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Background In the last decade several authors have reviewed the features of pilot and feasibility studies and advised on the issues that should be addressed within them. We extend this literature by examining published pilot/feasibility trials that incorporate random allocation, examining their stated objectives, results presented and conclusions drawn, and comparing drug and non-drug trials. Methods A search of EMBASE and MEDLINE databases for 2000 to 2009 revealed 3652 papers that met our search criteria. A random sample of 50 was selected for detailed review. Results Most of the papers focused on efficacy: those reporting drug trials additionally addressed safety/toxicity; while those reporting non-drug trials additionally addressed methodological issues. In only 56% (95% confidence intervals 41% to 70%) were methodological issues discussed in substantial depth, 18% (95% confidence interval 9% to 30%) discussed future trials and only 12% (95% confidence interval 5% to 24%) of authors were actually conducting one. Conclusions Despite recent advice on topics that can appropriately be described as pilot or feasibility studies the large majority of recently published papers where authors have described their trial as a pilot or addressing feasibility do not primarily address methodological issues preparatory to planning a subsequent study, and this is particularly so for papers reporting drug trials. Many journals remain willing to accept the pilot/feasibility designation for a trial, possibly as an indication of inconclusive results or lack of adequate sample size.

ObjectiveChildren with Down syndrome are at high risk of obstructive sleep apnoea (OSA) and screening is recommended. Diagnosis of OSA should be confirmed with multichannel sleep studies. We aimed to determine whether home pulse oximetry (HPO) discriminates children at high risk of OSA, who need further diagnostic multichannel sleep studies.DesignCross-sectional prospective study in a training sample recruited through three UK centres. Validation sample used single-centre retrospective analysis of clinical data.PatientsChildren with Down syndrome aged 0.5–6 years.InterventionDiagnostic multichannel sleep study and HPO.Main outcome measuresSensitivity and specificity of HPO to predict moderate-to-severe OSA.Results161/202 children with Down syndrome met quality criteria for inclusion and 25 had OSA. In this training sample, the best HPO parameter predictors of OSA were the delta 12 s index >0.555 (sensitivity 92%, specificity 65%) and 3% oxyhaemoglobin (SpO2) desaturation index (3% ODI)>6.15 dips/hour (sensitivity 92%, specificity 63%). Combining variables (delta 12 s index, 3% ODI, mean and minimum SpO2) achieved sensitivity of 96% but reduced specificity to 52%. All predictors retained or improved sensitivity in a clinical validation sample of 50 children with variable loss of specificity, best overall was the delta 12 s index, a measure of baseline SpO2 variability (sensitivity 92%; specificity 63%).ConclusionsHPO screening could halve the number of children with Down syndrome needing multichannel sleep studies and reduce the burden on children, families and health services alike. This approach offers a practical universal screening approach for OSA in Down syndrome that is accessible to the non-specialist paediatrician.

Background Research into relational care in hospitals will be facilitated by a focus on staff-patient interactions. The Quality of Interactions Schedule (QuIS) uses independent observers to measure the number of staff-patient interactions within a healthcare context, and to rate these interactions as ‘positive social’; ‘positive care’; ‘neutral’; ‘negative protective’; or ‘negative restrictive’. QuIS was developed as a research instrument in long term care settings and has since been used for quality improvement in acute care. Prior to this study, its use had not been standardised, and reliability and validity in acute care had not been established. Methods In 2014 and 2015 a three - phase study was undertaken to develop and test protocols for the use of QuIS across three acute wards within one NHS trust in England. The phases were: (1) A pilot of 16 h observation which developed implementation strategies for QuIS in this context; (2) training two observers and undertaking 16 h of paired observation to inform the development of training protocols; (3) training four nurses and two lay volunteers according to a finalised protocol followed by 36 h of paired observations to test inter-rater agreement. Additionally, patients were asked to rate interactions and to complete a shortened version of the Patient Evaluation of Emotional Care during Hospitalisation (PEECH) questionnaire. Results Protocols were developed for the use of QuIS in acute care. Patients experienced an average of 6.7 interactions/patient/h ( n  = 447 interactions). There was close agreement between observers in relation to the number of interactions observed (Intraclass correlation coefficient (ICC) = 0.97) and moderate to substantial agreement on the quality of interactions (absolute agreement 73%, kappa 0.53 to 0.62 depending on weighting scheme). There was 79% agreement (weighted kappa 0.40: P  < 0.001; indicating fair agreement) between patients and observers over whether interactions were positive, negative or neutral. Conclusions Observers using clear QuIS protocols can achieve levels of agreement that are acceptable for the use of QuIS as a research instrument. There is fair agreement between observers and patients’ rating of interactions. Further research is needed to explore the relationship between QuIS measures and reported patient experience.

