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Single-blinded, randomised, parallel-group, controlled trial comparing the efficacy and cost-effectiveness of therapist- and self-guided internet-delivered behavioural activation versus treatment as usual for adolescents with mild to moderate depression: study protocol

Single-blinded, randomised, parallel-group, controlled trial comparing the efficacy and cost-effectiveness of therapist- and self-guided internet-delivered behavioural activation versus treatment as usual for adolescents with mild to moderate depression: study protocol

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Introduction

The number of adolescents seeking professional help for depression is increasing and, despite advances in treatment, large unmet treatment needs remain. In the current protocol, we describe the design and methodology of a randomised controlled trial (RCT) to evaluate the clinical efficacy of two forms of internet-delivered behavioural activation (I-BA), with and without therapist support, in reducing depressive symptoms, compared with treatment as usual (TAU). Secondary objectives include examining the 12-month maintenance of the treatment effects and conducting a health economic evaluation of the interventions.

Methods and analysis

In this single-blinded RCT, we aim to include 215 participants aged 13–17 years with mild to moderate depression who will be randomised (1:1:1 ratio) to 10 weeks of either therapist-guided or self-guided I-BA, or TAU provided by regular mental health clinics. Data will be collected at baseline, weekly for the initial 10 weeks, post-treatment and at 3 and 12-month follow-ups. The primary endpoint is the 3-month follow-up. The primary outcome is blinded clinician-rated severity of depressive symptoms, measured by the Children’s Depression Rating Scale-Revised. Treatment response is defined as a score of ‘Much improved’ or ‘Very much improved’ on the Clinical Global Impression-Improvement Scale, administered at the primary endpoint. Outcome assessors will be blinded to treatment conditions at all assessment points. A health economic evaluation of I-BA will be performed, both in the short term (primary endpoint) and the long term (12-month follow-up).

Ethics and dissemination

Ethical approval was obtained from the Swedish Ethical Review Authority in June 2021. The final participant was enrolled on 3 May 2024 and expected to reach the primary endpoint by November 2024. The results of this study will be disseminated through publication in peer-reviewed journals, presented at conferences and communicated to healthcare providers and the public.

Trial registration number

NCT04977856.

Introduction
The number of adolescents seeking professional help for depression is increasing and, despite advances in treatment, large unmet treatment needs remain. In the current protocol, we describe the design and methodology of a randomised controlled trial (RCT) to evaluate the clinical efficacy of two forms of internet-delivered behavioural activation (I-BA), with and without therapist support, in reducing depressive symptoms, compared with treatment as usual (TAU). Secondary objectives include examining the 12-month maintenance of the treatment effects and conducting a health economic evaluation of the interventions.

Methods and analysis
In this single-blinded RCT, we aim to include 215 participants aged 13–17 years with mild to moderate depression who will be randomised (1:1:1 ratio) to 10 weeks of either therapist-guided or self-guided I-BA, or TAU provided by regular mental health clinics. Data will be collected at baseline, weekly for the initial 10 weeks, post-treatment and at 3 and 12-month follow-ups. The primary endpoint is the 3-month follow-up. The primary outcome is blinded clinician-rated severity of depressive symptoms, measured by the Children’s Depression Rating Scale-Revised. Treatment response is defined as a score of ‘Much improved’ or ‘Very much improved’ on the Clinical Global Impression-Improvement Scale, administered at the primary endpoint. Outcome assessors will be blinded to treatment conditions at all assessment points. A health economic evaluation of I-BA will be performed, both in the short term (primary endpoint) and the long term (12-month follow-up).

Ethics and dissemination
Ethical approval was obtained from the Swedish Ethical Review Authority in June 2021. The final participant was enrolled on 3 May 2024 and expected to reach the primary endpoint by November 2024. The results of this study will be disseminated through publication in peer-reviewed journals, presented at conferences and communicated to healthcare providers and the public.

