Stakeholder perspectives of mental healthcare services in Bangladesh, its challenges and opportunities: a qualitative study.

This study explores Bangladesh's mental health services from an individual- and system-level perspective and provides insights and recommendations for strengthening it's mental health system. We conducted 13 in-depth interviews and 2 focus group discussions. Thirty-one participants were recruited using a combination of purposive and snowball sampling methods. All interviews and group discussions were audio-recorded and transcribed, and key findings were translated from Bengali to English. Data were coded manually and analysed using a thematic and narrative analysis approach. Stakeholders perceived scarcity of service availability at the peripheral level, shortage of professionals, weak referral systems, lack of policy implementation and regulatory mechanisms were significant challenges to the mental health system in Bangladesh. At the population level, low levels of mental health literacy, high societal stigma, and treatment costs were barriers to accessing mental healthcare. Key recommendations included increasing the number of mental health workers and capacity building, strengthening regulatory mechanisms to enhance the quality of care within the health systems, and raising awareness about mental health. Introducing measures that relate to tackling stigma, mental health literacy as well as building the capacity of the health workforce and governance systems will help ensure universal mental health coverage.

Transpalpebral mini-orbitozygomatic approach for nonvascular skull base lesions: a single neurosurgeon's experience.

OBJECTIVE: The authors aim to describe the advantages, utility, and disadvantages of the transpalpebral mini-orbitozygomatic (MOZ) approach for tumors of the lateral and superior orbit, orbital apex, anterior clinoid, anterior cranial fossa, middle cranial fossa, and parasellar region. METHODS: The surgical approach from skin incision to closure is described while highlighting key technical and anatomical considerations, and cadaveric dissection demonstrates the surgical steps and focuses on important anatomy. Intraoperative images were included to supplement the cadaveric dissection. A retrospective review of adults who had undergone the MOZ approach for nonvascular pathology performed by a single neurosurgeon from 2017 to 2023 was included in this institutional review board-approved study. Descriptive statistics was used to summarize the data. Four representative cases were included to demonstrate the utility of the MOZ approach. RESULTS: The study included 65 patients (46 female, 19 male), average age 54.84 years, who had undergone transpalpebral MOZ surgery. Presenting symptoms included visual changes (53.8% of cases), vision loss (23.1%), diplopia (21.8%), and proptosis (13.8%). The optic nerve and optic chiasm were involved in 32.3% and 10.8% of cases, respectively. The most common pathology was meningioma (81.5% of cases), and gross-total resection was achieved in 50% of all cases. Major complications included an infection and a carotid injury. Improvement of preoperative symptoms was reported in 92.2% of cases. Visual acuity improved in 12 patients. The mean follow-up was 8.57 ± 8.45 months. CONCLUSIONS: The MOZ approach is safe and durable. The transpalpebral incision provides better cosmesis and functional outcomes than those of standard anterolateral approaches to the skull base. Careful consideration of the limits of the approach is paramount to appropriate application on a case-by-case basis. Further quantitative anatomical studies can help to define and compare the utility of the approach to open cranio-orbital and endoscopic transorbital approaches.

Nurse-delivered sleep restriction therapy in primary care for adults with insomnia disorder: a mixed-methods process evaluation.

