At the second follow-up visit, all parameters were significantly lower in the rhEPO group compared with the control group except for itchiness. The results of the next two follow-up sessions were also the same. The total value of the modified Vancouver Scar Scale (VSS) at days 5, 7, and 14 was significantly lower in the rhEPO group compared with the routine of care group. Trial Registry Date: 2022-03-02, Trial Registry number: IRCT20190810044500N23 CONCLUSIONS: The results of the present study suggested that topical rhEPO is a potential option in burn wounds and patient satisfaction, without causing intolerable side effects., Competing Interests: Declaration of Competing Interest The authors declare that they have no competing interests regarding the publication of this paper., (Copyright © 2024 Elsevier Ltd and International Society of Burns Injuries. All rights reserved.)

Background: To assess long-term effectiveness and safety of edoxaban in Europe., Methods and Results: ETNA-AF-Europe, a prospective, multinational, multi-centre, post-authorisation, observational study was conducted in agreement with the European Medicines Agency. The primary and secondary objectives assessed real-world safety (including bleeding and deaths) and effectiveness (including stroke, systemic embolic events and clinical edoxaban use), respectively. Median (interquartile range) age of the 13,164 patients was 75.0 (68.0-80.0) years; CHA 2 DS 2 -VASc and HAS-BLED scores were 3.0 (2.0-4.0) and 2.0 (1.0-2.0), respectively. Follow-up duration was 3.98 (3.21-4.05) years. Patients on edoxaban 30 mg (n = 3042) at baseline were older (80.0 vs 73.0 years), more likely assessed as frail by investigators (27.0% vs 6.6%) and had more comorbidities than those on edoxaban 60 mg (n = 9617; missing dosing information for n = 505). Annualised event rates of all-cause and cardiovascular death in the overall population, edoxaban 60 mg and edoxaban 30 mg groups were 4.1%, 2.8% and 8.4%, and 1.0%, 0.7% and 2.0%, respectively. Annualised rates of stroke were relatively constant throughout the follow-up, transient ischaemic attack and systemic embolism were < 1% in the overall population. Rates of any major and major gastrointestinal bleeding were low, with slightly higher rates for edoxaban 30 vs 60 mg group. Intracranial haemorrhage was uncommon (0.2%)., Conclusions: In European patients with AF, long-term therapy with edoxaban is associated with low and relatively constant annualised rates of stroke and major bleeding. Differences in outcomes between the two approved doses are attributable to differences in clinical characteristics., Competing Interests: Declaration of competing interest P.K. receives research support for basic, translational, and clinical research projects from European Union Big- Data@Heart (grant agreement EU IMI 116074) CATCH ME (grant agreement ID: 633196) AFFECT-EU (grant agreement ID: 847770); Leducq foundation, Medical Research Council (UK); German Centre for Cardiovascular Research supported by the German Ministry of Education and Research; from several drug and device companies active in atrial fibrillation and has received honoraria from several such companies in the past, but not in the last three years. P.K. is listed as inventor on two patents held by University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). P.K. is employed as Director of the Department of Cardiology, University Heart and Vascular Centre UKE Hamburg and Professor of Cardiovascular Medicine (part-time), University of Birmingham, UK. He is Speaker of the board of AFNET, Germany, and Board member of the ESC. A.B. is founder and clinical trial design advisor of Amore Health Ltd., reports support from Daiichi Sankyo for attending meetings and advisory boards; receives honorarium from Daiichi Sankyo, Pfizer, BMS, Bayer, Novartis, Roche, Napp, Boehringer Ingelheim for lecturing and scientific advice outside the submitted work. C.d.A. has received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Atricure, Biosense Webster, Boston Scientific, Acutus Medical and research grants on behalf of the