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Effectiveness and cost-effectiveness of a progressive, individualised walking and education programme for prevention of low back pain recurrence in adults: study protocol for the WalkBack randomised controlled trial

Por: Pocovi · N. C. · Lin · C.-W. C. · Latimer · J. · Merom · D. · Tiedemann · A. · Maher · C. · van Tulder · M. W. · Macaskill · P. · Clavisi · O. · Tong · S. Y. K. · Hancock · M. J.
Introduction

Low back pain (LBP) is recognised globally as a prevalent, costly and disabling condition. Recurrences are common and contribute to much of the burden of LBP. Current evidence favours exercise and education for prevention of LBP recurrence, but an optimal intervention has not yet been established. Walking is a simple, widely accessible, low-cost intervention that has yet to be evaluated. This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).

Methods and analysis

A pragmatic, two-armed RCT comparing walking and education (n=349) with a no treatment control group (n=349). Inclusion criteria are adults recovered from an episode of non-specific LBP within the last 6 months. Those allocated to the intervention group will receive six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education over a 6-month period. The primary outcome will be days to first recurrence of an episode of activity-limiting LBP. The secondary outcomes include days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life measured at 3, 6, 9 and 12 months and costs associated with LBP recurrence. All participants will be followed up monthly for a minimum of 12 months. The primary intention-to-treat analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. The cost-effectiveness analysis will be conducted from the societal perspective.

Ethics and dissemination

Approved by Macquarie University Human Research Ethics Committee (Reference: 5201949218164, May 2019). Findings will be disseminated through publication in peer-reviewed journals and conference presentations.

Trial registration number

ACTRN12619001134112.

Determinants of citation in the literature on diesel exhaust exposure and lung cancer: a citation analysis

Por: Duyx · B. · Urlings · M. J. E. · Swaen · G. M. H. · Bouter · L. M. · Zeegers · M. P.
Objectives

Epidemiological research on the association between diesel exhaust exposure and lung cancer risk has some methodological challenges that give rise to different conclusions and intense debates. This raises the question about the role of selective citation and of citation bias in particular. Our aim was to investigate the occurrence and prevalence of selective citation in this field.

Design

Citation analysis.

Setting

Web of Science Core Collection.

Participants

We identified 96 publications in this network, with 4317 potential citations. For each publication, we extracted characteristics such as study conclusion and funding source. Some of these characteristics are related to the study content: study design, sample size, method of diesel exposure assessment, type of diesel technology under investigation, and whether smoking had been adjusted for.

Primary and secondary outcome measures

Whether a citation occurs or not, measured and analysed according to the preregistered protocol. Exploratively we analysed the association between funding source and study conclusion.

Results

Methodological content of a study was clearly related to citation, studies using more sophisticated methods were more likely to be cited. There was some evidence for citation bias: supportive publications had a higher chance of being cited than non-supportive ones, but after adjustment for study quality, this effect decreased substantially (adjusted OR 1.3, 95% CI 1.0 to 1.7). Explorative analyses indicated that three quarters of non-profit funded publications had a supportive study conclusion against only one quarter of the industry-funded publications.

Conclusions

There is evidence for selective citation within this field, but the evidence for citation bias was weak. It seems that factors related to the methodology had more impact on citation than the conclusion of a study. Interestingly, publications that were funded by industry were more skeptical about a causal relationship between diesel exhaust and lung cancer compared to non-profit-funded publications.

Protocol of a multicentre, prospective cohort study that evaluates cost-effectiveness of two perioperative care strategies for potential obstructive sleep apnoea in morbidly obese patients undergoing bariatric surgery

Por: van Veldhuisen · S. L. · Kuppens · K. · de Raaff · C. A. L. · Wiezer · M. J. · de Castro · S. M. M. · van Veen · R. N. · Swank · D. J. · Demirkiran · A. · Boerma · E.-J. G. · Greve · J.-W. M. · van Dielen · F. M. H. · Frederix · G. W. J. · Hazebroek · E. J.
Introduction

Despite the high prevalence of obstructive sleep apnoea (OSA) in obese patients undergoing bariatric surgery, OSA is undiagnosed in the majority of patients and thus untreated. While untreated OSA is associated with an increased risk of preoperative and postoperative complications, no evidence-based guidelines on perioperative care for these patients are available. The aim of the POPCORN study (Post-Operative Pulse oximetry without OSA sCreening vs perioperative continuous positive airway pressure (CPAP) treatment following OSA scReeNing by polygraphy (PG)) is to evaluate which perioperative strategy is the most cost-effective for obese patients undergoing bariatric surgery without a history of OSA.

Methods and analysis

In this multicentre observational cohort study, data from 1380 patients who will undergo bariatric surgery will be collected. Patients will receive either postoperative care with pulse oximetry monitoring and supplemental oxygen during the first postoperative night, or care that includes preoperative PG and CPAP treatment in case of moderate or severe OSA. Local protocols for perioperative care in each participating hospital will determine into which cohort a patient is placed. The primary outcome is cost-effectiveness, which will be calculated by comparing all healthcare costs with the quality-adjusted life-years (QALYs, calculated using EQ-5D questionnaires). Secondary outcomes are mortality, complications within 30 days after surgery, readmissions, reoperations, length of stay, weight loss, generic quality of life (QOL), OSA-specific QOL, OSA symptoms and CPAP adherence. Patients will receive questionnaires before surgery and 1, 3, 6 and 12 months after surgery to report QALYs and other patient-reported outcomes.

