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Ayer — Mayo 14th 2024BMJ Open

Tobacco policies and changes in the tendency of smoking cessation in cigarette users in Chile: a longitudinal cross-sectional study

Objective

To assess the impact of tobacco control regulations and policy implementation on smoking cessation tendencies in cigarette users born between 1982 and 1991 in Chile.

Design

Longitudinal cross-sectional study.

Setting

National level.

Participants

Data from the National Survey of Drug Consumption (Service of Prevention and Rehabilitation for Drug and Alcohol Consumption). A pseudo-cohort of smokers born between 1982 and 1991 (N=17 905) was tracked from 2002 to 2016.

Primary and secondary outcomes measures

Primary outcome was the tendency to cease smoking conceptualised as the report of using cigarettes 1 month or more ago relative to using cigarettes in the last 30 days. The main exposure variable was the Tobacco Policy Index—tracking tobacco policy changes over time. Logistic regression, controlling for various factors, was applied.

Results

Models suggested a 14% increase in the smoking cessation tendency of individuals using cigarettes 1 month or more ago relative to those using cigarettes in the last 30 days (OR 1.14, CI 95% CI 1.10 to 1.19) for each point increment in the Tobacco Policy index.

Conclusions

Our study contributes to documenting a positive impact of the implementation of interventions considered in the MPOWER strategy in the progression of smoking cessation tendencies in smokers born between 1982 and 1991 in Chile.

Medical researchers perceptions regarding research evaluation: a web-based survey in Japan

Por: Minoura · A. · Shimada · Y. · Kuwahara · K. · Kondo · M. · Fukushima · H. · Sugiyama · T.
Objectives

Japanese medical academia continues to depend on quantitative indicators, contrary to the general trend in research evaluation. To understand this situation better and facilitate discussion, this study aimed to examine how Japanese medical researchers perceive quantitative indicators and qualitative factors of research evaluation and their differences by the researchers’ characteristics.

Design

We employed a web-based cross-sectional survey and distributed the self-administered questionnaire to academic society members via the Japanese Association of Medical Sciences.

Participants

We received 3139 valid responses representing Japanese medical researchers in any medical research field (basic, clinical and social medicine).

Outcomes

The subjective importance of quantitative indicators and qualitative factors in evaluating researchers (eg, the journal impact factor (IF) or the originality of the research topic) was assessed on a four-point scale, with 1 indicating ‘especially important’ and 4 indicating ‘not important’. The attitude towards various opinions in quantitative and qualitative research evaluation (eg, the possibility of research misconduct or susceptibility to unconscious bias) was also evaluated on a four-point scale, ranging from 1, ‘strongly agree’, to 4, ‘completely disagree’.

Results

Notably, 67.4% of the medical researchers, particularly men, younger and basic medicine researchers, responded that the journal IF was important in researcher evaluation. Most researchers (88.8%) agreed that some important studies do not get properly evaluated in research evaluation using quantitative indicators. The respondents perceived quantitative indicators as possibly leading to misconduct, especially in basic medicine (strongly agree—basic, 22.7%; clinical, 11.7%; and social, 16.1%). According to the research fields, researchers consider different qualitative factors, such as the originality of the research topic (especially important—basic, 46.2%; social, 39.1%; and clinical, 32.0%) and the contribution to solving clinical and social problems (especially important—basic, 30.4%; clinical, 41.0%; and social, 52.0%), as important. Older researchers tended to believe that qualitative research evaluation was unaffected by unconscious bias.

Conclusion

Despite recommendations from the Declaration on Research Assessment and the Leiden Manifesto to de-emphasise quantitative indicators, this study found that Japanese medical researchers have actually tended to prioritise the journal IF and other quantitative indicators based on English-language publications in their research evaluation. Therefore, constantly reviewing the research evaluation methods while respecting the viewpoints of researchers from different research fields, generations and genders is crucial.

Contextually appropriate nurse staffing models: a realist review protocol

Introduction

Decisions about nurse staffing models are a concern for health systems globally due to workforce retention and well-being challenges. Nurse staffing models range from all Registered Nurse workforce to a mix of differentially educated nurses and aides (regulated and unregulated), such as Licensed Practical or Vocational Nurses and Health Care Aides. Systematic reviews have examined relationships between specific nurse staffing models and client, staff and health system outcomes (eg, mortality, adverse events, retention, healthcare costs), with inconclusive or contradictory results. No evidence has been synthesised and consolidated on how, why and under what contexts certain staffing models produce different outcomes. We aim to describe how we will (1) conduct a realist review to determine how nurse staffing models produce different client, staff and health system outcomes, in which contexts and through what mechanisms and (2) coproduce recommendations with decision-makers to guide future research and implementation of nurse staffing models.

