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Hoy — Abril 13th 2021Tus fuentes RSS

Randomised controlled feasibility trial of an active communication education programme plus hearing aid provision versus hearing aid provision alone (ACE To HEAR)

Por: Watson · J. · Coleman · E. · Jackson · C. · Bell · K. · Maynard · C. · Hickson · L. · Forster · A. · Fairhurst · C. · Hewitt · C. · Gardner · R. · Iley · K. · Gailey · L. · Thyer · N. J.
Objective

To establish the acceptability and feasibility of delivering the Active Communication Education (ACE) programme to increase quality of life through improving communication and hearing aid use in the UK National Health Service.

Design

Randomised controlled, open feasibility trial with embedded economic and process evaluations.

Setting

Audiology departments in two hospitals in two UK cities.

Participants

Twelve hearing aid users aged 18 years or over who reported moderate or less than moderate benefit from their new hearing aid.

Interventions

Consenting participants (along with a significant other) were to be randomised by a remote, centralised randomisation service in groups to ACE plus treatment-as-usual (intervention group) or treatment-as-usual only (control group).

Primary outcome measures

The primary outcomes were related to feasibility: recruitment, retention, treatment adherence and acceptability to participants and fidelity of treatment delivery.

Secondary outcome measures

International Outcomes Inventory for Hearing Aids, Self-Assessment of Communication, EQ-5D-5L and Short-Form 36. Blinding of the participants and facilitator was not possible.

Results

Twelve hearing aid users and six significant others consented to take part. Eight hearing aid users were randomised: four to the intervention group; and four to treatment-as-usual only. Four significant others participated alongside the randomised participants. Recruitment to the study was very low and centres only screened 466 hearing aid users over the 15-month recruitment period, compared with the approximately 3500 anticipated. Only one ACE group and one control group were formed. ACE could be delivered and appeared acceptable to participants. We were unable to robustly assess attrition and attendance rates due to the low sample size.

Conclusions

While ACE appeared acceptable to hearing aid users and feasible to deliver, it was not feasible to identify and recruit participants struggling with their hearing aids at the 3-month posthearing aid fitting point.

Trial registration number

ISRCTN28090877.

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Population-based otoscopic and audiometric assessment of a birth cohort recruited for a pneumococcal vaccine trial 15-18 years earlier: a protocol

Por: Chan · K. · Carosone-Link · P. · Bautista · M. T. G. · Sanvictores · D. · Uhler · K. · Tallo · V. · Lucero · M. G. · De Jesus · J. · Simoes · E. A. F.
Introduction

A cohort of 12 000 children in the Philippines who had enrolled in a 2000–2004 (current ages 16 to 20 years) Phase 3 11-valent pneumococcal conjugate vaccine for the prevention of radiographically confirmed pneumonia are now being asked to participate in a separate study (expected completion date September 2021) to assess the cohort’s current long-term audiometric and otologic status. This new study would allow assessments of the utility of the pneumococcal vaccine in conferring its protective effects on the long-term sequelae of otitis media (OM), if any. Lack of trained local healthcare providers in otolaryngology/audiology and testing equipment in Bohol, Philippines, necessitates the development of a distinct methodology that would lead to meaningful data analysis.

Methods and analysis

Reliable data collection and transfer are achieved by a US otolaryngologist/audiologist team training local nurses on all procedures in a didactic and hands-on process. An assortment of portable otolaryngologic and audiologic equipment suitable for field testing has been acquired, including an operating otoscope (Welch-Allyn), a video-otoscope (JedMed), a tympanometer with distortion product otoacoustic emission measurements (Path Sentiero) and a screening audiometer (HearScreen). Data will then be uploaded to a Research Electronic Data Capture database in the USA.

Tympanometric and audiologic data will be codified through separate conventional algorithms. A team of paediatric otolaryngology advanced practice providers (APPs) have been trained and validated in interpreting video otoscopy. The protocol for classification of diagnostic outcome variables based on video otoscopy and tympanometry has been developed and is being used by APPs to evaluate all otoscopy data.

Ethics and dissemination

The study was approved by the Research Institute of Tropical Medicine, Alabang, Manila, Philippines, and the institutional review board and the Colorado Multiple Institutional Review Board of the University of Colorado School of Medicine, Aurora, Colorado, USA.

Research results will be made available to children and their caregivers with abnormal audiologic outcomes, the funders and other researchers.

Trial registration number

ISRCTN 62323832; Post-results.