BACKGROUND: Sleep restriction therapy (SRT) is a behavioural therapy for insomnia. AIM: To conduct a process evaluation of a randomised controlled trial comparing SRT delivered by primary care nurses plus a sleep hygiene booklet with the sleep hygiene booklet only for adults with insomnia disorder. DESIGN AND SETTING: A mixed-methods process evaluation in a general practice setting. METHOD: Semi-structured interviews were conducted in a purposive sample of patients receiving SRT, the practice nurses who delivered the therapy, and also GPs or practice managers at the participating practices. Qualitative data were explored using framework analysis, and integrated with nurse comments and quantitative data, including baseline Insomnia Severity Index score and serial sleep efficiency outcomes to investigate the relationships between these. RESULTS: In total, 16 patients, 13 nurses, six practice managers, and one GP were interviewed. Patients had no previous experience of behavioural therapy, needed flexible appointment times, and preferred face-to-face consultations; nurses felt prepared to deliver SRT, accommodating patient concerns, tailoring therapy, and negotiating sleep timings despite treatment complexity and delays between training and intervention delivery. How the intervention produced change was explored, including patient and nurse interactions and patient responses to SRT. Difficulties maintaining SRT, negative attitudes towards treatment, and low self-efficacy were highlighted. Contextual factors, including freeing GP time, time constraints, and conflicting priorities for nurses, with suggestions for alternative delivery options, were raised. Participants who found SRT a positive process showed improvements in sleep efficiency, whereas those who struggled did not. CONCLUSION: SRT was successfully delivered by practice nurses and was generally well received by patients, despite some difficulties delivering and applying the intervention in practice.

Consecutive resections of double pituitary adenoma for resolution of Cushing disease: illustrative case.

BACKGROUND: Double pituitary adenomas are rare presentations of two distinct adenohypophyseal lesions seen in <1% of surgical cases. Increased rates of recurrence or persistence are reported in the resection of Cushing microadenomas and are attributed to the small tumor size and localization difficulties. The authors report a case of surgical treatment failure of Cushing disease because of the presence of a secondary pituitary adenoma. OBSERVATIONS: A 32-year-old woman with a history of prolactin excess and pituitary lesion presented with oligomenorrhea, weight gain, facial fullness, and hirsutism. Urinary and nighttime salivary cortisol elevation were elevated. Magnetic resonance imaging confirmed a 4-mm3 pituitary lesion. Inferior petrosal sinus sampling was diagnostic for Cushing disease. Primary endoscopic endonasal transsphenoidal resection was performed to remove what was determined to be a lactotroph-secreting tumor on immunohistochemistry with persistent hypercortisolism. Repeat resection yielded a corticotroph-secreting tumor and postoperative hypoadrenalism followed by long-term normalization of the hypothalamic-pituitary-adrenal axis. LESSONS: This case demonstrates the importance of multidisciplinary management and postoperative hormonal follow-up in patients with Cushing disease. Improved strategies for localization of the active tumor in double pituitary adenomas are essential for primary surgical success and resolution of endocrinopathies.

Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial.

BACKGROUND: Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented. METHODS: We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563). FINDINGS: Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19-88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference -3·05, 95% CI -3·83 to -2·28; p<0·0001; Cohen's d -0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention. INTERPRETATION: Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder. FUNDING: The National Institute for Health and Care Research Health Technology Assessment Programme.

An Integrated In Vivo/In Vitro Protein Production Platform for Site-Specific Antibody Drug Conjugates.

The XpressCF+® cell-free protein synthesis system is a robust platform for the production of non-natural amino acids containing antibodies, which enable the site-specific conjugation of homogeneous antibody drug conjugates (ADCs) via click chemistry. Here, we present a robust and scalable means of achieving a 50-100% increase in IgG titers by combining the high productivity of cell-based protein synthesis with the unique ability of XpressCF+® reactions to produce correctly folded and assembled IgGs containing multiple non-natural amino acids at defined positions. This hybrid technology involves the pre-expression of an IgG light-chain (LC) protein in a conventional recombinant E. coli expression system, engineered to have an oxidizing cytoplasm. The prefabricated LC subunit is then added as a reagent to the cell-free protein synthesis reaction. Prefabricated LC increases IgG titers primarily by reducing the protein synthesis burden per IgG since the cell free translation machinery is only responsible for synthesizing the HC protein. Titer increases were demonstrated in four IgG products in scales ranging from 100-µL microplate reactions to 0.25-L stirred tank bioreactors. Similar titer increases with prefabricated LC were also demonstrated for a bispecific antibody in the scFvFc-FabFc format, demonstrating the generality of this approach. Prefabricated LC also increases robustness in cell-free reactions since it eliminates the need to fine-tune the HC-to-LC plasmid ratio, a critical parameter influencing IgG assembly and quality when the two IgG subunits are co-expressed in a single reaction. ADCs produced using prefabricated LC were shown to be identical to IgGs produced in cell-free alone by comparing product quality, in vitro cell killing, and FcRn receptor binding assays. This approach represents a significant step towards improving IgG titers and the robustness of cell-free protein synthesis reactions by integrating in vivo and in vitro protein production platforms.

