ABSTRACT
Aim To determine the effects of computer‐based interventions aimed at reducing alcohol consumption in adult populations.
Methods The review was undertaken following standard Cochrane and ...Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) guidance for systematic reviews. The literature was searched until December 2008, with no restrictions on language. Randomized trials with parallel comparator groups were identified in the form of published and unpublished data. Two authors independently screened s and papers for inclusion. Data extraction and bias assessment was undertaken by one author and checked by a second author. Studies that measured total alcohol consumption and frequency of binge drinking episodes were eligible for inclusion in meta‐analyses. A random‐effects model was used to pool mean differences.
Results Twenty‐four studies were included in the review (19 combined in meta‐analyses). The meta‐analyses suggested that computer‐based interventions were more effective than minimally active comparator groups (e.g. assessment‐only) at reducing alcohol consumed per week in student and non‐student populations. However, most studies used the mean to summarize skewed data, which could be misleading in small samples. A sensitivity analysis of those studies that used suitable measures of central tendency found that there was no difference between intervention and minimally active comparator groups in alcohol consumed per week by students. Few studies investigated non‐student populations or compared interventions with active comparator groups.
Conclusion Computer‐based interventions may reduce alcohol consumption compared with assessment‐only; the conclusion remains tentative because of methodological weaknesses in the studies. Future research should consider that the distribution of alcohol consumption data is likely to be skewed and that appropriate measures of central tendency are reported.
Nursing homes have an important role in the provision of care for dependent older people. Ensuring quality of care for residents in these settings is the subject of ongoing international debates. ...Poor quality care has been associated with inadequate nurse staffing and poor skills mix.
To review the evidence-base for the relationship between nursing home nurse staffing (proportion of RNs and support workers) and how this affects quality of care for nursing home residents and to explore methodological lessons for future international studies.
A systematic mapping review of the literature.
Published reports of studies of nurse staffing and quality in care homes.
Systematic search of OVID databases. A total of 13,411 references were identified. References were screened to meet inclusion criteria. 80 papers were subjected to full scrutiny and checked for additional references (
n
=
3). Of the 83 papers, 50 were included. Paper selection and data extraction completed by one reviewer and checked by another. Content analysis was used to synthesise the findings to provide a systematic technique for categorising data and summarising findings.
A growing body of literature is examining the relationships between nurse staffing levels in nursing homes and quality of care provided to residents, but predominantly focuses on US nursing facilities. The studies present a wide range and varied mass of findings that use disparate methods for defining and measuring quality (42 measures of quality identified) and nurse staffing (52 ways of measuring staffing identified).
A focus on numbers of nurses fails to address the influence of other staffing factors (e.g. turnover, agency staff use), training and experience of staff, and care organisation and management. ‘Quality’ is a difficult concept to capture directly and the measures used focus mainly on ‘clinical’ outcomes for residents. This systematic mapping review highlights important methodological lessons for future international studies and makes an important contribution to the evidence-base of a relationship between the nursing workforce and quality of care and resident outcomes in nursing home settings.
OBJECTIVE:To undertake a randomized comparison of the Biodesign Surgisis anal fistula plug against surgeonʼs preference in treating cryptoglandular transsphincteric fistula-in-ano.
SUMMARY BACKGROUND ...DATA:The efficacy of the Biodesign Surgisis anal fistula plug in healing anal fistulae is uncertain.
METHODS:Participants were randomized to the fistula plug with surgeonʼs preference (advancement flap, cutting seton, fistulotomy, Ligation of the Intersphincteric Fistula Tract procedure). The primary outcome was faecal incontinence quality of life (FIQoL) at 12-months. Secondary outcomes were fistula healing, incontinence rates, and complication and reintervention rates.
RESULTS:Between May 2011 and March 2016, 304 participants were randomized to fistula plug or surgeonʼs preference. No differences were seen in FIQoL between the 2 groups at 12 months. Clinical fistula healing was reported in 66/122 (54%) of the fistula plug and 66/119 (55%) of the surgeonʼs preference groups at 12 months. Fecal incontinence rates improved marginally in both the groups. Complications and reinterventions were frequent, with significantly more complications in the fistula plug group at 6-weeks (49/142, 35% vs 25/137, 18%; P=0.002). The mean total costs were £2738 (s.d. £1151) for the fistula plug and £2308 (s.d. £1228) for the surgeonʼs preference group (mean difference +£430, P=0.0174). The average total quality adjusted life years (QALYs) gained was marginally higher in the fistula plug group. The fistula plug was 35% to 45% likely to be cost-effective across a willingness to pay threshold of £20,000 to £30,000 / QALY.