Endoscopic polypectomy performed in clinic for chronic rhinosinusitis with nasal polyps: study protocol for the EPIC multicentre randomised controlled trial

Por: Kilty · S. · Thavorn · K. · Janjua · A. · Lee · J. · MacDonald · K. · Meen · E. · Micomonaco · D. · Rotenberg · B. · Sowerby · L. J. · Tewfik · M. · Adams · S. · Frenette · H. · Lasso · A. · Fergusson · D. A.
Introduction

Chronic rhinosinusitis (CRS) is common, with a Canadian prevalence of 5%, and associated with significant morbidity. Understandably, CRS impairs workplace productivity but that productivity substantially increases following surgical treatment. CRS with nasal polyps (CRSwNP), the most common type of CRS, is usually treated with a combination of medications and endoscopic sinus surgery (ESS). Historically, surgical treatment has only been performed in the operating room at a cost of about $C3500. However, recent studies have shown that a de-escalated procedure, endoscopic polypectomy performed in clinic (EPIC), can provide an improvement in patient symptoms to levels equal to those for ESS. Moreover, EPIC has additional proposed advantages including shorter recovery time, significantly lower cost to the healthcare system and shorter wait time for the patient. There is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRSwNP.

Methods and analysis

We designed a multicentre, open-label, randomised controlled trial to evaluate whether EPIC was non-inferior to the current clinical standard, ESS for the treatment of CRSwNP. The primary outcome is the Sinonasal Outcome Test-22 score measured at baseline and at 3 months after surgery. Other outcomes include peak nasal inspiratory flow, quality of life measured by the EuroQoL 5 Dimensions 5 Levels questionnaire and work impairment using the Work Productivity and Activity Impairment Questionnaire.

We aim to recruit 140 patients from sites across Canada. Participants will be randomly assigned to EPIC or ESS and followed up for 3 months in clinic after the procedure. Additionally, participants will enter a 5-year long-term follow-up period.

Ethics and dissemination

This study was approved by the Ottawa Health Sciences Network Research Ethics Board for all sites in Ontario, Canada (study number CTO0801). Sites located outside of Ontario obtained approval from their local/institutional research ethics board.

Trial registration number

NCT02975310.

Effectiveness of ear, nose and throat outreach programmes for Aboriginal and Torres Strait Islander Australians: a systematic review

Por: Gotis-Graham · A. · Macniven · R. · Kong · K. · Gwynne · K.
Objective

To examine the ability of ear, nose and throat (ENT) outreach programmes to improve health outcomes among Aboriginal and Torres Strait Islander people.

Methods

We conducted a systematic literature search of nine databases (Medline, CINAHLS, PsycINFO, Embase, Cochrane, Scopus, Global health, Informit Rural health database and Indigenous collection) and grey literature sources for primary studies evaluating ENT outreach services for Aboriginal and Torres Strait Islander people. This review included English language studies of all types, published between 2000 and 2018, that supplied ENT outreach services to Aboriginal and Torres Strait Islander Australians and provided data to evaluate their aims. Two authors independently evaluated the eligible articles and extracted relevant information. Risk of bias was assessed using the Mixed Methods Assessment Tool.

Results

Of the 506 studies identified, 15 were included in this review. These 15 studies evaluated eight different programs/activities. Studies were heterogeneous in design so a meta-analysis could not be conducted. Seven studies measured health-related outcomes in middle ear or hearing status; six reported overall positive changes one reported no clinically significant improvements. Five programmes/activities and their corresponding studies involved Aboriginal and Torres Strait Islander people and organisations in delivery and evaluation, but involvement in programme or study design was unclear.

Conclusion

While some studies demonstrated improved outcomes, the overall ability of ENT programmes to improve health outcomes for Aboriginal and Torres Strait Islander children is unclear. The impact of ENT outreach may be limited by a lack of quality evidence, service coordination and sustainability. Community codesign and supporting and resourcing local capacity must be a component of outreach programmes and ongoing evaluation is also recommended. Improvements in these areas would likely improve health outcomes.

PROSPERO registration number

CRD42019134757.

Laryngopharyngeal reflux in war-torn Syria and its association with smoking and other risks: an online cross-sectional population study

Por: Kakaje · A. · Alhalabi · M. M. · Alyousbashi · A. · Hamid · A. · Mahmoud · Y.
Objectives

To demonstrate the burden of laryngopharyngeal reflux (LPR) in Syria and its associated variables.

