Patient-directed self-management of pain (PaDSMaP) compared to treatment as usual following total knee replacement; a randomised controlled trial.

BACKGROUND: Self-administration of medicines by patients whilst in hospital is being increasingly promoted despite little evidence to show the risks and benefits. Pain control after total knee replacement (TKR) is known to be poor. The aim of the study was to determine if patients operated on with a TKR who self-medicate their oral analgesics in the immediate post-operative period have better pain control than those who receive their pain control by nurse-led drug rounds (Treatment as Usual (TAU)). METHODS: A prospective, parallel design, open-label, randomised controlled trial comparing pain control in patient-directed self-management of pain (PaDSMaP) with nurse control of oral analgesia (TAU) after a TKR. Between July 2011 and March 2013, 144 self-medicating adults were recruited at a secondary care teaching hospital in the UK. TAU patients (n = 71) were given medications by a nurse after their TKR. PaDSMaP patients (n = 73) took oral medications for analgesia and co-morbidities after two 20 min training sessions reinforced with four booklets. Primary outcome was pain (100 mm visual analogue scale (VAS)) at 3 days following TKR surgery or at discharge (whichever came soonest). Seven patients did not undergo surgery for reasons unrelated to the study and were excluded from the intention-to-treat (ITT) analysis. RESULTS: ITT analysis did not detect any significant differences between the two groups' pain scores. A per protocol (but underpowered) analysis of the 60% of patients able to self-medicate found reduced pain compared to the TAU group at day 3/discharge, (VAS -9.9 mm, 95% CI -18.7, - 1.1). One patient in the self-medicating group over-medicated but suffered no harm. CONCLUSION: Self-medicating patients did not have better (lower) pain scores compared to the nurse-managed patients following TKR. This cohort of patients were elderly with multiple co-morbidities and may not be the ideal target group for self-medication. TRIAL REGISTRATION: ISRCTN10868989 . Registered 22 March 2012, retrospectively registered.

Nurse-Facilitated Health Checks for Persons With Severe Mental Illness: A Cluster-Randomized Controlled Trial.

OBJECTIVE: This study tested the effectiveness of a nurse-delivered health check with the Health Improvement Profile (HIP), which takes approximately 1.5 hours to complete and code, for persons with severe mental illness. METHODS: A single-blind, cluster-randomized controlled trial was conducted in England to test whether health checks improved the general medical well-being of persons with severe mental illness at 12-month follow-up. RESULTS: Sixty nurses were randomly assigned to the HIP group or the treatment-as-usual group. From their case lists, 173 patients agreed to participate. HIP group nurses completed health checks for 38 of their 90 patients (42%) at baseline and 22 (24%) at follow-up. No significant between-group differences were noted in patients' general medical well-being at follow-up. CONCLUSIONS: Nurses who had volunteered for a clinical trial administered health checks only to a minority of participating patients, suggesting that it may not be feasible to undertake such lengthy structured health checks in routine practice.

Holding Back the Tears: Individual Differences in Adult Crying Proneness Reflect Attachment Orientation and Attitudes to Crying.

Despite being a universal human attachment behavior, little is known about individual differences in crying. To facilitate such examination we first recommend shortened versions of the attitudes and proneness sections of the Adult Crying Inventory using two independent samples. Importantly, we examine attachment orientation differences in crying proneness and test the mediating role of attitudes toward crying in this relationship. Participants (Sample 1 N = 623, Sample 2 N = 781), completed online measures of adult attachment dimensions (avoidance and anxiety), attitudes toward crying, and crying proneness. Exploratory factor analyses in Sample 1 revealed four factors for crying attitudes: crying helps one feel better; crying is healthy; hatred of crying; and crying is controllable; and three factors for crying proneness: threat to self; sadness; and joy. Confirmatory factor analyses in Sample 2 replicated these structures. Theoretically and statistically justified short forms of each scale were created. Multiple mediation analyses revealed similar patterns of results across the two samples, with the attitudes "crying is healthy" and "crying is controllable" consistently mediating the positive links between attachment anxiety and crying proneness, and the negative links between attachment avoidance and crying proneness. Results are discussed in relation to attachment and emotion regulation literature.