Methods and analysis

Using an integrated knowledge translation approach with researchers and decision-makers as partners, we are conducting a three-phase realist review. In this protocol, we report on the final two phases of this realist review. We will use Citation tracking, tracing Lead authors, identifying Unpublished materials, Google Scholar searching, Theory tracking, ancestry searching for Early examples, and follow-up of Related projects (CLUSTER) searching, specifically designed for realist searches as the review progresses. We will search empirical evidence to test identified programme theories and engage stakeholders to contextualise findings, finalise programme theories document our search processes as per established realist review methods.

Ethics and dissemination

Ethical approval for this study was provided by the Health Research Ethics Board of the University of Alberta (Study ID Pro00100425). We will disseminate the findings through peer-reviewed publications, national and international conference presentations, regional briefing sessions, webinars and lay summary.

Effects of physiotherapy and home-based training in parkinsonian syndromes: protocol for a randomised controlled trial (MobilityAPP)

Por: Raccagni · C. · Sidoroff · V. · Paraschiv-Ionescu · A. · Roth · N. · Schönherr · G. · Eskofier · B. · Gassner · H. · Kluge · F. · Teatini · F. · Seppi · K. · Goebel · G. · Benninger · D. H. · Aminian · K. · Klucken · J. · Wenning · G.
Introduction

Gait and mobility impairment are pivotal signs of parkinsonism, and they are particularly severe in atypical parkinsonian disorders including multiple system atrophy (MSA) and progressive supranuclear palsy (PSP). A pilot study demonstrated a significant improvement of gait in patients with MSA of parkinsonian type (MSA-P) after physiotherapy and matching home-based exercise, as reflected by sensor-based gait parameters. In this study, we aim to investigate whether a gait-focused physiotherapy (GPT) and matching home-based exercise lead to a greater improvement of gait performance compared with a standard physiotherapy/home-based exercise programme (standard physiotherapy, SPT).

Methods and analysis

This protocol was deployed to evaluate the effects of a GPT versus an active control undergoing SPT and matching home-based exercise with regard to laboratory gait parameters, physical activity measures and clinical scales in patients with Parkinson’s disease (PD), MSA-P and PSP. The primary outcomes of the trial are sensor-based laboratory gait parameters, while the secondary outcome measures comprise real-world derived parameters, clinical rating scales and patient questionnaires. We aim to enrol 48 patients per disease group into this double-blind, randomised-controlled trial. The study starts with a 1 week wearable sensor-based monitoring of physical activity. After randomisation, patients undergo a 2 week daily inpatient physiotherapy, followed by 5 week matching unsupervised home-based training. A 1 week physical activity monitoring is repeated during the last week of intervention.

Ethics and dissemination

This study, registered as ‘Mobility in Atypical Parkinsonism: a Trial of Physiotherapy (Mobility_APP)’ at clinicaltrials.gov (NCT04608604), received ethics approval by local committees of the involved centres. The patient’s recruitment takes place at the Movement Disorders Units of Innsbruck (Austria), Erlangen (Germany), Lausanne (Switzerland), Luxembourg (Luxembourg) and Bolzano (Italy). The data resulting from this project will be submitted to peer-reviewed journals, presented at international congresses and made publicly available at the end of the trial.

Trial registration number

NCT04608604.

Status of the midwifery workforce and childbirth services and the impact of midwife staffing on birth outcomes in China: a multicentre cross-sectional study

Por: Zhu · W. · Zhu · C. · Min · H. · Li · L. · Wang · X. · Wu · J. · Zhu · X. · Gu · C.
Objective

To investigate the status of the midwifery workforce and childbirth services in China and to identify the association between midwife staffing and childbirth outcomes.

Design

A descriptive, multicentre cross-sectional survey.

Setting

Maternity hospitals from the eastern, central and western regions of China.

Participants

Stratified sampling of maternity hospitals between 1 July and 31 December 2021.

The sample hospitals received a package of questionnaires, and the head midwives from the participating hospitals were invited to fill in the questionnaires.

Results

A total of 180 hospitals were selected and investigated, staffed with 4159 midwives, 412 obstetric nurses and 1007 obstetricians at the labour and delivery units. The average efficiency index of annual midwifery services was 272 deliveries per midwife. In the sample hospitals, 44.9% of women had a caesarean delivery and 21.4% had an episiotomy. Improved midwife staffing was associated with reduced rates of instrumental vaginal delivery (adjusted β –0.032, 95% CI –0.115 to –0.012, p

Conclusion

The rates of childbirth interventions including the overall caesarean section in China and the episiotomy rate, especially in the central region, remain relatively high. Improved midwife staffing was associated with reduced rates of instrumental vaginal delivery and episiotomy, indicating that further investments in the midwifery workforce could produce better childbirth outcomes.