Design

This is a cross-sectional study that used online questionnaires that included demographics, smoking, war-related questions and reflux symptom index (RSI).

Setting

This research was conducted online across Syria and included the general population.

Participants

Participants who lived in Syria, agreed to participate, and responded to all the RSI questions were included. This research comprised 734 participants, with 94.6% response rate, 75.5% being females, and a mean age of 24 years.

Results

Overall, 31.9% of subjects had symptoms suggestive of LPR. Participants who were 30 years and younger had fewer symptoms suggestive of LPR compared with the older group p=0.012 (OR 0.534; 95% CI 0.325 to 0.877). While having an epigastric burning sensation, chest pain and indigestion were the most common symptoms, having a sore throat was the least common. Being distressed from war noises was associated with more symptoms p=0.009 (OR 1.562; 95% CI 1.117 to 2.183). However, losing someone or changing place of living due to war were not significantly associated with these symptoms p>0.05. RSI scores were associated with cigarette and/or shisha smoking p

Conclusions

War, smoking, asthma, allergies, respiratory conditions and having a job were associated with LPR symptoms. However, they may be associated with these symptoms independently from LPR; for instance, similar symptoms can be caused by the mental disorders from war, the unique environment and irritant substances of the laryngeal mucosa.

Needs assessment for a decision support tool in oral cancer requiring major resection and reconstruction: a mixed-methods study protocol

Por: Forner · D. · Hong · P. · Corsten · M. · Rac · V. E. · Martino · R. · Shuman · A. G. · Chepeha · D. B. · Sawka · A. M. · de Almeida · J. R. · Irish · J. C. · Brown · D. H. · Taylor · S. M. · Gullane · P. J. · Trites · J. R. · Gilbert · R. · Rigby · M. H. · Ringash · J. · Goldstein · D.
Introduction

Advanced oral cancer and its ensuing treatment engenders significant morbidity and mortality. Patients are often elderly with significant comorbidities. Toxicities associated with surgical resection can be devastating and they are often highlighted by patients as impactful. Given the potential for suboptimal oncological and functional outcomes in this vulnerable patient population, promotion and performance of shared decision making (SDM) is crucial.

Decision aids (DAs) are useful instruments for facilitating the SDM process by presenting patients with up-to-date evidence regarding risks, benefits and the possible postoperative course. Importantly, DAs also help elicit and clarify patient values and preferences. The use of DAs in cancer treatment has been shown to reduce decisional conflict and increase SDM. No DAs for oral cavity cancer have yet been developed.

This study endeavours to answer the question: Is there a patient or surgeon driven need for development and implementation of a DA for adult patients considering major surgery for oral cancer?

Methods and analysis

This study is the first step in a multiphase investigation of SDM during major head and neck surgery. It is a multi-institutional convergent parallel mixed-methods needs assessment study. Patients and surgeon dyads will be recruited to complete questionnaires related to their perception of the SDM process (nine-item Shared Decision-Making Questionnaire, SDM-Q-9 and SDM-Q-Doc) and to take part in semistructured interviews. Patients will also complete questionnaires examining decisional self-efficacy (Ottawa Decision Self-Efficacy Scale) and decisional conflict (Decisional Conflict Scale). Questionnaires will be completed at time of recruitment and will be used to assess the current level of SDM, self-efficacy and conflict in this setting. Thematic analysis will be used to analyse transcripts of interviews. Quantitative and qualitative components of the study will be integrated through triangulation, with matrix developed to promote visualisation of the data.

Ethics and Dissemination

This study has been approved by the research ethics boards of the Nova Scotia Health Authority (Halifax, Nova Scotia) and the University Health Network (Toronto, Ontario). Dissemination to clinicians will be through traditional approaches and creation of a head and neck cancer SDM website. Dissemination to patients will include a section within the website, patient advocacy groups and postings within clinical environments.

End-stage renal disease as a risk factor for epiglottitis: a population-based cohort study in Taiwan

Por: Tsai · Y.-T. · Tsai · M.-S. · Hsu · C.-M. · Fang · K.-H. · Huang · E. I. · Liu · C.-Y. · Lin · M.-H. · Yang · Y.-H. · Lee · Y.-C. · Chang · G.-H.
Objectives

Patients with uremia are prone to infection; however, end-stage renal disease (ESRD) as a risk factor for acute epiglottitis warrants study. We investigated the risk of severe epiglottitis requiring hospitalisation in patients with ESRD.

Setting

We conducted a retrospective matched cohort study by using the claims data of Taiwan’s National Health Insurance Research Database.