Treatment retention, drug use and social functioning outcomes in those receiving 3 months versus 1 month of supervised opioid maintenance treatment. Results from the Super C randomized controlled trial.

AIM: Supervised consumption of opioid maintenance treatment (OMT) is standard in many drug centres reducing drug diversion, but is costly. We aimed to determine whether supervised consumption of OMT improved retention and other measures of drug use. DESIGN: Pragmatic randomized controlled trial comparing 3 months of daily supervised consumption of OMT with 1 month or less of daily supervised OMT, then daily unsupervised consumption. SETTING: Four community drug services in the United Kingdom. PARTICIPANTS: A total of 293 opioid-dependent patients entering OMT. PRIMARY OUTCOME: retention in treatment at 12 weeks. Secondary: retention at 6 months; illicit drug use [Maudsley Addiction Profile (MAP)]; quality of life (SF-12 and MAP); criminality (MAP); and social functioning. FINDINGS: No significant between-group difference was observed for the primary outcome: 69% (100 of 145) supervised and 74% (109 of 148) unsupervised were retained [odds ratio (OR) = 0.74, 95% confidence interval (CI) = 0.43-1.27]. Per protocol survival analysis suggested that supervised patients were less well retained (hazard ratio for retention = 0.71, 95% CI = 0.51-1.00). Illicit opioid use reduced in both groups and, while not statistically significant by intention-to-treat analysis, favoured unsupervised patients in per protocol analysis (odds of positive opioid screen for supervised versus unsupervised = 2.07, 95% CI = 1.05-4.06). Data on criminal activity also favoured unsupervised patients with 21% supervised patients committing crime versus 9% unsupervised (OR = 3.37, 95% CI = 1.28-8.86). CONCLUSIONS: There was no evidence of a difference in treatment retention or opioid use rates between patients whose consumption of opioid maintenance treatment was supervised for 3 months daily (except Saturdays) compared with supervision for 1 month. There was some evidence that longer periods of supervised consumption were associated with higher levels of criminality.

Do older patients find multi-compartment medication devices easy to use and which are the easiest?

BACKGROUND: multi-compartment medication devices (MMDs) are widely used, primarily by older people, to aid correct-medication taking. Several MMD types are available yet little is known about the ease with which patients with varying functional ability use these devices and whether some types are easier than others. Such knowledge would assist healthcare practitioners in advising patients on a suitable choice of device. OBJECTIVE: this study investigates the ease with which patients with differing functional ability use three types of MMD. METHOD: participants were recruited from an older person's medical ward. Demographic and medication information, cognitive function, visual acuity and manual dexterity were recorded. The Venalink®, Nomad Clear® and Dosett® MMDs were tested. Participants rated each MMD according to text readability, ease of opening, ease of medication removal, transportability and overall rating. These ratings were compared between MMDs for all patients and for subgroups with differing functional abilities. RESULTS: the MMDs were trialled by 50 patients; the majority rated text readability well but rated MMDs poorly according to the other criteria. Cognitively impaired participants may encounter difficulties in opening and removing medication from Venalink® and Nomad®. The Dosett® consistently rated better across all criteria. Transportability was the most influential criterion for overall MMD usability. CONCLUSION: the poor patient rating of MMDs which are widely used in practice is of concern. Some MMDs may be difficult to open and access, especially for patients with cognitive impairment. This offers some guidance to health professionals in advising patients on MMD choice however, overall MMD rating appears dominated by transportability.

Patient directed self management of pain (PaDSMaP) compared to treatment as usual following total knee replacement: study protocol for a randomized controlled trial.