centre from Biotronik, Medtronic Abbott, Microport, Boston Scientific, Biosense Webster, Acutus Medical. J.R.d.G. reports personal fees from Daiichi Sankyo during the conduct of the study; grants from Abbott, Atricure, Bayer, Boston Scientific, Daiichi Sankyo, Johnson & Johnson and Medtronic; personal fees from Atricure, Bayer, Berlin Chemie, Daiichi Sankyo, Johnson & Johnson, Menarini, Medtronic, Novartis, and Servier; and other from RhythmCARE outside the submitted work. J.C.D. has received honoraria for lectures from Bayer, Boehringer Ingelheim, and Bristol Myers Squibb. J.C.D. has also received research grants from Boston Scientific, Sorin Group, Biotronik, and Abbott. P.K. has received speaker's and committee membership from Daiichi Sankyo, and received consulting fee (<€5000) from Alexion and Novo Nordisk. He is the Lead Investigator of the HRB Stroke Clinical Trials Network Ireland, which has received grant funding from the Irish government, Irish Heart Foundation, Daiichi Sankyo, Bayer, Boehringer Ingelheim, Pfizer, Bristol Myers Squibb, Amgen, and A Menarini. E.L.-d.-S. reports personal fees from Daiichi Sankyo; grants and personal fees from Servier, ZOLL Medical, and Becton Dickinson; grants from AstraZeneca, MedImmune LLC and Novartis, during the conduct of the study. P.M. is an ETNA-AF investigator and has received lecture and research fees from Daiichi Sankyo, Bayer, Boehringer Ingelheim, and Pfizer/BMS. E.-M.F., M.L., P.L., and R.S. are employees of Daiichi Sankyo Europe GmbH, Munich, Germany. J.S. has received consultant and/or speaker fees from Abbott, Alexion, Astra-Zeneca, Bayer, Berlin-Chemie, Biosense Webster, Biotronik, Boehringer-Ingelheim, Boston Scientific, BMS, Daiichi Sankyo, Medscape, Medtronic, Menarini, Merck/MSD, Organon, Pfizer, Saja, Servier, and WebMD. He reports ownership of Swiss EP and CorXL. J.W. reports personal fees and non-financial support from Biotronik, Boehringer Ingelheim, and Daiichi Sankyo; personal fees from Akzea, Bayer Vital, MSD, Berlin-Chemie and Siemens Healthineers, outside the submitted work. T.W.W. has received fees, honoraria and research funding from AstraZeneca, Boehringer Ingelheim, Bayer, Bristol Myers Squibb/Pfizer, Daiichi Sankyo, Medtronic, Menarini Pharma, Novartis, and Sanofi Aventis. R.D.C. reports grants, personal fees and non-financial support from Daiichi Sankyo, during the conduct of the study; and reports consulting fees, honoraria and other financial or non-financial interests: Amgen, Boehringer Ingelheim, Bayer, BMS/Pfizer, Daiichi Sankyo, Janssen, Milestone, Novartis, Sanofi, Menarini, Guidotti, and Roche, outside the submitted work. Consultancy fees from Daiichi Sankyo Europe for the Chairing of the ETNA-AF Europe registry., (Copyright © 2023. Published by Elsevier B.V.)

Blended cognitive-behavioural therapy (bCBT) combines face-to-face CBT (FtFCBT) and Internet-based CBT (iCBT) into one integrated treatment protocol, opening up new ways to deliver therapy, increase cost-effectiveness and resolve scarcity of therapist availability. When traditional therapy is transformed into a new format, there is a need to evaluate whether principles of the new protocol are consistently applied.This study aimed to explore therapist fidelity to bCBT protocols for anxiety disorders in specialised mental health care and to assess whether fidelity is related to patient characteristics. Adult patients (N = 44) received bCBT within a randomised controlled trial. Ratio of FtF to online sessions, session frequency and therapist adherence to instructions were assessed.Overall therapist fidelity with regard to ratio of blending, session frequency and instructions was high. Correlations were found between patients' share of online sessions and both session frequency (r = 0.373, p = .013), as well as patient computer experience (r = 0.314, p = .038). Adherence to instructions in FtF sessions was based on a subset of patients (n = 23) and should therefore be interpreted with caution.The blended approach was generally delivered as intended, indicating that the format is feasible in specialised mental health.

