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Background: The LiGHT trial (Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial) is a multicentre randomised controlled trial of two treatment pathways for patients who are newly diagnosed with open-angle glaucoma (OAG) and ocular hypertension (OHT). The main hypothesis for the trial is that lowering intraocular pressure (IOP) with selective laser trabeculoplasty (SLT) as the primary treatment ('Laser-1st') leads to a better health-related quality of life than for those started on IOP-lowering drops as their primary treatment ('Medicine-1st') and that this is associated with reduced costs and improved tolerability of treatment. This paper describes the statistical analysis plan for the study.Methods/design: The LiGHT trial is an unmasked, multi-centre randomised controlled trial. A total of 718 patients (359 per arm) are being randomised to two groups: medicine-first or laser-first treatment. Outcomes are recorded at baseline and at 6-month intervals up to 36 months. The primary outcome measure is health-related quality of life (HRQL) at 36 months measured using the EQ-5D-5L. The main secondary outcome is the Glaucoma Utility Index. We plan to analyse the patient outcome data according to the group to which the patient was originally assigned. Methods of statistical analysis are described, including the handling of missing data, the covariates used in the adjusted analyses and the planned sensitivity analyses.Trial Registration: The trial was registered with the ISRCTN register on 23/07/2012, number ISRCTN32038223 . [ABSTRACT FROM AUTHOR]

A kuma A .O . & J ordan S . (2012) Pain management in neonates: a survey of nurses and doctors. Journal of Advanced Nursing 68(6), 1288-1301. Abstract Aim. This paper is a report of a descriptive survey of nurses' and doctors' knowledge and reported practice regarding procedural pain assessment and management in neonatal intensive care units. Background. There are concerns that pain is often unrecognized and under-treated in neonates. Current guidelines advocate administration of analgesia and comfort measures, but may be vulnerable to inter-professional differences in guideline implementation. Methods. All nurses and doctors working in all seven neonatal intensive care units in one area of the United Kingdom were surveyed between January to August 2007. Lead clinicians distributed and collected anonymous questionnaires. Findings. Response rate was 44% (62 doctors, 137 nurses). Internal consistency was high, overall Cronbach's alpha 0·976. Respondents were knowledgeable, mean score 82% (SD13·3%). They agreed that neonates feel pain and need analgesia. Chest drain insertion was perceived to be the most painful procedure, heel-prick the least. Respondents reported that analgesia and comfort measures were not usually administered for most procedures: nurses were more likely than doctors to report adhering to guidelines advocating administration of analgesia and comfort measures. Statistically significant differences between current and optimal practice were acknowledged. Few (21% and 37%) had received training on neonatal pain and fewer (2·5%) employed recognized pain assessment instruments. Pain management guidelines were available to 29(47%) doctors and 85(62%) nurses; 20(18%) reported that these had been audited. Conclusion. Clinicians were knowledgeable about neonatal pain, but gaps between knowledge and practice remain. This hiatus could be bridged by providing research evidence for the efficacy of guidelines incorporating validated pain assessment instruments. [ABSTRACT FROM AUTHOR]

Primary objective: Operant conditioning interventions are effective in the management of post-acute ABI challenging behaviour. However, when this serves an avoidance or escape function, reinforcement approaches may be ineffective. In this paper the utility of a range of operant-derived ABI interventions is considered specifically with regard to behaviour whose prime function is avoidance or escape from rehabilitation activities. Methods and procedures: Efficacy of three operant interventions was determined by describing a single case study whose aggressive behaviour served an avoidance-escape function. Two interventions comprised variants of differential reinforcement: differential reinforcement of incompatible behaviour (DRI) and differential reinforcement of low rates of responding (DRL). The third intervention comprised situational time out (STO) and sustained verbal prompting. Main outcome: Despite reports of the efficacy of DRI and DRL, neither was beneficial in this case. However, STO and sustained verbal prompting proved highly effective in reducing aggression. Conclusions: Results are discussed in relation to two levels of explanation: function and cognition. Special emphasis is laid upon the extent to which interventions actively involve the patient and the degree of intrusiveness necessary for staff to implement therapeutic procedures. The case demonstrates how a scientifically-derived formulation regarding behaviour disorder can support multiple treatment options. [ABSTRACT FROM AUTHOR]

