Andy Barton

The Watcombe Housing Study: the short term effect of improving housing conditions on the health of residents

Objective: To assess the short term health effects of improving housing. Design: Randomised to waiting list. Setting: 119 council owned houses in south Devon, UK. Participants: About 480 residents of these houses. Intervention: Upgrading houses (including central heating, ventilation, rewiring, insulation, and re-roofing) in two phases a year apart. Main outcome measures: All residents completed an annual health questionnaire: SF36 and GHQ12 (adults). Residents reporting respiratory illness or arthritis were interviewed using condition-specific questionnaires, the former also completing peak flow and symptom diaries (children) or spirometry (adults). Data on health service use and time lost from school were collected. Results: Interventions improved energy efficiency. For those living in intervention houses, non-asthma-related chest problems (Mann–Whitney test, p = 0.005) and the combined asthma symptom score for adults (Mann–Whitney test, z = 2.7, p = 0.007) diminished significantly compared with control houses. No difference between intervention and control houses was seen for SF36 or GHQ12. Conclusions: Rigorous study designs for the evaluation of complex public health and community based interventions are possible. Quantitatively measured health benefits are small, but as health benefits were measured over a short time scale, there may have been insufficient time for measurable improvements in general and disease-specific health to become apparent.

Postural modification to the standard Valsalva manoeuvre for emergency treatment of supraventricular tachycardias (REVERT): a randomised controlled trial

BACKGROUND The Valsalva manoeuvre is an internationally recommended treatment for supraventricular tachycardia, but cardioversion is rare in practice (5-20%), necessitating the use of other treatments including adenosine, which patients often find unpleasant. We assessed whether a postural modification to the Valsalva manoeuvre could improve its effectiveness. METHODS We did a randomised controlled, parallel-group trial at emergency departments in England. We randomly allocated adults presenting with supraventricular tachycardia (excluding atrial fibrillation and flutter) in a 1:1 ratio to undergo a modified Valsalva manoeuvre (done semi-recumbent with supine repositioning and passive leg raise immediately after the Valsalva strain), or a standard semi-recumbent Valsalva manoeuvre. A 40 mm Hg pressure, 15 s standardised strain was used in both groups. Randomisation, stratified by centre, was done centrally and independently, with allocation with serially numbered, opaque, sealed, tamper-evident envelopes. Patients and treating clinicians were not masked to allocation. The primary outcome was return to sinus rhythm at 1 min after intervention, determined by the treating clinician and electrocardiogram and confirmed by an investigator masked to treatment allocation. This study is registered with Current Controlled Trials (ISRCTN67937027). FINDINGS We enrolled 433 participants between Jan 11, 2013, and Dec 29, 2014. Excluding second attendance by five participants, 214 participants in each group were included in the intention-to-treat analysis. 37 (17%) of 214 participants assigned to standard Valsalva manoeuvre achieved sinus rhythm compared with 93 (43%) of 214 in the modified Valsalva manoeuvre group (adjusted odds ratio 3·7 (95% CI 2·3-5·8; p<0·0001). We recorded no serious adverse events. INTERPRETATION In patients with supraventricular tachycardia, a modified Valsalva manoeuvre with leg elevation and supine positioning at the end of the strain should be considered as a routine first treatment, and can be taught to patients. FUNDING National Institute for Health Research.

Handbook for good clinical research practice (GCP): guidance for implementation

Published by the World Health Organization, Geneva, 2005, pp 125 (softcover) + CD. ISBN 92-4-159392 Ever thought good clinical practice (GCP) dull? Ever felt abbreviated out? Well, I’d like to report that the WHO’s Handbook for good clinical practice (GCP): guidelines for implementation is an antidote to the mind-boggling stream of acronyms bandied about in research and development departments throughout the world, and that it provides an interesting and amusing narrative on the current minefield that constitutes Research Governance… Well, as the title might …

From local concern to randomized trial: the Watcombe Housing Project

Background  A randomized study of the effect on peoples health of improving their housing is underway in Torbay. The link between poor health, particularly respiratory health, and poor housing conditions has been recognized for a long time, but there have been few intervention studies to demonstrate that improving housing can improve health. In 1994, South and West Devon Health Authority set up a community development project in a deprived area of Torbay, in response to the concerns of local primary health‐care workers. A community development worker helped local residents survey their homes for dampness and record their respiratory symptoms. The survey reported high levels of condensation/dampness and respiratory illness and the Council agreed to direct the majority of their housing improvement funds to the estate over the next 3 years. The Health Authority, University of Plymouth and Torbay Council were successful in obtaining funding to evaluate the housing improvements from the NHS R & D programme.

