Parent and healthcare professional experiences of critical congenital heart disease in New Zealand to advance health equity.

BACKGROUND: Higher odds of survival have been reported in European infants compared to Indigenous Maori and Pasifika infants with critical congenital heart disease in New Zealand. We therefore aimed to understand how to mitigate this disparity by investigating the parent and healthcare professional experiences' of critical congenital heart disease healthcare in New Zealand. METHODS: A prospective qualitative study utilising semi-structured interviews was conducted on a cohort of purposefully sampled parents and health professionals with experience of critical congenital heart disease healthcare in New Zealand. Parents were recruited after a fetal critical congenital heart disease diagnosis and offered two interviews at least three months apart, whilst multidisciplinary fetal and cardiosurgical health professionals were interviewed once. Interviews were recorded and transcribed verbatim before coding, categorization and qualitative analysis. RESULTS: During 2022 and 2023, 45 people participated in 57 interviews (25 parents: 19 mothers, 6 fathers; Indigenous Maori, n = 5; Pasifika, n = 6; Asian, n = 4; European, n = 10; and 20 healthcare professionals: European n = 17). The three lessons learned from participants were: (1) Minoritized groups experience disparate healthcare quality; (2) healthcare systems are under-resourced to provide equitable support for the differential needs of grieving parents; and (3) healthcare systems could engage minoritized families more optimally in shared decision-making. CONCLUSIONS: According to the experiences of parents and healthcare professionals, persisting inequities in CCHD healthcare quality occur by ethnic group, with the New Zealand healthcare system privileging European families. The concepts from this study could be translated by healthcare leaders, policymakers, and professionals into evidence-based healthcare system improvements to enhance experiences for non-European families more broadly.

The impact of visiting restrictions in intensive care units for families during the COVID-19 pandemic: An integrative review.

AIM: To synthesize current evidence about the impact visiting restrictions in adult intensive care units have on family members during the COVID-19 pandemic. DESIGN: Integrative literature review. METHODS: A total of 104 articles were retrieved. Screening yielded a total of 23 articles which were appraised for quality. Reflexive thematic analysis was applied to synthesize findings and extract themes. DATA SOURCES: CINAHL Plus, Ovid MEDLINE, PubMed and ProQuest databases were searched for articles between January 2020 and November 2022. RESULTS: The findings were grouped into two main themes with six subthemes. Theme 1: not being present at the bedside, and Theme 2: altered communication added to family members' distress. Findings indicate that visiting restrictions imposed during the COVID-19 pandemic had negative consequences for family members. CONCLUSION: The patient and their family are inherently connected, prioritizing family presence with the return of flexible, open visitation policies in ICU must be a priority to mitigate further harm and adverse outcomes for all. REPORTING METHOD: The review complies with the PRISMA guidelines for reporting systematic reviews. IMPLICATIONS FOR PROFESSION: Nursing leaders must be included in the development of future pandemic policies that advocate family-centred care. NO PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution was included in this review.

A Mixed Methods Study Exploring Patient Perspectives and Outcome Measures From Not Fasting Before Cardiac Catheterisation.

BACKGROUND & AIM: This study aimed to describe the patient experience and incidence of adverse events in unfasted patients undergoing coronary angiography and angioplasty. In addition, to identify any association between duration of fasting and adverse events. Historically, patients were fasted before elective cardiac catheterisation. Routine fasting was not evidence-based, and many centres, including our unit, have discontinued the practice. METHODS: Patients undergoing cardiac catheterisation at a large urban teaching hospital were invited to participate in a prospective observational cohort study documenting the duration of fasting and incidence of adverse events (n=508). Of these participants, 257 also completed a survey that captured perspectives and opinions regarding not fasting. RESULTS: The mean time since last fluid was 1.9±2.2 hours and for food was 3.9±3.7 hours. The most common adverse event was hypotension (10.0%). Rates of nausea (3.9%) and vomiting (0.6%) were low, and there were no episodes of aspiration. No associations were identified between the time since the last food or fluid and any adverse events. Thematic analysis of survey data yielded three themes: (1) in most, not fasting is preferable to fasting; (2) being able to eat and drink before the procedure positively affected well-being, and (3) one-fifth of the cohort expressed no preference between fasting and non-fasting. CONCLUSIONS: Not fasting before cardiac catheterisation is viewed favourably by patients. While this study provides additional evidence that not fasting is safe, event rates are low, and larger multicentre studies are needed for confirmation.