Background PDSAFE is an individually-tailored, physiotherapist-delivered, balance, strength and strategy training programme aimed at preventing falls among people with Parkinson’s. We evaluated the cost-effectiveness of PDSAFE compared with usual care for people with Parkinson’s at higher risk of falling, from a UK National Health Service and Personal Social Service perspective. Methods Resource use and quality of life data (EQ-5D-3L) were collected from 238 participants randomised to the PDSAFE intervention and 236 participants randomised to control, at baseline, 3 months, 6 months (primary outcome), and 12 months. Adjusted cost and quality-adjusted life-years (QALYs) were estimated using generalised linear models and uncertainty estimated using a non-parametric bootstrap. Results Over 6 months, the PDSAFE intervention was associated with an incremental cost of £925 (95% CI £428 to £1422) and a very small and statistically insignificant QALY gain of 0.008 (95% CI − 0.006 to 0.021). The resulting incremental cost-effectiveness ratio (ICER) was £120,659 per QALY and the probability of the intervention being cost-effective at a UK threshold of £30,000/QALY was less than 1%. The ICER varied substantially across subgroups although no subgroup had an ICER lower than the £30,000 threshold. The result was sensitive to the time horizon with the ICER reducing to £55,176 per QALY when adopting a 12-month time horizon and assuming a sustained treatment effect on QoL, nevertheless, the intervention was still not cost-effective according to the current UK threshold. Conclusions Evidence from this trial suggests that the PDSAFE intervention is unlikely to be cost-effective at 6 months. The 12-month analysis suggested that the intervention became closer to being cost-effective if quality of life effects were sustained beyond the intervention period, however this would require confirmation. Further research, including qualitative studies, should be conducted to better understand the treatment effect of physiotherapy and its impact on quality of life in people with Parkinson’s given existing mixed evidence on this topic. Trial registration ISRCTN48152791. Registered 17 April 2014. http://www.isrctn.com/ISRCTN48152791

BackgroundExisting evidence indicates that reducing nurse staffing and/or skill mix adversely affects care quality. Nursing shortages may lead managers to dilute nursing team skill mix, substituting assistant personnel for registered nurses (RNs). However, no previous studies have described the relationship between nurse staffing and staff–patient interactions.SettingSix wards at two English National Health Service hospitals.MethodsWe observed 238 hours of care (n=270 patients). Staff–patient interactions were rated using the Quality of Interactions Schedule. RN, healthcare assistant (HCA) and patient numbers were used to calculate patient-to-staff ratios. Multilevel regression models explored the association between staffing levels, skill mix and the chance of an interaction being rated as ‘negative’ quality, rate at which patients experienced interactions and total amount of time patients spent interacting with staff per observed hour.Results10% of the 3076 observed interactions were rated as negative. The odds of a negative interaction increased significantly as the number of patients per RN increased (p=0.035, OR of 2.82 for ≥8 patients/RN compared with >6 to <8 patients/RN). A similar pattern was observed for HCA staffing but the relationship was not significant (p=0.056). When RN staffing was low, the odds of a negative interaction increased with higher HCA staffing. Rate of interactions per patient hour, but not total amount of interaction time, was related to RN and HCA staffing levels.ConclusionLow RN staffing levels are associated with changes in quality and quantity of staff–patient interactions. When RN staffing is low, increases in assistant staff levels are not associated with improved quality of staff–patient interactions. Beneficial effects from adding assistant staff are likely to be dependent on having sufficient RNs to supervise, limiting the scope for substitution.