CONCLUSIONS:The Biodesign Surgisis anal fistula plug is associated with similar FIQoL and healing rates to surgeonʼs preference at 12 months. Higher costs and highly uncertain gains in QALYs mean that the fistula plug may not be considered as a cost-effective treatment in the UK NHS.
About a third of women receiving pethidine for labour pain subsequently require an epidural, which provides effective pain relief but increases the risk of instrumental vaginal delivery. Remifentanil ...patient-controlled analgesia (PCA) in labour is an alternative to pethidine, but is not widely used. We aimed to evaluate epidural analgesia progression among women using remifentanil PCA compared with pethidine.
We did an open-label, multicentre, randomised controlled trial in 14 UK maternity units. We included women aged 16 years or older, beyond 37 weeks' gestation, in labour with a singleton cephalic presentation, and who requested opioid pain relief. We randomly assigned eligible participants (1:1) to either the intravenous remifentanil PCA group (40 μg bolus on demand with a 2 min lockout) or the intramuscular pethidine group (100 mg every 4 h, up to 400 mg in 24 h), using a web-based or telephone randomisation service with a minimisation algorithm for parity, maternal age, ethnicity, and mode of labour onset. Because of the differences in routes of drug administration, study participants and health-care providers were not masked to the group allocation. The primary outcome was the proportion of women who received epidural analgesia after enrolment for pain relief in labour. Primary analyses were unadjusted and analysed by the intention-to-treat principle. This study is registered with the ISRCTN registry, number ISRCTN29654603.
Between May 13, 2014, and Sept 2, 2016, 201 women were randomly assigned to the remifentanil PCA group and 200 to the pethidine group. One participant in the pethidine group withdrew consent, leaving 199 for analyses. The proportions of epidural conversion were 19% (39 of 201) in the remifentanil PCA group and 41% (81 of 199) in the pethidine group (risk ratio 0·48, 95% CI 0·34–0·66; p<0·0001). There were no serious adverse events or drug reactions directly attributable to either analgesic during the study.
Intravenous remifentanil PCA halved the proportion of epidural conversions compared with intramuscular pethidine. This finding challenges routine pethidine use as standard of care in labour.
National Institute for Health Research Clinician Scientist Award.
Objective: Physician gender may be a source of differences in communication between physicians and their patients, which may in turn contribute to patient satisfaction and other outcomes. Our aim was ...to review systematically research on gender differences in the length, style and content of communication with patients. Methods: Seven electronic databases were searched from inception to September 2010 with no language restrictions (included MEDLINE; PsychINFO; EMBASE; CINAHL; Health Management Information Consortium; Web of Science; and ASSIA). 'Grey' literature was also searched. Data extraction and quality assessment was carried out in accordance with Cochrane Collaboration guidelines by at least two reviewers. The review uses mainly narrative synthesis due to the heterogeneous nature of the studies, with only data on consultation length being pooled in a random effects generic inverse variance meta-analysis. Results: Searches yielded 6412 articles, of which 33 studies fulfilled the inclusion criteria. Studies were heterogenous and of mixed quality. Conflicting results are reported for many communication variables. There is some evidence that female physicians adopt a more partnership building style and spend on average 2.24 min longer with patients per consultation (95% CI 0.62–3.86) than their male colleagues. Conclusions: Greater patient engagement by female doctors may reflect a more patient-centred approach, but their longer consultation times will limit the number of consultations they can provide. This has implications for planning and managing services.