Experiences of parents whose children participated in a longitudinal follow-up study.

BACKGROUND: Long-term follow-up is necessary to understand the impact of perinatal interventions. Exploring parents' motives and experiences in consenting to their children taking part in longitudinal studies and understanding what outcomes are important to families may enhance participation and mitigate the loss to follow-up. As existing evidence is largely based on investigators' perspectives using Western samples, the present pilot study explored parents' perspectives in a multicultural New Zealand context. METHODS: Data were generated using semi-structured interviews with parents whose children had participated in a longitudinal study after neonatal recruitment. Parents' experiences of being part of the study were analysed thematically using an inductive approach. RESULTS: Parents (n = 16) were generally happy with the outcomes measured. Additionally, parents were interested in lifelong goals such as the impact of parental diabetes. We identified three themes: (1) Facilitators: Research participation was aided by motives and parent and research characteristics such as wishing to help others and straightforward recruitment; (2) Barriers: A hesitancy to participate was due to technical and clinical research aspects, participation burden and cultural barriers, such as complex wording, time commitment and nonindigenous research and (3) Benefits: Children and parents experienced advantages such as the opportunity for education. CONCLUSIONS: Parents reported positive experiences and described the unexpected benefit of increasing families' health knowledge through participation. Improvements for current follow-up studies were identified. Different ethnicities reported different experiences and perspectives, which warrants ongoing research, particularly with indigenous research participants. PATIENT OR PUBLIC CONTRIBUTION: No active partnership with parents of patients took place.

Describing objectively measured intensive care nurses' physical work activity behavioural patterns during a 12-hr shift.

AIM AND OBJECTIVES: To describe intensive care unit (ICU) nurses' physical work activity behavioural patterns over 12 hr using dual accelerometry, following a job demands-recovery framework. BACKGROUND: Limited studies utilised accelerometry to objectively analyse nurses' physical workloads. Little is known about intensive care nurses' physical activity patterns during a 12-hr shift. DESIGN: A cross-sectional study was conducted with intensive care nurses from four units in Auckland, New Zealand. METHODS: Each participant wore two Axivity AX3 accelerometers to measure physical activity during a 12-hr day or night shift. An online survey captured participants' demographic information. R software (version 3.6.1) and SPSS version 26 were utilised for data analysis. The STROBE was followed. RESULTS: A total of 102 nurses were included in this study. A high level of light intensity activity behaviours (standing, dynamic standing, walking) was observed throughout the day shifts, with no higher intensity behaviours identified. Activity levels were highest at the beginning of shifts and followed a consistent pattern, with an additional peak around midday for day shifts and at the end of the shift for night shifts. Observable differences were seen between day and night shifts with a greater prevalence of sitting and lying during night shifts. Standing, dynamic standing, sitting, lying and walking were significant factors in the differences of the physical work behaviours between the day shift nurses and the night shift nurses. Significant differences in dynamic standing and lying were found between ICUs. CONCLUSIONS: Intensive care nurses' physical work activity involved a large amount of standing and dynamic standing during a 12-hr shift. The overall physical workload during a 12-hr day shift was significantly higher than that during a 12-hr night shift. RELEVANCE TO CLINICAL PRACTICE: Results may help managers attain a better understanding of nurses' physical workloads during a 12-hr shift.

Physical activity and personal factors associated with nurse resilience in intensive care units.

AIM AND OBJECTIVES: To assess intensive care nurses' resilience and identify associated personal factors and physical activity behaviours using a job demands-recovery framework. BACKGROUND: Currently, there is inconsistent evidence as to whether nurse resilience is associated with personal factors or with physical activity at work or during leisure time. DESIGN: A cross-sectional study was conducted with nurses from four intensive care units in Auckland, New Zealand. METHODS: An online survey was conducted to collect nurses' personal information and assess their resilience levels using the Connor-Davidson Resilience Scale 25. Participants were nurses working at least 32 hr fortnightly and providing direct patient care. Physical activity was objectively measured using a pair of accelerometers worn on the back and thigh over four consecutive days (two workdays followed by two nonworkdays). Bivariable and multivariable regression were used to identify personal factors and physical activity behaviours associated with resilience (followed the STROBE checklist). RESULTS: A total of 93 nurses were included in the study. The participants' average resilience level was low. Resilience was positively associated with the objectively measured physical job demands factors: occupational physical activity, moderate-to-vigorous physical activity at work and dynamic standing at work. Resilience was negatively associated with one objectively measured recovery factor: sleep during leisure time. In multivariable modelling, being married and moderate-to-vigorous physical activity at work were positively associated with resilience, while not having religious beliefs and sleep during leisure time were negatively associated with resilience. CONCLUSIONS: Resilient nurses have a greater tolerance to high physical activity at work and lower sleep duration during leisure time. Strategies are needed to improve intensive care nurses' resilience levels. RELEVANCE TO CLINICAL PRACTICE: Results may help managers gain a better understanding of the ICU nurses' characteristics associated with resilience, leading them to develop strategies for improving ICU nurse resilience.