Implementation of a primary-tertiary shared care model to improve the detection of familial hypercholesterolaemia (FH): a mixed methods pre-post implementation study protocol

Por: Birkenhead · K. · Sullivan · D. · Trumble · C. · Spinks · C. · Srinivasan · S. · Partington · A. · Elias · L. · Hespe · C. M. · Fleming · G. · Li · S. · Calder · M. · Robertson · E. · Trent · R. · Sarkies · M. N.
Introduction

Familial hypercholesterolaemia (FH) is an autosomal dominant inherited disorder of lipid metabolism and a preventable cause of premature cardiovascular disease. Current detection rates for this highly treatable condition are low. Early detection and management of FH can significantly reduce cardiac morbidity and mortality. This study aims to implement a primary-tertiary shared care model to improve detection rates for FH. The primary objective is to evaluate the implementation of a shared care model and support package for genetic testing of FH. This protocol describes the design and methods used to evaluate the implementation of the shared care model and support package to improve the detection of FH.

Methods and analysis

This mixed methods pre-post implementation study design will be used to evaluate increased detection rates for FH in the tertiary and primary care setting. The primary-tertiary shared care model will be implemented at NSW Health Pathology and Sydney Local Health District in NSW, Australia, over a 12-month period. Implementation of the shared care model will be evaluated using a modification of the implementation outcome taxonomy and will focus on the acceptability, evidence of delivery, appropriateness, feasibility, fidelity, implementation cost and timely initiation of the intervention. Quantitative pre-post and qualitative semistructured interview data will be collected. It is anticipated that data relating to at least 62 index patients will be collected over this period and a similar number obtained for the historical group for the quantitative data. We anticipate conducting approximately 20 interviews for the qualitative data.

Ethics and dissemination

Ethical approval has been granted by the ethics review committee (Royal Prince Alfred Hospital Zone) of the Sydney Local Health District (Protocol ID: X23-0239). Findings will be disseminated through peer-reviewed publications, conference presentations and an end-of-study research report to stakeholders.

AnteayerBMJ Open

Codesigned online cognitive bias modification of interpretations for anxiety and depression in children: study protocol of a randomised controlled trial

Por: Sicouri · G. · Daniel · E. · Salemink · E. · Mackinnon · A. · Allsop · A. · Hudson · J.
Introduction

Previous research has shown that cognitive bias modification of interpretations (CBM-I) may be a promising intervention for anxiety in youth; however, results are mixed. Given the high comorbidity between anxiety and depression in youth, it is surprising that no child studies have targeted biases associated with both. This study aims to evaluate the effectiveness and acceptability of an online CBM-I intervention (Mindmaster) for children with symptom scores of anxiety or depression above a borderline or clinical threshold. The intervention has been codesigned with children, parents and mental health professionals to promote user engagement.

Methods and analysis

The study is a randomised controlled trial, with two parallel arms. Participants are 143 children aged 8–10 years with scores of anxiety and/or depressive symptoms above a borderline or clinical threshold. They will be allocated to either the intervention group or the waitlist control group. The intervention consists of 2 weeks of online CBM-I training, with four sessions (10–15 min) per week. Outcome assessments will be conducted at baseline, 4 weeks after baseline (post-training/post-waitlist) and 8 weeks after baseline (follow-up) for the intervention group only. The primary outcome is interpretation bias. Secondary outcomes are anxiety and depressive symptoms and life interference. Analyses will be conducted within an intention-to-treat framework using mixed models for repeated measures.

Ethics and dissemination

The study was approved by the University of New South Wales Human Research Ethics Committee (HC220758). Findings will be reported to (1) participating families; (2) presented at scientific conferences and (3) disseminated to peer-review publications. Data will be available from the corresponding author on request.

Trial registration number

ACTRN12622001493730.

Information needs on type 1 diabetes mellitus (T1DM) and its management in children and adolescents: a qualitative study

Por: Muhammed Elamin · S. · Muhamad Arshad · N. F. · Md Redzuan · A. · Abdul Aziz · S. A. · Hong · J. · Chua · X. Y. · Bin-Abbas · B. S. · Alsagheir · A. · Mohamed Shah · N.
Objective

The objective of this study is to explore the information needs related to insulin therapy in children and adolescents with type 1 diabetes mellitus (T1DM) from the children’s perspectives as well as their caregivers.

Design

Qualitative study; semistructured interviews. To identify emerging themes relating to information needs, open coding and thematic analysis were employed.

Setting

Participants were recruited from a tertiary care children’s hospital in Kuala Lumpur, Malaysia and a specialist hospital in Riyadh, Saudi Arabia.

Participants

Thirty one children with a mean age of 11.5 years (SD=1.9) and their caregivers were interviewed. Seventeen participants were from Malaysia and 14 were from Saudi Arabia.

Results

Four themes of information emerged from the interviews, including information related to (1) hypoglycaemia and hyperglycaemia, (2) insulin therapy, (3) injection technique and (4) other information needs pertaining to continuous glucose monitoring, access to peer groups and future advances in insulin therapy.