AbstractObjectiveTo evaluate the effectiveness of telephone health coaching delivered by a nurse to support self management in a primary care population with mild symptoms of chronic obstructive ...pulmonary disease (COPD).DesignMulticentre randomised controlled trial.Setting71 general practices in four areas of England.Participants577 patients with Medical Research Council dyspnoea scale scores of 1 or 2, recruited from primary care COPD registers with spirometry confirmed diagnosis. Patients were randomised to telephone health coaching (n=289) or usual care (n=288).InterventionsTelephone health coaching intervention delivered by nurses, underpinned by Social Cognitive Theory. The coaching promoted accessing smoking cessation services, increasing physical activity, medication management, and action planning (4 sessions over 11 weeks; postal information at weeks 16 and 24). The nurses received two days of training. The usual care group received a leaflet about COPD.Main outcome measuresThe primary outcome was health related quality of life at 12 months using the short version of the St George’s Respiratory Questionnaire (SGRQ-C).ResultsThe intervention was delivered with good fidelity: 86% of scheduled calls were delivered; 75% of patients received all four calls. 92% of patients were followed-up at six months and 89% at 12 months. There was no difference in SGRQ-C total score at 12 months (mean difference −1.3, 95% confidence interval −3.6 to 0.9, P=0.23). Compared with patients in the usual care group, at six months follow-up, the intervention group reported greater physical activity, more had received a care plan (44% v 30%), rescue packs of antibiotics (37% v 29%), and inhaler use technique check (68% v 55%).ConclusionsA new telephone health coaching intervention to promote behaviour change in primary care patients with mild symptoms of dyspnoea did lead to changes in self management activities, but did not improve health related quality of life.Trial registrationCurrent controlled trials ISRCTN 06710391
Lateral compression type-1 pelvic fractures are a common fragility fracture in older adults. Patients who do not mobilise due to ongoing pain are at greater risk of immobility-related complications. ...Standard treatment in the United Kingdom is provision of pain relief and early mobilisation, unlike fragility hip fractures, which are usually treated surgically based on evidence that early surgery is associated with better outcomes. Currently there is no evidence on whether patients with lateral compression type-1 fragility fractures would have a better recovery with surgery than non-surgical management.
To assess the clinical and cost effectiveness of surgical fixation with internal fixation device compared to non-surgical management of lateral compression type-1 fragility fractures in older adults.
Pragmatic, randomised controlled superiority trial, with 12-month internal pilot; target sample size was 600 participants. Participants were randomised between surgical and non-surgical management (1 : 1 allocation ratio). An economic evaluation was planned.
UK Major Trauma Centres.
Patients aged 60 years or older with a lateral compression type-1 pelvic fracture, arising from a low-energy fall and unable to mobilise independently to a distance of 3 m and back due to pelvic pain 72 hours after injury.
Internal fixation device surgical fixation and non-surgical management. Participants, surgeons and outcome assessors were not blinded to treatment allocation.
Primary outcome - average patient health-related quality of life, over 6 months, assessed by the EuroQol-5 Dimensions, five-level version utility score. Secondary outcomes (over the 6 months following injury) - self-rated health, physical function, mental health, pain, delirium, displacement of pelvis, mortality, complications and adverse events, and resource use data for the economic evaluation.
The trial closed early, at the end of the internal pilot, due to low recruitment. The internal pilot was undertaken in two separate phases because of a pause in recruitment due to the coronavirus disease 2019 pandemic. The planned statistical and health economic analyses were not conducted. Outcome data were summarised descriptively. Eleven sites opened for recruitment for a combined total of 92 months. Three-hundred and sixteen patients were assessed for eligibility, of whom 43 were eligible (13.6%). The main reason for ineligibility was that the patient was able to mobilise independently to 3 m and back (
= 161). Of the 43 eligible participants, 36 (83.7%) were approached for consent, of whom 11 (30.6%) provided consent. The most common reason for eligible patients not consenting to take part was that they were unwilling to be randomised to a treatment (
= 10). There were 11 participants, 5 randomised to surgical management with internal fixation device and 6 to non-surgical management. The average age of participants was 83.0 years (interquartile range 76.0, 89.0) and the EuroQol-5 Dimensions, five-level version utility score at 6 months post randomisation (
= 8) was 0.32 (standard deviation 0.37). A limitation of the trial was that study objectives were not addressed due to poor recruitment.
It was not feasible to recruit to this trial in the current context. Further research to understand the treatment and recovery pathways of this group of patients, along with their outcomes, would be needed prior to undertaking a future trial.
Exploration of equipoise across different healthcare professional groups. Investigate longer-term patient outcomes.
This trial is registered as ISRCTN16478561.
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/167/57) and is published in full in
; Vol. 28, No. 15. See the NIHR Funding and Awards website for further award information.