Ethics and dissemination

Approval from the Medical Research Ethics Committees United was granted in accordance with the Dutch law for Medical Research Involving Human Subjects Act (WMO) (reference number W17.050). Results will be submitted for publication in peer-reviewed journals and presented at (inter)national conferences.

Trial registration number

NTR6991.

The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial

Por: Gobarani · R. K. · Abramson · M. J. · Bonevski · B. · Weeks · G. R. · Dooley · M. J. · Smith · B. J. · Veale · A. · Webb · A. · Kirsa · S. · Thomas · D. · Miller · A. · Gasser · R. · Paul · E. · Parkinson · J. · Meanger · D. · Coward · L. · Kopsaftis · Z. · Rofe · O. · Lee · P. · George · J.
Introduction

Smoking is a leading cause of premature deaths globally. The health benefits of smoking cessation are many. However, majority of quit attempts are unsuccessful. One way to potentially improve success rates is to evaluate new combinations of existing smoking cessation therapies that may work synergistically to decrease the intensity of withdrawal symptoms and cravings.

Aims

To evaluate the feasibility, efficacy and safety of the combination of varenicline and nicotine replacement therapy (NRT) lozenges versus varenicline alone in assisting hospitalised smokers to quit.

Methods and analysis

This is a multicentre, randomised, placebo-controlled trial. Adults with a history of smoking ≥10 cigarettes per day on average in the 4 weeks prior to their hospitalisation will be recruited. Participants will be randomly assigned to either the intervention group and will receive varenicline and NRT lozenges, or the control group and will receive varenicline and placebo lozenges. All participants will be actively referred to behavioural support from telephone Quitline. Participants are followed up at 1 and 3 weeks and 3, 6 and 12 months from the start of treatment. The primary outcome is carbon monoxide validated prolonged abstinence from 2 weeks to 6 months after treatment initiation. Secondary outcomes include self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others. According to the Russell Standard, all randomised participants will be accounted for in the primary intention-to-treat analysis.

Ethics and dissemination

The trial will be conducted in compliance with the protocol, the principles of Good Clinical Practice, the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (updated 2015) and the Australian Code for the Responsible Conduct of Research (2018). Approval will be sought from the Human Ethics Committees of all the participating hospitals and the university. Written informed consent will be obtained from each participant at the time of recruitment.

Trial registration number

Australia New Zealand Clinical Trials Registry (ACTRN12618001792213).

Access to primary healthcare during lockdown measures for COVID-19 in rural South Africa: an interrupted time series analysis

Por: Siedner · M. J. · Kraemer · J. D. · Meyer · M. J. · Harling · G. · Mngomezulu · T. · Gabela · P. · Dlamini · S. · Gareta · D. · Majozi · N. · Ngwenya · N. · Seeley · J. · Wong · E. · Iwuji · C. · Shahmanesh · M. · Hanekom · W. · Herbst · K.
Objectives

We evaluated whether implementation of lockdown orders in South Africa affected ambulatory clinic visitation in rural Kwa-Zulu Natal (KZN).

Design

Observational cohort

Setting

Data were analysed from 11 primary healthcare clinics in northern KZN.

Participants

A total of 46 523 individuals made 89 476 clinic visits during the observation period.

Exposure of interest

We conducted an interrupted time series analysis to estimate changes in clinic visitation with a focus on transitions from the prelockdown to the level 5, 4 and 3 lockdown periods.

Outcome measures

Daily clinic visitation at ambulatory clinics. In stratified analyses, we assessed visitation for the following subcategories: child health, perinatal care and family planning, HIV services, non-communicable diseases and by age and sex strata.

Results

We found no change in total clinic visits/clinic/day at the time of implementation of the level 5 lockdown (change from 90.3 to 84.6 mean visits/clinic/day, 95% CI –16.5 to 3.1), or at the transitions to less stringent level 4 and 3 lockdown levels. We did detect a >50% reduction in child healthcare visits at the start of the level 5 lockdown from 11.9 to 4.7 visits/day (–7.1 visits/clinic/day, 95% CI –8.9 to 5.3), both for children aged

Conclusions

In rural KZN, we identified a significant, although temporary, reduction in child healthcare visitation but general resilience of adult ambulatory care provision during the first 4 months of the lockdown. Future work should explore the impacts of the circulating epidemic on primary care provision and long-term impacts of reduced child visitation on outcomes in the region.