Participants

We identified an ESRD cohort with 87 908 patients newly diagnosed in 2000–2013 and underwent dialysis. The non-ESRD cohort comprised patients who had not received a diagnosis of ESRD, and they were matches to the ESRD cohort (1:1) by sex, age, residence urbanisation level, monthly income, and diabetes and hypertension status.

Primary and secondary outcome measures

The cumulative incidence of epiglottitis at the end of 2013 was analysed with Kaplan-Meier methods and log-rank tests. The HR of epiglottitis was calculated using the Cox proportional hazards model after adjustment for confounding factors.

Results

The overall epiglottitis incidence rate was 94% greater in the ESRD cohort than in the non-ESRD cohort (10.3 vs 5.3 cases per 100 000 person-years, p=0.002), with an adjusted HR of 1.89 (95% CI: 1.23 to 2.91, p=0.004). In the log-rank analysis, compared with the non-ESRD group, the epiglottitis cumulative incidence was significantly higher in the ESRD group (p=0.003). Epiglottitis did not exhibit an association with higher rates of airway interventions, intensive care unit admissions or longer hospitalisation in patients with ESRD than in controls.

Conclusions

This nationwide matched cohort study indicated that ESRD patients should be monitored for the risk of severe epiglottitis requiring hospitalisation.

Applications of qualitative grounded theory methodology to investigate hearing loss: protocol for a qualitative systematic review

Por: Ali · Y. H. K. · Wright · N. · Charnock · D. · Henshaw · H. · Hoare · D.
Introduction

Hearing loss is a chronic condition affecting 12 million individuals in the UK. People with hearing loss regularly experience difficulties interacting in everyday conversations. These difficulties in communication can result in a person with hearing loss withdrawing from social situations and becoming isolated. While hearing loss research has largely deployed quantitative methods to investigate various aspects of the condition, qualitative research is becoming more widespread. Grounded theory is a specific qualitative methodology that has been used to establish novel theories on the experiences of living with hearing loss.

Method and analysis

The aim of this systematic review is to establish how grounded theory has been applied to investigate the psychosocial aspects of hearing loss. Methods are reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols 2015 checklist. Studies included in this review will have applied grounded theory as an overarching methodology or have grounded theory embedded among other methodologies. Studies included will have adult participants (≥18 years) who are either people with an acquired hearing loss, their family and friends (communication partners), or healthcare practitioners including audiologists, general practitioners, ear, nose and throat specialists and hearing therapists. The quality of application of grounded theory in each study will be assessed using the Guideline for Reporting and Evaluating Grounded Theory Research Studies.

Ethics and dissemination

As only secondary data will be used in this systematic review, ethical approval is not required. No other ethical issues are foreseen. This review is registered with the International Prospective Register of Systematic Reviews (http://www.crd.york.ac.uk/PROSPERO). Findings will be disseminated via peer-reviewed publications and at relevant academic conferences. Findings may also be published in relevant professional and third sector newsletters and magazines as appropriate. Data will inform future research and guideline development.

PROSPERO registration number

CRD42019134197.

Taste test using an edible taste film kit: a randomised controlled trial

Por: Kim · J.-s. · Kim · D.-H. · Jeon · E.-j. · Kim · B. G. · Yu · J. · Shin · H.-I.
Objectives

We developed an edible taste film test that can be stored easily as a kit. This study was conducted to confirm the agreement between the results of the edible taste film kit test and the conventional taste solution test.

Design

Prospective, randomised, controlled trial.

Setting

Single tertiary hospital.

Participants

Sixty-two healthy volunteers with no self-described taste problems.

Interventions

A randomisation scheme was used to determine the order of use of the edible taste film kit and the taste solution test for each subject. The taste solution test was performed using a cotton swab. In the taste film kit test, an edible taste film was placed on the tongue, and the subject detected the taste after the film was dissolved by saliva.

Outcome measures

For each test, we measured the taste identification threshold, taste detection time and total test time.

Results

We confirmed the consistency of the taste identification thresholds of the two tests, and the results were consistent with each other except for the bitter taste results, which used coffee in the edible taste film kit and quinine in the taste solution test. Although the detection time for each taste quality was faster for the taste solution test, the mean total time was significantly shorter for the taste film kit test than for the taste solution test (6.16±2.27 min vs 7.04±1.98 min, respectively; p=0.004).

Conclusions

The edible taste film kit along with the taste solution test will be useful for quantitative taste testing.