In routine care, internet-delivered cognitive behaviour therapy (iCBT) regularly includes therapist support delivered via secure email, but the optimal response time to emails is unknown. In this study, we compared the benefits of therapists providing support once-weekly versus therapists providing support once-weekly supplemented with a one-business-day response to all patient emails. This pragmatic randomized controlled trial included therapists employed by a specialized iCBT clinic or community mental health clinics, where providing iCBT is a secondary service. Patients with depression and/or anxiety who enrolled in transdiagnostic iCBT (5 core lessons over 8 weeks) were randomized to: 1) once-weekly support supplemented with a one-business-day response to patient emails by specialized therapists (n = 233); 2) once-weekly support also offered by specialized therapists (n = 216); or 3) once-weekly support offered by community clinic therapists (n = 226). Outcomes were measured at 8, 12, 24, and 52-weeks post-enrollment. Patient engagement and treatment experiences (e.g., treatment satisfaction, therapist alliance) were also assessed and a focus group was conducted with therapists. Supplementing once-weekly therapist support with a one-business-day response to patient emails resulted in therapists sending more emails to patients (M: 13 versus 9) and required more therapist time over treatment (M: 155 versus 109 min), but was not associated with improved outcomes, patient engagement or treatment experiences. All groups showed large improvements in symptoms of depression and anxiety maintained at 52-week follow-up, strong engagement and positive treatment experiences. Therapists viewed challenges of responding to patient emails within one-business-day to outweigh benefits. Contrary to expectations, supplementing once-weekly therapist support with a one-business-day response to all patient emails did not benefit patients and increased therapist time as well as therapist challenges when delivering iCBT in routine care.

Objectives: Effective measurement and monitoring of health status in patients with spine-related musculoskeletal (MSK) disorders are essential for providing appropriate care and improving outcomes. Minimal clinical datasets are standardized sets of key data elements and patient-centered outcomes that can be measured and recorded during routine clinical care. Our scoping review aimed to identify and map current evidence on minimal clinical datasets for measuring and monitoring health status in patients with spine-related MSK disorders in primary and outpatient healthcare settings., Study Design and Setting: We followed the JBI (formerly Joanna Briggs Institute) methodology for scoping reviews. MEDLINE, CINAHL, Cochrane Library, Index to Chiropractic Literature, MANTIS, ProQuest Dissertations and Theses Global, and medRxiv preprint repository were searched from database inception to August 1, 2021. Two reviewers independently screened titles and abstracts, full-text articles, and charted the evidence. Findings were synthesized and summarized descriptively., Results: After screening 5,583 citations and 301 full-text articles, 104 studies about 32 individual minimal clinical datasets were included. Most minimal clinical datasets were developed for patient populations with spine-involving inflammatory arthritis, nonspecific or degenerative spinal pain, and MSK disorders in general. The minimal clinical datasets varied substantially in terms of the author-reported time-to-complete (1-48 minutes) and the number of items (5-100 items). Fifty percent of the datasets involved healthcare professionals in their development process, and only 28% involved patients. Health domain items were most frequently linked to the components of activities and participation (43.9%) and body functions (28.6%), according to the International Classification of Functioning, Disability, and Health. There is no standardized definition of minimal clinical datasets to measure and monitor health status of patients with spine-related MSK disorders in routine clinical practice. Common core elements identified were practicality, feasibility in a busy routine practice, time efficiency, and the capability to be used across different healthcare settings., Conclusion: Due to the absence of a standard definition for minimal clinical datasets for patients with spine-related MSK disorders, there is a lack of consistency in the selection of key data elements and patient-centered outcomes that should be included. More research on the implementation and feasibility of minimal clinical datasets in routine care settings is warranted and needed. It is essential to involve all relevant partners in the development process of minimal clinical datasets to ensure successful implementation and adoption in routine primary care., Competing Interests: Declaration of competing interest A.C.T. is an editor of Journal of Clinical Epidemiology. She had no part in the editorial or peer-review process of this manuscript., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: Core