BACKGROUND: There has been a resurgence of interest in the controversial relation between dietary protein and bone health. OBJECTIVE: This article reports on the first systematic review and ...meta-analysis of the relation between protein and bone health in healthy human adults. DESIGN: The MEDLINE (January 1966 to September 2007) and EMBASE (1974 to July 2008) databases were electronically searched for all relevant studies of healthy adults; studies of calcium excretion or calcium balance were excluded. RESULTS: In cross-sectional surveys, all pooled r values for the relation between protein intake and bone mineral density (BMD) or bone mineral content at the main clinically relevant sites were significant and positive; protein intake explained 1-2% of BMD. A meta-analysis of randomized placebo-controlled trials indicated a significant positive influence of all protein supplementation on lumbar spine BMD but showed no association with relative risk of hip fractures. No significant effects were identified for soy protein or milk basic protein on lumbar spine BMD. CONCLUSIONS: A small positive effect of protein supplementation on lumbar spine BMD in randomized placebo-controlled trials supports the positive association between protein intake and bone health found in cross-sectional surveys. However, these results were not supported by cohort study findings for hip fracture risk. Any effects found were small and had 95% CIs that were close to zero. Therefore, there is a small benefit of protein on bone health, but the benefit may not necessarily translate into reduced fracture risk in the long term.
The aim of fistula surgery is to eradicate the disease while preserving anal sphincter function. The efficacy of the Surgisis
anal fistula plug (Cook Medical, Bloomington, IN, USA) in the treatment ...of trans-sphincteric fistula-in-ano has been variably reported.
To undertake a randomised comparison of the safety and efficacy of the Surgisis anal fistula plug in comparison with surgeon's preference for the treatment of trans-sphincteric anal fistulas.
A randomised, unblinded, parallel-arm, prospective, multicentre clinical trial.
Hospitals in the UK NHS involving colorectal surgeons accredited by the Association of Coloproctology of Great Britain and Ireland.
Adult patients suffering from trans-sphincteric fistula-in-ano of cryptoglandular origin.
Patients were randomised on a 1 : 1 basis to either the fistula plug or the surgeon's preference e.g. fistulotomy, cutting seton, advancement flap or ligation of intersphincteric fistula tract (LIFT) procedure.
The primary outcome measure was quality of life as measured by the Faecal Incontinence Quality of Life (FIQoL) questionnaire at 12-month follow-up. Secondary outcome measures included clinical and radiological fistula healing rates, faecal incontinence rates, complications rates, reintervention rates and cost-effectiveness.
Between May 2011 and March 2016, 304 participants were recruited (152 fistula plug vs. 152 surgeon's preference). No difference in FIQoL score between the two trial groups was seen at the 6-week, 6-month or 12-month follow-up. Clinical evidence of fistula healing was reported in 66 of 122 (54%) participants in the fistula plug group and in 66 of 119 (55%) participants in the surgeon's preference group at 12 months. Magnetic resonance imaging (MRI) showed fistula healing in 54 of 110 (49%) participants in the fistula plug group and in 63 of 112 (56%) participants in the surgeon's preference group. Variation in 12-month clinical healing rates was observed: 55%, 64%, 75%, 53% and 42% for fistula plug, cutting seton, fistulotomy, advancement flap and LIFT procedure, respectively. Faecal incontinence rates were low at baseline, with small improvement in both groups post treatment. Complications and reinterventions were frequent. The mean total costs were £2738 standard deviation (SD) £1151 in the fistula plug group and £2308 (SD £1228) in the surgeon's preference group. The average total quality-adjusted life-years (QALYs) gain was much smaller in the fistula plug group (0.829, SD 0.174) than in the surgeon's preference group (0.790, SD 0.212). Using multiple imputation and probabilistic sensitivity analysis, and adjusting for differences in baseline EuroQol-5 Dimensions, three-level version utility, there was a 35-45% chance that the fistula plug was as cost-effective as surgeon's preference over a range of thresholds of willingness to pay for a single QALY of £20,000-30,000.
Limitations include a smaller sample size than originally calculated, a lack of blinding that perhaps biased patient-reported outcomes and a lower compliance rate with MRI at 12-month follow-up.
The Surgisis anal fistula plug is associated with similar FIQoL score to surgeon's preference at 12-month follow-up. The higher costs and highly uncertain and small gains in QALYs associated with the fistula plug mean that this technology is unlikely to be considered a cost-effective use of resources in the UK NHS.
Further in-depth analysis should consider the clinical and MRI characteristics of fistula-in-ano in an attempt to identify predictors of fistula response to treatment.
Current Controlled Trials ISRCTN78352529.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in
; Vol. 23, No. 21. See the NIHR Journals Library website for further project information.
Effective recruitment and retention are essential to successful clinical research but we have little good evidence about how to achieve this. Joy Adamson and colleagues call for more use of ...methodological trials embedded within clinical trials to improve our knowledge
PDF