Trial registration number
NCT04977856.

Effect of calcium channel blockers on influenza incidence: a population-based retrospective cohort study using administrative claims data in Japan

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Objectives

Laboratory experiments have indicated that calcium channel blockers (CCBs) inhibit the entry and replication of influenza A virus in cells. However, no clinical studies have assessed the incidence of influenza among patients receiving CCBs. This study aimed to investigate the association between CCB use and the incidence of influenza among patients with hypertension using administrative claims data in Japan.

Design

Retrospective cohort study.

Setting

Administrative health insurance claims database of Kumamoto Prefecture, Japan.

Participants

360 515 patients with hypertension (10th edition of the International Classification of Diseases code I10) who were prescribed CCBs and 171 142 patients who were prescribed angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin receptor blockers (ARBs) between 2012 and 2016.

Primary outcome

We compared the incidence of influenza between the CCB and ACEI/ARB groups using high-dimensional propensity-score (HD-PS) matching.

Results

A total of 166 814 HD-PS matched pairs were obtained. Before HD-PS matching, the CCB group had a significantly lower influenza incidence than the ACEI/ARB group in the overall analysis (2.4% vs 2.5%, p=0.007; risk ratio 0.95, 95% CI 0.92 to 0.99). However, no significant difference was observed between the two groups after HD-PS matching (2.4% vs 2.5%, p=0.067; risk ratio 0.96, 95% CI 0.92 to 1.00); only in 2012 did the CCB group have a significantly lower likelihood of influenza than the ACEI/ARB group.

Conclusions

No significant difference was observed in the influenza incidence between the CCB and ACEI/ARB groups. A direct comparative study between background-matched patients with and without CCBs is warranted to confirm the effect of CCBs on reducing the incidence of influenza.

Objectives
Laboratory experiments have indicated that calcium channel blockers (CCBs) inhibit the entry and replication of influenza A virus in cells. However, no clinical studies have assessed the incidence of influenza among patients receiving CCBs. This study aimed to investigate the association between CCB use and the incidence of influenza among patients with hypertension using administrative claims data in Japan.

Design
Retrospective cohort study.

Setting
Administrative health insurance claims database of Kumamoto Prefecture, Japan.

Participants
360 515 patients with hypertension (10th edition of the International Classification of Diseases code I10) who were prescribed CCBs and 171 142 patients who were prescribed angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin receptor blockers (ARBs) between 2012 and 2016.

Primary outcome
We compared the incidence of influenza between the CCB and ACEI/ARB groups using high-dimensional propensity-score (HD-PS) matching.

Results
A total of 166 814 HD-PS matched pairs were obtained. Before HD-PS matching, the CCB group had a significantly lower influenza incidence than the ACEI/ARB group in the overall analysis (2.4% vs 2.5%, p=0.007; risk ratio 0.95, 95% CI 0.92 to 0.99). However, no significant difference was observed between the two groups after HD-PS matching (2.4% vs 2.5%, p=0.067; risk ratio 0.96, 95% CI 0.92 to 1.00); only in 2012 did the CCB group have a significantly lower likelihood of influenza than the ACEI/ARB group.

Conclusions
No significant difference was observed in the influenza incidence between the CCB and ACEI/ARB groups. A direct comparative study between background-matched patients with and without CCBs is warranted to confirm the effect of CCBs on reducing the incidence of influenza.

Metabolic and bariatric surgery for obstructive sleep apnoea syndrome: bibliometric analysis and visualisation from 1999 to 2023

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Objectives

Metabolic and bariatric surgery (MBS) for obstructive sleep apnoea syndrome (OSAS) has garnered significant research interest. The main aim of this study was to analyse the unique characteristics of publications centred around MBS for OSAS. We aimed to provide valuable insights into the present status of the field and offer predictions regarding future trends.

Design

Bibliometric analysis through science mapping and performance analysis methods.

Data sources

Scientific articles.