outcome sets (COS) represent the minimum health outcomes to be measured for a given health condition. Interest is growing in using COS within routine care to support delivery of patient-focused care. This review aims to systematically map COS developed for routine care to understand their scope, stakeholder involvement, and development methods., Methods: Medline (Ovid), Scopus, and Web of Science Core collection were searched for studies reporting development of COS for routine care. Data on scope, methods, and stakeholder groups were analyzed in subgroups defined by setting., Results: Screening 25,301 records identified 262 COS: 164 for routine care only and 98 for routine care and research. Nearly half of the COS (112/254, 44%) were developed with patients, alongside input from experts in registries, insurance, legal, outcomes measurement, and performance management. Research publications were often searched to generate an initial list of outcomes (115/198, 58%) with few searching routine health records (47/198, 24%)., Conclusion: An increasing number of COS is being developed for routine care. Although involvement of patient stakeholders has increased in recent years, further improvements are needed. Methodology and scope are broadly similar to COS for research but implementation of the final set is a greater consideration during development., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: This paper examines factors that enabled successful integration of testing for sexually transmissible infections into routine care in Aboriginal Community Controlled Health Services., Methods: This paper reports analysis of qualitative interview data recorded with 19 purposively sampled key informants in New South Wales, Australia, representing six Aboriginal Community Controlled Health Services and five government health bodies supporting those services. The analysis explicitly adopted a strengths-based approach., Results: Participants reported a strong belief that routine screening overcomes shame and increases engagement with sexual health screening. Incorporating sexual health screening into general medical consultations increases the capture of asymptomatic cases. The Medicare Benefits Schedule 715 Adult Health Check was highlighted as an ideal lever for effective integration into routine care., Conclusion: Integration of testing for sexually transmissible infections into routine care is widely perceived as best practice by senior stakeholders in Aboriginal healthcare in NSW. Findings support continued work to optimise the MBS 715 as a lever to increase testing., Implications for Public Health: Identifying accessible strategies to increase testing for sexually transmissible infections in Aboriginal Community Controlled Health Services can reduce disparities in notifications affecting Aboriginal young people., (© 2022 The Authors.)

Background: Regional differences in the profile and treatment strategies of patients with cardiometabolic diseases have been studied in several different countries. The Cardio-Vascular and metabolic treatments in Canada: Assessment of REal-life therapeutic value (CV-CARE) registry was designed to evaluate patient profiles and medical management of cardiometabolic diseases in routine clinical care settings across Canada. Primary objectives were to (1) evaluate regional variability of patient profiles with cardiometabolic disease(s) and (2) assess treatment differences of patients treated for type 2 diabetes (T2D), hypercholesterolemia (HCh), and hypertension (HTN) across Canada., Methods: CV-CARE is a multi-center, observational, prospective registry that enrolled Canadian patients treated with metformin-extended release (MetER) for T2D, colesevelam (C) for HCh, azilsartan (AZI) for mild-to-moderate essential HTN and azilsartan/chlorthalidone (AZI/CHL) for severe, essential HTN. Patient characteristics and treatments were assessed at baseline., Results: The registry enrolled 6960 patients, with a total of 4194 patients making up the primary analysis population [MetER (n=995); C (n=1639); AZI (n=1364); AZI/CHL (n=498)]. First-line use of MetER was more common in British Columbia (BC; 45.5%) compared to Ontario (ON; 29.8%), and Quebec (QC; 12.9%). C treatment for HCh was used as monotherapy most readily in BC (68.7%) compared with QC (59.7%) and ON (35.8%). Dual action of low-density lipoprotein cholesterol and hemoglobin A1c reduction was the predominant reason for C add-on therapy (46.8%), with highest usage seen in ON (62.9%). AZI treatment for HTN was most frequently used in BC (43.8%), and AZI/CHL was most commonly used in ON (12.0%). First-line use of AZI was more common in QC (50%) vs. ON (34.9%) and BC (24.1%). The primary reason for switching to AZI and AZI/CHL from prior treatment was lack of efficacy across provinces., Conclusion: This is the first regional description of the CV-CARE cohort. Significant variations in both baseline profile and treatments were observed which could have an impact on long-term outcomes., (Copyright © 2020 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Objective: