Using a prognostic medical device for early identification of pressure ulcers: protocol for study design.

BACKGROUND: An objective, physiological measurement taken using a medical device may reduce the incidence of pressure ulcers through earlier detection of problems signs before visual signs appear. Research in this field is hampered by variations in clinical practice and patient-level confounders. AIM: The authors outline key considerations for designing a protocol for a study to assess the efficacy and safety of a prognostic medical device in reducing pressure ulcer incidence in a hospital, including comparators, randomisation, sample size, ethics and practical issues. METHOD: Key issues relating to methodology and ethics are considered alongside a theoretical protocol, which could support future researchers in wound care trials. RESULTS: A prospective, three-armed, multi-centre, stratified cluster-randomised controlled trial is proposed. The third arm is recommended as it is expected that patients will need to be moved for the medical device to be used and repositioning is a preventive strategy. A minimum of 16 200 patients in 33 wards would needed to be recruited to achieve statistical significance. Ethical considerations in terms of consent or assent need to be considered. CONCLUSION: The hypothetical study designed to evaluate the effectiveness of a diagnostic or prognostic medical device in reducing pressure ulcer incidence in secondary care, while accounting for biases, would require large sample sizes and involves risks of inter-operator and inter-device reliability, heterogeneity of users and the vague clinical interpretation of device results. Robust research in this field has the potential to influence or change policy and practice relating to the prevention of pressure ulcers in secondary care.

Early activation of cochlear implants: a systematic review and narrative synthesis.

BACKGROUND: Device activation typically occurs four weeks post cochlear implant surgery. Emerging evidence suggests earlier activation is feasible and beneficial, giving patients quicker access to sound and rehabilitation. OBJECTIVES: Assess current literature for effects of early cochlear implant activation. METHODS: Electronic searches of Medline/PubMed, AMED, EMBASE, CINAHL and the Cochrane Library following PRISMA guidelines. Studies investigating any aspect of early activation were included for review. RESULTS: From 15 studies, 625 patients received early activation, compared with 243 patients in the control groups. Early activation was considered as within 7 days post-operatively with 12 studies reporting within 1 day post-operatively, compared with standard activation of 9-46 days post-operatively in the control group. Some studies indicated earlier low levels of impedance in the early activation group. Magnet strength adjustment or off-ear processor wear was often recommended within the early activation cohort. Complication rates were low in both groups. Early activation improved patient satisfaction and anxiety levels without detriment to speech recognition or rehabilitation. CONCLUSION: Early cochlear implant activation is feasible and allows patients with no contraindications, earlier access to auditory perception and rehabilitation and reduces anxiety linked to delay in activation. Further evidence is required to monitor long-term effects of early activation.

Precision medicine in laryngeal cancer: protocol of the laryngeal cancer cohort (LARCH).

INTRODUCTION: Laryngeal cancer disproportionately affects socioeconomically disadvantaged patients. Treatment can render a patient nil by mouth or in need of a permanent tracheostomy. In the past 30 years, survival has remained at best static and at worst it has declined. Currently, there is no method of prognosticating how a patient will respond to treatment.The LARyngeal Cancer coHort (LARCH) aims to establish how survival and quality-of-life outcomes compare between surgery and (chemo)radiotherapy in early and advanced laryngeal cancer and how the presenting features of laryngeal cancer influence oncological, functional and quality-of-life outcome. METHODS AND ANALYSIS: This study is the first enhanced laryngeal cancer disease cohort. In the initial phase, we aim to deliver a prospective cohort study of 150 patients in 8 centres over a 3-year period.Patient, tumour, quality-of-life and laryngeal functional data will be collected from patients with squamous cell carcinoma of the larynx at baseline, 6, 12 and 24 months. Multiple logistic regression analyses will be used to quantify locoregional control and identify factors associated with control overall and by treatment modality and identify factors associated with quality of life overall and by treatment modality. ETHICS AND DISSEMINATION: Most interventions take place as part of routine care, with LARCH providing a mechanism for recording this data centrally. When successfully recruiting in the North of England, we plan to roll out LARCH nationwide; in the future, LARCH can be used as a trial platform in the disease. The results will be submitted for publication in high-impact international peer-reviewed journals and presented to scientific meetings. Access to the anonymised LARCH dataset by other researchers will be publicised and promoted. TRIAL REGISTRATION NUMBER: ISRCTN27819867.

Evaluation of the Benefits of Bilateral Fitting in Bone-Anchored Hearing System Users: Spatial Resolution and Memory for Speech.

OBJECTIVES: The purpose of this study was to evaluate the benefits of bilateral implantation for bone-anchored hearing system (BAHS) users in terms of spatial resolution abilities and auditory memory for speech. DESIGN: This is a prospective, single-center, comparative, single-blinded study where the listeners served as their own control. Twenty-four experienced bone-anchored users with a bilateral conductive or mixed hearing loss participated in the study. After fitting the listeners unilaterally and bilaterally with BAHS sound processor(s) (Ponto 3 SuperPower), spatial resolution was estimated by measuring the minimum audible angle (MAA) to achieve an 80% correct response via a two-alternative-forced choice task (right-left discrimination of noise bursts) in two conditions: both sound processors active (bilateral condition) and only one sound processor active (unilateral condition). In addition, a memory recall test, the Sentence-final Word Identification and Recall (SWIR) test was performed with five lists of seven sentences for each of the two conditions (unilateral and bilateral). Self-reported performance in everyday life with the listener's own sound processors was also evaluated via a questionnaire (the abbreviated version of the Speech, Spatial and Qualities of Hearing scale). RESULTS: The MAA to discriminate noise bursts improved significantly from 75.04° in the unilateral condition to 3.61° in the bilateral condition ( p < 0.0001). The average improvement in performance was 54.28°. The SWIR test results showed that the listeners could recall, on average, 55.03% of the last words in a list of seven sentences in the unilateral condition and 57.23% in the bilateral condition. While the main effect of condition was not significant, there was a significant interaction between condition and repetition (list), revealing a significantly higher recall performance in the bilateral condition than in the unilateral condition for the second repetition/list out of five (10.2% difference; p = 0.022). Self-reported performance with bilateral BAHS obtained via the Speech, Spatial and Qualities of Hearing scale questionnaire was, on average, 4.4 for speech, 3.7 for spatial, and 5.1 for qualities of hearing. There was no correlation between self-reported performance in everyday life and bilateral performance in the MAA test, while significant correlations were obtained between self-reported performance and recall performance in the SWIR test. CONCLUSIONS: These results showed a large benefit in spatial resolution for users with symmetric BC thresholds when being fitted with two BAHS, although their self-reported performance with bilateral BAHS in everyday life was rather low. In addition, there was no overall benefit of bilateral fitting on memory for speech, despite observing a benefit in one out of five repetitions of the SWIR test. Performance in the SWIR test was correlated with the users' self-reported performance in everyday life, such that users with higher recall ability reported to achieve better performance in real life. These findings highlight the advantages of bilateral fitting on spatial resolution, although bilaterally fitted BAHS users continue to experience some difficulties in their daily lives, especially when locating sounds, judging distance and movement. More research is needed to support a higher penetration of bilateral BAHS treatment for bilateral conductive and mixed hearing losses.