Background Recent studies of the quality of in-hospital care have used the Quality of Interaction Schedule (QuIS) to rate interactions observed between staff and inpatients in a variety of ward conditions. The QuIS was developed and evaluated in nursing and residential care. We set out to develop methodology for summarising information from inter-rater reliability studies of the QuIS in the acute hospital setting. Methods Staff-inpatient interactions were rated by trained staff observing care delivered during two-hour observation periods. Anticipating the possibility of the quality of care varying depending on ward conditions, we selected wards and times of day to reflect the variety of daytime care delivered to patients. We estimated inter-rater reliability using weighted kappa, κ w , combined over observation periods to produce an overall, summary estimate, κ ^ w . Weighting schemes putting different emphasis on the severity of misclassification between QuIS categories were compared, as were different methods of combining observation period specific estimates. Results Estimated κ ^ w did not vary greatly depending on the weighting scheme employed, but we found simple averaging of estimates across observation periods to produce a higher value of inter-rater reliability due to over-weighting observation periods with fewest interactions. Conclusions We recommend that researchers evaluating the inter-rater reliability of the QuIS by observing staff-inpatient interactions during observation periods representing the variety of ward conditions in which care takes place, should summarise inter-rater reliability by κ w , weighted according to our scheme A4. Observation period specific estimates should be combined into an overall, single summary statistic κ ^ w random , using a random effects approach, with κ ^ w random , to be interpreted as the mean of the distribution of κ w across the variety of ward conditions. We draw attention to issues in the analysis and interpretation of inter-rater reliability studies incorporating distinct phases of data collection that may generalise more widely.

ObjectiveTo evaluate the success rates of home cardiorespiratory polygraphy in children under investigation for sleep-disordered breathing and parent perspectives on equipment use at home.DesignProspective observational study.SettingSheffield, Evelina London and Southampton Children’s Hospitals.PatientsData are reported for 194 research participants with Down syndrome, aged 0.5–5.9 years across the three centres and 61 clinical patients aged 0.4–19.5 years from one centre, all of whom had home cardiorespiratory polygraphy including respiratory movements, nasal pressure flow, pulse oximetry, body position and motion.Main outcome measuresPercentage of home cardiorespiratory studies successfully acquiring ≥4 hours of artefact-free data at the first attempt. Parental report of ease of use of equipment and preparedness to repeat home diagnostics in the future.Results143/194 (74%; 95% CI 67% to 79%) of research participants and 50/61 (82%; 95% CI 71% to 90%) of clinical patients had successful home cardiorespiratory polygraphy at the first attempt. Some children required multiple attempts to achieve a successful study. Overall, this equated to 1.3 studies per research participant and 1.2 studies per clinical child. The median artefact-free sleep time for successful research studies was 515 min (range 261–673) and for clinical studies 442 min (range 291–583). 84% of research and 87% of clinical parents expressed willingness to repeat home cardiorespiratory polygraphy in the future. 67% of research parents found the equipment ‘easy or okay’ to use, while 64% of clinical parents reported it as ‘easy’ or ‘very easy’.ConclusionsHome cardiorespiratory polygraphy offers an acceptable approach to the assessment of sleep-disordered breathing in children.