BACKGROUND: In 2009, 665 patients underwent total knee replacements (TKRs) at the Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH), representing nearly 1% of the national total. Pain control following the operation can be poor, and this can cause poor mobilization and potential long-term adverse events. Although high levels of pain are not associated with patient dissatisfaction, brief periods of pain may lead to neuronal remodeling and sensitization. Patient controlled oral analgesia (PCOA) may improve pain relief; however, the evidence to date has been inconclusive. Patient directed self management of pain (PaDSMaP) is a single center randomized controlled trial, which aims to establish if patient self-medication improves, or is equivalent to, treatment as usual and to create an educational package to allow implementation elsewhere. METHODS/DESIGN: Patients eligible for a TKR will be recruited and randomized in the outpatient clinic. All patients will undergo their operations according to normal clinical practice but will be randomized into two groups. Once oral medication has commenced, one group will have pain relief administered by nursing staff in the usual way (treatment as usual; TAU), whilst the second group will self manage their pain medication (patient directed self management of pain; PaDSMaP). Those recruited for self-medication will undergo a training program to teach the use of oral analgesics according to the World Health Organization (WHO) pain cascade and how to complete the study documentation. The primary endpoint of the trial is the visual analogue scale (VAS) pain score at 3 days or discharge, whichever is sooner. The follow-up time is 6 weeks with a planned trial period of 3 years. The secondary objectives are satisfaction with the management of patient pain post-operatively whilst an inpatient after primary TKR; overall pain levels and pain on mobilization; satisfaction with pain management information provided; global outcomes, such as quality of life (QOL) and activities of daily living (ADLs); time to mobilization and whether time to mobilization is associated with frequency of adverse events, improvements in QOL, ADLs and pain at 6 weeks after the operation; incidence of adverse events; quantity and type of pain medications used whilst an inpatient; the acceptability of PaDSMaP and/or TAU protocols for patients and the healthcare professionals involved in their care; to investigate the health-related costs associated with a PaDSMaP system; and to estimate the cost-effectiveness of PaDSMaP compared to TAU. TRIAL REGISTRATION: Current Controlled Trials ISRCTN: 10868989.

Computerised therapy for depression with clinician vs. assistant and brief vs. extended phone support: study protocol for a randomised controlled trial.

BACKGROUND: Computerised cognitive behaviour therapy (cCBT) involves standardised, automated, interactive self-help programmes delivered via a computer. Randomised controlled trials (RCTs) and observational studies have shown than cCBT reduces depressive symptoms as much as face-to-face therapy and more than waiting lists or treatment as usual. cCBT's efficacy and acceptability may be influenced by the "human" support offered as an adjunct to it, which can vary in duration and can be offered by people with different levels of training and expertise. METHODS/DESIGN: This is a two-by-two factorial RCT investigating the effectiveness, cost-effectiveness and acceptability of cCBT supplemented with 12 weekly phone support sessions are either brief (5-10 min) or extended (20-30 min) and are offered by either an expert clinician or an assistant with no clinical training. Adults with non-suicidal depression in primary care can self-refer into the study by completing and posting to the research team a standardised questionnaire. Following an assessment interview, eligible referrals have access to an 8-session cCBT programme called Beating the Blues and are randomised to one of four types of support: brief-assistant, extended-assistant, brief-clinician or extended-clinician.A sample size of 35 per group (total 140) is sufficient to detect a moderate effect size with 90% power on our primary outcome measure (Work and Social Adjustment Scale); assuming a 30% attrition rate, 200 patients will be randomised. Secondary outcome measures include the Beck Depression and Anxiety Inventories and the PHQ-9 and GAD-7. Data on clinical outcomes, treatment usage and patient experiences are collected in three ways: by post via self-report questionnaires at week 0 (randomisation) and at weeks 12 and 24 post-randomisation; electronically by the cCBT system every time patients log-in; by phone during assessments, support sessions and exit interviews. DISCUSSION: The study's factorial design increases its efficiency by allowing the concurrent investigation of two types of adjunct support for cCBT with a single sample of participants. Difficulties in recruitment, uptake and retention of participants are anticipated because of the nature of the targeted clinical problem (depression impairs motivation) and of the studied interventions (lack of face-to-face contact because referrals, assessments, interventions and data collection are completed by phone, computer or post). TRIAL REGISTRATION: Current Controlled Trials ISRCTN98677176.