Microsurgical resection of a large petroclival meningioma via translabyrinthine approach combined with middle fossa craniotomy.

Petroclival meningiomas arise from the upper two-thirds of the clivus at the petroclival junction and are reached via various approaches. As petroclival meningiomas expand, they displace the brainstem and basilar artery toward the contralateral side. Because of their proximity to critical structures and deep skull base location, surgical treatment is challenging. Although several approaches have been introduced, their rationales vary. Herein, the authors demonstrate microsurgical resection of a large petroclival meningioma via a translabyrinthine approach combined with middle fossa craniotomy. For each approach, the pros and cons should be carefully evaluated based on the patient's presentation and lesion characteristics. The video can be found here: https://stream.cadmore.media/r10.3171/2022.1.FOCVID21253.

Development of an E. coli strain for cell-free ADC manufacturing.

Recent advances in cell-free protein synthesis have enabled the folding and assembly of full-length antibodies at high titers with extracts from prokaryotic cells. Coupled with the facile engineering of the Escherichia coli translation machinery, E. coli based in vitro protein synthesis reactions have emerged as a leading source of IgG molecules with nonnatural amino acids incorporated at specific locations for producing homogeneous antibody-drug conjugates (ADCs). While this has been demonstrated with extract produced in batch fermentation mode, continuous extract fermentation would facilitate supplying material for large-scale manufacturing of protein therapeutics. To accomplish this, the IgG-folding chaperones DsbC and FkpA, and orthogonal tRNA for nonnatural amino acid production were integrated onto the chromosome with high strength constitutive promoters. This enabled co-expression of all three factors at a consistently high level in the extract strain for the duration of a 5-day continuous fermentation. Cell-free protein synthesis reactions with extract produced from cells grown continuously yielded titers of IgG containing nonnatural amino acids above those from extract produced in batch fermentations. In addition, the quality of the synthesized IgGs and the potency of ADC produced with continuously fermented extract were indistinguishable from those produced with the batch extract. These experiments demonstrate that continuous fermentation of E. coli to produce extract for cell-free protein synthesis is feasible and helps unlock the potential for cell-free protein synthesis as a platform for biopharmaceutical production.

Ventriculoperitoneal Shunt Drainage Increases With Gravity and Cerebrospinal Fluid Pressure Pulsations: Benchtop Model.

BACKGROUND: There have been few improvements in cerebrospinal fluid (CSF) shunt technology since John Holter introduced the silicon valve, with overdrainage remaining a major source of complications. OBJECTIVE: To better understand why valves are afflicted by supra-normal CSF flow rates. We present in Vitro benchtop analyses of flow through a differential pressure valve under simulated physiological conditions. METHODS: The pseudo-ventricle benchtop valve testing platform that comprises a rigid pseudo-ventricle, compliance chamber, pulsation generator, and pressure sensors was used to measure flow rates through a differential pressure shunt valve under the following simulated physiological conditions: orientation (horizontal/vertical), compliance (low/medium/high), and pulsation generator force (low/medium/high). RESULTS: Our data show that pulse pressures are faithfully transmitted from the ventricle to the valve, that lower compliance and higher pulse generator forces lead to higher pulse pressures in the pseudo-ventricle, and that both gravity and higher pulse pressure lead to higher flow rates. The presence of a valve mitigates but does not eliminate these higher flow rates. CONCLUSION: Shunt valves are prone to gravity-dependent overdrainage, which has motivated the development of gravitational valves and antisiphon devices. This study shows that overdrainage is not limited to the vertical position but that pulse pressures that simulate rhythmic (eg, cardiac) and provoked (eg, Valsalva) physiological CSF pulsations increase outflow in both the horizontal and vertical positions and are dependent on compliance. A deeper understanding of the physiological parameters that affect intracranial pressure and flow through shunt systems is prerequisite to the development of novel valves.