Trial registration number

KCT0002865.

Drug-induced sleep endoscopy compared with systematic adenotonsillectomy in the management of obstructive sleep apnoea in children: a systematic review and meta-analysis protocol

Por: Prevost · A.-S. · Hylands · M. · Gervais · M. · Praud · J.-P. · Battista · M.-C. · Deziel-Malouin · S. · Lachance · M. · Lamontagne · F.
Introduction

Obstructive sleep apnoea affects up to 6% of children worldwide. Although current guidelines recommend systematic tonsillectomy and adenoidectomy, many children do not benefit from these interventions. Drug-induced sleep endoscopy (DISE) allows the dynamic evaluation of patients’ airways to identify the specific anatomic sites of obstruction. This intervention can potentially guide subsequent invasive procedures to optimise outcomes and minimise the number of children exposed to unnecessary operations.

Methods and analysis

We will identify randomised controlled trials and controlled observational studies comparing DISE-directed interventions to systematic tonsillectomy and adenoidectomy in paediatric populations. We will search MEDLINE, EMBASE, CINAHL, CENTRAL as well as clinical trial registries and conference proceedings (initial electronic search date 9 October 2018). Screening, data extraction and risk of bias assessments will be performed in duplicate by independent reviewers. We will use the Grading of Recommendations Assessment, Development and Evaluation approach to assess the overall quality of evidence and present our results.

Ethics and dissemination

Ethics approval is not required for this systematic review of published data. This review will be presented according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We will present our findings at otorhinolaryngology conferences and publish a report in a peer-reviewed journal.

PROSPERO registration number

CRD42018085370.

Effect modification by gender of the influence of obstructive sleep apnoea characteristics on dyslipidaemia in China: a cross-sectional study

Por: Xia · Y. · Zou · J. · Xu · H. · Yi · H. · Guan · J. · Yin · S.
Objectives

Obstructive sleep apnoea (OSA) characteristics differ by gender, possibly affecting any association between OSA and dyslipidaemia. We explored whether gender influenced any association between OSA characteristics and dyslipidaemia.

Methods/Design

This was a cross-sectional, large-scale hospital-based study. Male and female risks of dyslipidaemia by OSA characteristics were assessed with logistic regression. Additive interactions were measured using three indices: the relative excess risk due to interaction, the attributable proportion due to interaction and the synergy index. Multiplicative interaction was evaluated via logistic regression.

Setting

A single secondary-care setting in China.

Participants

3760 patients with OSA.

Primary and secondary outcome measures

Outcomes were male and female risks of dyslipidaemia, and the associated additive and multiplicative interactions between the apnoea–hypopnea index (AHI), the oxygen-desaturation index (ODI), the microarousal index (MAI), and gender.

Results

After controlling for confounding factors, males (but not females) with AHIs>30 were at higher risk of hyper-total cholesterol (TC), hypo-high-density lipoprotein cholesterol (HDL-C) status and a hyper-TC/HDL-C ratio than males with AHIs≤30. Positive additive interactions were evident between the male gender and AHI on a hyper-TC/HDL-C ratio and hypo-HDL-C status. Males with ODIs>40.1 were at higher risk of hypo-HDL-C status and a hyper-TC/HDL-C ratio than males with ODIs≤40.1. Positive additive and multiplicative interactions were evident between male gender and ODI on hyper-TC/HDL-C ratio. Males with MAIs>28.6 were at higher risk of hyper-TC and hyper-low-density lipoprotein cholesterol status than males with MAIs≤28.6, but no statistically significant interactions were apparent between gender and MAI.

Conclusions

Males (but not females) with higher AHIs, ODIs or MAIs were at higher risks of some measures of dyslipidaemia. Positive interactions between male and severe OSA or intermittent hypoxia on some measures of dyslipidaemia were apparent. Thus, dyslipidaemia should be evaluated in patients with OSA, especially males with severe OSA or intermittent hypoxia.

Effects of adenotonsillectomy on the growth of children with obstructive sleep apnoea-hypopnea syndrome (OSAHS): protocol for a systematic review

Por: Hua · F. · Zhao · T. · Walsh · T. · Sun · Q. · Chen · X. · Worthington · H. · Jiang · F. · He · H.
Introduction

Obstructive sleep apnoea-hypopnea syndrome (OSAHS) is characterised by recurring episodes of complete or partial upper airway collapse during sleep. Persistent OSAHS is associated with long-term consequences, such as growth failure, cardiovascular and neurocognitive problems in children. Different from the aetiology of OSAHS in adults, the most common cause of paediatric OSAHS is adenotonsillar hypertrophy. Adenotonsillectomy (AT) has been recommended as the first-line treatment of paediatric OSAHS. Several studies have suggested that retarded growth caused by OSAHS can improve after AT during the prepubertal period. This review will systematically search and summarise the available evidence on the effects of AT on children’s growth.