Data extraction and synthesis

A comprehensive search was conducted in the Web of Science database to retrieve publications on MBS for OSAS within the time frame of 1999–2023. The search was performed using keywords such as “Obstructive Sleep Apnea syndrome”, “OSAS”, “metabolic surgery” and “bariatric surgery” to identify relevant papers. To analyse the bibliometric characteristics of these publications, VOSviewer and R software were used. This analysis encompassed various aspects, including the number of publications, contributions by different countries and institutions, the most cited author, journal publications, citation frequency and the identification of keywords related to popular scientific fields.

Results

1264 papers on MBS for OSAS were identified and are currently in a stage of rapid growth. The relevant study involved 1230 institutions from 53 different countries, with the USA topping the field with 465 publications contributed. Assistance Publique Hopitaux Paris proved to be the most productive institution, with De Vries N posting the highest number of papers (n=24). The most prolific journal was Obesity Surgery, with 241 publications. Keywords “Bariatric surgery”, “Obstructive sleep apnea”, “Obesity”, “Weight loss” and “Morbid obesity” have the highest frequency of occurrence.

Conclusions

The relationship between obesity and OSAS, various metabolic surgical techniques, and the mechanism of MBS for OSAS will continue to be related areas of frontiers. Furthermore, while there has been a gradual increase in basic research, the mechanisms involved and the long-term efficacy of bariatric MBS for OSAS still require further investigation. It is anticipated that these research areas may emerge as potential hot topics in the future.

Objectives
Metabolic and bariatric surgery (MBS) for obstructive sleep apnoea syndrome (OSAS) has garnered significant research interest. The main aim of this study was to analyse the unique characteristics of publications centred around MBS for OSAS. We aimed to provide valuable insights into the present status of the field and offer predictions regarding future trends.

Design
Bibliometric analysis through science mapping and performance analysis methods.

Data sources
Scientific articles.

Data extraction and synthesis
A comprehensive search was conducted in the Web of Science database to retrieve publications on MBS for OSAS within the time frame of 1999–2023. The search was performed using keywords such as “Obstructive Sleep Apnea syndrome”, “OSAS”, “metabolic surgery” and “bariatric surgery” to identify relevant papers. To analyse the bibliometric characteristics of these publications, VOSviewer and R software were used. This analysis encompassed various aspects, including the number of publications, contributions by different countries and institutions, the most cited author, journal publications, citation frequency and the identification of keywords related to popular scientific fields.

Results
1264 papers on MBS for OSAS were identified and are currently in a stage of rapid growth. The relevant study involved 1230 institutions from 53 different countries, with the USA topping the field with 465 publications contributed. Assistance Publique Hopitaux Paris proved to be the most productive institution, with De Vries N posting the highest number of papers (n=24). The most prolific journal was Obesity Surgery, with 241 publications. Keywords “Bariatric surgery”, “Obstructive sleep apnea”, “Obesity”, “Weight loss” and “Morbid obesity” have the highest frequency of occurrence.

Conclusions
The relationship between obesity and OSAS, various metabolic surgical techniques, and the mechanism of MBS for OSAS will continue to be related areas of frontiers. Furthermore, while there has been a gradual increase in basic research, the mechanisms involved and the long-term efficacy of bariatric MBS for OSAS still require further investigation. It is anticipated that these research areas may emerge as potential hot topics in the future.

NHS gives nurses option to anonymously report sexual misconduct

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The post NHS gives nurses option to anonymously report sexual misconduct appeared first on Nursing Times.

A new tool for NHS staff in England to anonymously report sexual misconduct has been launched.
The post NHS gives nurses option to anonymously report sexual misconduct appeared first on Nursing Times.

