Alan Watkins

Predictors of poor attendance at an outpatient pulmonary rehabilitation programme

BACKGROUND Pulmonary rehabilitation (PR) is recommended for patients with respiratory disease who feel limited by breathlessness. Poor attendance wastes finite resources, increases waiting times and is probably associated with poorer clinical outcomes. We investigated what factors, identifiable from routine hospital data, predict poor attendance once enrolled in a pulmonary rehabilitation programme (PRP). METHODS Retrospective case note study of 239 patients (60% male) of mean (S.D.) age of 66.6 (8.7) years, mean FEV(1) 39.6 (14.6)% predicted, who attended a 6 (short) or 18 (long) week, 18 session, outpatient PRP. Attendance data was analysed using linear multiple regression analysis with the log transformed odds ratio of attendance as the dependant variable. RESULTS Overall median attendance was 16 out of 18 sessions. Being a current smoker (p<0.05), attending a long PRP (p<0.05), more previous hospital admissions (p<0.01), higher Medical Research Council (MRC) dyspnoea score (p<0.01) or enduring a long journey (p<0.001) were independent risk factors for low attendance. Lower body mass index (BMI) and distance from PR centre were of borderline importance (p<0.1) but age, gender, co-morbidity, respiratory diagnosis, FEV(1) and St. Georges Respiratory Questionnaire Score at baseline did not predict later attendance (p>0.2). CONCLUSIONS Attendance at PRPs is independently influenced by smoking status, the degree of breathlessness, frequency of hospital admissions, length of the programme and journey time.

The impact of intrapartum analgesia on infant feeding

Objective  To investigate the impact of intrapartum analgesia on infant feeding at hospital discharge.

Coagulation and inflammatory markers in Alzheimer's and vascular dementia

Alzheimers disease is classified as a degenerative dementia while vascular dementia is known to be associated with atherothrombosis and classical vascular risk factors. However, over the last decade, there is increasing evidence of the role of haemostatic factors and inflammatory mechanisms in the pathogenesis of Alzheimers disease. Serum markers of hypercoagulability and markers of inflammation could lead to thrombosis, accelerated atherogenesis and resulting dementia of both Alzheimers and vascular dementia. In this case control study, we studied these serum markers of coagulation and inflammation in patients suffering from dementia.

Associations of drugs routinely given in labour with breastfeeding at 48 hours: analysis of the Cardiff Births Survey

Background  Little is known about how breastfeeding rates are affected by drugs routinely administered in labour.

A randomised controlled trial comparing TVTTM, PelvicolTM and autologous fascial slings for the treatment of stress urinary incontinence in women

Please cite this paper as: Guerrero K, Emery S, Wareham K, Ismail S, Watkins A, Lucas M. A randomised controlled trial comparing TVTTM, PelvicolTM and autologous fascial slings for the treatment of stress urinary incontinence in women. BJOG 2010;117:1493–1503.

Volunteer Bias in Recruitment, Retention, and Blood Sample Donation in a Randomised Controlled Trial Involving Mothers and Their Children at Six Months and Two Years: a longitudinal analysis.

Background The vulnerability of clinical trials to volunteer bias is under-reported. Volunteer bias is systematic error due to differences between those who choose to participate in studies and those who do not. Methods and Results This paper extends the applications of the concept of volunteer bias by using data from a trial of probiotic supplementation for childhood atopy in healthy dyads to explore 1) differences between a) trial participants and aggregated data from publicly available databases b) participants and non-participants as the trial progressed 2) impact on trial findings of weighting data according to deprivation (Townsend) fifths in the sample and target populations. 1) a) Recruits (n = 454) were less deprived than the target population, matched for area of residence and delivery dates (n = 6,893) (mean [SD] deprivation scores 0.09[4.21] and 0.79[4.08], t = 3.44, df = 511, p<0.001). b) i)As the trial progressed, representation of the most deprived decreased. These participants and smokers were less likely to be retained at 6 months (n = 430[95%]) (OR 0.29,0.13–0.67 and 0.20,0.09–0.46), and 2 years (n = 380[84%]) (aOR 0.68,0.50–0.93 and 0.55,0.28–1.09), and consent to infant blood sample donation (n = 220[48%]) (aOR 0.72,0.57–0.92 and 0.43,0.22–0.83). ii)Mothers interested in probiotics or research or reporting infants’ adverse events or rashes were more likely to attend research clinics and consent to skin-prick testing. Mothers participating to help children were more likely to consent to infant blood sample donation. 2) In one trial outcome, atopic eczema, the intervention had a positive effect only in the over-represented, least deprived group. Here, data weighting attenuated risk reduction from 6.9%(0.9–13.1%) to 4.6%(−1.4–+10.5%), and OR from 0.40(0.18–0.91) to 0.56(0.26–1.21). Other findings were unchanged. Conclusions Potential for volunteer bias intensified during the trial, due to non-participation of the most deprived and smokers. However, these were not the only predictors of non-participation. Data weighting quantified volunteer bias and modified one important trial outcome. Trial Registration This randomised, double blind, parallel group, placebo controlled trial is registered with the International Standard Randomised Controlled Trials Register, Number (ISRCTN) 26287422. Registered title: Probiotics in the prevention of atopy in infants and children.

A randomised controlled trial comparing fixation of mandibular angle fractures with a single miniplate placed either transbuccally and intra-orally, or intra-orally alone.