Current Fertility Status Does Not Predict Sociosexual Attitudes and Desires in Normally Ovulating Women.

Previous research has found that women at peak fertility show greater interest in extra-pair sex. However, recent replications have failed to detect this effect. In this study, we add to this ongoing debate by testing whether sociosexuality (the willingness to have sex in the absence of commitment) is higher in women who are at peak fertility. A sample of normally ovulating women (N = 773) completed a measure of sociosexuality and had their current fertility status estimated using the backward counting method. Contrary to our hypothesis, current fertility was unrelated to sociosexual attitudes and desires, even when relationship status was included as a moderator. These findings raise further doubts about the association between fertility and desire for extra-pair sex.

Intraoperative application of a new-generation 3D IV-DSA technology in resection of a hemorrhagic cerebellar AVM.

Although intravenous digital subtraction angiography (IV-DSA), cone-beam CT, and rotational angiography are well-established technologies, using them in a single system in the hybrid operating room to acquire high-quality noninvasive 3D images is a recent development. This video demonstrates microsurgical excision of a ruptured cerebellar arteriovenous malformation (AVM) in a 66-year-old male followed by intraoperative IV-DSA acquisition using a new-generation system (Artis Icono). IV-DSA confirmed in real time that no residual remained following excision without the need to reposition the patient. To the best of the authors' knowledge, this is the first surgical video to demonstrate the simplified workflow and application of this technology in neurovascular surgery. The video can be found here: https://youtu.be/bo5ya9DQQPw.

Do National and International Ethics Documents Accord With the Consent Substitute Model for Emergency Research?

In 2010 Largent, Wendler, and Emanuel proposed the "consent substitute model" for emergency research with incapacitated participants. The model provides a means to enroll participants in emergency research without consent, if five conditions are met: 1) the research addresses the patients' urgent medical needs, 2) the risk-benefit ratio is favorable, 3) there are no known conflicts with patients' values or interests, 4) cumulative net risk is minimal, and 5) consent is given as soon as possible. We review national and international ethics laws, regulations, and guidelines to determine 1) whether they accord with the consent substitute model's five conditions and 2) the level of congruence across these documents. We find that only one document meets all five conditions and that there is significant disparity among the documents, particularly between national and international ones. These differences may have stymied international collaboration in emergency research. We recommend that the two international documents used most, the International Council for Harmonization's Guideline for Good Clinical Practice and the World Medical Association's Declaration of Helsinki, are revised to include more specific provisions on emergency medical research.

Cost-Effectiveness and Cost-Benefit of Cervical Cancer Screening with Liquid Based Cytology Compared with Conventional Cytology in Germany.

OBJECTIVE: To assess the health economic impact of cervical screening with liquid based cytology (LBC) compared with conventional cytology (CC) in Germany. METHODS: An economic model was constructed depicting the management of a hypothetical cohort of women aged ≥20 years who undergo cervical screening in Germany. The model estimated the cost-effectiveness and cost-benefit of LBC compared with CC at 2017/18 prices over a time-horizon of 70 years. RESULTS: Performing cervical screens with LBC instead of CC is expected to increase the probability of detecting a true positive over a subject's lifetime by 73% (0.038 versus 0.022) and of diagnosing a subject with stage 3 cervical intraepithelial neoplasia (CIN3) (0.019 versus 0.011). Women screened with LBC instead of CC are expected to have a 57% reduction in the probability of having undetected CIN3 (0.006 versus 0.014) and to experience a 44% reduction in the probability of transitioning into disease progression (from 0.018 to 0.010). The mean discounted lifetime cost of healthcare resource use associated with performing cervical screens with LBC and CC was estimated at €4852 and €7523 per subject respectively. For every Euro invested in cervical screening with LBC instead of CC, the German healthcare system could potentially save ~€170 over a subject's lifetime. CONCLUSION: Within the study's limitations, the analysis showed that LBC affords a cost-effective cervical screening test compared with CC in Germany, since it improves detection rates and has the potential to lead to a reduction in disease progression for less cost.