National review of end-of-life care withdrawal guidelines for non-invasive advanced respiratory support using document analysis

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Objectives

This study aims to understand the breadth of practice around end-of-life withdrawal of non-invasive advanced respiratory support (encompassing both continuous positive airway pressure and non-invasive ventilation) by analysing NHS-published guidelines and guidance for clinicians. This study seeks validity in the guidelines through a confluence of findings and reassurance of practice despite having little to no high-quality research to inform the content of the guidelines. Ultimately, where discordance is found between guidelines, there will be a strong mandate for future research.

Methods

Guidelines were gathered through snowball sampling and analysed using document analysis techniques. Analysis was mixed in inductive and deductive and facilitated across several authors using framework analysis. 20 guidelines were analysed but saturation was found after 15. Further guidelines were analysed beyond saturation to provide reassurance of the endpoint of the study.

Results

There were common components to the guidelines presented as themes: legal and ethical frameworks, decision-making around withdrawal, the process of withdrawal, post-withdrawal care and when to contact palliative care. There were significant areas of confluence, where multiple guidelines were in agreement on best practice. However, there was significant discordance in some key areas including the use of post-withdrawal oxygen therapy and pressure weaning practice.

Conclusion

This study provides reassurance through a confluence of findings for the majority of withdrawal practices. However, key areas of discordance highlight an urgent need for further research to support clinicians, patients and their families during challenging clinical events.

Objectives
This study aims to understand the breadth of practice around end-of-life withdrawal of non-invasive advanced respiratory support (encompassing both continuous positive airway pressure and non-invasive ventilation) by analysing NHS-published guidelines and guidance for clinicians. This study seeks validity in the guidelines through a confluence of findings and reassurance of practice despite having little to no high-quality research to inform the content of the guidelines. Ultimately, where discordance is found between guidelines, there will be a strong mandate for future research.

Methods
Guidelines were gathered through snowball sampling and analysed using document analysis techniques. Analysis was mixed in inductive and deductive and facilitated across several authors using framework analysis. 20 guidelines were analysed but saturation was found after 15. Further guidelines were analysed beyond saturation to provide reassurance of the endpoint of the study.

Results
There were common components to the guidelines presented as themes: legal and ethical frameworks, decision-making around withdrawal, the process of withdrawal, post-withdrawal care and when to contact palliative care. There were significant areas of confluence, where multiple guidelines were in agreement on best practice. However, there was significant discordance in some key areas including the use of post-withdrawal oxygen therapy and pressure weaning practice.

Conclusion
This study provides reassurance through a confluence of findings for the majority of withdrawal practices. However, key areas of discordance highlight an urgent need for further research to support clinicians, patients and their families during challenging clinical events.

Impacts of the COVID-19 pandemic on deprivation-level differences in cardiovascular hospitalisations: a comparison of England and Denmark using the OpenSAFELY platform and National Registry Data

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Objectives

To examine the impact of the COVID-19 pandemic on deprivation-related inequalities in hospitalisations for cardiovascular disease (CVD) conditions in Denmark and England between March 2018 and December 2021.

Design

Time-series studies in England and Denmark.

Setting

With the approval of National Health Service England, we used English primary care electronic health records, linked to secondary care and death registry data through the OpenSAFELY platform and nationwide Danish health registry data.

Participants

We included adults aged 18 and over without missing age, sex or deprivation information. On 1 March 2020, 16 234 700 people in England and 4 491 336 people in Denmark met the inclusion criteria.

Primary outcome measures

Hospital admissions with the primary reason for myocardial infarction (MI), ischaemic or haemorrhagic stroke, heart failure and venous thromboembolism (VTE).

Results

We saw deprivation gradients in monthly CVD hospitalisations in both countries, with differences more pronounced in Denmark. Based on pre-pandemic trends, in England, there were an estimated 2608 fewer admissions than expected for heart failure in the most deprived quintile during the pandemic compared with an estimated 979 fewer admissions in the least deprived quintile. For all other outcomes, there was little variation by deprivation quintile. In Denmark, there were an estimated 1013 fewer admissions than expected over the pandemic for MI in the most deprived quintile compared with 619 in the least deprived quintile. Similar trends were seen for stroke and VTE, though absolute numbers were smaller. Heart failure admissions were similar to pre-pandemic levels with little variation by deprivation quintile.