The Dundee Ready Education Environment Measure (DREEM): a review of its adoption and use.

BACKGROUND: The Dundee Ready Education Environment Measure (DREEM) was published in 1997 as a tool to evaluate educational environments of medical schools and other health training settings and a recent review concluded that it was the most suitable such instrument. AIMS: This study aimed to review the settings and purposes to which the DREEM has been applied and the approaches used to analyse and report it, with a view to guiding future users towards appropriate methodology. METHOD: A systematic literature review was conducted using the Web of Knowledge databases of all articles reporting DREEM data between 1997 and 4 January 2011. RESULTS: The review found 40 publications, using data from 20 countries. DREEM is used in evaluation for diagnostic purposes, comparison between different groups and comparison with ideal/expected scores. A variety of non-parametric and parametric statistical methods have been applied, but their use is inconsistent. CONCLUSIONS: DREEM has been used internationally for different purposes and is regarded as a useful tool by users. However, reporting and analysis differs between publications. This lack of uniformity makes comparison between institutions difficult. Most users of DREEM are not statisticians and there is a need for informed guidelines on its reporting and statistical analysis.

The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial.

BACKGROUND: The serious mental illness Health Improvement Profile [HIP] is a brief pragmatic tool, which enables mental health nurses to work together with patients to screen physical health and take evidence-based action when variables are identified to be at risk. Piloting has demonstrated clinical utility and acceptability. METHODS/DESIGN: A single blind parallel group cluster randomised controlled trial with secondary economic analysis and process observation. Unit of randomisation: mental health nurses [MHNs] working in adult community mental health teams across two NHS Trusts. SUBJECTS: Patients over 18 years with a diagnosis of schizophrenia, schizoaffective or bipolar disorder on the caseload of participating MHNs. PRIMARY OBJECTIVE: To determine the effects of the HIP programme on patients' physical wellbeing assessed by the physical component score of the Medical Outcome Study (MOS) 36 Item Short Form Health Survey version 2 [SF-36v2]. SECONDARY OBJECTIVES: To determine the effects of the HIP programme on: cost effectiveness, mental wellbeing, cardiovascular risk, physical health care attitudes and knowledge of MHNs and to determine the acceptability of the HIP Programme in the NHS. Consented nurses (and patients) will be randomised to receive the HIP Programme or treatment as usual. Outcomes will be measured at baseline and 12 months with a process observation after 12 months to include evaluation of patients' and professionals' experience and observation of any effect on care plans and primary-secondary care interface communication. Outcomes will be analysed on an intention-to-treat (ITT) basis. DISCUSSION: The results of the trial and process observation will provide information about the effectiveness of the HIP Programme in supporting MHNs to address physical comorbidity in serious mental illness. Given the current unacceptable prevalence of physical comorbidity and mortality in the serious mental illness population, it is hoped the HIP trial will provide a timely contribution to evidence on organisation and delivery of care for patients, clinicians and policy makers. ISRCTN: ISRCTN41137900.

Statistics teaching in medical school: opinions of practising doctors.