Epidural Fibrin Sealant Injection for the Management of Cerebrospinal Fluid Leak Following Dural Puncture in Children.

Cerebrospinal fluid (CSF) leak, intracranial hypotension, and postdural puncture headaches are common following dural punctures. Management usually consists of conservative treatments with medications (e.g. caffeine, nonsteroidal anti-inflammatory drugs, steroids, opioids), increased fluid intake, and bed rest. In more severe and persistent cases, epidural blood patches (EBPs) are indicated. When multiple EBPs fail, epidural injection of fibrin sealant has been successful in a few reported adult cases. The authors describe the first reported clinical experiences of epidural fibrin patch in children for repair of CSF leak and resolution of intracranial hypotension. This technique was used in three cases where serial EBPs failed to resolve symptoms related to intracranial hypotension following dural puncture. Following the procedure, each patient had resolution of their presenting clinical symptoms and radiographic abnormalities, and there were no noted complications. Epidural fibrin sealant injection is a reasonable option for relieving intracranial hypotension due to CSF leak following dural puncture in children.

Primary care treatment of insomnia: study protocol for a pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy to sleep hygiene (the HABIT trial).

INTRODUCTION: Insomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction therapy (SRT) is one of the principal active components of CBT and could be delivered by generalist staff in primary care. The aim of this randomised controlled trial is to establish whether nurse-delivered SRT for insomnia disorder is clinically and cost-effective compared with sleep hygiene advice. METHODS AND ANALYSIS: In the HABIT (Health-professional Administered Brief Insomnia Therapy) trial, 588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet on its own. SRT will be delivered over 4 weekly sessions; total therapy time is approximately 1 hour. Outcomes will be collected at baseline, 3, 6 and 12 months post-randomisation. The primary outcome is self-reported insomnia severity using the Insomnia Severity Index at 6 months. Secondary outcomes include health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity. Analyses will be intention-to-treat. Moderation and mediation analyses will be conducted and a cost-utility analysis and process evaluation will be performed. ETHICS AND DISSEMINATION: Ethical approval was granted by the Yorkshire and the Humber - Bradford Leeds Research Ethics Committee (reference: 18/YH/0153). We will publish our primary findings in high-impact, peer-reviewed journals. There will be further outputs in relation to process evaluation and secondary analyses focussed on moderation and mediation. Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder. TRIAL REGISTRATION NUMBER: ISRCTN42499563.

Ethical considerations in prehospital ambulance based research: qualitative interview study of expert informants.

BACKGROUND: Prehospital ambulance based research has unique ethical considerations due to urgency, time limitations and the locations involved. We sought to explore these issues through interviews with experts in this research field. METHODS: We undertook semi-structured interviews with expert informants, primarily based in the UK, seeking their views and experiences of ethics in ambulance based clinical research. Participants were questioned regarding their experiences of ambulance based research, their opinions on current regulations and guidelines, and views about their general ethical considerations. Participants were chosen because they were actively involved in, or in their expert capacity (e.g. law) expressed an interest in, ambulance based research. RESULTS: Fourteen participants were interviewed including principal investigators, researchers, ethicists and medical lawyers. Five major themes were identified: Capacity, Consent, Clinical Considerations, Consultation and Regulation. Questions regarding consent and capacity were foremost in the discussions as all participants highlighted these as areas for concern. The challenges and use of multiple consent models reflected the complexity of research in this environment. The clinical theme referred to the role of paramedics in research and how research involving ambulance services is increasingly informing improvements to patient care and outcomes and reducing the burden on hospital services. Most felt that, although current regulations were fit for purpose, more specific guidance on implementing these in the ambulance setting would be beneficial. This related closely to the theme of consultation, which examined the key role of ethics committees and other regulatory bodies, as well as public engagement. CONCLUSIONS: By interviewing experts in research or ethics in this setting we were able to identify key concerns and highlight areas for future development such as improved guidance.

