Study Advisory Group Research Articles

Implementing psychosocial interventions for teachers' mental health: Protocol for integrating scoping review with teachers lived experiences in LMICs.

Teachers are pivotal in shaping educational environments and student development but face significant occupational stress and high rates of mental problems. Despite the availability of various psychosocial interventions, comprehensive evidence of their effectiveness and implementation is limited for this occupational group, especially in low- and middle-income countries (LMICs). This mixed methods study aims to conduct a scoping review of characteristics, effectiveness, and implementation outcomes of psychosocial interventions for teachers' mental health and mental problems, integrating these with teachers' lived experiences to inform the implementation of mental health interventions in LMICs. The study combines a scoping review with insights from an advisory group of teaching professionals with relevant lived experiences (PWLEs). The review will focus on examining psychosocial interventions studies promoting mental health or addressing mental problems among grade 1-12 school teachers of all genders, ages and contexts, except those working in specialized settings, such as special education centers, or disaster- or crisis-stricken zones. Intervention studies exclusively focusing on physical health or job-related outcomes will be excluded. Using pre-defined search terms, quantitative and qualitative research studies, including unpublished literature, will be searched across multiple databases. Titles and abstracts of identified studies will be screened against inclusion criteria, and the potentially relevant sources will be retrieved in full. Data will be extracted using a data extraction sheet developed for the study covering variables related to participant characteristics, intervention characteristics, study context, effectiveness and implementation outcomes. A purposively selected sample of 10 PWLEs will form the study advisory group and participate in four online workshop-group discussions. The meetings will include a presentation of the scoping review findings, followed by discussions on the relevance of these intervention packages for LMICs, adaptations needed to make them acceptable among school teachers and feasible for delivery in low-resourced settings like India. The synthesis of the data will employ narrative and thematic approaches to generate actionable insights for implementing psychosocial interventions in LMICs. This study will provide comprehensive evidence on the characteristics and outcomes of psychosocial interventions for teachers' mental health and mental problems. By integrating insights from teachers with relevant lived experiences, the study will provide practical guidelines for adapting and implementing psychosocial interventions among school teachers in LMICs. Review registration number: Open Science Framework, doi.org/10.17605/OSF.IO/GF59J.

Digging for Literature on Tailoring Cultural Offers With and for Older People From Ethnic Minority Groups: A Scoping Review.

Social prescribing addresses non-medical issues (e.g., loneliness, financial worries, housing problems) affecting physical and/or mental health. It involves connecting people to external support or services, including 'cultural offers'-events, groups and activities run within or by cultural organisations. Such offers need to be acceptable and accessible to diverse populations if forming part of a social prescription. A scoping review was conducted to identify what existing literature, conducted in the United Kingdom, tells us about tailoring cultural offers for older people (aged 60+ years) from ethnic minority groups. Relevant literature was searched for on electronic databases, through Google, via a questionnaire to cultural organisations and by contacting the study's advisory group. Screening of 906 references-59 of which were read as full documents-resulted in six sources being included in the review. Some cultural activities described within them were run in traditional cultural spaces (e.g., museums, art galleries). Others were held in community centres. Data suggested that attending with others could reduce concerns about belonging. Barriers to engagement included low energy, language, poor confidence, accessing transport and unfamiliarity with a setting and/or activities. Provision of familiar food could help make people feel welcomed. Reviewed papers showed that consulting with target groups is important to ensure that activities are inclusive and sympathetically delivered. The review also highlighted a paucity of published research on the topic; this means that cultural providers have little evidence to draw on when developing cultural offers for older people from ethnic minority groups.

Exploring General Practitioners' Management of Self-Harm in Young People: A Qualitative Study.

General practitioners (GPs) are key to the frontline assessment and treatment of young people after self-harm. Young people value GP-led self-harm care, but little is known about how GPs manage young people after self-harm. This study aimed to understand the approaches of GPs to self-harm in young people and explore their perspectives on ways they might help young people avoid repeat self-harm. We conducted semi-structured interviews with GPs from the National Health Service in England in 2021. GPs were recruited from four geographically spread clinical research networks and a professional special interest group. Data were analysed using reflexive thematic analysis. The study's patient and public involvement and community of practice groups supported participant recruitment and data analysis. Fifteen interviews were undertaken with a mean age of participants being 41 years and a breadth of experience in practice ranging from 1 to 22 years. Four themes were generated: GPs' understanding of self-harm; approaches to managing self-harm; impact of COVID-19 on consultations about self-harm; and ways to avoid future self-harm. Negative attitudes towards self-harm within clinical settings are well documented, but GPs said they took self-harm seriously, listened to young people, sought specialist support when concerned and described appropriate ways to help young people avoid self-harm. GPs felt that relationship-based care is an important element of self-harm care but feared remote consultations for self-harm may impede on this. There is a need for brief GP-led interventions to reduce repeat self-harm in young people. A study advisory group consisting of young people aged 16-25 years with personal experience of self-harm and parents and carers of young people who have self-harmed designed the recruitment poster of this study, informed its topic guide and contributed to its findings.

