Keele University

About: Keele University is a education organization based out in Newcastle-under-Lyme, United Kingdom. It is known for research contribution in the topics: Population & Stars. The organization has 11318 authors who have published 26323 publications receiving 894671 citations. The organization is also known as: Keele University.

Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys.

Abstract: Background: The monitoring of adverse drug reactions (ADRs) through pharmacovigilance is vital to patient safety. Spontaneous reporting of ADRs is one method of pharmacovigilance, and in the UK this is undertaken through the Yellow Card Scheme (YCS). Yellow Card reports are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) by post, telephone or via the internet. The MHRA electronically records and reviews information submitted so that important safety issues can be detected. While previous studies have shown differences between patient and healthcare professional (HCP) reports for the types of drugs and reactions reported, relatively little is known about the pharmacovigilance impact of patient reports. There have also been few studies on the views and experiences of patients/consumers on the reporting of suspected ADRs. Objectives: To evaluate the pharmacovigilance impact of patient reporting of ADRs by analysing reports of suspected ADRs from the UK YCS and comparing reports from patients and HCPs. To elicit the views and experiences of patients and the public about patient reporting of ADRs. Design: (1) Literature review and survey of international experiences of consumer reporting of ADRs; (2) descriptive analysis of Yellow Card reports; (3) signal generation analysis of Yellow Card reports; (4) qualitative analysis of Yellow Card reports; (5) questionnaire survey of patients reporting on Yellow Cards; (6) qualitative analysis of telephone interviews with patient reporters to the scheme; (7) qualitative analysis of focus groups and usability testing of the patient YCS; and (8) national omnibus telephone survey of public awareness of the YCS. Participants: Patients (n = 5180) and HCPs (n = 20,949) submitting Yellow Card reports from October 2005 to September 2007. Respondents to questionnaire survey (n = 1362). Participants at focus groups and usability testing sessions (n = 40). National omnibus telephone survey (n = 2028). Setting: The literature review included studies in English from across the world. All other components included populations from the UK; the omnibus survey was restricted to Great Britain. Interventions: None. Main outcome measures: Characteristics of patient reports: types of drug and suspected ADR reported; seriousness of reports; and content of reports. The relative contributions of patient reports and of HCP reports to signal generation. Views and experiences of patient reporters. Views of members of the public about the YCS, including user-friendliness and usability of different ways of patient reporting. Public awareness of the YCS. Suggestions for improving patient reporting to the YCS. Results: Compared with HCPs, patient reports to the YCS contained a higher median number of suspected ADRs per report, and described reactions in more detail. The proportions of reports categorised as 'serious' were similar; the patterns of drugs and reactions reported differed. Patient reports were richer in their descriptions of reactions than those from HCPs, and more often noted the effects of ADRs on patients' lives. Combining patient and HCP reports generated more potential signals than HCP reports alone; some potential signals in the 'HCP-only' data set were lost when combined with patient reports, but fewer than those gained; the addition of patient reports to HCP reports identified 47 new 'serious' reactions not previously included in 'Summaries of Product Characteristics'. Most patient reporters found it fairly easy to make reports, although improvements to the scheme were suggested, including greater publicity and the redesign of web- and paper-based reporting systems. Among members of the public, 8.5% were aware of the YCS in 2009. Conclusions: Patient reporting of suspected ADRs has the potential to add value to pharmacovigilance by reporting types of drugs and reactions different from those reported by HCPs; generating new potential signals; and describing suspected ADRs in enough detail to provide useful information on likely causality and impact on patients' lives. These findings suggest that further promotion of patient reporting to the YCS is justified, along with improvements to existing reporting systems. In order of priority, future work should include further investigation of (1) the pharmacovigilance impact of patient reporting in a longer-term study; (2) the optimum approach to signal generation analysis of patient and HCP reports; (3) the burden of ADRs in terms of impact on patients' lives; (4) the knowledge and attitudes of HCPs towards patient reporting of ADRs; (5) the value of using patient reports of ADRs to help other patients and HCPs who are seeking information on patient experiences of ADRs; and (6) the impact of increasing publicity and/or enhancements to reporting systems on the numbers and types of Yellow Card reports from patients. Funding: The National Institute for Health Research Health Technology Assessment programme.