Using Survivors' Voices to Guide the Identification and Care of Trafficked Persons by U.S. Health Care Professionals: A Systematic Review.

Evidence suggests that trafficked persons in the United States frequently seek health care, yet little is known of their experiences, including reasons for seeking assistance, interactions with professionals, and barriers to obtaining care. To gain a better understanding, a search was conducted for empirical data collected directly from trafficked persons about their US health care experiences, published in peer-reviewed journals within the past 10 years, and in the English language. Four databases were searched and of the 1,605 articles initially identified, 8 met all inclusion criteria. Data from 420 participants demonstrated a wide range of physical and mental health complaints and 50%-98% reported seeking health care services in diverse medical settings during their exploitation. Barriers to care occurred at various levels, and although some are not modifiable, others are amendable by changes in the behaviors of professionals. A trauma-informed, rights-based approach to care would address many of these issues and create feasible treatment plans.

Psychotropic Medication Monitoring: A Review.

OBJECTIVE: To address a gap in the literature for concise recommendations on psychotropic medication monitoring geared to prescribers in primary care psychiatry. DATA SOURCES: Large institutional guidelines from the United States, United Kingdom, Canada, and Australia/New Zealand combined with manual searches for psychiatric medication monitoring consensus and other recommendations up to January 31, 2018. STUDY SELECTION: Any available guidelines and consensus statements making psychotropic medication monitoring recommendations for treatment of adults and published in English. DATA EXTRACTION: Manual identification of all specific recommendations on psychotropic medication monitoring from the sources. RESULTS: Psychotropic medication monitoring recommendations vary by source, but there is considerable agreement among English-language sources, which can be readily summarized for teaching and everyday use. CONCLUSIONS: For prescribers working in many disciplines, medication monitoring may be improved by having more ready access to recommendations.

Pre-treatment patient characteristics as predictors of drop-out and treatment outcome in individual and family therapy for adolescents and adults with anorexia nervosa: A systematic review and meta-analysis.

Understanding variables predicting drop-out or unfavourable outcome following treatment for anorexia nervosa (AN) may help to improve upon intervention efforts. However, the current literature has demonstrated sparse and inconsistent significant findings. The current systematic review and meta-analysis summarised the evidence base examining baseline predictors of drop-out and outcome in AN treatment. A literature search was conducted to identify research investigating predictors of drop-out and outcome in individuals treated for AN. Four online databases were searched, and predictors were organised by category and dependent variable (outcome versus drop-out). 27 studies were included. Lower motivation, lower BMI, and having the binge-purge subtype of AN predicted drop-out. Greater ED pathology and poorer motivation predicted poorer outcome. Clinical recommendations include taking particular care during assessment stages to identify patients at risk of drop-out and/or poor outcome based on their clinical profile and level of motivation for recovery. At-risk patients should be receiving tailored treatment to enhance engagement and reduce risk of drop-out. In conclusion, there's some evidence that motivation, BMI, subtype, and ED pathology predicts drop-out and/or outcome in individual and family-based therapy for AN amongst adolescents and adults; however, research incorporating carefully designed multi-site studies is required to further examine these findings.

Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review.

BACKGROUND: We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. METHODS: A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. RESULTS: In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. CONCLUSIONS: Consent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.