Parent training is recommended for attention-deficit/hyperactivity disorder (ADHD) in preschool children. Evidence-based interventions are important, but only if they produce better outcomes than usual care., Method: The authors conducted a multicenter, 2-arm, parallel-group, randomized controlled trial in routine specialist ADHD clinics in the Danish Child and Adolescent Mental Health Services. Children (N = 164, 3-7 years old) with ADHD received a well-established parent training program (New Forest Parenting Programme; n = 88) or treatment as usual (n = 76). The primary outcome was parent ratings of child ADHD symptoms. Secondary outcomes included teacher ratings and direct observations of ADHD symptoms. Outcomes were measured at baseline, after treatment, and at follow-up (36 weeks later). Representativeness of participants was evaluated against the total national cohort of children (N = 1,378, 3-7 years old) diagnosed with ADHD during the same period using the Danish Civil Registration System. Statistical analysis used a repeated measure model., Results: After treatment, the parent training program was superior to treatment as usual on parent-rated ADHD symptoms (p = .009; effect size d = 0.30) and on parenting self-efficacy and family strain. Effects persisted to 36 weeks after treatment. There were no effects on teacher ratings or direct observations of ADHD or on ratings of conduct problems or parenting. The clinical sample was similar to the national cohort of young children with ADHD., Conclusion: Evidence-based parent training has value as an intervention for preschool ADHD in routine clinical settings. As in previous trials, effects were restricted to parent-reported outcomes. Surprisingly, there were no effects on child conduct problems., Clinical Trial Registration Information: A Controlled Study of Parent Training in the Treatment of ADHD in Young Children (D'SNAPP). http://clinicaltrial.gov/;NCT01684644., (Copyright © 2018 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.)

Objective: Pragmatic trials offer the opportunity to obtain real-life data on the relative effectiveness and safety of a treatment before or after market authorization. This is the penultimate paper in a series of eight, describing the impact of design choices on the practical implementation of pragmatic trials., Study Design and Setting: This paper focuses on the practical challenges of collecting and reporting safety data and of monitoring trial conduct while maintaining routine clinical care practice., Conclusion: Current ICH guidance recommends that all serious adverse events and all drug-related events must be reported in an interventional trial. In line with current guidance, we propose a risk-based approach to the collection of non-drug-related non-serious adverse events and even serious events not related to treatment based on the risk profile of the medicine/class in the patient population of interest. Different options available to support the collection and reporting of safety data while minimizing study-related follow-up visits are discussed. A risk-based approach to monitoring trial conduct is also discussed, highlighting the difference in the balance of risks likely to occur in a pragmatic trial compared to traditional clinical trials and the careful consideration that must be given to the mitigation and management of these risks to maintain routine care., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the effect of mother-infant immediate skin-to-skin contact on primiparous mother's breastfeeding self-efficacy., Study Design: A randomised control trial., Settings: The study was conducted in Omolbanin obstetrics hospital (large tertiary hospital), Mashhad, Iran., Participants: 114 18-35 year-old primiparous, Iranian, healthy and full term mothers who anticipated normal vaginal delivery and intended to breastfeed their babies., Intervention: Skin-to-skin contact immediately after birth and then controlling breastfeeding self-efficacy at 28 days postpartum., Main Outcome Measure: Maternal breastfeeding self-efficacy at 28 days postpartum and success in first breastfeeding and mean time of first breastfeeding initiation., Results: A total of 92 mother-infant dyads (47 dyads in skin-to-skin care skin-to-skin contact group and 45 dyads in routine care group) were monitored and analysed. In skin-to-skin contact group, breastfeeding self-efficacy was 53.42±8.57 SD as compared to 49.85±5.50 SD in routine care group which is significantly higher in skin-to-skin contact group (p=0.0003). Successful breastfeeding initiation rate was 56.6% in skin-to-skin contact group as compared to 35.6% in routine care group (p=0.02). Time to initiate first feed was 21.98±9.10 SD min in SSC group vs. 66.55±20.76 min in routine care group (p<0.001)., Conclusion: Mother-infant immediate skin-to-skin contact is an easy and available method of enhancing maternal breastfeeding self-efficacy. High breastfeeding self-efficacy increases exclusive breastfeeding duration., (Copyright © 2013 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)