Effectiveness of a gentamicin impregnated collagen sponge on reducing sternal wound infections following cardiac surgery: a meta-analysis of randomised controlled trials

INTRODUCTION Gentamicin impregnated collagen sponges are licensed for use after cardiac surgery in over 50 countries but their effectiveness at preventing sternal wound infections (SWIs) remains uncertain. The aim of this meta-analysis was to assess the current evidence for effectiveness of such sponges at preventing SWIs in patients after cardiac surgery. METHODS A systematic search of the literature was undertaken and meta-analyses were performed on the results of the identified, eligible studies. Using random effects models, odds ratios (OR) and corresponding 95% confidence intervals (Cl) were calculated for all SWIs and deep SWIs for: a) all participants, and b) participants deemed as high risk. RESULTS Three unique randomised controlled trials (published between 2005 and 2010) involving 3,994 participants met the inclusion criteria. There was insufficient evidence of a significant difference between intervention and control groups for all SWIs (all participants: OR: 0.66, 95% Cl: 0.39–1.14; high risk participants: OR: 0.60, 95% Cl: 0.24–1.52). There was insufficient evidence of a significant benefit of the sponge in deep SWIs across all participants (OR: 0.72, 95% Cl: 0.47–1.10) but some evidence of benefit in terms of reducing the incidence of deep SWIs in high risk participants (OR: 0.62, 95% Cl: 0.39–0.98). CONCLUSIONS There is insufficient evidence of the effectiveness (or otherwise) of gentamicin impregnated sponges in preventing SWIs following cardiac surgery. However, some evidence does exist that such sponges can reduce the incidence of deep infections in high risk patients.

PAin SoluTions In the Emergency Setting (PASTIES)—patient controlled analgesia versus routine care in emergency department patients with pain from traumatic injuries: randomised trial

Objective To determine whether patient controlled analgesia (PCA) is better than routine care in patients presenting to emergency departments with moderate to severe pain from traumatic injuries. Design Pragmatic, multicentre, parallel group, randomised controlled trial. Setting Five English hospitals. Participants 200 adults (71% (n=142) male), aged 18 to 75 years, who presented to the emergency department requiring intravenous opioid analgesia for the treatment of moderate to severe pain from traumatic injuries and were expected to be admitted to hospital for at least 12 hours. Interventions PCA (n=99) or nurse titrated analgesia (treatment as usual; n=101). Main outcome measures The primary outcome was total pain experienced over the 12 hour study period, derived by standardised area under the curve (scaled from 0 to 100) of each participant’s hourly pain scores, captured using a visual analogue scale. Pre-specified secondary outcomes included total morphine use, percentage of study period in moderate/severe pain, percentage of study period asleep, length of hospital stay, and satisfaction with pain management. Results 200 participants were included in the primary analyses. Mean total pain experienced was 47.2 (SD 21.9) for the treatment as usual group and 44.0 (24.0) for the PCA group. Adjusted analyses indicated slightly (but not statistically significantly) lower total pain experienced in the PCA group than in the routine care group (mean difference 2.7, 95% confidence interval −2.4 to 7.8). Participants allocated to PCA used more morphine in total than did participants in the treatment as usual group (mean 44.3 (23.2) v 27.2 (18.2) mg; mean difference 17.0, 11.3 to 22.7). PCA participants spent, on average, less time in moderate/severe pain (36.2% (31.0) v 44.1% (31.6)), but the difference was not statistically significant. A higher proportion of PCA participants reported being perfectly or very satisfied compared with the treatment as usual group (86% (78/91) v 76% (74/98)), but this was also not statistically significant. Conclusions PCA provided no statistically significant reduction in pain compared with routine care for emergency department patients with traumatic injuries. Trial registration European Clinical Trials Database EudraCT2011-000194-31; Current Controlled Trials ISRCTN25343280.

The effectiveness of foot reflexology in inducing ovulation: a sham-controlled randomized trial

OBJECTIVE To determine whether foot reflexology, a complementary therapy, has an effect greater than sham reflexology on induction of ovulation. DESIGN Sham-controlled randomized trial with patients and statistician blinded. SETTING Infertility clinic in Plymouth, United Kingdom. PATIENT(S) Forty-eight women attending the clinic with anovulation. INTERVENTION(S) Women were randomized to receive eight sessions of either genuine foot reflexology or sham reflexology with gentle massage over 10 weeks. MAIN OUTCOME MEASURE(S) The primary outcome was ovulation detected by serum progesterone level of >30 nmol/L during the study period. RESULT(S) Twenty-six patients were randomized to genuine reflexology and 22 to sham (one randomized patient was withdrawn). Patients remained blinded throughout the trial. The rate of ovulation during true reflexology was 11 out of 26 (42%), and during sham reflexology it was 10 out of 22 (46%). Pregnancy rates were 4 out of 26 in the true group and 2 out of 22 in the control group. Because of recruitment difficulties, the required sample size of 104 women was not achieved. CONCLUSION(S) Patient blinding of reflexology studies is feasible. Although this study was too small to reach a definitive conclusion on the specific effect of foot reflexology, the results suggest that any effect on ovulation would not be clinically relevant. Sham reflexology may have a beneficial general effect, which this study was not designed to detect.