Conclusions

Overall, we did not find that the pandemic substantially worsened pre-existing deprivation-related differences in CVD hospitalisations, though there were exceptions in both countries.

Objectives
To examine the impact of the COVID-19 pandemic on deprivation-related inequalities in hospitalisations for cardiovascular disease (CVD) conditions in Denmark and England between March 2018 and December 2021.

Design
Time-series studies in England and Denmark.

Setting
With the approval of National Health Service England, we used English primary care electronic health records, linked to secondary care and death registry data through the OpenSAFELY platform and nationwide Danish health registry data.

Participants
We included adults aged 18 and over without missing age, sex or deprivation information. On 1 March 2020, 16 234 700 people in England and 4 491 336 people in Denmark met the inclusion criteria.

Primary outcome measures
Hospital admissions with the primary reason for myocardial infarction (MI), ischaemic or haemorrhagic stroke, heart failure and venous thromboembolism (VTE).

Results
We saw deprivation gradients in monthly CVD hospitalisations in both countries, with differences more pronounced in Denmark. Based on pre-pandemic trends, in England, there were an estimated 2608 fewer admissions than expected for heart failure in the most deprived quintile during the pandemic compared with an estimated 979 fewer admissions in the least deprived quintile. For all other outcomes, there was little variation by deprivation quintile. In Denmark, there were an estimated 1013 fewer admissions than expected over the pandemic for MI in the most deprived quintile compared with 619 in the least deprived quintile. Similar trends were seen for stroke and VTE, though absolute numbers were smaller. Heart failure admissions were similar to pre-pandemic levels with little variation by deprivation quintile.

Conclusions
Overall, we did not find that the pandemic substantially worsened pre-existing deprivation-related differences in CVD hospitalisations, though there were exceptions in both countries.

Risk of infections among persons treated with opioids for chronic pain: a systematic review and meta-analysis protocol

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Introduction

Millions of persons with chronic pain across North America and Europe use opioids. While the immunosuppressive properties of opioids are associated with risks of infections, these outcomes could be mitigated through careful patient selection and monitoring practices when appropriate. It is important to recognise that some patients do benefit from a carefully tailored opioid therapy. Enough primary studies have been published to date regarding the role of opioids in potential immunosuppression presenting as an increased rate of infection acquisition, infectious complications and mortality. There is thus a critical need for a consensus in this area.

Methods and analysis

The methodology is based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, the MOOSE Guidelines for Meta-Analyses and Systematic Reviews of Observational Studies and the Cochrane Handbook for Systematic Reviews of Interventions. We plan to systematically search Ovid MEDLINE, CINAHL, PsycINFO, EMB Review, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials and Google Scholar databases from their inception date to December 2023. Full-text primary studies that report measurable outcomes in adults with chronic pain, all routes of opioid use, all types of infections and all settings will be included. We will identify a scope of reported infections and the evidence on the association of opioid use (including specific opioid, dosage, formulation and duration of use) with the risk of negative infectious outcomes. Opioid use-associated outcomes, comparing opioid use with another opioid or a non-opioid medication, will be reported. The meta-analysis will incorporate individual risk factors. If data are insufficient, the results will be synthesised narratively. Publication bias and confounding evaluation will be performed. The Grading of Recommendations Assessment, Development and Evaluation framework will be used.

Ethics and dissemination

Approval for the use of published data is not required. The results will be published, presented at conferences and discussed in deliberative dialogue groups.

PROSPERO registration number

CRD42023402812.