Outbreak response intervention models of vaccine-preventable diseases in humans and foot-and-mouth disease in livestock: a protocol for a systematic review

Por: Azam · J. M. · Are · E. B. · Pang · X. · Ferrari · M. J. · Pulliam · J. R. C.
Introduction

Outbreaks of vaccine-preventable diseases continue to threaten public health, despite the proven effectiveness of vaccines. Interventions such as vaccination, social distancing and palliative care are usually implemented, either individually or in combination, to control these outbreaks. Mathematical models are often used to assess the impact of these interventions and for supporting outbreak response decision making. The objectives of this systematic review, which covers all human vaccine-preventable diseases, are to determine the relative impact of vaccination compared with other outbreak interventions, and to ascertain the temporal trends in the use of modelling in outbreak response decision making. We will also identify gaps and opportunities for future research through a comparison with the foot-and-mouth disease outbreak response modelling literature, which has good examples of the use of modelling to inform outbreak response intervention decision making.

Methods and analysis

We searched on PubMed, Scopus, Web of Science, Google Scholar and some preprint servers from the start of indexing to 15 January 2020. Inclusion: modelling studies, published in English, that use a mechanistic approach to evaluate the impact of an outbreak intervention. Exclusion: reviews, and studies that do not describe or use mechanistic models or do not describe an outbreak. We will extract data from the included studies such as their objectives, model types and composition, and conclusions on the impact of the intervention. We will ascertain the impact of models on outbreak response decision making through visualisation of time trends in the use of the models. We will also present our results in narrative style.

Ethics and dissemination

This systematic review will not require any ethics approval since it only involves scientific articles. The review will be disseminated in a peer-reviewed journal and at various conferences fitting its scope.

PROSPERO registration number

CRD42020160803.

Randomised multicentre clinical trial to evaluate voriconazole pre-emptive genotyping strategy in patients with risk of aspergillosis: vorigenipharm study protocol

Por: Monserrat Villatoro · J. · Garcia Garcia · I. · Bueno · D. · de la Camara · R. · Estebanez · M. · Lopez de la Guia · A. · Abad-Santos · F. · Anton · C. · Mejia · G. · Otero · M. J. · Ramirez Garcia · E. · Frias Iniesta · J. · Carcas · A. · Borobia · A. M.
Introduction

Invasive aspergillosis is the most important cause of morbidity and mortality in patients with haematological diseases. At present, voriconazole is the first-line treatment for invasive fungal disease. The pharmacokinetic interindividual variability of voriconazole depends on genetic factors. CYP450 is involved in 70%–75% of total metabolism of voriconazole, mainly CYP3A4 and CYP2C19, with the remaining 25%–30% of metabolism conducted by monooxygenase flavins. CYP2C19 single nucleotide polymorphisms could explain 50%–55% of variability in voriconazole metabolism.

Materials and methods

The main objective is to compare efficiency of pre-emptive voriconazole genotyping with routine practice. The primary outcome is serum voriconazole on the fifth day within the therapeutic range. The secondary outcome is the combined variables of therapeutic failure and adverse events within 90 days of first administration, associated with voriconazole. A total of 146 patients at risk of invasive aspergillosis who will potentially receive voriconazole will be recruited, and CYP2C19 will be genotyped. If the patient ultimately receives voriconazole, they will be randomised (1:1 experimental/control). In the experimental arm, patients will receive a dose according to a pharmacogenetic algorithm, including CYP2C19 genotype and clinical and demographic information. In the control arm, patients will receive a dose according to clinical practice guidelines. In addition, a Spanish National Healthcare System (NHS) point-of-view cost-effectiveness evaluation will be performed. Direct cost calculations for each arm will be performed.

Conclusion

This trial will provide information about the viability and cost-effectiveness of the implementation of a pre-emptive voriconazole genotyping strategy in the Spanish NHS.

Ethics and dissemination

A Spanish version of this protocol has been evaluated and approved by the La Paz University Hospital Ethics Committee and the Spanish Agency of Medicines and Medical Devices. Trial results will be submitted for publication in an open peer-reviewed medical speciality-specific publication.

Trial registration number

Eudra-CT: 2019-000376-41 and NCT04238884; Pre-results.

Estimating the global cost of vision impairment and its major causes: protocol for a systematic review

Por: Marques · A. P. · Ramke · J. · Cairns · J. · Butt · T. · Zhang · J. H. · Faal · H. B. · Taylor · H. · Jones · I. · Congdon · N. · Bastawrous · A. · Braithwaite · T. · Jovic · M. · Resnikoff · S. · Nandakumar · A. · Khaw · P. T. · Bourne · R. R. A. · Gordon · I. · Frick · K. · Burton · M. J.
Introduction

Vision impairment (VI) places a burden on individuals, health systems and society in general. In order to support the case for investing in eye health services, an updated cost of illness study that measures the global impact of VI is necessary. To perform such a study, a systematic review of the literature is needed. Here we outline the protocol for a systematic review to describe and summarise the costs associated with VI and its major causes.

Methods and analysis

We will systematically search in Medline (Ovid) and the Centre for Reviews and Dissemination database which includes the National Health Service Economics Evaluation Database. No language or geographical restriction will be applied. Additional literature will be identified by reviewing the references in the included studies and by contacting field experts. Grey literature will be considered. The review will include any study published from 1 January 2000 to November 2019 that provides information about costs of illness, burden of disease and/or loss of well-being in participants with VI due to an unspecified cause or due to one of the seven leading causes globally.