Contracting out to improve the use of clinical health services and health outcomes in low- and middle-income countries.

BACKGROUND: Contracting out of governmental health services is a financing strategy that governs the way in which public sector funds are used to have services delivered by non-governmental health service providers (NGPs). It represents a contract between the government and an NGP, detailing the mechanisms and conditions by which the latter should provide health care on behalf of the government. Contracting out is intended to improve the delivery and use of healthcare services. This Review updates a Cochrane Review first published in 2009. OBJECTIVES: To assess effects of contracting out governmental clinical health services to non-governmental service provider/s, on (i) utilisation of clinical health services; (ii) improvement in population health outcomes; (iii) improvement in equity of utilisation of these services; (iv) costs and cost-effectiveness of delivering the services; and (v) improvement in health systems performance. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, NHS Economic Evaluation Database, EconLit, ProQuest, and Global Health on 07 April 2017, along with two trials registers - ClinicalTrials.gov and the International Clinical Trials Registry Platform - on 17 November 2017. SELECTION CRITERIA: Individually randomised and cluster-randomised trials, controlled before-after studies, interrupted time series, and repeated measures studies, comparing government-delivered clinical health services versus those contracted out to NGPs, or comparing different models of non-governmental-delivered clinical health services. DATA COLLECTION AND ANALYSIS: Two authors independently screened all records, extracted data from the included studies and assessed the risk of bias. We calculated the net effect for all outcomes. A positive value favours the intervention whilst a negative value favours the control. Effect estimates are presented with 95% confidence intervals. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence and we prepared a Summary of Findings table. MAIN RESULTS: We included two studies, a cluster-randomised trial conducted in Cambodia, and a controlled before-after study conducted in Guatemala. Both studies reported that contracting out over 12 months probably makes little or no difference in (i) immunisation uptake of children 12 to 24 months old (moderate-certainty evidence), (ii) the number of women who had more than two antenatal care visits (moderate-certainty evidence), and (iii) female use of contraceptives (moderate-certainty evidence).The Cambodia trial reported that contracting out may make little or no difference in the mortality over 12 months of children younger than one year of age (net effect = -4.3%, intervention effect P = 0.36, clustered standard error (SE) = 3.0%; low-certainty evidence), nor to the incidence of childhood diarrhoea (net effect = -16.2%, intervention effect P = 0.07, clustered SE = 19.0%; low-certainty evidence). The Cambodia study found that contracting out probably reduces individual out-of-pocket spending over 12 months on curative care (net effect = $ -19.25 (2003 USD), intervention effect P = 0.01, clustered SE = $ 5.12; moderate-certainty evidence). The included studies did not report equity in the use of clinical health services and in adverse effects. AUTHORS' CONCLUSIONS: This update confirms the findings of the original review. Contracting out probably reduces individual out-of-pocket spending on curative care (moderate-certainty evidence), but probably makes little or no difference in other health utilisation or service delivery outcomes (moderate- to low-certainty evidence). Therefore, contracting out programmes may be no better or worse than government-provided services, although additional rigorously designed studies may change this result. The literature provides many examples of contracting out programmes, which implies that this is a feasible response when governments fail to provide good clinical health care. Future contracting out programmes should be framed within a rigorous study design to allow valid and reliable measures of their effects. Such studies should include qualitative research that assesses the views of programme implementers and beneficiaries, and records implementation mechanisms. This approach may reveal enablers for, and barriers to, successful implementation of such programmes.

Analyzing implementation dynamics using theory-driven evaluation principles: lessons learnt from a South African centralized chronic dispensing model.