Background: The effects of postal questionnaire burden on return rates and answers given are unclear following treatment on an intensive care unit (ICU). We aimed to establish the effects of different postal questionnaire burdens on return rates and answers given.Methods: Design: A parallel group randomised controlled trial. We assigned patients by computer-based randomisation to one of two questionnaire packs (Group A and Group B).Setting: Patients from 26 ICUs in the United Kingdom.Inclusion Criteria: Patients who had received at least 24 h of level 3 care and were 16 years of age or older. Patients did not know that there were different questionnaire burdens. The study included 18,490 patients. 12,170 were eligible to be sent a questionnaire pack at 3 months. We sent 12,105 questionnaires (6112 to group A and 5993 to group B).Interventions: The Group A pack contained demographic and EuroQol group 5 Dimensions 3 level (EQ-5D-3 L) questionnaires, making four questionnaire pages. The Group B pack also contained the Hospital Anxiety and Depression Score (HADS) and the Post-Traumatic Stress Disorder Check List-Civilian (PCL-C) questionnaires, making eight questionnaire pages in total.Main Outcome Measure: Questionnaire return rate 3 months after ICU discharge by group.Results: In group A, 2466/6112 (40.3%) participants responded at 3 months. In group B 2315/ 5993 (38.6%) participants responded (difference 1.7% CI for difference 0-3.5% p = 0.053). Group A reported better functionality than group B in the EQ-5D-3 L mobility (41% versus 37% reporting no problems p = 0.003) and anxiety/depression (59% versus 55% reporting no problems p = 0.017) domains.Conclusions: In survivors of intensive care, questionnaire burden had no effect on return rates. However, questionnaire burden affected answers to the same questionnaire (EQ-5D-3 L).Trial Registration: ISRCTN69112866 (assigned 02/05/2006). [ABSTRACT FROM AUTHOR]

Objectives: To quantify patient eligibility for cochlear implantation following National Institute for Health and Care Excellence 2019 guidelines (TA566) over five years at our institution, and identify factors influencing patients' decisions surrounding cochlear implantation referral. Methods: A multi-perspective service evaluation was conducted at a district general hospital, comprising cochlear implantation eligible patients. The main outcome measures were: eligibility numbers for 2014–2019, comparing application of TA566 versus 2009 (TA166) guidelines; and patient interview transcripts and questionnaires. Results: There was a 259 per cent average increase in cochlear implantation eligibility from 2014 to 2019. Most patients' thresholds were 80 dB HL or more at 3 kHz and 4 kHz. There are several cochlear implantation barriers, including patient-centred issues (e.g. health-related anxieties, implantation misperceptions) and external barriers (difficulty getting to regional implant centres). Motivating factors for cochlear implantation include improved quality of life and access to local cochlear implantation services. Conclusion: The TA566 guidelines have increased cochlear implantation eligibility, putting pressure on cochlear implantation centres and referring hospitals. Current referral systems have external and patient-centred implantation barriers. British cochlear implantation delivery may need rethinking to meet increasing populational demands and improve accessibility for those most vulnerable to these barriers. [ABSTRACT FROM AUTHOR]

Background: Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or "Kaloba®", is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries. Study design: Feasibility double-blind randomised placebo-controlled clinical trial. Methods: We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2–4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial. Results: Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18–21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. Conclusions: It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition. Trial registration: HATRIC was registered on the ISRCTN registry (ISRCTN17672884) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884. [ABSTRACT FROM AUTHOR]