Target Product Profile for a Machine Learning-Automated Retinal Imaging Analysis Software for Use in English Diabetic Eye Screening: Protocol for a Mixed Methods Study.

Diabetic eye screening (DES) represents a significant opportunity for the application of machine learning (ML) technologies, which may improve clinical and service outcomes. However, successful integration of ML into DES requires careful product development, evaluation, and implementation. Target product profiles (TPPs) summarize the requirements necessary for successful implementation so these can guide product development and evaluation. This study aims to produce a TPP for an ML-automated retinal imaging analysis software (ML-ARIAS) system for use in DES in England. This work will consist of 3 phases. Phase 1 will establish the characteristics to be addressed in the TPP. A list of candidate characteristics will be generated from the following sources: an overview of systematic reviews of diagnostic test TPPs; a systematic review of digital health TPPs; and the National Institute for Health and Care Excellence's Evidence Standards Framework for Digital Health Technologies. The list of characteristics will be refined and validated by a study advisory group (SAG) made up of representatives from key stakeholders in DES. This includes people with diabetes; health care professionals; health care managers and leaders; and regulators and policy makers. In phase 2, specifications for these characteristics will be drafted following a series of semistructured interviews with participants from these stakeholder groups. Data collected from these interviews will be analyzed using the shortlist of characteristics as a framework, after which specifications will be drafted to create a draft TPP. Following approval by the SAG, in phase 3, the draft will enter an internet-based Delphi consensus study with participants sought from the groups previously identified, as well as ML-ARIAS developers, to ensure feasibility. Participants will be invited to score characteristic and specification pairs on a scale from "definitely exclude" to "definitely include," and suggest edits. The document will be iterated between rounds based on participants' feedback. Feedback on the draft document will be sought from a group of ML-ARIAS developers before its final contents are agreed upon in an in-person consensus meeting. At this meeting, representatives from the stakeholder groups previously identified (minus ML-ARIAS developers, to avoid bias) will be presented with the Delphi results and feedback of the user group and asked to agree on the final contents by vote. Phase 1 was completed in November 2023. Phase 2 is underway and expected to finish in March 2024. Phase 3 is expected to be complete in July 2024. The multistakeholder development of a TPP for an ML-ARIAS for use in DES in England will help developers produce tools that serve the needs of patients, health care providers, and their staff. The TPP development process will also provide methods and a template to produce similar documents in other disease areas. DERR1-10.2196/50568.

NCOG-26. CORE OUTCOME SETS FOR USE IN FUTURE MENINGIOMA CLINICAL STUDIES: RESULTS OF THE COSMIC PROJECT

Abstract OBJECTIVE Core Outcome Sets (COS) define the minimum outcomes that should be measured and reported in all clinical trials for a specific health condition or health area. The aim was to develop two COS for intracranial meningioma; one for clinical trials (COSMIC: Intervention) and one for observational studies (COSMIC: Observation). METHODS A study advisory group was formed with representation from international stakeholders of charities (IBTA, TBTC, brainstust), neurosurgery societies (SBNS, BIMS) and neuro-oncology societies (BNOS, EANO, EORTC, ICOM, RANO-PRO, SNO). Two systematic literature reviews and trial registry searches were performed to identify outcomes reported in published and ongoing 1) meningioma clinical trials, and 2) studies of incidental/untreated meningioma. Outcomes were deduplicated and categorised. Individuals were recruited from stakeholder groups (including meningioma patients and carers, healthcare professionals, researchers) to participate in 2-round, international, modified eDelphi surveys. The final core outcome sets were ratified through online consensus meetings. RESULTS The COSMIC: Intervention systematic review identified 660 verbatim outcomes, rationalized into 24 Delphi survey items. Following the consensus meeting, 15 outcomes were included in the final set. For COSMIC: Observation, 267 verbatim outcomes were identified and rationalized into 17 Delphi survey items. 16 outcomes were included in the final set. There were eight core outcomes common to both COSMIC: Intervention and COSMIC: Observation COS, namely tumour growth, physical, emotional, and neurocognitive functioning, overall quality of life, progression-free survival, meningioma specific mortality and overall survival. Role and social functioning were core outcomes in COSMIC Observation but not COSMIC intervention. CONCLUSIONS The COSMIC study has defined the core outcome sets for use in future meningioma clinical trials and studies. Role and social functioning were important to incidental meningioma patients and likely reflects the anxiety and uncertainty around clinical treatment. International stakeholder agreement should ensure widespread use and adoption.