Surgery for obstructive sleep apnoea.

Abstract: BACKGROUND Obstructive sleep apnoea/hypopnoea syndrome(OSAHS) is the periodic reduction or cessation of airflow during sleep. The syndrome is associated with loud snoring, disrupted sleep and observed apnoeas. Surgery for obstructive sleep apnoea/hypopnoea syndrome aims to alleviate symptoms of daytime sleepiness, improve quality of life, and reduce the signs of sleep apnoea recorded by polysomnography. OBJECTIVES The objective of this review was to assess the effects of any type of surgery for the treatment of the symptoms of obstructive sleep apnoea/hypopnoea syndrome in adults. SEARCH STRATEGY We searched the Cochrane Airways Group Specialised Register and reference lists of articles. We contacted experts in the field, research dissemination bodies and other Cochrane Review Groups. Searches were current as of July 2005. SELECTION CRITERIA Randomised trials comparing any surgical intervention for obstructive sleep apnoea/hypopnoea syndrome with other surgical or non-surgical interventions or no intervention. DATA COLLECTION AND ANALYSIS Two reviewers assessed electronic literature search results for possibly relevant studies. Characteristics and data from studies meeting the inclusion criteria were extracted and entered into RevMan 4.2. MAIN RESULTS In the 2005 update for this review eight studies (412 participants) of mixed quality met the inclusion criteria. Data from seven studies were eligible for assessment in the review. No data could be pooled. Uvulopalatopharyngoplasty (UPPP) versus conservative management (one trial): An un validated symptom score showed intermittent significant differences over a 12-month follow-up period. No differences in Polysomnography (PSG) outcomes were reported. Laser-assisted uvulopalatoplasty (LAUP) versus conservative management/placebo (two trials): One study recruited mixed a population, and separate data could not be obtained for this trial. In the other study no significant differences in Epworth scores or quality of life reported. A significant difference in favour of LAUP was reported in terms of apnoea hypopnoea index (AHI) and frequency and intensity of snoring. UPPP versus oral appliance (OA) (one trial): AHI was significantly lower with OA therapy than with UPPP. No significant differences were observed in quality of life. UPPP versus lateral pharyngoplasty (lateral PP) (one trial): No significant difference in Epworth scores, but a greater reduction in AHI with lateral PP was reported. Tongue advancement (mandibular osteotomy) + PPP versus tongue suspension + PPP (one trial): There was a significant reduction in symptoms in both groups, but no significant difference between the two surgery types. Complications reported with all surgical techniques included nasal regurgitation, pain and bleeding. These did not persist in the long term. An additional study assessed the effects of four different techniques. No data were available on between group comparisons. Multilevel temperature-controlled radiofrequency tissue ablation (TCRFTA) versus sham placebo and CPAP (one trial): There was an improvement in primary and secondary outcomes of TCRFTA over sham placebo and but no difference in symptomatic improvement when compared with CPAP. AUTHORS' CONCLUSIONS There are now a small number of trials assessing different surgical techniques with inactive and active control treatments. The studies assembled in the review do not provide evidence to support the use of surgery in sleep apnoea/hypopnoea syndrome, as overall significant benefit has not been demonstrated. The participants recruited to the studies had mixed levels of AHI, but tended to suffer from moderate daytime sleepiness where this was measured. Short-term outcomes are unlikely to consistently identify suitable candidates for surgery. Long-term follow-up of patients who undergo surgical correction of upper airway obstruction is required. This would help to determine whether surgery is a curative intervention, or whether there is a tendency for the signs and symptoms of sleep apnoea to re-assert themselves, prompting patients to seek further treatment for sleep apnoea.