BACKGROUND: Centralized dispensing of essential medicines is one of South Africa's strategies to address the shortage of pharmacists, reduce patients' waiting times and reduce over-crowding at public sector healthcare facilities. This article reports findings of an evaluation of the Chronic Dispensing Unit (CDU) in one province. The objectives of this process evaluation were to: (1) compare what was planned versus the actual implementation and (2) establish the causal elements and contextual factors influencing implementation. METHODS: This qualitative study employed key informant interviews with the intervention's implementers (clinicians, managers and the service provider) [N = 40], and a review of policy and program documents. Data were thematically analyzed by identifying the main influences shaping the implementation process. Theory-driven evaluation principles were applied as a theoretical framework to explain implementation dynamics. RESULTS: The overall participants' response about the CDU was positive and the majority of informants concurred that the establishment of the CDU to dispense large volumes of medicines is a beneficial strategy to address healthcare barriers because mechanical functions are automated and distribution of medicines much quicker. However, implementation was influenced by the context and discrepancies between planned activities and actual implementation were noted. Procurement inefficiencies at central level caused medicine stock-outs and affected CDU activities. At the frontline, actors were aware of the CDU's implementation guidelines regarding patient selection, prescription validity and management of non-collected medicines but these were adapted to accommodate practical realities and to meet performance targets attached to the intervention. Implementation success was a result of a combination of 'hardware' (e.g. training, policies, implementation support and appropriate infrastructure) and 'software' (e.g. ownership, cooperation between healthcare practitioners and trust) factors. CONCLUSION: This study shows that health system interventions have unpredictable paths of implementation. Discrepancies between planned and actual implementation reinforce findings in existing literature suggesting that while tools and defined operating procedures are necessary for any intervention, their successful application depends crucially on the context and environment in which implementation occurs. We anticipate that this evaluation will stimulate wider thinking about the implementation of similar models in low- and middle-income countries.

Reasons for missed appointments linked to a public-sector intervention targeting patients with stable chronic conditions in South Africa: results from in-depth interviews and a retrospective review of medical records.

BACKGROUND: Missed appointments serve as a key indicator for adherence to therapy and as such, identifying patient reasons for this inconsistency could assist in developing programmes to improve health outcomes. In this article, we explore the reasons for missed appointments linked to a centralised dispensing system in South Africa. This system dispenses pre-packed, patient-specific medication parcels for clinically stable patients to health facilities. However, at least 8%-12% of about 300,000 parcels are not collected each month. This article aims to establish whether missed appointments for collection of medicine parcels are indicative of loss-to-follow-up and also to characterise the patient and health system factors linked to missed appointments. METHODS: We applied an exploratory mixed-methods design in two overlapping research phases. This involved in-depth interviews to yield healthcare practitioners' and patients' experiences and medical record reviews. Data collection was conducted during the period 2014-2015. Qualitative data were analysed through a hybrid process of inductive and deductive thematic analysis which integrated data-driven and theory-driven codes. Data from medical records (N = 89) were analysed in MS excel using both descriptive statistics and textual descriptions. RESULTS: Review of medical records suggests that the majority of patients (67%) who missed original appointments later presented voluntarily to obtain medicines. This could indicate a temporal effect of some barriers. The remaining 33% revealed a range of CDU implementation issues resulting from, among others, erroneous classification of patients as defaulters. Interviews with patients revealed the following reasons for missed appointments: temporary migration, forgetting appointments, work commitments and temporary switch to private care. Most healthcare practitioners confirmed these barriers to collection but perceived that some were beyond the scope of health services. In addition, healthcare practitioners also identified a lack of patient responsibility, under-utilisation of medicines and use of plural healthcare sources (e.g. traditional healers) as contributing to missed appointments. CONCLUSION: We suggest developing a patient care model reflecting the  local context, attention to improving CDU's implementation processes and strengthening information systems in order to improve patient monitoring. This model presents lessons for other low-and-middle income countries with increasing need for dispensing of medicines for chronic illnesses.

Improving access to medicines through centralised dispensing in the public sector: a case study of the Chronic Dispensing Unit in the Western Cape Province, South Africa.