Conclusion

This study provided valuable insights into the information needs related to T1DM and insulin therapy among children and adolescents with T1DM that should be considered by stakeholders in the development of age-appropriate education materials. Such materials will assist children and adolescents to better manage their life-long T1DM condition from adolescence until adulthood.

Operational priorities for engaging with Indias private healthcare sector for the control of tuberculosis: a modelling study

Por: Ricks · S. · Singh · A. · Sodhi · R. · Pal · A. · Arinaminpathy · N.
Objectives

To estimate the potential impact of expanding services offered by the Joint Effort for Elimination of Tuberculosis (JEET), the largest private sector engagement initiative for tuberculosis (TB) in India.

Design

We developed a mathematical model of TB transmission dynamics, coupled with a cost model.

Setting

Ahmedabad and New Delhi, two cities with contrasting levels of JEET coverage.

Participants

Estimated patients with TB in Ahmedabad and New Delhi.

Interventions

We investigated the epidemiological impact of expanding three different public–private support agency (PPSA) services: provider recruitment, uptake of cartridge-based nucleic acid amplification tests and uptake of adherence support mechanisms (specifically government supplied fixed-dose combination drugs), all compared with a continuation of current TB services.

Results

Our results suggest that in Delhi, increasing the use of adherence support mechanisms among private providers should be prioritised, having the lowest incremental cost-per-case-averted between 2020 and 2035 of US$170 000 (US$110 000–US$310 000). Likewise in Ahmedabad, increasing provider recruitment should be prioritised, having the lowest incremental cost-per-case averted of US$18 000 (US$12 000–US$29 000).

Conclusion

Results illustrate how intervention priorities may vary in different settings across India, depending on local conditions, and the existing degree of uptake of PPSA services. Modelling can be a useful tool for identifying these priorities for any given setting.

Exploring young peoples attitudes to HIV prevention medication (PrEP) in England: a qualitative study

Por: Rathbone · A. · Cartwright · N. · Cummings · L. · Noble · R. · Budaiova · K. · Ashton · M. · Foster · J. · Payne · B. · Duncan · S.
Introduction

Young people aged 18–24 years old are a key demographic target for eliminating HIV transmission globally. Pre-exposure prophylaxis (PrEP), a prevention medication, reduces HIV transmission. Despite good uptake by gay and bisexual men who have sex with men, hesitancy to use PrEP has been observed in other groups, such as young people and people from ethnic minority backgrounds. The aim of this study was to explore young people’s perceptions and attitudes to using PrEP.

Design

A qualitative transcendental phenomenological design was used.

Participants and setting

A convenience sample of 24 young people aged between 18 and 24 years was recruited from England.

Methods

Semistructured interviews and graphical elicitation were used to collect data including questions about current experiences of HIV care, awareness of using PrEP and decision-making about accessing PrEP. Thematic and visual analyses were used to identify findings.

Results

Young people had good levels of knowledge about HIV but poor understanding of using PrEP. In this information vacuum, negative stigma and stereotypes about HIV and homosexuality were transferred to using PrEP, which were reinforced by cultural norms portrayed on social media, television and film—such as an association between using PrEP and being a promiscuous, white, gay male. In addition, young people from ethnic minority communities appeared to have negative attitudes to PrEP use, compared with ethnic majority counterparts. This meant these young people in our study were unable to make decisions about when and how to use PrEP.

Conclusion

Findings indicate an information vacuum for young people regarding PrEP. A strength of the study is that theoretical data saturation was reached. A limitation of the study is participants were largely from Northern England, which has low prevalence of HIV. Further work is required to explore the information needs of young people in relation to PrEP.

Effectiveness of a community-based multicomponent lifestyle intervention (the ADA programme) to improve the quality of life of French breast cancer survivors: protocol for a pragmatic cluster randomised trial and embedded qualitative study

Por: El-Khoury · F. · Mino · J.-C. · Deschamps · N. · Lopez · C. · Menvielle · G. · Dargent-Molina · P.
Introduction

Breast cancer survivors (BCSs) are often faced with multiple mental and physical sequelae and are at increased risk of emotional distress, degraded health-related quality of life (HRQoL), chronic pain and fatigue.

Physical activity is strongly associated with improved HRQoL and survival rates; however, adherence rates to recommendations for a healthy lifestyle are seldom satisfactory among BCSs. Also, few studies have examined the effectiveness of multicomponent and personalised interventions that integrate physical activity and motivational techniques to improve the HRQoL of BCS.

Method and analysis

"Activité physique adaptée Doublée d’un Accompagnement d’après cancer" (ADA) is an integrated programme of physical activity enriched with a dietary and supportive care approach targeting BCS in the early post-treatment phase. The effectiveness of the ADA intervention will be evaluated using a cluster randomised controlled trial design with two arms (ADA programme vs usual care; 1:1 ratio).