Participatory research with women in the perinatal period: Considerations for reflexive, community-oriented and power-sensitive research practices

This article provides an account of using reflexive participatory methods including study advisory group membership to evaluate a perinatal wellbeing service in an economically deprived area of Scotland. There is little qualitative research that explores the experiences of women accessing perinatal mental health services. This article draws on feminist values and narrative theory to explore the practice, process and ethics of using participatory methods with women in the perinatal period. We explore the blurring of intervention and research group boundaries to consider the service and study advisory group as a space which provided the conditions for collective care and re-storying the self. We explore the study advisory group as an extension of the intervention itself, highlighting the role of community in research practices and in interventions, for women who experience perinatal mental health difficulties. We reflect on the ‘sticky’ practice of navigating epistemic and decision-making power in participatory research, including the dual positionalities of being two academic researchers who come to research with therapeutic training in counselling, psychotherapy and social work. We call for reflexive, community-oriented and flexible approaches when using participatory methods with populations that might be considered vulnerable, marginalised or stigmatised.

Core outcome set development for childhood epilepsy treated with ketogenic diet therapy: Results of a scoping review and parent interviews

PurposeClinical trials on childhood epilepsy treated with ketogenic diet (KD) use a wide range of outcomes, however, patients and decision-makers often do not perceive the outcomes used as the most important. We sought parental opinion on outcomes of importance and compared these to outcomes reported in published research. MethodsEthical approval (London-Surrey-REC19/LO/1680). A scoping review identified outcomes reported in previous studies of childhood epilepsy and KD. Parents were recruited from nine KD centres (UK), charities and social media (international), then interviewed (Jan-April 2020) to explore priority outcomes. Content analysis identified all outcomes in transcripts. Parent identified outcomes were compared with those in the scoping review. Outcomes were collated and grouped into domains according to the COMET Taxonomy. ResultsOf 2663 articles;147 met inclusion criteria. 921 verbatim outcomes were sorted into 90 discrete outcomes, reduced to 70 in consultation with the study advisory group, then classified into 21 domains. Parents (n = 21) identified 39 outcomes as important from the scoping review and seven new outcomes. They prioritised both physiological and functional outcomes in contrast to past studies, which prioritised physiological outcomes. ConclusionLittle consistency exists in the outcomes used in childhood epilepsy and KD research. Those traditionally used do not adequately reflect parents’ important outcomes for their child. Clinical trials should consider the broader priorities of parents when choosing outcomes, in particular, functional outcomes. Identified outcomes will inform an international two-round Delphi-study with parent, professional and researcher participants to develop a core outcome set for this clinical area (COMET registration #1116).

Stakeholder Perspectives on Clinical Decision Support Tools to Inform Clinical Artificial Intelligence Implementation: Protocol for a Framework Synthesis for Qualitative Evidence.

BackgroundQuantitative systematic reviews have identified clinical artificial intelligence (AI)-enabled tools with adequate performance for real-world implementation. To our knowledge, no published report or protocol synthesizes the full breadth of stakeholder perspectives. The absence of such a rigorous foundation perpetuates the “AI chasm,” which continues to delay patient benefit.ObjectiveThe aim of this research is to synthesize stakeholder perspectives of computerized clinical decision support tools in any health care setting. Synthesized findings will inform future research and the implementation of AI into health care services.MethodsThe search strategy will use MEDLINE (Ovid), Scopus, CINAHL (EBSCO), ACM Digital Library, and Science Citation Index (Web of Science). Following deduplication, title, abstract, and full text screening will be performed by 2 independent reviewers with a third topic expert arbitrating. The quality of included studies will be appraised to support interpretation. Best-fit framework synthesis will be performed, with line-by-line coding completed by 2 independent reviewers. Where appropriate, these findings will be assigned to 1 of 22 a priori themes defined by the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability framework. New domains will be inductively generated for outlying findings. The placement of findings within themes will be reviewed iteratively by a study advisory group including patient and lay representatives.ResultsStudy registration was obtained from PROSPERO (CRD42021256005) in May 2021. Final searches were executed in April, and screening is ongoing at the time of writing. Full text data analysis is due to be completed in October 2021. We anticipate that the study will be submitted for open-access publication in late 2021.ConclusionsThis paper describes the protocol for a qualitative evidence synthesis aiming to define barriers and facilitators to the implementation of computerized clinical decision support tools from all relevant stakeholders. The results of this study are intended to expedite the delivery of patient benefit from AI-enabled clinical tools.Trial RegistrationPROSPERO CRD42021256005; https://tinyurl.com/r4x3thvpInternational Registered Report Identifier (IRRID)DERR1-10.2196/33145