Two reviewers will independently screen studies and extract relevant data from included studies. Methodological quality of economic studies will be assessed based on the British Medical Journal checklist for economic submissions adapted to costs of illness studies. This protocol has been prepared following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis protocols and has been published prospectively in Open Science Framework.

Ethics and dissemination

Formal ethical approval is not required, as primary data will not be collected in this review. The findings of this study will be disseminated through peer-reviewed publications, stakeholder meetings and inclusion in the ongoing Lancet Global Health Commission on Global Eye Health.

Registration details

https://osf.io/9au3w (DOI 10.17605/OSF.IO/6F8VM).

Newborn signal functions in Bangladesh: identification through expert consultation and assessment of readiness among public health facilities--study protocol using Delphi technique

Por: Rahman · A. E. · Banik · G. · Mhajabin · S. · Tahsina · T. · Islam · M. J. · Uddin Ahmed · F. · Islam · M. U. · Mannan · M. A. · Dey · S. K. · Sharmin · S. · Mehran · F. · Khan · M. · Ahmed · A. · Al Sabir · A. · Sultana · S. · Ahsan · Z. · Rubayet · S. · George · J. · Karim · A. · Shahidull
Introduction

There is a set of globally accepted and nationally adapted signal functions for categorising health facilities for maternal services. Newborn resuscitation is the only newborn intervention which is included in the WHO recommended list of emergency obstetric care signal functions. This is not enough to comprehensively assess the readiness of a health facility for providing newborn services. In order to address the major causes of newborn death, the Government of Bangladesh has prioritised a set of newborn interventions for national scale-up, the majority of which are facility-based. Effective delivery of these interventions depends on a core set of functions (skills and services). However, there is no standardised and approved set of newborn signal functions (NSFs) based on which the service availability and readiness of a health facility can be assessed for providing newborn services. Thus, this study will be the first of its kind to identify such NSFs. These NSFs can categorise health facilities and assist policymakers and health managers to appropriately plan and adequately monitor the progress and performance of health facilities delivering newborn healthcare.

Methods and analysis

We will adopt the Delphi technique of consensus building for identification of NSFs and 1–2 indicator for each function while employing expert consultation from relevant experts in Bangladesh. Based on the identified NSFs and signal function indicators, the existing health facility assessment (HFA) tools will be updated, and an HFA survey will be conducted to assess service availability and readiness of public health facilities in relation to the new NSFs. Descriptive statistics (proportion) with a 95% CI will be used to report the level of service availability and readiness of public facilities regarding NSFs.

Ethics and dissemination

Ethical approval was obtained from Research Review and Ethical Review Committee of icddr, b (PR-17089). Results will be disseminated through meetings, seminars, conference presentations and international peer-review journal articles.

Role of endoscopic ultrasonography in the diagnostic work-up of idiopathic acute pancreatitis (PICUS): study protocol for a nationwide prospective cohort study

Por: Umans · D. S. · Timmerhuis · H. C. · Hallensleben · N. D. · Bouwense · S. A. · Anten · M.-P. G. · Bhalla · A. · Bijlsma · R. A. · Boermeester · M. A. · Brink · M. A. · Hol · L. · Bruno · M. J. · Curvers · W. L. · van Dullemen · H. M. · van Eijck · B. C. · Erkelens · G. W. · Fockens
Introduction

Idiopathic acute pancreatitis (IAP) remains a dilemma for physicians as it is uncertain whether patients with IAP may actually have an occult aetiology. It is unclear to what extent additional diagnostic modalities such as endoscopic ultrasonography (EUS) are warranted after a first episode of IAP in order to uncover this aetiology. Failure to timely determine treatable aetiologies delays appropriate treatment and might subsequently cause recurrence of acute pancreatitis. Therefore, the aim of the Pancreatitis of Idiopathic origin: Clinical added value of endoscopic UltraSonography (PICUS) Study is to determine the value of routine EUS in determining the aetiology of pancreatitis in patients with a first episode of IAP.

Methods and analysis

PICUS is designed as a multicentre prospective cohort study of 106 patients with a first episode of IAP after complete standard diagnostic work-up, in whom a diagnostic EUS will be performed. Standard diagnostic work-up will include a complete personal and family history, laboratory tests including serum alanine aminotransferase, calcium and triglyceride levels and imaging by transabdominal ultrasound, magnetic resonance imaging or magnetic resonance cholangiopancreaticography after clinical recovery from the acute pancreatitis episode. The primary outcome measure is detection of aetiology by EUS. Secondary outcome measures include pancreatitis recurrence rate, severity of recurrent pancreatitis, readmission, additional interventions, complications, length of hospital stay, quality of life, mortality and costs, during a follow-up period of 12 months.

Ethics and dissemination

PICUS is conducted according to the Declaration of Helsinki and Guideline for Good Clinical Practice. Five medical ethics review committees assessed PICUS (Medical Ethics Review Committee of Academic Medical Center, University Medical Center Utrecht, Radboud University Medical Center, Erasmus Medical Center and Maastricht University Medical Center). The results will be submitted for publication in an international peer-reviewed journal.