BACKGROUND: The Chronic Dispensing Unit (CDU) is an out-sourced, public sector centralised dispensing service that has been operational in the Western Cape Province in South Africa since 2005. The CDU dispenses medicines for stable patients with chronic conditions. The aim is to reduce pharmacists' workload, reduce patient waiting times and decongest healthcare facilities. Our objectives are to describe the intervention's scope, illustrate its interface with the health system and describe its processes and outcomes. Secondly, to quantify the magnitude of missed appointments by enrolled patients and to describe the implications thereof in order to inform a subsequent in-depth empirical study on the underlying causes. METHODS: We adopted a case study design in order to elicit the programme theory underlying the CDU strategy. We consulted 15 senior and middle managers from the provincial Department of Health who were working closely with the intervention and the contractor using focus group discussions and key informant interviews. In addition, relevant literature, and policy and programme documents were reviewed and analysed. RESULTS: We found that the CDU scope has significantly expanded over the last 10 years owing to technological advancements. As such, in early 2015, the CDU produced nearly 300,000 parcels monthly. Medicines supply, patient enrollment processes, healthcare professionals' compliance to legislation and policies, mechanisms for medicines distribution, management of non-collected medicines (emanating from patients' missed appointments) and the array of actors involved are all central to the CDU's functioning. Missed appointments by patients are a problem, affecting an estimated 8%-12% of patients each month. However, the causes have not been investigated thoroughly. Implications of missed appointments include a cost to government for services rendered by the contractor, potential losses due to expired medicines, additional workload for the contractor and healthcare facility staff and potential negative therapeutic outcomes for patients. CONCLUSIONS: The CDU demonstrates innovation in a context of overwhelming demand for dispensing medicines for chronic conditions. However, it is not a panacea to address access-to-medicines related challenges. A multi-level assessment that is currently underway will provide more insights on how existing challenges can be addressed.

Participants' views of telephone interviews within a grounded theory study.

AIM: To offer a unique contribution to the evolving debate around the use of the telephone during semistructured interview by drawing on interviewees' reflections on telephone interview during a grounded theory study. BACKGROUND: The accepted norm for qualitative interviews is to conduct them face-to-face. It is typical to consider collecting qualitative data via telephone only when face-to-face interview is not possible. During a grounded theory study, exploring users' experiences with overnight mask ventilation for sleep apnoea, the authors selected the telephone to conduct interviews. This article reports participants' views on semistructured interview by telephone. DESIGN: An inductive thematic analysis was conducted on data pertaining to the use of the telephone interview in a grounded theory study. METHODS: The data were collected during 4 months of 2011 and 6 months in 2014. The article presents an inductive thematic analysis of sixteen participants' opinions about telephone interviewing and discusses these in relation to existing literature reporting the use of telephone interviews in grounded theory studies. FINDINGS: Overall, participants reported a positive experience of telephone interviewing. From each participants reports we identified four themes from the data: being 'phone savvy; concentrating on voice instead of your face; easy rapport; and not being judged or feeling inhibited. CONCLUSION: By drawing on these data, we argue that the telephone as a data collection tool in grounded theory research and other qualitative methodologies need not be relegated to second best status. Rather, researchers can consider telephone interview a valuable first choice option.

Assessing equity in the geographical distribution of community pharmacies in South Africa in preparation for a national health insurance scheme.

OBJECTIVE: To investigate equity in the geographical distribution of community pharmacies in South Africa and assess whether regulatory reforms have furthered such equity. METHODS: Data on community pharmacies from the national department of health and the South African pharmacy council were used to analyse the change in community pharmacy ownership and density (number per 10,000 residents) between 1994 and 2012 in all nine provinces and 15 selected districts. In addition, the density of public clinics, alone and with community pharmacies, was calculated and compared with a national benchmark of one clinic per 10,000 residents. Interviews were conducted with nine national experts from the pharmacy sector. FINDINGS: Community pharmacies increased in number by 13% between 1994 and 2012--less than the 25% population growth. In 2012, community pharmacy density was higher in urban provinces and was eight times higher in the least deprived districts than in the most deprived ones. Maldistribution persisted despite the growth of corporate community pharmacies. In 2012, only two provinces met the 1 per 10,000 benchmark, although all provinces achieved it when community pharmacies and clinics were combined. Experts expressed concerns that a lack of rural incentives, inappropriate licensing criteria and a shortage of pharmacy workers could undermine access to pharmaceutical services, especially in rural areas. CONCLUSION: To reduce inequity in the distribution of pharmaceutical services, new policies and legislation are needed to increase the staffing and presence of pharmacies.