A core outcome set for clinical trials of first- and second-degree perineal tears prevention and treatment: a study protocol for a systematic review and a Delphi survey

BackgroundPerineal tear is a common consequence of vaginal births affecting females globally. Even mild perineal tears could cause short- and long-term complications for females. Though many studies of interventions to prevent or treat perineal tears to minimize the consequences have been conducted, there is a significant heterogeneity in the outcomes measured and reported in existing studies, which makes meaningful comparison difficult and makes the generalizability to clinical practice challenging. Developing a core outcome set (COS) could solve these methodological concerns. In this paper, we report a protocol to develop a COS for clinical trials of mild perineal tears, which shall assist in establishing the evidence base and implementation of effective measures to reduce the incidence and minimize the consequences of mild perineal tears.Methods/designThe development of this COS will be guided by a study advisory group composed of obstetricians, midwives, nursing managers, service users, and methodologists. This study will include four stages: (1) a systematic research of the literature to identify outcomes reported in prior studies, (2) a semi-structured interview with key stakeholders to collect their opinions on important outcomes, (3) a panel of experts will be invited to conduct a three-round Delphi survey to prioritize these outcomes, and (4) a consensus meeting with key stakeholders to determine the list of outcomes included in the final COS.DiscussionThe development of this COS will provide international standards for the outcomes to be collected and reported in all clinical trials and audits of practice, which involve prevention and treatment of first- and second-degree perineal tears for women with vaginal delivery. This will facilitate comparing and contrasting of studies and allow for combining of appropriate studies with the ultimate goal of improved perineal care for women choosing vaginal delivery.Trial registrationThis study was registered in the database of Core Outcome Measures in Effectiveness Trials (COMET) on June11th, 2021 (https://comet-initiative.org/Studies/Details/1884).

Development of ‘Core Outcome Sets’ for meningioma in clinical studies: The COSMIC project

Abstract Aims To date, meningioma clinical trial activity has been limited, but a number of high-quality studies are underway, with more in development. There is heterogeneity in the outcomes reported in meningioma clinical trials. The COSMIC Project will develop two ‘Core Outcome Sets’ (COS) through comprehensive, transparent, consensus methodology; to ensure outcomes relevant to key stakeholders are reported within and across future meningioma clinical studies. The first will be for use in clinical effectiveness trials (COSMIC: Intervention), the second will be for use in clinical studies of incidental meningioma (COSMIC: Observation). Method Three systematic literature reviews will be performed to generate a long-list of outcomes potentially relevant to meningioma patients, healthcare professionals, researchers, and other stakeholder groups. The first systematic review will present the outcomes reported in published and ongoing meningioma clinical effectiveness trials. The second systematic review will present patient-reported outcomes (PRO) from the measurement tools utilised in meningioma PRO studies. The third systematic review will present the outcomes reported in published and ongoing clinical studies of untreated meningioma. Outcomes will be deduplicated, unique outcomes categorised according to the taxonomy presented by COMET, and the lists combined. The long-list of outcomes will be prioritised through two, 2-round, modified eDelphi surveys including meningioma patients, healthcare professionals, researchers, and other stakeholder groups. Undecided outcomes from both eDelphi surveys will be ratified at two, one-day consensus meeting, with representation from all key stakeholder groups. Results We have formed a study advisory group with international representation from key organisations. The project already has confirmed support from the International Consortium on Meningioma (ICOM), the European Association of Neuro-Oncology (EANO), the Response Assessment in Neuro-Oncology Patient-Reported Outcome group (RANO-PRO), the Society for Neuro-Oncology (SNO), British Neuro-Oncology Society (BNOS), Society of British Neurological Surgeons (SBNS), The Brain Tumour Charity (TBTC), and Brainstrust. Conclusion Standardising minimum outcome reporting in meningioma clinical effectiveness trials and meningioma clinical studies, through the development of these two COS will ensure outcomes reported are relevant to key stakeholder groups, including patients, whilst reducing research waste for a disease with increasing clinical trial activity. We seek to raise awareness of this project and invite participation from a wide range of stakeholders to ensure that the final COS reflects the opinion of the neuro-oncology community. Registration will take place via the study website www.thecosmicproject.org between June-August 2021.