Methods and analysis

We will conduct electronic searches in MEDLINE (via PubMed), Embase, Google Scholar and the Cochrane Central Register of Controlled Trials for randomised controlled trials (RCTs) or cohort studies that included a control group. Additional records will be searched by checking the references included in the selected studies and relevant reviews. At least two authors will undertake selection of studies and data extraction independently and in duplicate. The Cochrane Risk of Bias tool and Risk Of Bias In Non-randomised Studies—of Interventions will be used to assess the risk of bias of RCT and cohort studies, respectively. A random-effects model will be used for meta-analyses. Data synthesis and other analyses will be carried out using the RevMan V.5.3 software. The Grades of Recommendation, Assessment, Development and Evaluation will be used to assess the quality of the supporting evidence behind each main comparison.

Ethics and dissemination

There is no ethical issue in this systematic review given that we will only include published studies. The results will be disseminated via peer-reviewed publications and social networks.

PROSPERO registration number

CRD42019125882

An auditory brainstem implant for treatment of unilateral tinnitus: protocol for an interventional pilot study

Por: van den Berge · M. J. C. · van Dijk · M. J. M. C. · Metzemaekers · J. D. M. · Maat · B. · Free · R. H. · van Dijk · P.
Introduction

Tinnitus may have a very severe impact on the quality of life. Unfortunately, for many patients, a satisfactory treatment modality is lacking. The auditory brainstem implant (ABI) was originally indicated for hearing restoration in patients with non-functional cochlear nerves, for example, in neurofibromatosis type II. In analogy to a cochlear implant (CI), it has been demonstrated that an ABI may reduce tinnitus as a beneficial side effect. For tinnitus treatment, an ABI may have an advantage over a CI, as cochlear implantation can harm inner ear structures due to its invasiveness, while an ABI is presumed to not damage anatomical structures. This is the first study to implant an ABI to investigate its effect on intractable tinnitus.

Methods and analysis

In this pilot study, 10 adults having incapacitating unilateral intractable tinnitus and ipsilateral severe hearing loss will have an ABI implanted. The ABI is switched on 6 weeks after implantation, followed by several fitting sessions aimed at finding an optimal stimulation strategy. The primary outcome will be the change in Tinnitus Functioning Index. Secondary outcomes will be tinnitus burden and quality of life (using Tinnitus Handicap Inventory and Hospital Anxiety and Depression Scale questionnaires), tinnitus characteristics (using Visual Analogue Scale, a tinnitus analysis), safety, audiometric and vestibular function. The end point is set at 1 year after implantation. Follow-up will continue until 5 years after implantation.

Ethics and dissemination

The protocol was reviewed and approved by the Institutional Review Board of the University Medical Centre Groningen, The Netherlands (METc 2015/479). The trial is registered at www.clinicialtrials.gov and will be updated if amendments are made. Results of this study will be disseminated in peer-reviewed journals and at scientific conferences.

Trial registration number

NCT02630589.

Trial status

Inclusion of first patient in November 2017. Data collection is in progress. Trial is open for further inclusion. The trial ends at 5 years after inclusion of the last patient.

Chronic rhinosinusitis: a qualitative study of patient views and experiences of current management in primary and secondary care

Por: Vennik · J. · Eyles · C. · Thomas · M. · Hopkins · C. · Little · P. · Blackshaw · H. · Schilder · A. · Savage · I. · Philpott · C. M.
Objectives

To explore patient views and perspectives of current management of chronic rhinosinusitis (CRS) in primary and secondary care.

Design

Semistructured qualitative telephone interviews as part of the MACRO programme (Defining best Management for Adults with Chronic RhinOsinusitis).

Setting

Primary care and secondary care ear, nose and throat outpatient clinics in the UK.

Participants

Twenty-five patients consented to in-depth telephone interviews. Transcribed recordings were managed using NVivo software and analysed using inductive thematic analysis.