The ADA intervention aims to recruit 160 participants and will be implemented by Siel Bleu, a non-profit association specialised in health prevention via adapted physical activity. Measurements will be performed at baseline, 3, 6 and 12 months after the start of the intervention. The primary outcome will be participants’ HRQoL, at 12 months measured by the Functional Assessment of Chronic Illness Therapy-Fatigue global score. Secondary outcome will include participants’ physical, social, emotional and functional well-being. The effect of the intervention on physical activity level, motivation for physical activity, relation to food and self-efficacy will also be evaluated.

Ethics and dissemination

The study was approved by the ‘CPP Paris XI’ Institutional Review Board on 5 May 2022 (Ref no.: 21.04512.000048-22004). The study’s findings will be shared through various channels, including academic publications, simplified reports for wider audiences and active engagement with medical and institutional organisations as well as patients’ associations.

Trial registration number

NCT05658341.

What do spouse primary caregivers of patients with glioblastoma want medical providers to know? A qualitative thematic reflexive analysis of letters written by primary caregivers from a secret Facebook support group

Por: Coman · D. L. · Chard · M. P. · Desautels · L. · Lutz · B. J. · Minns · L. A.
Objectives

To analyse the content of letters written by female spouse primary caregivers of patients with glioblastoma multiforme (GBM), a devastating and terminal primary brain cancer, and give voice to their experiences for medical providers of patients with GBM.

Design

A qualitative study using reflexive thematic analysis of letters written by female spouses/life partners and primary caregivers of patients with GBM.

Participants

101 current or former female spouse primary caregivers of patients with GBM wrote letters to share with the medical community between July 2019 and August 2019. Inclusion criteria: (1) the primary caregiver who is a spouse of a patient with glioblastoma, (2) be a member of the secret Facebook group, ‘We are the wives of GBM and this is our story’, and (3) completed informed consent for the contents of their letter to be included for primary and secondary data analysis. Participants who wrote letters but did not complete the informed consent were excluded from the study.

Results

Themes from the letters included the patient experiences: (1) medical details of the disease trajectory, (2) interactions of the patient/caregiver dyads with healthcare and (3) the changing patient condition over time. Themes focused on the caregiver experiences: (1) caregiver challenges, (2) caregiver responses and (3) caregiver coping strategies, and description of tangible needs that would help other caregivers in the future. Caregiver needs were highest during the living with disease progression phase. Caregivers wanted more education and to be valued as members of the care team.

Conclusion

Shared decision-making through family-centred care would be beneficial for primary caregivers of patients with GBM. These findings provide opportunities to guide more timely and tailored interventions to provide support and improve care for patient/caregiver dyads to help mitigate the burden of this progressive disease and improve quality of life for caregivers.

Good while it lasted? Estimating the long-term and withdrawal effects of results-based financing in Malawi on maternal care utilisation using routine data

Por: Dasgupta · T. · De Allegri · M. · Brenner · S. · Kaminjolo-Kambala · C. · Lohmann · J.
Objectives

This study aimed to evaluate the effect of introduction and subsequent withdrawal of the Results-based Financing for Maternal and Newborn Health Initiative (RBF4MNH) in Malawi on utilisation of facility-based childbirths, antenatal care (ANC) and postnatal care (PNC).

Design

A controlled interrupted time series design was used with secondary data from the Malawian Health Management Information System.

Setting

Healthcare facilities at all levels identified as providing maternity services in four intervention districts and 20 non-intervention districts in Malawi.

Participants

Routinely collected, secondary data of total monthly service utilisation of facility-based childbirths, ANC and PNC services.

Interventions

The intervention is the RBF4MNH initiative, introduced by the Malawian government in 2013 to improve maternal and infant health outcomes and withdrawn in 2018 after ceasing of donor funding.

Outcome measures

Differences in total volume and trends of utilisation of facility-based childbirths, ANC and PNC services, compared between intervention versus non-intervention districts, for the study period of 90 consecutive months.

Results

No significant effect was observed, on utilisation trends for any of the three services during the first 2.5 years of intervention. In the following 2.5 years after full implementation, we observed a small positive increase for facility-based childbirths (+0.62 childbirths/month/facility) and decrease for PNC (–0.55 consultations/month/facility) trends of utilisation respectively. After withdrawal, facility-based childbirths and ANC consultations dropped both in immediate volume after removal (–10.84 childbirths/facility and –20.66 consultations/facility, respectively), and in trends of utilisation over time (–0.27 childbirths/month/facility and -1.38 consultations/month/facility, respectively). PNC utilisation levels seemed unaffected in intervention districts against a decline in the rest of the country.

Conclusions

Concurrent with wider literature, our results suggest that effects of complex health financing interventions, such as RBF4MNH, can take a long time to be seen. They might not be sustained beyond the implementation period if measures are not adopted to reform existing health financing structures.