BACKGROUND: The General Medical Council expects UK medical graduates to gain some statistical knowledge during their undergraduate education; but provides no specific guidance as to amount, content or teaching method. Published work on statistics teaching for medical undergraduates has been dominated by medical statisticians, with little input from the doctors who will actually be using this knowledge and these skills after graduation. Furthermore, doctor's statistical training needs may have changed due to advances in information technology and the increasing importance of evidence-based medicine. Thus there exists a need to investigate the views of practising medical doctors as to the statistical training required for undergraduate medical students, based on their own use of these skills in daily practice. METHODS: A questionnaire was designed to investigate doctors' views about undergraduate training in statistics and the need for these skills in daily practice, with a view to informing future teaching. The questionnaire was emailed to all clinicians with a link to the University of East Anglia Medical School. Open ended questions were included to elicit doctors' opinions about both their own undergraduate training in statistics and recommendations for the training of current medical students. Content analysis was performed by two of the authors to systematically categorize and describe all the responses provided by participants. RESULTS: 130 doctors responded, including both hospital consultants and general practitioners. The findings indicated that most had not recognised the value of their undergraduate teaching in statistics and probability at the time, but had subsequently found the skills relevant to their career. Suggestions for improving undergraduate teaching in these areas included referring to actual research and ensuring relevance to, and integration with, clinical practice. CONCLUSIONS: Grounding the teaching of statistics in the context of real research studies and including examples of typical clinical work may better prepare medical students for their subsequent career.

The SUMMIT trial: a field comparison of buprenorphine versus methadone maintenance treatment.

This prospective patient-preference study examined the effectiveness in practice of methadone versus buprenorphine maintenance treatment and the beliefs of subjects regarding these drugs. A total of 361 opiate-dependent individuals (89% of those eligible, presenting for treatment over 2 years at a drug service in England) received rapid titration then flexible dosing with methadone or buprenorphine; 227 patients chose methadone (63%) and 134 buprenorphine (37%). Participants choosing methadone had more severe substance abuse and psychiatric and physical problems but were more likely to remain in treatment. Survival analysis indicated those prescribed methadone were over twice as likely to be retained (hazard ratio for retention was 2.08 and 95% confidence interval [CI] = 1.49-2.94 for methadone vs. buprenorphine), However, those retained on buprenorphine were more likely to suppress illicit opiate use (odds ratio = 2.136, 95% CI = 1.509-3.027, p < .001) and achieve detoxification. Buprenorphine may also recruit more individuals to treatment because 28% of those choosing buprenorphine (10% of the total sample) stated they would not have accessed treatment with methadone.

The UK pay-for-performance programme in primary care: estimation of population mortality reduction.

BACKGROUND: General practices in the UK contract with the government to receive additional payments for high-quality primary care. Little is known about the resulting impact on population health. AIM: To estimate the potential reduction in population mortality from implementation of the pay-for-performance contract in England. DESIGN OF STUDY: Cross-sectional and modelling study. SETTING: Primary care in England. METHOD: Twenty-five clinical quality indicators in the contract had controlled trial evidence of mortality benefit. This was combined with condition prevalence, and the differences in performance before and after contract implementation, to estimate the potential mortality reduction per indicator. Improvement was adjusted for pre-existing trends where data were available. RESULTS: The 2004 contract potentially reduced mortality by 11 lives per 100 000 people (lower-upper estimates 7-16) over 1 year, as performance improved from baseline to the target for full incentive payment. If all eligible patients were treated, over and above the target, 56 (29-81) lives per 100 000 might have been saved. For the 2006 contract, mortality reduction was effectively zero, because new baseline performance for a typical practice had already exceeded the target performance for full payment. CONCLUSION: The contract may have delivered substantial health gain, but potential health gain was limited by performance targets for full payment being set lower than typical baseline performance. Information on both baseline performance and population health gain should inform decisions about future selection of indicators for pay-for-performance schemes, and the level of performance at which full payment is triggered.

Limited shock wave therapy vs sham treatment in men with Peyronie's disease: results of a prospective randomized controlled double-blind trial.