Introduction
Millions of persons with chronic pain across North America and Europe use opioids. While the immunosuppressive properties of opioids are associated with risks of infections, these outcomes could be mitigated through careful patient selection and monitoring practices when appropriate. It is important to recognise that some patients do benefit from a carefully tailored opioid therapy. Enough primary studies have been published to date regarding the role of opioids in potential immunosuppression presenting as an increased rate of infection acquisition, infectious complications and mortality. There is thus a critical need for a consensus in this area.

Methods and analysis
The methodology is based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, the MOOSE Guidelines for Meta-Analyses and Systematic Reviews of Observational Studies and the Cochrane Handbook for Systematic Reviews of Interventions. We plan to systematically search Ovid MEDLINE, CINAHL, PsycINFO, EMB Review, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials and Google Scholar databases from their inception date to December 2023. Full-text primary studies that report measurable outcomes in adults with chronic pain, all routes of opioid use, all types of infections and all settings will be included. We will identify a scope of reported infections and the evidence on the association of opioid use (including specific opioid, dosage, formulation and duration of use) with the risk of negative infectious outcomes. Opioid use-associated outcomes, comparing opioid use with another opioid or a non-opioid medication, will be reported. The meta-analysis will incorporate individual risk factors. If data are insufficient, the results will be synthesised narratively. Publication bias and confounding evaluation will be performed. The Grading of Recommendations Assessment, Development and Evaluation framework will be used.

Ethics and dissemination
Approval for the use of published data is not required. The results will be published, presented at conferences and discussed in deliberative dialogue groups.

PROSPERO registration number
CRD42023402812.

Psychometric validation of the Cardiac Rehabilitation Barriers Scale Revised (CRBS-R) for hybrid delivery

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Objective

To test the measurement properties of the revised version of the English Cardiac Rehabilitation Barriers Scale (CRBS-R), suitable for hybrid delivery, structural validity, internal reliability, as well as face, cross-cultural, construct and criterion validity were assessed.

Design

Cross-sectional study, where participants completed an online survey via Qualtrics (2023–2024).

Setting

Multicentre, with cardiac rehabilitation (CR) programmes recruiting patients globally; most patients stemmed from a hybrid programme in Iran and supervised programme in Brazil.

Participants

Participants include inpatients or outpatients with a cardiovascular diagnosis or procedure that is indicated for participation in CR.

Measures

In addition to sociodemographic and CR use items, the 21-item CRBS-R was administered. It assesses multilevel barriers and was revised based on a literature review. Responses range from 1 to 5, with higher scores indicating greater barriers.

Results

235 patients participated from all 6 WHO regions. Items were rated as highly applicable, and open-ended responses revealing no key barriers were omitted, supporting face and cross-cultural validity. Cronbach’s α for the total CRBS-R was 0.82. Principal components analysis resulted in the extraction of 4 components, which collectively accounted for 60.5% of the variance and were all internally consistent. Construct validity was supported by associations of total CRBS scores with work status (p=0.04), exercise history (p=0.01) and social support (p=0.03). Total CRBS-R scores were significantly lower in patients who were referred and enrolled versus those who were not (both p≤0.01), confirming criterion validity.

Conclusions

The CRBS-R is a reliable and valid scale comprising four subscales, applicable to hybrid CR across diverse settings. It can serve as a valuable tool to support identification of patient’s CR barriers, to optimise secondary prevention utilisation globally.

Objective
To test the measurement properties of the revised version of the English Cardiac Rehabilitation Barriers Scale (CRBS-R), suitable for hybrid delivery, structural validity, internal reliability, as well as face, cross-cultural, construct and criterion validity were assessed.

Design
Cross-sectional study, where participants completed an online survey via Qualtrics (2023–2024).

Setting
Multicentre, with cardiac rehabilitation (CR) programmes recruiting patients globally; most patients stemmed from a hybrid programme in Iran and supervised programme in Brazil.

Participants
Participants include inpatients or outpatients with a cardiovascular diagnosis or procedure that is indicated for participation in CR.