Frontline health workers as brokers: provider perceptions, experiences and mitigating strategies to improve access to essential medicines in South Africa.

BACKGROUND: Front-line health providers have a unique role as brokers (patient advocates) between the health system and patients in ensuring access to medicines (ATM). ATM is a fundamental component of health systems. This paper examines in a South African context supply- and demand- ATM barriers from the provider perspective using a five dimensional framework: availability (fit between existing resources and clients' needs); accessibility (fit between physical location of healthcare and location of clients); accommodation (fit between the organisation of services and clients' practical circumstances); acceptability (fit between clients' and providers' mutual expectations and appropriateness of care) and affordability (fit between cost of care and ability to pay). METHODS: This cross-sectional, qualitative study uses semi-structured interviews with nurses, pharmacy personnel and doctors. Thirty-six providers were purposively recruited from six public sector Community Health Centres in two districts in the Eastern Cape Province representing both rural and urban settings. Content analysis combined structured coding and grounded theory approaches. Finally, the five dimensional framework was applied to illustrate the interconnected facets of the issue. RESULTS: Factors perceived to affect ATM were identified. Availability of medicines was hampered by logistical bottlenecks in the medicines supply chain; poor public transport networks affected accessibility. Organization of disease programmes meshed poorly with the needs of patients with comorbidities and circular migrants who move between provinces searching for economic opportunities, proximity to services such as social grants and shopping centres influenced where patients obtain medicines. Acceptability was affected by, for example, HIV related stigma leading patients to seek distant services. Travel costs exacerbated by the interplay of several ATM barriers influenced affordability. Providers play a brokerage role by adopting flexible prescribing and dispensing for 'stable' patients and aligning clinic and social grant appointments to minimise clients' routine costs. Occasionally they reported assisting patients with transport money. CONCLUSION: All five ATM barriers are important and they interact in complex ways. Context-sensitive responses which minimise treatment interruption are needed. While broad-based changes encompassing all disease programmes to improve ATM are needed, a beginning could be to assess the appropriateness, feasibility and sustainability of existing brokerage mechanisms.

Impactful co-design: Adult decision-makers' perspectives on actualising children's ideas for health-promoting neighbourhoods in Aotearoa New Zealand.

Our study sought to understand adult decision-makers' views on what was important for actualising children's ideas using co-design, towards creating health-promoting local environments. Ten adult decision-makers, experienced in co-design with children aged 5-13 years in Aotearoa New Zealand, participated in individual interviews. We generated three themes (Empowering children within co-design; Being intentional about children's influence; Curating who is involved) using reflexive thematic analysis. Our themes informed a novel framework of 'impactful co-design' accompanied by a practical checklist for adult decision-makers (practitioners, policy-makers, and researchers). Study findings affirm co-designing local neighbourhoods as an inherently social and technical endeavour, advocate for greater consideration of inclusivity and cultural context, and highlight the need for co-design with children to include safety, empowerment, and evaluation. We position impactful co-design as one useful process to enact children's meaningful participation.

The process of ratifying the treaty to establish the African Medicines Agency: perspectives of national regulatory agencies.

The vision of the African Medicines Agency (AMA) is to ensure that all Africans have access to affordable medical products that meet internationally recognized standards of quality, safety and efficacy for priority diseases/conditions. The AMA is being established by a treaty which had to be ratified by a minimum of 15 African countries. Although there was no deadline, the ratification process has been slower than expected. This study therefore analysed the rationale, perceived benefits, enabling factors and challenges of the AMA's establishment. This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of 45 African countries. The Heads of NRAs and a senior NRA staff member were contacted to complete self-administered questionnaires. The existence of mature NRAs, the desire to have harmonized regulatory systems, the presence of strong political will and appropriate advocacy to expedite treaty signing are all enabling factors for AMA treaty signing. The challenges reported include the fact that the process is slow and there is limited understanding of the process. Competing national priorities, changes in office bearers in the public system and stagnation of the process at the ministerial level were also challenges reported. This study has improved the understanding of the treaty signing and ratification process and the perceived benefits and enabling factors of signing and ratification from African NRAs' perspective. NRAs also highlighted challenges encountered in the process. Addressing these challenges will result in effective medicines regulation by galvanizing technical support, regulatory expertise and resources at a continental level.