OBJECTIVE: To assess the role of extracorporeal shock wave therapy (SWT), in a prospective randomized controlled trial, comparing limited SWT vs sham therapy in men with Peyronie's disease. PATIENTS AND METHODS: In all, 36 men were randomized to six sessions of SWT or sham treatment. Geometrical measurements of penile length and deformity, and the abridged International Index of Erectile Function (IIEF) score and visual analogue score (VAS) were recorded and re-evaluated at 6 months. The patient and assessor were unaware of the treatment type. Standard nonparametric tests were used for the statistical analysis. RESULTS: A full set of outcome data was obtained for 16 patients in the intervention group and 20 in the sham/control group (mean age 58 and 60 years, respectively, mean duration of symptoms 15 and 33 months). There was no significant difference in the mean change between the control and intervention groups on any outcome measure. There were improvements in the mean (sd) dorsal and lateral angle, of 5.3 (11.66)° and 3.5 (17.38)° in the control group, and a deterioration of 0.9 (16.01)° and 0.9 (15.56)° in SWT group. Mean improvements in curved and straight lengths were 0.2 (0.58) and 0.1 (0.8) cm in the control and mean reductions of 0.1 (0.9) and 0.1 (1.49) cm in the SWT group. The mean changes in the IIEF and VAS scores were 0.1 (3.32) and -0.8 (1.77) for control and 0.56 (2.6) and -1.05 (1.79) for SWT group. CONCLUSION: There were no significant differences in changes of variables in Peyronie's disease treated with short-term SWT.

Do doctors need statistics? Doctors' use of and attitudes to probability and statistics.

There is little published evidence on what doctors do in their work that requires probability and statistics, yet the General Medical Council (GMC) requires new doctors to have these skills. This study investigated doctors' use of and attitudes to probability and statistics with a view to informing undergraduate teaching.An email questionnaire was sent to 473 clinicians with an affiliation to the University of East Anglia's Medical School.Of 130 respondents approximately 90 per cent of doctors who performed each of the following activities found probability and statistics useful for that activity: accessing clinical guidelines and evidence summaries, explaining levels of risk to patients, assessing medical marketing and advertising material, interpreting the results of a screening test, reading research publications for general professional interest, and using research publications to explore non-standard treatment and management options.Seventy-nine per cent (103/130, 95 per cent CI 71 per cent, 86 per cent) of participants considered probability and statistics important in their work. Sixty-three per cent (78/124, 95 per cent CI 54 per cent, 71 per cent) said that there were activities that they could do better or start doing if they had an improved understanding of these areas and 74 of these participants elaborated on this. Themes highlighted by participants included: being better able to critically evaluate other people's research; becoming more research-active, having a better understanding of risk; and being better able to explain things to, or teach, other people.Our results can be used to inform how probability and statistics should be taught to medical undergraduates and should encourage today's medical students of the subjects' relevance to their future careers.

Imaging the femoral sulcus with ultrasound, CT, and MRI: reliability and generalizability in patients with patellar instability.

OBJECTIVE: Recent advances in surgical intervention for patellar instability have led to a need for long-term radiological monitoring. The aim of this study is to determine whether or not magnetic resonance imaging (MRI) or ultrasound (US) can replace computed tomography (CT) as the standard of care for the evaluation of the femoral sulcus. MATERIALS AND METHODS: This was a prospective study comparing the reliability of CT, magnetic resonance (MR), and US for measuring the femoral sulcus in patients with patellar instability. Twenty-four patients were recruited to undergo a CT, MR, and US examination of each knee. Two observers independently measured femoral sulcus angles from subchondral bone and hyaline cartilage on two occasions. Intraclass correlations and generalizability coefficients were calculated to measure the reliability of each of the techniques. Thereafter, two observers measured the femoral sulcus angle from ultrasound images recorded by two independent operators to estimate interobserver and interoperator reliability. RESULTS: Forty-seven knees were examined with CT and US and 44 with MRI. The sulcus angle was consistently smaller when measured from subchondral bone compared to cartilage (5-7 degrees ). Interobserver reliability for CT, MR, and US measurements from subchondral bone were 0.87, 0.80, and 0.82 and from cartilage 0.80, 0.81, and 0.50. Generalizability coefficients of measurements from subchondral bone for CT, MR, and US were 0.87, 0.76, and 0.81 and for cartilage 0.76, 0.73, and 0.05. Most of the variability in the US occurred at image acquisition rather than measurement. CONCLUSION: In patients with patellar instability, CT and MR are reliable techniques for measuring the femoral sulcus angle but US, particularly of the articular cartilage, is not. MR is therefore the most suitable tool for longitudinal studies of the femoral sulcus.