Comparative efficacy and safety of different anti-VEGF agents combined with different delivery methods for neovascular glaucoma: a systematic review and Bayesian network meta-analysis

Por: Wang · J. · Guo · Y.-M. · Wei · J. · Min · J. · Ye · L.
Objective

To compare the efficacy and safety of different anti-vascular endothelial growth factor (VEGF) agents combined with different delivery methods for neovascular glaucoma (NVG).

Design

Systematic review and Bayesian network meta-analysis (NMA).

Data sources

PubMed, Embase, Cochrane Library, Web of Science, ClinicalTrials.gov, ISRCTN and Chinese databases including the China National Knowledge Infrastructure, China Science Periodical Database (Wanfang Database), VIP Journal Integration Platform and China Biology Medicine Database were searched from inception to 5 September 2022.

Eligibility criteria

We included randomised controlled trials (RCTs) that investigated the treatment of NVG using different anti-VEGF agents combined with various methods of drug administration, without any language limitations. All patients included underwent panretinal laser photocoagulation and there were no restrictions on prior glaucoma surgery.

Data extraction and synthesis

Two independent reviewers extracted data and assessed the risk of bias. Random-effect Bayesian NMA was conducted to compare the efficacy and safety and rank priority of anti-VEGF regimens. The source of heterogeneity and the related factors affecting the stability of the results were also explored. CINeMA (Confidence in Network Meta-Analysis) was used to assess the certainty of evidence.

Results

Our analysis included 17 RCTs involving a total of 1311 eyes from 1228 patients. We examined five different treatment regimens, which used three different anti-VEGF drugs. The following treatments showed a significant decrease in intraocular pressure (IOP) compared with the control group at 1 month after glaucoma surgery: simultaneous intravitreal and intracameral injection of conbercept (ICCIVC) (mean difference (MD)=–11.56, 95% credible interval (CrI) –20.8 to –2.24), intravitreal injection of conbercept (MD=–8.88, 95% CrI –13.93 to –3.78), intravitreal injection of ranibizumab (MD=–7.62, 95% CrI –10.91 to –4.33) and intravitreal injection of bevacizumab IVB) (MD=–5.51, 95% CrI –10.79 to –0.35). The surface under the cumulative ranking curve (SUCRA) analysis indicated that ICCIVC (82.0%) may be the most effective regimen in reducing IOP. In terms of safety, there were no statistically significant differences among the interventions. According to the SUCRA analysis, ICCIVC (68.0%) was considered the safest choice with the fewest complications. Subgroup and meta-regression analyses showed that mean age was the main source of heterogeneity. Sensitivity analysis demonstrated the robustness of the study results.

Conclusion

ICCIVC was more effective and safer than other anti-VEGF regimens for NVG. Simultaneous intravitreal and intracameral injection was found to be the best route of administration, and conbercept was found to be the superior drug selection when compared with ranibizumab and bevacizumab.

PROSPERO registration number

CRD42022309676.

VersKiK qualitative study design: actual follow-up needs of paediatric cancer survivors, their informal caregivers and follow-up stakeholder perceptions in Germany

Por: Aleshchenko · E. · Swart · E. · Voigt · M. · Langer · T. · Calaminus · G. · Glogner · J. · Baust · K.
Introduction

This article presents the study design of the qualitative part of the VersKiK study (Long-term care, care needs and wellbeing of individuals after cancer in childhood or adolescence: study protocol of a large scale multi-methods non-interventional study) aiming to explore actual follow-up needs of childhood and adolescence cancer survivors and their informal caregivers, gaps in current follow-up care provision and trajectories of cancer survivors’ transition from paediatric to adult healthcare.

Methods and analysis

We will conduct up to 30 interviews with survivors of childhood and adolescence cancer and their informal caregivers with up to 20 participant observations of follow-up appointments. The results of these will be discussed in up to four focus groups with healthcare professionals and representatives of self-help groups. The study design aims to evaluate follow-up care after childhood cancer considering perspectives from survivors, their informal caregivers as well as healthcare providers. The combination of different data sources will allow us to get an in-depth understanding of the current state of follow-up care after paediatric cancer in Germany and to suggest recommendations for care improvement.

Ethics and dissemination

The VersKiK study was approved by the Ethics Committee Otto von Guericke University on 2 July 2021 (103/21), by the Ethics Committee of Johannes Gutenberg University Mainz on 16 June 2021 (2021-16035), by the Ethics Committee University of Lübeck on 10 November 2021 (21-451), by the Ethics Committee University of Hospital Bonn on 28 February 2022 (05/22). For each part of the qualitative study, a separate written informed consent is prepared and approved accordingly by the ethics committees named above.

Trial registration number

Registered at German Clinical Trial Register, ID: DRKS00026092.