Trial registration number

Netherlands Trial Registry (NL7066). Prospectively registered.

Interventions to improve the quality of cataract services: protocol for a global scoping review

Por: Yoshizaki · M. · Ramke · J. · Furtado · J. M. · Burn · H. · Gichuhi · S. · Gordon · I. · Aghaji · A. · Marques · A. P. · Dean · W. H. · Congdon · N. · Buchan · J. · Burton · M. J.
Introduction

Cataract is the leading cause of blindness globally and a major cause of vision impairment. Cataract surgery is an efficacious intervention that usually restores vision. Although it is one of the most commonly conducted surgical interventions worldwide, good quality services (from being detected with operable cataract to undergoing surgery and receiving postoperative care) are not universally accessible. Poor quality understandably reduces the willingness of people with operable cataract to undergo surgery. Therefore, it is critical to improve the quality of care to subsequently reduce vision loss from cataract. This scoping review aims to summarise the nature and extent of the published literature on interventions to improve the quality of services for primary age-related cataract globally.

Methods and analysis

We will search MEDLINE, Embase and Global Health for peer-reviewed manuscripts published since 1990, with no language, geographic or study design restrictions. To define quality, we have used the elements adopted by the WHO—effectiveness, safety, people-centredness, timeliness, equity, integration and efficiency—to which we have added the element of planetary health. We will exclude studies focused on the technical aspects of the surgical procedure and studies that only involve children (

Ethics and dissemination

Ethical approval was not sought, as our review will only include published and publicly accessible information. We will publish our findings in an open-access peer-reviewed journal and develop an accessible summary of the results for website posting. A summary of the results will be included in the ongoing Lancet Global Health Commission on Global Eye Health.

Registration details

Open Science Framework (https://osf.io/8gktz).

FIRST-line support for assistance in breathing in children (FIRST-ABC): a master protocol of two randomised trials to evaluate the non-inferiority of high-flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respira

Por: Richards-Belle · A. · Davis · P. · Drikite · L. · Feltbower · R. · Grieve · R. · Harrison · D. A. · Lester · J. · Morris · K. P. · Mouncey · P. R. · Peters · M. J. · Rowan · K. M. · Sadique · Z. · Tume · L. N. · Ramnarayan · P.
Introduction

Even though respiratory support is a common intervention in paediatric critical care, there is no randomised controlled trial (RCT) evidence regarding the effectiveness of two commonly used modes of non-invasive respiratory support (NRS), continuous positive airway pressure (CPAP) and high-flow nasal cannula therapy (HFNC). FIRST-line support for assistance in breathing in children is a master protocol of two pragmatic non-inferiority RCTs to evaluate the clinical and cost-effectiveness of HFNC (compared with CPAP) as the first-line mode of support in critically ill children.

Methods and analysis

We will recruit participants over a 30-month period at 25 UK paediatric critical care units (paediatric intensive care units/high-dependency units). Patients are eligible if admitted/accepted for admission, aged >36 weeks corrected gestational age and

Ethics and dissemination

This master protocol received favourable ethical opinion from National Health Service East of England—Cambridge South Research Ethics Committee (reference: 19/EE/0185) and approval from the Health Research Authority (reference: 260536). Results will be disseminated via publications in peer-reviewed medical journals and presentations at national and international conferences.

Trial registration number

ISRCTN60048867

Interventions with Music in PECTus excavatum treatment (IMPECT trial): a study protocol for a randomised controlled trial investigating the clinical effects of perioperative music interventions

Por: Billar · R. J. · Kühlmann · A. Y. R. · Schnater · J. M. · Vlot · J. · Tomas · J. J. P. · Zijp · G. W. · Rad · M. · de Beer · S. A. · Stevens · M. F. · Poley · M. J. · van Rosmalen · J. · Jeekel · J. F. · Wijnen · R. M. H.
Introduction

Pectus excavatum repair is associated with substantial postoperative pain, despite the use of epidural analgesia and other analgesic regimens. Perioperative recorded music interventions have been shown to alleviate pain and anxiety in adults, but evidence for children and adolescents is still lacking. This study protocol describes a randomised controlled trial that evaluates the effects of recorded music interventions on postoperative pain relief in children and adolescents after pectus excavatum repair.

Methods

A multicentre randomised controlled trial was set up comparing the effects of perioperative recorded music interventions in addition to standard care with those of standard care only in patients undergoing a Nuss procedure for pectus excavatum repair. One hundred and seventy subjects (12–18 years of age) will be included in three centres in the Netherlands. Patient inclusion has started in November 2018, and is ongoing. The primary outcome is self-reported perceived pain measured on the visual analogue scale. Secondary outcomes are anxiety level, analgesics consumption, vital parameters such as heart rate, blood pressure and respiratory rate, length of hospital stay, postoperative complications, quality of life and cost-effectiveness.

Ethics and dissemination

This study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.