A systematic review of analytical observational studies investigating the association between cardiovascular disease and drinking water hardness.

The aim of this study is to systematically review and critically assess analytical observational epidemiology studies investigating the association between levels of drinking water hardness and cardiovascular disease. We searched electronic databases and used standardised forms to extract data and assess study quality. Of 2,906 papers identified, 14 met the inclusion criteria (nine case control and five cohort studies). Of the nine case control studies, seven examined both drinking water magnesium and calcium and risk of death from cardiovascular disease. A pooled odds ratio showed a statistically significant inverse association between magnesium and cardiovascular mortality (OR 0.75 (95%CI 0.68, 0.82), p < 0.001). Only two studies reported a statistically significant effect for calcium. Substantial heterogeneity between studies made calculation of a summary estimate for drinking water calcium inappropriate. Of three cohort studies reviewed, two were of good quality. A weak suggestion that soft water was harmful in females and possibly associated with a slightly greater risk of sudden death was reported, but there was no association between water hardness and mortality from stroke or cardiovascular disease. This study found significant evidence of an inverse association between magnesium levels in drinking water and cardiovascular mortality following a meta-analysis of case control studies. Evidence for calcium remains unclear.

Prospective randomized crossover trial of lubricant gel against an anaesthetic gel for outpatient cystoscopy.

OBJECTIVE: Flexible cystoscopy is routinely performed under local anaesthetic. The aim of this study was to compare the outcomes of using an anaesthetic gel and a non-anaesthetic gel in the same patient. MATERIAL AND METHODS: Men undergoing 3-monthly check cystoscopies were recruited to this prospective, randomized, double-blind, crossover trial. Primary outcome measures were visual analogue scale scores for pain and the incidence of infection. A total of 51 men were randomized to receive 11 ml of either a non-anaesthetic gel or Instillagel as a lubricant on their first visit; they then crossed over to the other agent on their next visit. A nurse who was blinded to the type of lubricant used recorded post-procedural visual analogue scale scores for pain and contacted the patients 48 h postoperatively to check the incidence of infection. RESULTS: The median difference in pain score (non-anaesthetic minus anaesthetic) was 0 (range -5.3 to 7.5) and the mean difference 0.24 (SD 2.3), with no evidence of a 'time period effect' between instillations, i.e. the sequence of instillation with Instillagel followed by aqueous gel or aqueous gel followed by Instillagel in an individual did not have a significant effect. One patient had a urinary tract infection after using each type of gel. A non-inferiority test gave strong evidence that the mean difference in pain score was < 1 (p = 0.011). CONCLUSIONS: Our study suggests that the pain experienced with the non-anaesthetic gel is no greater than that experienced with the anaesthetic gel. The non-anaesthetic gel is as effective as the anaesthetic gel and its regular use should be advocated in routine practice.

The Relationship Between Contact and Child Adjustment in High Conflict Cases after Divorce or Separation.

BACKGROUND: The study explored the relationship between contact and child adjustment where parents are in legal dispute over contact following divorce. METHOD: The sample consisted of 156, 129 and 108 parents at three different time points. Resident and contact parents reported on child and parent wellbeing, contact, decision-making and concerns about their former partner's parenting. RESULTS: Children, particularly boys, had above average behaviour problems. Parent wellbeing and concerns about their ex-partner's parenting were associated with child adjustment. Contact and child adjustment were not related. CONCLUSIONS: Parenting education and therapeutic interventions are required to help parents focus on their children's needs.

A comparison of manual therapy and active rehabilitation in the treatment of non specific low back pain with particular reference to a patient's Linton & Hallden psychological screening score: a pilot study.