Cohort profile: the National Congenital Anomaly Registration Dataset in England

Por: Broughan · J. M. · Wreyford · B. · Martin · D. · Melis · G. · Randall · K. · Obaro · E. · Broggio · J. · Aldridge · N. · Stoianova · S. · Johnson · C. · Gibbard · D. · Stevens · S. · Fleming · K. M.
Purpose

The National Congenital Anomaly and Rare Disease Registration Service (NCARDRS), part of National Disease Registration Service in National Health Service England, quality assures, curates and analyses individual data on the pregnancies, fetuses, babies, children and adults with congenital anomalies and rare diseases across England. The congenital anomaly (CA) register provides a resource for patients and their families, clinicians, researchers and public health professionals in furthering the understanding of CAs.

Participants

NCARDRS registers CAs occurring in babies born alive and stillborn, fetal losses and terminations in England. NCARDRS collects data from secondary and tertiary healthcare providers, private providers and laboratories covering fetal medicine, maternity or paediatric services. Data describe the pregnancy, mother, baby and anomaly. Established in 2015, NCARDRS expanded CA registration coverage from 22% of total births in England in 2015 to national coverage, which was achieved in 2018. Prior to 2015, data collection was performed independently by regional registers in England; these data are also held by NCARDRS.

Findings to date

NCARDRS registers approximately 21 000 babies with CAs per year with surveillance covering around 600 000 total births, the largest birth coverage for a CA register globally. Data on prevalence, risk factors and survival for children with CAs are available. Data have been used in several peer-reviewed publications. Birth prevalence statistics, including public health indicators such as the association with maternal age, infant and perinatal mortality, are published annually. NCARDRS supports clinical audit for screening programmes and service evaluation.

Future plans

NCARDRS provides a valuable resource for the understanding of the epidemiology, surveillance, prevention and treatment of CAs. Currently, approximately 21 000 new registrations of babies or fetuses with suspected or confirmed CAs are added each year. Identifiers are collected, enabling linkage to routinely collected healthcare and population statistics, further enhancing the value of the data.

Randomised, siteless study to compare systematic atrial fibrillation screening using enrichment by a risk prediction model with standard care in a Swedish population aged >= 65 years: CONSIDERING-AF study design

Por: Etminani · F. · Sandgren · E. · Holm · J. · Magnusson · P. · Modica · A. · Moberg · K. · Davidsson · T. · Stalpe · L. · Kiflemariam · S. · Younan · N. · Parikh · P. · Wadhwa · M. · Sundin · A. · Engdahl · J.
Introduction

Atrial fibrillation (AF) is the most common arrhythmia and confers an increased risk of mortality, stroke, heart failure and cognitive decline. There is growing interest in AF screening; however, the most suitable population and device for AF detection remains to be elucidated. Here, we present the design of the CONSIDERING-AF (deteCtiON and Stroke preventIon by moDEl scRreenING for Atrial Fibrillation) study.

Methods and analysis

CONSIDERING-AF is a randomised, controlled, siteless, non-blinded diagnostic superiority trial with four parallel groups and a primary endpoint of identifying AF during a 6-month study period set in Region Halland, Sweden. In each group, 740 individuals aged≥65 years will be included. The primary objective is to compare the intervention of AF screening enrichment using a risk prediction model (RPM), followed by 14 days of a continuous ECG patch, with no intervention (standard care). Primary outcome is defined as the incident AF recorded in the Region Halland Information Database after 6 months as compared with standard care. Secondary endpoints include the difference in incident AF between groups enriched or not by the RPM, with and without an invitation to 14 days of continuous ECG recording, and the proportions of oral anticoagulation treatment in the four groups.

Ethics and dissemination

This study has ethical approval from the Swedish Ethical Review Authority. Results will be published in peer-reviewed international journals.

Trial registration number

NCT05838781.

MISSION ABC: transforming respiratory care through one-stop multidisciplinary clinics - an observational study

Por: Heiden · E. · Longstaff · J. · Chauhan · M. J. A. · DeVos · R. · Lanning · E. · Neville · D. · Jones · T. L. · Begum · S. · Amos · M. · Mottershaw · M. · Micklam · J. · Holdsworth · B. · Rupani · H. · Brown · T. · Chauhan · A. J. · Mission ABC Collaborators · Baghammar · Bannell · Domin
Objectives

The Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness and Chronic Obstructive Pulmonary Disease (COPD) (MABC) service aimed to enhance disease management for chronic respiratory conditions through specialist multidisciplinary clinics, predominantly in the community. This study assesses the outcomes of these clinics.

Design

This study used a prospective, longitudinal, participatory action research approach.

Setting

The study was conducted in primary care practices across Hampshire, UK.

Participants

Adults aged 16 years and above with poorly controlled asthma or COPD, as well as those with undifferentiated breathlessness not under specialist care, were included.

Interventions

Participants received care through the multidisciplinary, specialist-led MABC clinics.