A systematic review on outcome reporting in randomised controlled trials assessing treatment interventions in pregnant women with pregestational diabetes.

Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes. Studies assessing interventions to improve maternal and infant outcomes have increased exponentially over recent years. Several outcomes in this field of maternal diabetes are rare, making it difficult to synthesise evidence. To collect outcomes reported in studies assessing treatment interventions in pregnant women with PGDM. CENTRAL, Web of Science, Medline, CINAHL, Embase and ClinicalTrials.gov from their inception until 27 January 2020. Any randomised controlled trial assessing treatment interventions in pregnant women with PGDM reported in English. Two independent reviewers assessed the suitability of articles and retrieved the data. Outcomes extracted from the literature were broadly categorised into maternal, fetal/infant or other outcomes by the study advisory group. Sixty-seven of the 1475 studies identified fulfilled the inclusion criteria. The median number of outcomes reported per study was 15 (range 1-46). The majority of studies were from North America and Europe. Insulin and metformin were the most commonly investigated pharmacological interventions. Glucose monitoring was the most assessed technological intervention. In all, 131 unique outcomes were extracted: maternal (n=69), fetal/infant (n=61) and other (n=1). Outcome reporting in treatment interventions trials of pregnant women with PGDM is varied, making it difficult to synthesise evidence, especially for rare outcomes. Systems are needed to standardise outcome reporting in future clinical trials and so facilitate evidence synthesis in this area of maternal diabetes. The systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO) database (Registration number CRD42020173549). Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy.

Risk factors, symptom reporting, healthcare-seeking behaviour and adherence to public health guidance: protocol for Virus Watch, a prospective community cohort study

IntroductionThe coronavirus (COVID-19) pandemic has caused significant global mortality and impacted lives around the world. Virus Watch aims to provide evidence on which public health approaches are most likely to...

PROTOCOL: Involving men and boys in family planning: A systematic review of the effective components and characteristics of complex interventions in low- and middle-income countries.

PROTOCOL: Involving men and boys in family planning: A systematic review of the effective components and characteristics of complex interventions in low- and middle-income countries.

Involving service users in the Birth Timing project, a data linkage study analysing the timing of births and their outcomes.

IntroductionWe report on service user participation in a population-based data linkage study designed to analyse the daily, weekly and yearly cycles of births in England and Wales, the outcomes for women and babies, and their implications for the NHS. Public Involvement and Engagement (PI&E) has a long history in maternity services, though PI&E in maternity data linkage studies is new in the United Kingdom. We have used the GRIPP2 short form, a tool designed for reporting public involvement in research.ObjectivesWe aimed to involve and engage a wide range of maternity service users and their representatives to ensure that our use of patient-identifiable routinely collected maternity and birth records was acceptable and that our research analyses using linked data were relevant to their expressed safety and quality of care needs.MethodsA three-tiered approach to PI&E was used. Having both PI&E co-investigators and PI&E members of the Study Advisory Group ensured service user involvement was part of the strategic development of the project. A larger constituency of maternity service users from England and Wales was engaged through four regional workshops.ResultsTwo co-investigators with experience of PI&E in maternity research were involved as service user researchers from design stage to dissemination. Four PI&E study advisors contributed service user perspectives. Engagement workshops attracted around 100 attendees, recruited largely from Maternity Services Liaison Committees in England and Wales, and a community engagement group. They supported the use of patient-identifiable data, believing the study had potential to improve safety and quality of maternity services. They contributed their experiences and concerns which will assist with interpretation of the analyses.ConclusionUse of PI&E ‘knowledge intermediaries’ successfully bridged the gap between data intensive research and lived experience, but more inclusivity in involvement and engagement is required. Respecting the concerns and questions of service users provides social legitimacy and a relevance framework for researchers carrying out analyses.

Scaling the Peaks Research Protocol: understanding the barriers and drivers to providing and using dementia-friendly community services in rural areas—a mixed methods study

IntroductionScaling the Peaks is a cross-disciplinary research study that draws on medical ethnography, human geography and Geospatial Information Science (GIS) to address the issues surrounding the design and delivery of...