Measures
In addition to sociodemographic and CR use items, the 21-item CRBS-R was administered. It assesses multilevel barriers and was revised based on a literature review. Responses range from 1 to 5, with higher scores indicating greater barriers.

Results
235 patients participated from all 6 WHO regions. Items were rated as highly applicable, and open-ended responses revealing no key barriers were omitted, supporting face and cross-cultural validity. Cronbach’s α for the total CRBS-R was 0.82. Principal components analysis resulted in the extraction of 4 components, which collectively accounted for 60.5% of the variance and were all internally consistent. Construct validity was supported by associations of total CRBS scores with work status (p=0.04), exercise history (p=0.01) and social support (p=0.03). Total CRBS-R scores were significantly lower in patients who were referred and enrolled versus those who were not (both p≤0.01), confirming criterion validity.

Conclusions
The CRBS-R is a reliable and valid scale comprising four subscales, applicable to hybrid CR across diverse settings. It can serve as a valuable tool to support identification of patient’s CR barriers, to optimise secondary prevention utilisation globally.

Piloting a PREMs and PROMs longitudinal survey on the integration of healthcare services for patients living with hepatitis C in Tuscany region: study protocol

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Introduction

Patient-reported measures are an invaluable resource for health systems to improve the quality of healthcare services. Patients with hepatitis C virus (HCV) are an under-represented group within the stream of literature on collecting and using the experiences and outcomes reported by patients to improve healthcare performance. This protocol outlines the methodology to implement a longitudinal survey in Tuscany, Italy, to systematically gather patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) for patients with HCV, with a focus on the integration of primary and hospital care.

Methods and analysis

We designed and developed a longitudinal survey to collect HCV PREMs and PROMs. The survey, which lasts 1 year, consists of three questionnaires, starting with the first visit with a specialist/treatment initiation, with follow-ups at 6 and 12 months. It was implemented in six hospitals in Tuscany, Italy, of which three are University Hospitals. The survey was offered to all patients treated for HCV at these healthcare centres, deliberately not applying a specific criterion for patient selection, through both paper based and electronic modes of completion. The data from the three structured questionnaires will be analysed quantitatively.

Ethics and dissemination

The Ethics Committee for Clinical Experimentation of Area Vasta Nord Ovest approved the protocol (CEAVNO—CODE 18829). Participation in this study is voluntary. Study results will be disseminated through peer-reviewed publications and academic conferences.

Introduction
Patient-reported measures are an invaluable resource for health systems to improve the quality of healthcare services. Patients with hepatitis C virus (HCV) are an under-represented group within the stream of literature on collecting and using the experiences and outcomes reported by patients to improve healthcare performance. This protocol outlines the methodology to implement a longitudinal survey in Tuscany, Italy, to systematically gather patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) for patients with HCV, with a focus on the integration of primary and hospital care.

Methods and analysis
We designed and developed a longitudinal survey to collect HCV PREMs and PROMs. The survey, which lasts 1 year, consists of three questionnaires, starting with the first visit with a specialist/treatment initiation, with follow-ups at 6 and 12 months. It was implemented in six hospitals in Tuscany, Italy, of which three are University Hospitals. The survey was offered to all patients treated for HCV at these healthcare centres, deliberately not applying a specific criterion for patient selection, through both paper based and electronic modes of completion. The data from the three structured questionnaires will be analysed quantitatively.

Ethics and dissemination
The Ethics Committee for Clinical Experimentation of Area Vasta Nord Ovest approved the protocol (CEAVNO—CODE 18829). Participation in this study is voluntary. Study results will be disseminated through peer-reviewed publications and academic conferences.

Telephone lifestyle intervention to prevent diabetes in women with recent gestational diabetes mellitus attending the national health system: the LINDA-Brasil clinical trial

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Objectives

To evaluate a postpartum telephone-based lifestyle intervention to prevent diabetes in high-risk women with recent gestational diabetes mellitus (GDM).