Primary and secondary outcome measures

Primary outcomes included disease activity, quality of life and healthcare utilisation. Secondary outcomes encompassed clinic attendance, diagnostic changes, patient activation, participant and healthcare professional experiences and cost-effectiveness.

Results

A total of 441 participants from 11 general practitioner practices were recruited. Ninety-six per cent of participants would recommend MABC clinics. MABC assessments led to diagnosis changes for 64 (17%) participants with asthma and COPD and treatment adjustments for 252 participants (57%). Exacerbations decreased significantly from 236 to 30 after attending the clinics (p

Conclusions

Specialist-supported multidisciplinary teams in MABC clinics improved diagnosis accuracy and adherence to guidelines. High patient satisfaction, disease control improvements and reduced exacerbations resulted in decreased unscheduled healthcare use and cost savings.

Trial registration number

NCT03096509.

What is the optimal assessment of speech? A multicentre, international evaluation of speech assessment in 2500 patients with a cleft

Por: Ombashi · S. · Kurniawan · M. S. · Allori · A. · Sharif-Askary · B. · Rogers-Vizena · C. · Koudstaal · M. · Franken · M.-C. · Mink van der Molen · A. B. · Mathijssen · I. · Klassen · A. · Versnel · S. L.
Objectives

Speech problems in patients with a cleft palate are often complex and multifactorial. Finding the optimal way of monitoring these problems is challenging. The International Consortium of Health Outcomes Measurement (ICHOM) has developed a set of standardised outcome measures at specific ages for patients with a cleft lip and/or palate, including measures of speech assessment. This study evaluates the type and timing of speech outcome measures currently included in this ICHOM Standard Set. Additionally, speech assessments in other cleft protocols and initiatives are discussed.

Design, setting and participants

An international, multicentre study was set up including centres from the USA and the Netherlands. Outcomes of clinical measures and Patient Reported Outcome Measures (PROMs) were collected retrospectively according to the ICHOM set. PROM data from a field test of the CLEFT-Q, a questionnaire developed and validated for patients with a cleft, were collected, including participants from countries with all sorts of income statuses, to examine the value of additional moments of measurement that are used in other cleft initiatives.

Data from 2500 patients were included. Measured outcomes contained univariate regression analyses, trend analyses, t-tests, correlations and floor and ceiling effects.

Results

PROMs correlated low to moderate with clinical outcome measures. Clinical outcome measures correlated low to moderate with each other too. In contrast, two CLEFT-Q Scales correlated strongly with each other. All PROMs and the Percent Consonants Correct (PCC) showed an effect of age. In patients with an isolated cleft palate, a ceiling effect was found in the Intelligibility in Context Scale.

Conclusion

Recommendations for an optimal speech outcome assessment in cleft patients are made. Measurement moments of different cleft protocols and initiatives are considered in this proposition. Concerning the type of measures, adjustment of the current PCC score outcome seems appropriate. For centres with adequate resources and specific interest in research, translation and validation of an upcoming tool, the Cleft Audit Protocol for Speech Augmented, is recommended.

Country adoption of WHO 2019 guidance on HIV testing strategies and algorithms: a policy review across the WHO African region

Por: Fajardo · E. · Lastrucci · C. · Bah · N. · Mingiedi · C. M. · Ba · N. S. · Mosha · F. · Lule · F. J. · Paul · M. A. S. · Hughes · L. · Barr-DiChiara · M. · Jamil · M. S. · Sands · A. · Baggaley · R. · Johnson · C.
Objectives

In 2019, the WHO released guidelines on HIV testing service (HTS). We aim to assess the adoption of six of these recommendations on HIV testing strategies among African countries.

Design

Policy review.

Setting

47 countries within the WHO African region.

Participants

National HTS policies from the WHO African region as of December 2021.

Primary and secondary outcome measures: Uptake of WHO recommendations across national HTS policies including the standard three-test strategy; discontinuation of a tiebreaker test to rule in HIV infection; discontinuation of western blotting (WB) for HIV diagnosis; retesting prior to antiretroviral treatment (ART) initiation and the use of dual HIV/syphilis rapid diagnostic tests (RDTs) in antenatal care. Country policy adoption was assessed on a continuum, based on varying levels of complete adoption.

Results

National policies were reviewed for 96% (n=45/47) of countries in the WHO African region, 38% (n=18) were published before 2019 and 60% (n=28) adopted WHO guidance. Among countries that had not fully adopted WHO guidance, not yet adopting a three-test strategy was the most common reason for misalignment (45%, 21/47); of which 31% and 22% were in low-prevalence (

Conclusions

Many countries in the African region have adopted WHO-recommended HIV testing strategies; however, efforts are still needed to fully adopt WHO guidance. Countries should accelerate their efforts to adopt and implement a three-test strategy, retesting prior to ART initiation and the use of dual HIV/syphilis RDTs.

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