Results

CRS has a significant impact on patients’ quality of life, affecting their ability to work effectively, their social interactions and daily living. Patients seek help when symptoms become unmanageable, but can become frustrated with the primary care system with difficulties obtaining an appointment, and lack of continuity of care. Patients perceive that general practitioners can be dismissive of CRS symptoms, and patients often prioritise other concerns when they consult. Health system barriers and poor communication can result in delays in accessing appropriate treatment and referral. Adherence to intranasal steroids is a problem and patients are uncertain about correct technique. Nasal irrigation can be time-consuming and difficult for patients to use. Secondary care consultations can appear rushed, and patients would like specialists to take a more ‘holistic’ approach to their management. Surgery is often considered a temporary solution, appropriate when medical options have been explored.

Conclusions

Patients are frustrated with the management of their CRS, and poor communication can result in delays in receiving appropriate treatment and timely referral. Patients seek better understanding of their condition and guidance to support treatments decisions in light of uncertainties around the different medical and surgical options. Better coordinated care between general practice and specialist settings and consistency of advice has the potential to increase patient satisfaction and improve outcomes.

Hearing Norton Sound: mixed methods protocol of a community randomised trial to address childhood hearing loss in rural Alaska

Por: Emmett · S. D. · Robler · S. K. · Gallo · J. J. · Wang · N.-Y. · Labrique · A. · Hofstetter · P.
Introduction

Childhood hearing loss has implications for school achievement, economic outcomes and quality of life. This study will engage rural Alaska communities in research to improve the school hearing screening and referral process, partnering with stakeholders to develop a locally derived, evidence-based solution to improve timely identification and treatment of childhood hearing loss.

Methods and analysis

Mixed methods community randomised trial in 15 communities in the Norton Sound region of northwest Alaska. Data collection will span from April 2017 until February 2020. Qualitative and mixed methods components are described in this protocol and the community randomised trial in the companion protocol. Focus groups and community events will be held leading up to the randomised trial to obtain community perspectives on childhood hearing loss in Alaska and elicit community input during trial protocol refinement (exploratory sequential stage). Stakeholder groups, including parents, children, teachers, school administrators and community health aides, will participate, along with community leaders, tribal leaders and community members. The randomised trial will be combined with qualitative, semi-structured interviews to elicit stakeholder perspectives on the intervention (explanatory sequential stage). The five stakeholder groups described above will participate in interviews. The study will conclude with additional focus groups and community events to discuss results and provide community insight for future implementation. Concluding focus groups will include policymakers, healthcare administrators, and tribal and community leaders in addition to the stakeholder groups. Informed consent and child assent will be required. Recordings will be transcribed and deidentified, with only stakeholder group recorded. Analyses will include categorical coding as well as narrative and thematic analysis.

Ethics and dissemination

The Hearing Norton Sound study has been approved by the Institutional Review Boards of Alaska Area, Norton Sound, and Duke University, with trial registration on clinicaltrials.gov. Study results will be distributed with equal emphasis on scientific and community dissemination.

Trial registration number

NCT03309553; Results.

Hearing Norton Sound: a community randomised trial protocol to address childhood hearing loss in rural Alaska

Por: Emmett · S. D. · Robler · S. K. · Wang · N.-Y. · Labrique · A. · Gallo · J. J. · Hofstetter · P.
Introduction

The population in rural Alaska experiences a disproprionately high burden of infection-mediated hearing loss. While the state mandates school hearing screening, many children with hearing loss are not identified or are lost to follow-up before ever receiving treatment. A robust, tribally owned healthcare system exists in Alaska, but children with hearing loss must first be identified and referred for existing infrastructure to be used. This trial will evaluate a new school hearing screening and referral process in rural Alaska, with the goal of improving timely identification and treatment of childhood hearing loss.

Methods and analysis

Comparative effectiveness community randomised trial testing digital innovations to improve school hearing screening and referral in 15 communities in the Norton Sound region of northwest Alaska, with data collection from October 2017 to February 2020. All children (K-12) attending school in Bering Strait School District with parental informed consent and child assent will be eligible (target recruitment n=1500). Participating children will undergo both the current school hearing screen and new mobile health (mHealth) screen, with screening test validity evaluated against an audiometric assessment. Communities will be cluster randomised to continue the current primary care referral process or receive telemedicine referral for follow-up diagnosis and treatment. The primary outcome will be time to International Statistical Classification of Diseases, 10th Revision, ear/hearing diagnosis from screening date, measured in days. Secondary outcomes will include: sensitivity and specificity of current school and mHealth screening protocols measured against a benchmark audiometric assessment (air and bone conduction audiometry, tympanometry and digital otoscopy); hearing loss prevalence; hearing-related quality of life; and school performance (AIMSweb). Intention-to-treat analysis will be used.