PAin SoluTions In the Emergency Setting (PASTIES)—patient controlled analgesia versus routine care in emergency department patients with non-traumatic abdominal pain: randomised trial

Objective To determine whether patient controlled analgesia (PCA) is better than routine care in providing effective analgesia for patients presenting to emergency departments with moderate to severe non-traumatic abdominal pain. Design Pragmatic, multicentre, parallel group, randomised controlled trial Setting Five English hospitals. Participants 200 adults (66% (n=130) female), aged 18 to 75 years, who presented to the emergency department requiring intravenous opioid analgesia for the treatment of moderate to severe non-traumatic abdominal pain and were expected to be admitted to hospital for at least 12 hours. Interventions Patient controlled analgesia or nurse titrated analgesia (treatment as usual). Main outcome measures The primary outcome was total pain experienced over the 12 hour study period, derived by standardised area under the curve (scaled from 0 to 100) of each participant’s hourly pain scores, captured using a visual analogue scale. Pre-specified secondary outcomes included total morphine use, percentage of study period in moderate or severe pain, percentage of study period asleep, length of hospital stay, and satisfaction with pain management. Results 196 participants were included in the primary analyses (99 allocated to PCA and 97 to treatment as usual). Mean total pain experienced was 35.3 (SD 25.8) in the PCA group compared with 47.3 (24.7) in the treatment as usual group. The adjusted between group difference was 6.3 (95% confidence interval 0.7 to 11.9). Participants in the PCA group received significantly more morphine (mean 36.1 (SD 22.4) v 23.6 (13.1) mg; mean difference 12.3 (95% confidence interval 7.2 to 17.4) mg), spent less of the study period in moderate or severe pain (32.6% v 46.9%; mean difference 14.5% (5.6% to 23.5%)), and were more likely to be perfectly or very satisfied with the management of their pain (83% (73/88) v 66% (57/87); adjusted odds ratio 2.56 (1.25 to 5.23)) in comparison with participants in the treatment as usual group. Conclusions Significant reductions in pain can be achieved by PCA compared with treatment as usual in patients presenting to the emergency department with non-traumatic abdominal pain. Trial registration European Clinical Trials Database EudraCT2011-000194-31; Current Controlled Trials ISRCTN25343280.

Is audit running out of steam

Richard Thomson has research interests in quality in health care and health services research. He previously headed the Northern Regional Health Authoritys multidisciplinary quality directorate with responsibility for facilitating audit and quality assurance activities across the region. He has contributed to several national groups concerned with influencing policy on audit, including that at the purchaser-provider interface, and he is a member of the regional medical audit committee and chairman of the regional public health medicine audit promotion group. Andrew Barton s principal responsibility is organising postqualification training in audit for doctors and the professions allied to medicine and advising on the design and management of projects across all specialties. He is researching into the effectiveness ofguidelines in audit and the cost of implementing guidelines. A member of the North Tyneside Medical Audit Advisory Group, he is starting to assess the effectiveness of these groups in general.

Randomised Evaluation of modified Valsalva Effectiveness in Re-entrant Tachycardias (REVERT) study

Introduction The Valsalva manoeuvre (VM) is a recommended first-line physical treatment for patients with re-entrant supraventricular tachycardia (SVT), but is often ineffective in standard practice. A failed VM is typically followed by treatment with intravenous adenosine, which patients often find unpleasant. VM effectiveness might be improved by a modification to posture which exaggerates the manoeuvres vagal response and reduces the need for further emergency treatment. Methods and analysis This is a multicentre randomised controlled clinical trial in 10 UK emergency departments (EDs). It compares a standard VM with a modified VM incorporating leg elevation and a supine posture after a standardised strain in stable adult patients presenting to the ED with SVT. The primary outcome measure is return to sinus rhythm on a 12-lead ECG. Secondary outcome measures include the need for treatment with adenosine or other antiarrhythmic treatments and the time patients spend in the ED. We plan to recruit approximately 372 patients, with 80% power to demonstrate an absolute improvement in cardioversion rate of 12%. An improvement of this magnitude through the use of a modified VM would be of significant benefit to patients and healthcare providers, and justify a change to standard practice. Ethics and dissemination The study has been approved by the South West—Exeter Research Ethics Committee (REC reference 12/SW/0281). The trial will be published in an international peer reviewed journal. Study findings will be sent to the European and International resuscitation councils to inform future revisions of arrhythmia management guidelines. Results The trial will also be disseminated at international conferences and to patients through the Arrhythmia Alliance, a patient support charity. Registration The study is registered with Current Controlled Trials (ISRCTN67937027) and has been adopted by the National Institute for Health Research (NIHR) Clinical Research Network.