Trial registration number

NL6863

Are we advancing universal health coverage through cataract services? Protocol for a scoping review

Por: Lee · C. N. · Ramke · J. · McCormick · I. · Zhang · J. H. · Aghaji · A. · Mwangi · N. · Burn · H. · Gordon · I. · Yusufu · M. · He · M. · Silva · J. C. · Burton · M. J.
Introduction

Universal health coverage (UHC) includes the dimensions of equity in access, quality services that improve health and protection against financial hardship. Cataract continues to be the leading cause of blindness globally, despite cataract surgery being an efficacious intervention. The aim of this scoping review is to map the nature, extent and global distribution of data on cataract services for UHC in terms of equity, access, quality and financial protection.

Methods and analysis

The search will be constructed by an Information Specialist and undertaken in MEDLINE, Embase and Global Health databases. We will include all published non-interventional primary research studies and systematic reviews that report a quantitative assessment of access, equity, quality or financial protection of cataract surgical services for adults at the subnational, national, regional or global level from population-based surveys or routinely collected health service data since 1 January 2000 and published through to February 2020.

Screening and data charting will be undertaken using Covidence systematic review software. Titles and abstracts of identified studies will be screened by two authors independently. Full-text articles of potentially relevant studies will be obtained and reviewed independently by two authors against the inclusion criteria. Any discrepancies between the authors will be resolved by discussion, and with a third author as necessary. A data charting form will be developed and piloted on three studies by three authors and amendments made as necessary. Data will be extracted by two reviewers independently and summarised narratively and using maps.

Ethics and dissemination

Ethical approval was not sought as the scoping review will only use published and publicly accessible data. The review will be published in an open access peer-reviewed journal. A summary of the results will be developed for website posting, stakeholder meetings and inclusion in the ongoing Lancet Global Health Commission on Global Eye Health.

Central neurobiological effects of physical exercise in individuals with chronic musculoskeletal pain: a systematic review

Por: de Zoete · R. M. J. · Chen · K. · Sterling · M.
Objective

Primary objectives: to investigate the central neurobiological effects (using MRI) of physical exercise in individuals with chronic pain. Secondary objectives: (1) to investigate the associations between central changes and clinical outcomes and (2) to investigate whether different types and dosages of physical exercise exert different central changes.

Design

Systematic review searching four electronic databases up to September 2018: AMED, CINAHL, Embase and MEDLINE. Two reviewers independently assessed the methodological quality of included studies using the Cochrane Collaboration’s Risk of Bias in Non-Randomised Studies-I tool. A standardised extraction table was used for data extraction, which was performed by two reviewers.

Interventions

Studies reporting any physical exercise intervention in any chronic musculoskeletal pain condition were included. Eligibility of 4011 records was screened independently by two reviewers, and four studies were included in the review.

Primary and secondary outcome measures

Primary outcome: any brain outcome assessed with any MR technique. Secondary outcomes: any self-reported clinical outcomes, and type and dosage of the exercise intervention.

Results

All four studies had high risk of bias. There was heterogeneity between the brain areas studied and the types of exercise interventions delivered. All studies reported functional MRI changes in various brain areas following an exercise intervention. Insufficient data were available to conduct a meta-analysis or to answer the secondary aims.

Conclusions

Only a limited number of studies were available and all were at high risk of bias. None of the studies was randomised or included blinded assessment. Exercise may exert effects on brain neurobiology in people with chronic pain. Due to the high risk of bias, future studies should use a randomised study design. Investigation of morphological brain changes could be included.

PROSPERO registration number

CRD42018108179.

Learning a new way of living together: a qualitative study exploring the relationship changes and intervention needs of patients with cardiovascular disease and their partners

Por: Tulloch · H. · Bouchard · K. · Clyde · M. J. · Madrazo · L. · Demidenko · N. · Johnson · S. · Greenman · P.
Objectives

Cardiovascular disease (CVD) not only affects the patient, but has implications for the partner. Emerging evidence suggests that supportive couple relationships enhance CVD outcomes and reduce patient and partner distress. To date, however, little research has been done to address the couple relationship as a potentially important component of cardiac care. This article examines the impact of CVD on the couple relationship and assesses the perceived needs and desired intervention components of patients with CVD and their partners.

Design

Qualitative study using directed and conventional content analysis.

Setting

Single-centre, tertiary cardiac care hospital that serves a population of 1.4 million in the Champlain region of Ontario, Canada.

Participants

Patients with CVD and their partners (n=32, 16 couples) participated in focus groups. Patients were mainly male (75%), white (87.5%), aged 64.4 years (range 31–81 years), with varied cardiac diagnoses (50% coronary artery disease; 18.75% valve disease; 18.75% heart failure; 12.5% arrhythmia).

Results

Five categories were generated from the data reflecting changes within the couple relationship as a result of CVD: (1) emotional and communication disconnection; (2) overprotection of the patient; (3) role changes; (4) adjustment to lifestyle changes; and (5) positive relationship changes. Three categories were constructed regarding intervention needs and desired resources: (1) practical resources; (2) sharing with peers; and (3) relationship enhancement.