PROTOCOL: Mass deworming for improving health and cognition of children in endemic helminth areas: a systematic review and individual participant data network meta-analysis.

PROTOCOL: Mass deworming for improving health and cognition of children in endemic helminth areas: a systematic review and individual participant data network meta-analysis.

Chicago, Illinois, Smart Growth Study

As part of the state's balanced growth initiative, the Illinois Department of Transportation initiated a smart growth study designed to assist mature urban communities located on the North Side of Chicago and the near northern suburbs in addressing traffic, pedestrian, bicycle, and transit issues and to build an understanding of the land use-transportation relationship. One of the major goals of this study was to demonstrate how an interactive, multijurisdictional planning process could address common land use and transportation issues with smart growth principles. A four-phase approach was developed. Phase 1 resulted in building an understanding of the physical, economic, and political dynamics of the study area and a strategic assessment of opportunities and constraints for promoting smart growth, land use, and transportation principles. Phase 2 included a community workshop with breakout groups to discuss specific transportation and land use issues. With input from the workshop and the study advisory group, a set of case studies was identified. These case studies were performed in Phase 3. Six site-specific case studies were performed that examined possible solutions with balanced growth principles. Three programmatic case studies were performed that included traffic-calming program guidelines, a context-sensitive roadway functional classification, and transit station area zoning guidelines. A funding source guide was also developed. The final phase was the development of a toolbox that included a comprehensive set of smart growth techniques. The study results were compiled on a compact disc and distributed to local communities.

The rhetoric of midwifery: Conflicts and conversations in the Minnesota home birth community in the 1990s

This essay applies and tests Michel Foucault's theories about local centers of power and knowledge by rhetorically analyzing a Midwifery Study Advisory Group in Minnesota in 1991–1992. In particular, the dividing practices of traditional midwives and their spokespersons illustrate how knowledge may be produced or suppressed and how a rhetor may become empowered by projecting negative traits upon the “other. “ The essay demonstrates how a group of traditional midwives achieved status within the public sphere and temporarily resisted the surveillance and normalization of state authority.

The health effects of swimming at Sydney beaches. The Sydney Beach Users Study Advisory Group.

The purpose of the study was to determine the health risks of swimming at ocean beaches in Sydney, Australia. From people attending 12 Sydney beaches in the period from December 5, 1989 to February 26, 1990, we recruited a cohort of 8413 adults who agreed to participate in this study. Of these, 4424 were excluded either because they had been swimming in the previous 5 days or because they reported a current illness. Of the remainder, 2839 successfully completed a follow-up telephone interview conducted within 10 days after recruitment. We recorded reported respiratory, gastrointestinal, eye, and ear symptoms and fever that occurred within the 10 days between initial interview on the beach and the follow-up interview. A total of 683 participants (24.0%) reported experiencing symptoms in the 10 days following initial interview. Of these, 435 (63.7%) reported respiratory symptoms. Swimmers were almost twice as likely as nonswimmers to report symptoms. There was a linear relationship between water pollution and all reported symptoms with the exception of gastrointestinal complaints. Swimmers at Sydney ocean beaches are more likely to report respiratory, ear, and eye symptoms than beachgoers who do not swim. The incidence of these symptoms increases slightly with increasing levels of pollution.

Histamine release during induction of anaesthesia and preparation for operation in patients undergoing general surgery: Incidence and clinically severe cases

Histamine release events were shown in a prospective randomized controlled trial in patients undergoing elective general surgery with an extraordinarily high incidence: 73 per cent. This high incidence was explained by several factors: — the sample size which was much greater than in previous studies — the improved plasma histamine assay — the precise definition of histamine release in clinical conditions and its measurement at the top of Bateman functions — the standardized induction of anaesthesia and preparation of the surgical patient — and finally the considerable number of cancer patients since more than 60% of the reactions >5 ng/ml occurred in this group which comprised only 20% of the study population. Two cases of life-threatening anaphylactoid reactions occurred in this trial corresponding to an incidence of 1 per cent. This was — again — very high compared to previous epidemiological studies. Both cases were again cancer patients and occurred in the placebo group — information given by the external study advisory group for further treatment of the individual patient. The data on the high incidence of histamine release including the high incidence of life-threatening reactions favourrationally a preoperative H1 −+H2-prophylaxis with the drugs used in this study: dimetindene and cimetidine. The question of the incidence was one of the unsettled problems which led to this trial. Analysis of the first 180 patients already answered this question more than we had ever expected.