BACKGROUND: Clinical guidelines for the management of back pain frequently recommend 'manual therapy' as a first line intervention, with psychosocial screening and 'active rehabilitation' for those not improving at 6 weeks post onset. The potential for psychosocial factors to predict treatment response and therefore outcome has not been adequately explored. The purpose of this pilot study was to determine the feasibility of a study to compare manual therapy and active rehabilitation outcomes for subjects with sub-acute/chronic back pain, investigate whether any difference in outcome was related to psychosocial factors, and to inform the design of a main study. METHODS: A convenience sample of 39 patients with non-specific low back pain referred to the physiotherapy department of an acute NHS Trust hospital was recruited over a nine month period. Patients completed the Linton and Hallden psychological screening questionnaire (LH) and were allocated to a low LH (105 or below) or high LH (106 or above) scoring group. The low or high LH score was used to sequentially allocate patients to one of two treatment groups - Manual Therapy comprising physiotherapy based on manual means as chosen by the treating therapist or Active Rehabilitation comprising a progressive exercise and education programme - with the first low LH scoring patient being allocated to active rehabilitation and the next to manual therapy and so on. Treatment was administered for eight sessions over a four-week period and outcome measures were taken at baseline and at four weeks. Measures used were the Roland Morris Questionnaire (RMQ), two components of the Short Form McGill (total pain rating index [PRI] and pain intensity via visual analogue scale [VAS]), and the LH. RESULTS: The manual therapy group demonstrated a greater treatment effect compared with active rehabilitation for RMQ (mean difference 3.6, 95% CI 1.1 - 6.2, p = 0.006) and PRI (7.1, 95% CI 2.0 - 12.2, p = 0.007) and marginally significant results for VAS (15, 95% CI -1.1 to 31.2, p = 0.067). A linear model allowing for confounding effects and the interaction between high or low LH scores supported these results. The interaction effect was not significant for any outcome measure but this could be due to an insufficient number of subjects to detect this effect. CONCLUSION: Comparative evaluation of manual therapy and active rehabilitation with reference to LH psychosocial scores is likely to be detectable by the methods used here. However several alterations to the study design are recommended for the main study. A pragmatic trial using a randomisation process with stratification on the LH score and priori power analysis to determine sample size are suggested for the main study.

The acute morphologic changes that occur at the optic nerve head induced by medical reduction of intraocular pressure.

PURPOSE: The mechanical theory of glaucoma postulates that raised intraocular pressure (IOP) causes laminar distortion resulting in damage to axons at the optic nerve head. There is some evidence that the change in morphology may occur over a short time course. The aim of this paper was to detail the acute morphologic changes at the optic nerve head when IOP was lowered with medical therapy in a clinical population. METHODS: Subjects referred to the glaucoma clinic that had a documented IOP of over 28 mm Hg, on no treatment, in one or both eyes were included. Tonometry, pachymetry, and scanning laser ophthalmoscopy were performed before and after lowering IOP with topical apraclonidine and oral acetazolamide. The significance of change in outcome variables was assessed using a paired t test allowing for dependence within subjects and, for sensitivity, with a nonparametric Wilcoxon signed-rank test. RESULTS: Data were obtained from 38 eyes of 19 patients with a mean age of 67 years. After lowering IOP for only 1 hour, there was a significant decrease in mean cup volume (mean change in volume below surface 26.8 microm3, P< or =0.001) and mean cup depth (13.8 microm, P<0.01), there being a corresponding increase in mean rim area (37.3 microm2, P<0.034). There was no statistically significant change in central corneal thickness after administration of the IOP lowering medications. CONCLUSIONS: In the present study, it was shown that acute and statistically significant alterations in optic disc morphology occur when IOP is lowered medically with a combination of topical apraclonidine and systemic acetazolamide. The technique, therefore, may be useful to further investigate subgroups of glaucomatous eyes and test etiologic hypotheses.