Towards integrated mental health services in low-income and middle-income countries: organisation of primary healthcare providers - a scoping review protocol.

INTRODUCTION: Mental health conditions constitute a significant percentage of the global burden of disease. A shortfall of mental health specialists and a lack of integration of services in primary care in low-income and middle-income countries (LMICs) contribute towards a mental health treatment gap in excess of 70%. Organising and equipping non-specialist healthcare workers is, therefore, an important strategy for improving access to mental health services in LMICs. This scoping review aims to map literature that addresses the organisation of and support provided to health teams in primary care settings within the context of integrated mental healthcare and as it relates to detection, treatment and referral of mental health conditions. The review will be guided by the 'Innovative Care for Chronic Conditions' framework. METHODS AND ANALYSIS: This review protocol will employ the methodological framework first developed by Arksey and O'Malley and later advanced by others and will follow the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews guidelines. This process will entail identifying the research questions, locating relevant literature, choosing eligible reports and studies, extracting the data and summarising the results in English-language studies and reports from 2008 to 2023 will be sourced from PubMed, CINAHL, Cochrane Library, PsycARTICLES, Scopus, Web of Science, Academic Search Complete and the WHO website. A two-stage screening of titles and abstracts, followed by full-text literature will be done in duplicate with blinded authors. Data extraction will be based on predefined fields. ETHICS AND DISSEMINATION: All literature accessed for this scoping review is in the public domain and thus, no approval from an ethics review board is required. The findings of the scoping review report will inform future mental health research in LMIC and will be disseminated to relevant stakeholders and published in a peer-reviewed journal.

Perspectives of adult offspring of participants recruited to a randomised trial in pregnancy: a qualitative study.

BACKGROUND: Routinely assessed outcomes in paediatric health studies may not reflect families' priorities. Increasing our understanding of childhood experiences of research participation may contribute to improving the quality of consent and better align study aims with the concerns of relevant communities. OBJECTIVE: To explore young adults' views on their participation in medical research during their childhood, specifically around the acceptability of consent and their priorities regarding health, development and well-being as potential trial outcomes. METHODS: A qualitative descriptive 20-year follow-up study of a medical trial which aimed to improve outcomes after preterm birth. Semistructured dialogue transcripts were analysed using inductive thematic analysis. SETTING AND PARTICIPANTS: Seventeen young adults whose parents consented to their participation in a clinical trial when they were fetuses, and in follow-up studies as preschoolers and school-age children. RESULTS: Overall, participants expressed comfort with their parents consenting to medical research on their behalf. However, autonomous child assent may not be attainable due to children's susceptibility to suggestions. Participants generally expressed satisfaction with the outcomes investigated in the follow-up studies, although some suggested other outcomes of interest such as mental health and learning disabilities. CONCLUSIONS: Current consent procedures were deemed acceptable as parents hold responsibility for making decisions on behalf of their children, and their commitment to their child's well-being ensures that they make appropriate choices. The outcomes assessed in this trial and health and developmental outcomes in the follow-up assessments aligned well with outcomes of interest to the young adult participants.

High prevalence of undiagnosed obstructive sleep apnoea in the general population and methods for screening for representative controls.

PURPOSE: Undiagnosed obstructive sleep apnoea (OSA) in the community makes comparisons of OSA subjects with control samples from the general population problematic. This study aims to estimate undiagnosed moderate to severe OSA in a general population sample and to determine the capacity of questions from the Berlin questionnaire (BQ) to identify subjects without diagnosed OSA of this severity. METHODS: Using a general population sample (n = 793) with no history of OSA, case and control status for moderate-severe OSA was determined by home-based nasal flow and oximetry-derived apnoea-hypopnoea index using a cut-off value of ≥ 15 events/h to define cases. The diagnostic accuracy of the complete BQ and its component questions in identifying cases was assessed by calculating sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios and post-test probabilities. RESULTS: The age-standardised prevalence estimate of moderate-severe OSA was 9.1 % (12.4 % in men, 5.7 % in women). Sensitivity of the BQ in this population was 54 %, and specificity, 70 %. A combination of questions regarding snoring frequency and hypertension provided maximal post-test probability of OSA and greatest post-screen sample size. CONCLUSIONS: Undiagnosed OSA is highly prevalent in the Western Australian general population. While the complete BQ is a sub-optimal screening instrument for the general population, snoring frequency or hypertension can be used to screen out moderate-severe OSA from general population samples with limited reduction in sample size. As there are few general population samples available for epidemiological or genetic studies of OSA and its associated phenotypes, these results may usefully inform future case-control studies.