Objective: To examine the feasibility of a trial to evaluate web-based physiotherapy compared to a standard home exercise programme in people with multiple sclerosis. Design: Multi-centre, randomized controlled, feasibility study. Setting: Three multiple sclerosis out-patient centres. Participants: A total of 90 people with multiple sclerosis (Expanded Disability Status Scale 4–6.5). Interventions: Participants were randomized to a six-month individualized, home exercise programme delivered via web-based physiotherapy (n = 45; intervention) or a sheet of exercises (n = 45; active comparator). Outcome measures: Outcome measures (0, three, six and nine months) included adherence, two-minute walk test, 25 foot walk, Berg Balance Scale, physical activity and healthcare resource use. Interviews were undertaken with 24 participants and 3 physiotherapists. Results: Almost 25% of people approached agreed to take part. No intervention-related adverse events were recorded. Adherence was 40%–63% and 53%–71% in the intervention and comparator groups. There was no difference in the two-minute walk test between groups at baseline (Intervention-80.4(33.91)m, Comparator-70.6(31.20)m) and no change over time (at six-month Intervention-81.6(32.75)m, Comparator-74.8(36.16)m. There were no significant changes over time in other outcome measures except the EuroQol-5 Dimension at six months which decreased in the active comparator group. For a difference of 8(17.4)m in two-minute walk test between groups, 76 participants/group would be required (80% power, P > 0.05) for a future randomized controlled trial. Conclusion: No changes were found in the majority of outcome measures over time. This study was acceptable and feasible by participants and physiotherapists. An adequately powered study needs 160 participants. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcomes are vital in informing randomised controlled trials (RCTs) and health-care interventions and policies from the patient's perspective. However, participant non-response may introduce bias and can affect the generalisability of the trial. This study evaluates two interventions aimed at increasing response rates to postal questionnaires within a large, UK-wide RCT: pre-notification via short messenger service (SMS) text prior to sending the initial mailing of trial questionnaires versus no pre-notification; for non-responders to the initial mailing of the questionnaires, an e-mail reminder (containing a hyperlink to complete the questionnaire online) versus a postal reminder.Methods: This study is a 2 × 2 partial factorial design RCT nested within an RCT of medical expulsive therapy for ureteric stone disease. Participants who supplied a mobile telephone number were randomly assigned to receive an SMS text pre-notification of questionnaire delivery or no pre-notification. Those who supplied an e-mail address were randomly assigned to receive a questionnaire reminder by e-mail or post. Participants could be randomly assigned to the pre-notification comparison or the reminder comparison or both. The primary outcome measure was response rate at each questionnaire time point.Results: Four hundred eighteen participants were randomly assigned to the SMS pre-notification comparison (80% were male, and the mean age was 41 years with a standard deviation (SD) of 11.1). The intervention had no effect on response rate at either questionnaire time point. In subgroup analyses, SMS pre-notification increased response rates in women but only at the first questionnaire time point. One hundred nineteen participants were randomly assigned to the reminder comparison (80% were male, and the mean age was 42 years with an SD of 12.1). There was no difference in response rate in those who received an e-mail reminder compared with those who received a postal reminder.Conclusions: SMS text pre-notification of questionnaire delivery and email delivery of questionnaire reminders did not improve response rates. There was some evidence to suggest that SMS text pre-notification may be effective in women, and further studies to investigate this may be warranted. E-mail reminders for participants to return their postal questionnaire could be advantageous given that response rates were similar following either type of reminder and the low cost of delivering an e-mail compared with a postal reminder. This is a substudy of the SUSPEND trial (ISCTRN69423238) (18 Nov. 2010). [ABSTRACT FROM AUTHOR]

Information on dietary supplements, medications, and other xenobiotics in epidemiologic surveys is usually obtained from questionnaires and is subject to recall and reporting biases. The authors used metabolite data obtained from hydrogen-1 (or proton) nuclear magnetic resonance (1H NMR) analysis of human urine specimens from the International Study of Macro-/Micro-Nutrients and Blood Pressure (INTERMAP Study) to validate self-reported analgesic use. Metabolic profiling of two 24-hour urine specimens per individual was carried out for 4,630 participants aged 40–59 years from 17 population samples in Japan, China, the United Kingdom, and the United States (data collection, 1996–1999). 1H NMR-detected acetaminophen and ibuprofen use was low (∼4%) among East Asian population samples and higher (>16%) in Western population samples. In a comparison of self-reported acetaminophen and ibuprofen use with 1H NMR-detected acetaminophen and ibuprofen metabolites among 496 participants from Chicago, Illinois, and Belfast, Northern Ireland, the overall rate of concordance was 81%–84%; the rate of underreporting was 15%–17%; and the rate of underdetection was approximately 1%. Comparison of self-reported unspecified analgesic use with 1H NMR-detected acetaminophen and ibuprofen metabolites among 2,660 Western INTERMAP participants revealed similar levels of concordance and underreporting. Screening for urinary metabolites of acetaminophen and ibuprofen improved the accuracy of exposure information. This approach has the potential to reduce recall bias and other biases in epidemiologic studies for a range of substances, including pharmaceuticals, dietary supplements, and foods. [ABSTRACT FROM PUBLISHER]