Ethics and dissemination

This study has been approved by the Institutional Review Boards of Alaska Area, Norton Sound and Duke University and is registered on clinicaltrials.gov. Results will be distributed with equal emphasis on scientific and community dissemination.

Trial registration number

NCT03309553; Pre-results.

Management strategies for chronic rhinosinusitis: a qualitative study of GP and ENT specialist views of current practice in the UK

Por: Vennik · J. · Eyles · C. · Thomas · M. · Hopkins · C. · Little · P. · Blackshaw · H. · Schilder · A. · Boardman · J. · Philpott · C. M.
Objectives

To explore general practitioner (GP) and ears, nose and throat (ENT) specialist perspectives of current treatment strategies for chronic rhinosinusitis (CRS) and care pathways through primary and secondary care.

Design

Semi-structured qualitative telephone interviews as part of the MACRO programme (Defining best Management for Adults with Chronic Rhinosinusitis)

Setting

Primary care and secondary care ENT outpatient clinics in the UK.

Participants

Twelve GPs and 9 ENT specialists consented to in-depth telephone interviews. Transcribed recordings were managed using NVivo software and analysed using inductive thematic analysis.

Main outcome measures

Healthcare professional views of management options and care pathways for CRS.

Results

GPs describe themselves as confident in recognising CRS, with the exception of assessing nasal polyps. In contrast, specialists report common missed diagnoses (eg, allergy; chronic headache) when patients are referred to ENT clinics, and attribute this to the limited ENT training of GPs. Steroid nasal sprays provide the foundation of treatment in primary care, although local prescribing restrictions can affect treatment choice and poor adherence is perceived to be the causes of inadequate symptom control. Symptom severity, poor response to medical treatment and patient pressure drive referral, although there is uncertainty about optimal timing. Treatment decisions in secondary care are based on disease severity, polyp status, prior medical treatment and patient choice, but there is major uncertainty about the place of longer courses of antibiotics and the use of oral steroids. Surgery is regarded as an important treatment option for patients with severe symptoms or with nasal polyps, although timing of surgery remains unclear, and the uncertainty about net long-term benefits of surgery makes balancing of benefits and risks more difficult.

Conclusions

Clinicians are uncertain about best management of patients with CRS in both primary and secondary care and practice is varied. An integrated care pathway for CRS is needed to improve patient management and timely referral.

Regional differences in endoscopic sinus surgery in Finland: a nationwide register-based study

Por: Toppila-Salmi · S. · Rihkanen · H. · Arffman · M. · Manderbacka · K. · Keskimaki · I. · Hytönen · M. L.
Objectives

Endoscopic sinus surgery (ESS) is a common operation typically performed due to chronic rhinosinusitis (CRS). There are limited data on the nationwide ESS rate and factors contributing to its regional variation. The aim was to evaluate factors causing variation of ESS rate.

Design

Cross-sectional nationwide observational study.

Setting

A ll patients undergoing ESS in Finland 2013–2015.

Population

Nationwide Finnish population aged 15 years or over.

Main outcome measures

ESS rate per 1000 inhabitants between 2013 and 2015 in all 21 hospital districts and independent factors for multilevel model analyses.

Methods

We used the Finnish register data of all patients with CRS who underwent ESS in 2013–2015. Patients aged under 15 years and those with ESS due to neoplasia were excluded. The age and gender standardised ESS rates were calculated, and multilevel Poisson regression models were used to evaluate variation in ESS in the 21 hospital districts. The likelihood ratio test was applied to assess the statistical significance of random components in the models.

Results

The nationwide annual rate of ESS is 0.71 per 1000 people in Finland. Hospital district rates varied from 0.25/1000 (95% CI 0.18 to 0.32) to 1.15/1000 (95% CI 1.09 1.21). Compared with males, females undergo ESS significantly more frequently (57% of the procedures), more often due to CRS without nasal polyps, and at a younger age (mean age 44.2 and 46.2 years, correspondingly). Multilevel analyses showed that lower age (between 24 years and 45 years) and availability/ease of medical services were independently associated with higher ESS rates.

Conclusions

This study confirms marked regional variation in the ESS rate in Finland, explained only in part by patients’ age and differing availability of medical services. To analyse ESS across different CRS phenotypes or to compare quality registers on ESS properly, more research on regional variation is needed.

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