This study compared fixation of simple mandibular angle fractures with a single miniplate either placed from a combined transbuccal and intra-oral approach, or intra-orally alone. 140 consecutive patients were randomly allocated to the two treatment groups. Complications were noted and compared. An email questionnaire to all the participating surgeons examined their personal preferences between the two methods. 20% of plates needed to be removed during the 3 month study period in the combined transbuccal/intra-oral group compared with 36% in the intra-oral alone group (p<or=0.05). For the small number of cases (5) that required additional fixation, there was no significant difference between the groups. The combined transbuccal/intra-oral procedure was safer and more effective than the standard intra-oral technique in terms of complications requiring further surgery. The surgeons expressed a strong preference (11/12) for fixation using the combined transbuccal/oral approach. The principal reasons given were ease of use, minimal requirement to bend the plate and facilitation of placement of the plate in the neutral mid-point area of the mandible.

Infliximab versus ciclosporin for steroid-resistant acute severe ulcerative colitis (CONSTRUCT): a mixed methods, open-label, pragmatic randomised trial

Summary Background Infliximab and ciclosporin are of similar efficacy in treating acute severe ulcerative colitis, but there has been no comparative evaluation of their relative clinical effectiveness and cost-effectiveness. Methods In this mixed methods, open-label, pragmatic randomised trial, we recruited consenting patients aged 18 years or older at 52 district general and teaching hospitals in England, Scotland, and Wales who had been admitted, unscheduled, with severe ulcerative colitis and failed to respond to intravenous hydrocortisone within about 5 days. Patients were randomly allocated (1:1) to receive either infliximab (5 mg/kg intravenous infusion given over 2 h at baseline, and again at 2 weeks and 6 weeks after the first infusion) or ciclosporin (2 mg/kg per day by continuous infusion for up to 7 days, followed by twice-daily tablets delivering 5·5 mg/kg per day for 12 weeks). Randomisation used a web-based password-protected site, with a dynamic algorithm to generate allocations on request, thus protecting against investigator preference or other subversion, while ensuring that each trial group was balanced by centre, which was the only stratification used. Local investigators and participants were aware of the treatment allocated, but the chief investigator and analysts were masked. Analysis was by treatment allocated. The primary outcome was quality-adjusted survival—ie, the area under the curve (AUC) of scores from the Crohns and Ulcerative Colitis Questionnaire (CUCQ) completed by participants at baseline, 3 months, and 6 months, then every 6 months from 1 year to 3 years. This trial is registered with the ISRCTN Registry, number ISRCTN22663589. Findings Between June 17, 2010, and Feb 26, 2013, 270 patients were recruited. 135 patients were allocated to the infliximab group and 135 to the ciclosporin group. 121 (90%) patients in each group were included in the analysis of the primary outcome. There was no significant difference between groups in quality-adjusted survival (mean AUC 564·0 [SD 241·9] in the infliximab group vs 587·0 [226·2] in the ciclosporin group; mean adjusted difference 7·9 [95% CI −22·0 to 37·8]; p=0·603). Likewise, there were no significant differences between groups in the secondary outcomes of CUCQ scores, EQ-5D, or SF-6D scores; frequency of colectomy (55 [41%] of 135 patients in the infliximab group vs 65 [48%] of 135 patients in the ciclosporin group; p=0·223); or mean time to colectomy (811 [95% CI 707–912] days in the infliximab group vs 744 [638–850] days in the ciclosporin group; p=0·251). There were no differences in serious adverse reactions (16 reactions in 14 participants receiving infliximab vs ten in nine patients receiving ciclosporin); serious adverse events (21 in 16 patients vs 25 in 17 patients); or deaths (three in the infliximab group vs none in the ciclosporin group). Interpretation There was no significant difference between ciclosporin and infliximab in clinical effectiveness. Funding NIHR Health Technology Assessment programme.

Antegrade continence enema in the treatment of obstructed defaecation with or without faecal incontinence

BackgroundObstructed defaecation and faecal incontinence are complex functional disorders that pose management challenges. In recent times, the antegrade continence enema (ACE) has been tried both as a primary procedure and as a final resort to avoid a colostomy in patients with a variety of functional problems. The purpose of this study was to evaluate the role of the ACE procedure as a treatment option for adult patients suffering from obstructed defaecation with or without faecal incontinence, some of whom also had slow transit constipation.MethodsTwenty female patients underwent ACE as an appendicostomy (65%) or caecostomy (35%). The median age was 44 years (range, 20–65 years). The indications were obstructed defaecation with faecal incontinence (65%) and obstructed defaecation alone (35%). Fifteen of these patients were followed for 3–51 months (median, 6 months). Cleveland continence score, bowel score and quality of life score were recorded pre– and postoperatively along with post–procedure complications.ResultsThirteen (65%) patients were satisfied with the outcome and recorded improvement in their scores while two (10%) remained the same and one (5%) was worse. This latter woman and another patient stopped using their ACE, whilst follow–up data was unavailable for three patients. Minor wound infections were noted in nine patients (45%), of whom one needed drainage of an abscess; the rest settled with antibiotics and dressings. Bowel and Cleveland continence scores improved postoperatively (p<0.001 and p=0.001, respectively) but SF36 scores did not. To date, no patient has had a colostomy following an ACE procedure.ConclusionsColostomies can be avoided in patients with obstructed defaecation. There is, however, a need to minimise wound infections which seem to be the most troublesome complication.

An algorithm for maximum likelihood estimation in the three parameter Burr XII distribution

Abstract This paper outlines an algorithm for calculating the maximum likelihood estimates of the three parameter Burr XII distribution. The algorithm exploits the link between this distribution and the two parameter Weibull distribution, which emerges as a limiting case of the distribution, and also calculates a discriminating Δ statistic, used to determine which distribution provides a better fit to data. We outline the basis behind the discriminating Δ, discuss an implementation of the algorithm, and illustrate our discussion with the output from this implementation for published data sets.