Conclusions

Overall, the data suggest that there were profound changes in the couple relationship as a result of CVD, and that there is considerable need to better support the caregiving spouses and the couple as a unit. These results call for interventions designed to provide instrumental support, peer-sharing opportunities and relationship quality enhancement to help couples cope with CVD. Future studies should examine whether couples-based programming embedded into cardiac rehabilitation can be effective at improving relationship quality and reducing patient and partner stress in the aftermath of a cardiac event.

Response to physical rehabilitation and recovery trajectories following critical illness: individual participant data meta-analysis protocol

Por: Jones · J. R. A. · Berney · S. · Berry · M. J. · Files · D. C. · Griffith · D. M. · McDonald · L. A. · Morris · P. E. · Moss · M. · Nordon-Craft · A. · Walsh · T. · Gordon · I. · Karahalios · A. · Puthucheary · Z. · Denehy · L. · CRITICALConnect Study Investigators · Berney · Berry
Introduction

The number of inconclusive physical rehabilitation randomised controlled trials for patients with critical illness is increasing. Evidence suggests critical illness patient subgroups may exist that benefit from targeted physical rehabilitation interventions that could improve their recovery trajectory. We aim to identify critical illness patient subgroups that respond to physical rehabilitation and map recovery trajectories according to physical function and quality of life outcomes. Additionally, the utilisation of healthcare resources will be examined for subgroups identified.

Methods and analysis

This is an individual participant data meta-analysis protocol. A systematic literature review was conducted for randomised controlled trials that delivered additional physical rehabilitation for patients with critical illness during their acute hospital stay, assessed chronic disease burden, with a minimum follow-up period of 3 months measuring performance-based physical function and health-related quality of life outcomes. From 2178 records retrieved in the systematic literature review, four eligible trials were identified by two independent reviewers. Principal investigators of eligible trials were invited to contribute their data to this individual participant data meta-analysis. Risk of bias will be assessed (Cochrane risk of bias tool for randomised trials). Participant and trial characteristics, interventions and outcomes data of included studies will be summarised. Meta-analyses will entail a one-stage model, which will account for the heterogeneity across and the clustering between studies. Multiple imputation using chained equations will be used to account for the missing data.

Ethics and dissemination

This individual participant data meta-analysis does not require ethical review as anonymised participant data will be used and no new data collected. Additionally, eligible trials were granted approval by institutional review boards or research ethics committees and informed consent was provided for participants. Data sharing agreements are in place permitting contribution of data. The study findings will be disseminated at conferences and through peer-reviewed publications.

PROSPERO registration number

CRD42019152526.

Evaluating the Alimentary and Respiratory Tracts in Health and disease (EARTH) research programme: a protocol for prospective, longitudinal, controlled, observational studies in children with chronic disease at an Australian tertiary paediatric hospital

Por: Coffey · M. J. · McKay · I. R. · Doumit · M. · Chuang · S. · Adams · S. · Stelzer-Braid · S. · Waters · S. A. · Kasparian · N. A. · Thomas · T. · Jaffe · A. · Katz · T. · Ooi · C. Y.
Introduction

Chronic gastrointestinal and respiratory conditions of childhood can have long-lasting physical, psychosocial and economic effects on children and their families. Alterations in diet and intestinal and respiratory microbiomes may have important implications for physical and psychosocial health. Diet influences the intestinal microbiome and should be considered when exploring disease-specific alterations. The concepts of gut-brain and gut-lung axes provide novel perspectives for examining chronic childhood disease(s). We established the ‘Evaluating the Alimentary and Respiratory Tracts in Health and disease’ (EARTH) research programme to provide a structured, holistic evaluation of children with chronic gastrointestinal and/or respiratory conditions.

Methods and analysis

The EARTH programme provides a framework for a series of prospective, longitudinal, controlled, observational studies (comprised of individual substudies), conducted at an Australian tertiary paediatric hospital (the methodology is applicable to other settings). Children with a chronic gastrointestinal and/or respiratory condition will be compared with age and gender matched healthy controls (HC) across a 12-month period. The following will be collected at baseline, 6 and 12 months: (i) stool, (ii) oropharyngeal swab/sputum, (iii) semi-quantitative food frequency questionnaire, (iv) details of disease symptomatology, (v) health-related quality of life and (vi) psychosocial factors. Data on the intestinal and respiratory microbiomes and diet will be compared between children with a condition and HC. Correlations between dietary intake (energy, macro-nutrients and micro-nutrients), intestinal and respiratory microbiomes within each group will be explored. Data on disease symptomatology, quality of life and psychosocial factors will be compared between condition and HC cohorts.

Results will be hypothesis-generating and direct future focussed studies. There is future potential for direct translation into clinical care, as diet is a highly modifiable factor.

Ethics and dissemination

Ethics approval: Sydney Children’s Hospitals Network Human Research Ethics Committee (HREC/18/SCHN/26). Results will be presented at international conferences and published in peer-reviewed journals.