The domestication of the African Union model law on medical products regulation: Perceived benefits, enabling factors, and challenges.

Introduction: In 2016, the African Union (AU) Model Law on Medical Products Regulation was endorsed by AU Heads of State and Government. The aims of the legislation include harmonisation of regulatory systems, increasing collaboration across countries, and providing a conducive regulatory environment for medical product/health technology development and scale-up. A target was set to have at least 25 African countries domesticating the model law by 2020. However, this target has not yet been met. This research aimed to apply the Consolidated Framework for Implementation Research (CFIR) in analysing the rationale, perceived benefits, enabling factors, and challenges of AU Model Law domestication and implementation by AU Member States. Methods: This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of Anglophone and Francophone AU Member States. The heads of NRAs and a senior competent person were contacted to complete self-administered questionnaires. Results: The perceived benefits of model law implementation include enabling the establishment of an NRA, improving NRA governance and decision-making autonomy, strengthening the institutional framework, having streamlined activities which attract support from donors, as well as enabling harmonisation, reliance, and mutual recognition mechanisms. The factors enabling domestication and implementation are the presence of political will, leadership, and advocates, facilitators, or champions for the cause. Additionally, participation in regulatory harmonisation initiatives and the desire to have legal provisions at the national level that allow for regional harmonisation and international collaboration are enabling factors. The challenges encountered in the process of domesticating and implementing the model law are the lack of human and financial resources, competing priorities at the national level, overlapping roles of government institutions, and the process of amending/repealing laws being slow and lengthy. Conclusion: This study has enabled an improved understanding of the AU Model Law process, the perceived benefits of its domestication, and the enabling factors for its adoption from the perspective of African NRAs. NRAs have also highlighted the challenges encountered in the process. Addressing these challenges will result in a harmonised legal environment for medicines regulation in Africa and be an important enabler for the effective operation of the African Medicines Agency.

Does OSA Increase Risk for Cancer?: A Large Historical Sleep Clinic Cohort Study.

BACKGROUND: The relationship between OSA and cancer is unclear. RESEARCH QUESTION: What is the association between OSA and cancer prevalence and incidence in a large Western Australian sleep clinic cohort (N = 20,289)? STUDY DESIGN AND METHODS: OSA severity was defined by apnea-hypopnea index (AHI) and nocturnal hypoxemia (duration and percentage at oxygen saturation < 90%) measured by in-laboratory polysomnogram. Measures of potential confounding included age, sex, BMI, smoking status, socioeconomic status, and BP. Outcomes were determined from the Western Australian cancer and death registries. Analyses were confined within periods using consistent AHI scoring criteria: January 1, 1989, to July 31, 2002 (American Sleep Disorders Association criteria), and August 1, 2002, to June 30, 2013 (Chicago criteria). We examined associations of AHI and nocturnal hypoxemia with cancer prevalence using logistic regression and cancer incidence using Cox regression analyses. RESULTS: Cancer prevalence at baseline was 329 of 10,561 in the American Sleep Disorders Association period and 633 of 9,728 in the Chicago period. Nocturnal hypoxemia but not AHI was independently associated with prevalent cancer following adjustment for participant age, sex, BMI, smoking status, socioeconomic status, and BP. Of those without prevalent cancer, cancer was diagnosed in 1,950 of 10,232 (American Sleep Disorders Association) and 623 of 9,095 (Chicago) participants over a median follow-up of 11.2 years. Compared with the reference category (no OSA, AHI < 5 events per hour), univariable models estimated higher hazard ratios for cancer incidence for mild (AHI 5-15 events per hour), moderate (AHI 15.1-30 events per hour), and severe (AHI > 30 events per hour) OSA. Multivariable analyses consistently revealed associations between age and, in some cases, sex, BMI, and smoking status, with cancer incidence. After adjusting for confounders, multivariable models showed no independent association between OSA severity and increased cancer incidence. INTERPRETATION: Nocturnal hypoxemia is independently associated with prevalent cancer. OSA severity is associated with incident cancer, although this association seems secondary to other risk factors for cancer development. OSA is not an independent risk factor for cancer incidence.