ObjectiveCompassionate care continues to be a focus for national and international attention, but the existing evidence base lacks the experimental methodology necessary to guide the selection of effective interventions for practice. This study aimed to evaluate the Creating Learning Environments for Compassionate Care (CLECC) intervention in improving compassionate care.SettingWard nursing teams (clusters) in two English National Health Service hospitals randomised to intervention (n=4) or control (n=2). Intervention wards comprised two medicines for older people (MOPs) wards and two medical/surgical wards. Control wards were both MOPs.ParticipantsData collected from 627 patients and 178 staff. Exclusion criteria: reverse barrier nursed, critically ill, palliative or non-English speaking. All other patients and all nursing staff and Health Care Assistant HCAs were invited to participant, agency and bank staff were excluded.InterventionCLECC, a workplace intervention focused on developing sustainable leadership and work-team practices to support the delivery of compassionate care. Control: No educational activity.Primary and secondary outcome measuresPrimary—Quality of Interaction Schedule (QuIS) for observed staff–patient interactions. Secondary—patient-reported evaluations of emotional care in hospital (PEECH); nurse-reported empathy (Jefferson Scale of Empathy).ResultsTrial proceeded as per protocol, randomisation was acceptable. Some but not all blinding strategies were successful. QuIS observations achieved 93% recruitment rate with 25% of patient sample cognitively impaired. At follow-up there were more total positive (78% vs 74%) and less total negative (8% vs 11%) QuIS ratings for intervention wards versus control wards. Sixty-three per cent of intervention ward patients scored lowest (ie, more negative) scores on PEECH connection subscale, versus 79% of control. This was not a statistically significant difference. No statistically significant differences in nursing empathy were observed.ConclusionsUse of experimental methods is feasible. The use of structured observation of staff–patient interaction quality is a promising outcome measure inclusive of hard to reach groups.Trial registration number ISRCTN16789770.

Abstract Objectives To evaluate the impact of labouring in water during first stage of labour on rates of epidural analgesia and operative delivery in nulliparous women with dystocia. Design Randomised controlled trial. Setting University teaching hospital in southern England. Participants 99 nulliparous women with dystocia (cervical dilation rate < 1 cm/hour in active labour) at low risk of complications. Interventions Immersion in water in birth pool or standard augmentation for dystocia (amniotomy and intravenous oxytocin). Main outcome measures Primary: epidural analgesia and operative delivery rates. Secondary: augmentation rates with amniotomy and oxytocin, length of labour, maternal and neonatal morbidity including infections, maternal pain score, and maternal satisfaction with care. Results Women randomised to immersion in water had a lower rate of epidural analgesia than women allocated to augmentation (47% v 66%, relative risk 0.71 (95% confidence interval 0.49 to 1.01), number needed to treat for benefit (NNT) 5). They showed no difference in rates of operative delivery (49% v 50%, 0.98 (0.65 to 1.47), NNT 98), but significantly fewer received augmentation (71% v 96%, 0.74 (0.59 to 0.88), NNT 4) or any form of obstetric intervention (amniotomy, oxytocin, epidural, or operative delivery) (80% v 98%, 0.81 (0.67 to 0.92), NNT 5). More neonates of women in the water group were admitted to the neonatal unit (6 v 0, P = 0.013), but there was no difference in Apgar score, infection rates, or umbilical cord pH. Conclusions Labouring in water under midwifery care may be an option for slow progress in labour, reducing the need for obstetric intervention, and offering an alternative pain management strategy.

Background: The risk of people with Parkinson’s disease (PD) falling is greater than that of the general population but to date, disease-specific predictors of falling have not been identified. Objectives: To identify one or more features, which would predict individuals at risk of falling during a 3-month prospective follow-up study. Method: A battery of standardised tests administered in the home and the laboratory with a 3-month follow-up telephone interview. Results: Sixty-three people with PD were recruited from GP practices. Eleven interview variables and six gait laboratory variables were used with subsamples (55 and 44 subjects, respectively) to fit predictive models for identifying future fallers. The number of falls in the previous year was the most important variable, without exception, to be selected as a predictor in various logistic regression models. A history of two or more falls had a sensitivity of 86.4% (95% CI 67.3–96.2%) and a specificity of 85.7% (95% CI 71.2–94.2%) in predicting falling in the next 3 months. Conclusion: Healthcare workers should be asking their patients with PD regularly and carefully about falling, and should consider instigating programmes of fall management for patients with PD who have fallen two or more times in the previous 12 months.