Design

Multicentre parallel randomised clinical trial.

Setting

Specialised antenatal clinics in the Brazilian National System.

Methods

Lifestyle Intervention for Diabetes Prevention After Pregnancy compared (1:1) postpartum telephone support for lifestyle changes with conventional care in women with recent GDM at substantial risk for diabetes. Randomisation started on 28 March 2015 and ended on 13 March 2020, with the onset of the COVID-19 pandemic. We used Cox regression to estimate HRs for diabetes and analysis of covariance adjusted for follow-up time to assess weight change.

Outcomes

The primary outcome was incident diabetes ascertained with blinded measurements of oral glucose tolerance tests. The secondary outcome was a change in measured weight.

Results

We enrolled 5323 women with GDM, 2735 (51%) being at high risk. After invitations, baseline assessment and exclusions, we assigned 466 women to intervention (231) or control (235) groups. Attendance was satisfactory (≥7/20 phone sessions) in 75%. Over an average follow-up of 29.7 (15.6) months, 142 (30.5%) women progressed to diabetes, 75 (32%) in the control and 67 (29%) in the intervention group. There was no reduction in the incidence of diabetes (HR=0.84; 0.60–1.19) and only a non-significant 0.97 kg less weight gain (p=0.09). Among the 305 women randomised more than 1 year before the COVID-19 pandemic, the intervention did not reduce the incidence of diabetes (HR=0.71; 0.48–1.04) despite a 2.09 kg (p=0.002) lesser weight gain.

Conclusion

The strategy to identify women with GDM at high risk proved valid, as women often gained weight and frequently developed diabetes. Over a 30-month follow-up, telephone support for lifestyle changes at postpartum did not reduce weight gain or diabetes incidence, although only 75% attended the minimum number of telephone sessions. The COVID-19 pandemic negatively impacted trial conduction.

Trial registration number

NCT02327286.

Objectives
To evaluate a postpartum telephone-based lifestyle intervention to prevent diabetes in high-risk women with recent gestational diabetes mellitus (GDM).

Design
Multicentre parallel randomised clinical trial.

Setting
Specialised antenatal clinics in the Brazilian National System.

Methods
Lifestyle Intervention for Diabetes Prevention After Pregnancy compared (1:1) postpartum telephone support for lifestyle changes with conventional care in women with recent GDM at substantial risk for diabetes. Randomisation started on 28 March 2015 and ended on 13 March 2020, with the onset of the COVID-19 pandemic. We used Cox regression to estimate HRs for diabetes and analysis of covariance adjusted for follow-up time to assess weight change.

Outcomes
The primary outcome was incident diabetes ascertained with blinded measurements of oral glucose tolerance tests. The secondary outcome was a change in measured weight.

Results
We enrolled 5323 women with GDM, 2735 (51%) being at high risk. After invitations, baseline assessment and exclusions, we assigned 466 women to intervention (231) or control (235) groups. Attendance was satisfactory (≥7/20 phone sessions) in 75%. Over an average follow-up of 29.7 (15.6) months, 142 (30.5%) women progressed to diabetes, 75 (32%) in the control and 67 (29%) in the intervention group. There was no reduction in the incidence of diabetes (HR=0.84; 0.60–1.19) and only a non-significant 0.97 kg less weight gain (p=0.09). Among the 305 women randomised more than 1 year before the COVID-19 pandemic, the intervention did not reduce the incidence of diabetes (HR=0.71; 0.48–1.04) despite a 2.09 kg (p=0.002) lesser weight gain.

Conclusion
The strategy to identify women with GDM at high risk proved valid, as women often gained weight and frequently developed diabetes. Over a 30-month follow-up, telephone support for lifestyle changes at postpartum did not reduce weight gain or diabetes incidence, although only 75% attended the minimum number of telephone sessions. The COVID-19 pandemic negatively impacted trial conduction.

Trial registration number
NCT02327286.

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