Trial registration number

NCT04071314

Prevalence and clinical implications of respiratory viruses in stable chronic obstructive pulmonary disease (COPD) and exacerbations: a systematic review and meta-analysis protocol

Por: Kefala · A. M. · Fortescue · R. · Alimani · G. S. · Kanavidis · P. · McDonnell · M. J. · Magiorkinis · E. · Megremis · S. · Paraskevis · D. · Voyiatzaki · C. · Mathioudakis · G. A. · Papageorgiou · E. · Papadopoulos · N. G. · Vestbo · J. · Beloukas · A. · Mathioudakis · A. G.
Introduction

Both stable chronic obstructive pulmonary disease (COPD) and acute exacerbations represent leading causes of death, disability and healthcare expenditure. They are complex, heterogeneous and their mechanisms are poorly understood. The role of respiratory viruses has been studied extensively but is still not adequately addressed clinically. Through a rigorous evidence update, we aim to define the prevalence and clinical burden of the different respiratory viruses in stable COPD and exacerbations, and to investigate whether viral load of usual respiratory viruses could be used for diagnosis of exacerbations triggered by viruses, which are currently not diagnosed or treated aetiologically.

Methods and analysis

Based on a prospectively registered protocol, we will systematically review the literature using standard methods recommended by the Cochrane Collaboration and the Grading of Recommendations Assessment, Development and Evaluation working group. We will search Medline/PubMed, Excerpta Medica dataBASE (EMBASE), the Cochrane Library, the WHO’s Clinical Trials Registry and the proceedings of relevant international conferences on 2 March 2020. We will evaluate: (A) the prevalence of respiratory viruses in stable COPD and exacerbations, (B) differences in the viral loads of respiratory viruses in stable COPD vs exacerbations, to explore whether the viral load of prevalent respiratory viruses could be used as a diagnostic biomarker for exacerbations triggered by viruses and (C) the association between the presence of respiratory viruses and clinical outcomes in stable COPD and in exacerbations.

Ethics and dissemination

Ethics approval is not required since no primary data will be collected. Our findings will be presented in national and international scientific conferences and will be published in peer reviewed journals. Respiratory viruses currently represent a lost opportunity to improve the outcomes of both stable COPD and exacerbations. Our work aspires to ‘demystify’ the prevalence and clinical burden of viruses in stable COPD and exacerbations and to promote clinical and translational research.

PROSPERO registration number

CRD42019147658.

Accuracy and consequences of using trial-of-antibiotics for TB diagnosis (ACT-TB study): protocol for a randomised controlled clinical trial

Por: Divala · T. H. · Fielding · K. L. · Sloan · D. J. · French · N. · Nliwasa · M. · MacPherson · P. · Kandulu · C. C. · Chiume · L. · Chilanga · S. · Ndaferankhande · M. J. · Corbett · E. L.
Introduction

Over 40% of global tuberculosis case notifications are diagnosed clinically without mycobacteriological confirmation. Standard diagnostic algorithms include ‘trial-of-antibiotics’—empirical antibiotic treatment given to mycobacteriology-negative individuals to treat infectious causes of symptoms other than tuberculosis, as a ‘rule-out’ diagnostic test for tuberculosis. Potentially 26.5 million such antibiotic courses/year are prescribed globally for the 5.3 million/year mycobacteriology-negative patients, making trial-of-antibiotics the most common tuberculosis diagnostic, and a global-scale risk for antimicrobial resistance (AMR). Our systematic review found no randomised controlled trial (RCT) to support use of trial-of-antibiotic. The RCT aims to determine the diagnostic and clinical value and AMR consequences of trial-of-antibiotics.

Methods and analysis

A three-arm, open-label, RCT randomising (1:1:1) Malawian adults (≥18 years) seeking primary care for cough into: (a) azithromycin 500 mg one time per day for 3 days or (b) amoxicillin 1 g three times per day for 5 days or (c) standard-of-care (no immediate antibiotic). We will perform mycobacteriology tests (microscopy, Xpert MTB/RIF (Mycobacterium tuberculosis/rifampicin) and Mycobacterium tuberculosis culture) at baseline. We will use audiocomputer-assisted self-interview to assess clinical improvement at day 8. First primary outcome will be proportion of patients reporting day 8 improvement out of those with negative mycobacteriology (specificity). Second primary outcome will be day 29 incidence of a composite endpoint of either death or hospitalisation or missed tuberculosis diagnosis. To determine AMR impact we compare proportion of resistant nasopharyngeal Streptococcus pneumoniae isolates on day 29. 400 mycobacteriology-negative participants/arm will be required to detect a ≥10% absolute difference in diagnostic specificity with 80% power. We will estimate measures of effect by comparing outcomes in antibiotic arms (combined and individually) to standard-of-care.

Ethics and dissemination

The study has been reviewed and approved by Malawi College of Medicine Research and Ethics Committee, London School of Hygiene & Tropical Medicine (LSHTM) Research Ethics Committee and Regional Committee for Health and Research Ethics – Norway, and Malawi Pharmacy, Medicines and Poisons Board. We will present abstracts at relevant conferences, and prepare a manuscript for publication in a peer-reviewed journal.

Trial registration number

The clinical trial is registered with ClinicalTrials.gov, NCT03545373

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