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Biomedical subjects

R J Lilford

Publications and source records attributed to R J Lilford.

At least 19 recordsLinked to original sources
PubMed2006

Resources and costs associated with incidental extracolonic findings from CT colonogaphy: a study in a symptomatic population.

CT colonography (CTC) is increasingly used to detect colonic polyps and cancers, but its impact in practice is also influenced by frequent detection of extracolonic lesions. We have previously documented the frequency and nature of such lesions. The current study was performed to assess the clinical resources and costs associated with the investigation and treatment of extracolonic lesions. We reviewed the reports of 225 consecutive CTC examinations carried out on patients with symptoms of bowel cancer. 116 of the 225 were reported to have one or more extracolonic findings. All 116 patients with an abnormality were followed up for 12-24 months. 24 patients underwent further actions (outpatient attendance, investigations, or surgical procedures) as a result of previously undiagnosed lesions unrelated to bowel cancer. The costs of these further actions were derived from the NHS Reference Costs manual 2004. The total cost for further investigations and interventions was 34,329 pounds sterling and the mean cost over the sample of 225 patients was 153 pounds sterling--more than the cost of the CTC itself. The costs were mainly generated by surgical procedures. Resources consumed as a result of extracolonic findings approximately doubled the costs of diagnostic CTC. These costs, along with inconvenience, anxiety, morbidity and occasionally even mortality suffered by patients, must be offset by the good done to some of those with sub-clinical but potentially lethal diseases.

Adult↗
PubMed2005

Laparoscopic "drilling" by diathermy or laser for ovulation induction in anovulatory polycystic ovary syndrome.

BACKGROUND: Problems in inducing ovulation in women with polycystic ovary syndrome (PCOS) and anovulation (failure to ovulate) are well recognised. Surgical ovarian wedge resection was the first established treatment for anovulatory PCOS patients but was largely abandoned due to the risk of post-surgical adhesions and the introduction of medical ovulation induction with clomiphene and gonadotrophins. However patients with PCOS treated with gonadotrophins often have an over-production of follicles and are exposed to the risks of ovarian hyperstimulation syndrome (OHSS) and multiple pregnancy. Moreover ovulation induction with gonadotrophins, though effective, is an expensive, inconvenient and time-consuming treatment requiring intensive monitoring. Surgical therapy with laparoscopic ovarian "drilling" (LOD) may avoid or reduce the need for gonadotrophins or may facilitate their use. The procedure can be done on an outpatient basis with less trauma and fewer postoperative adhesions. Many uncontrolled observational studies have claimed that ovarian drilling is followed, at least temporarily, by a high rate of spontaneous ovulation and conception, and/or that subsequent medical ovulation induction becomes easier. OBJECTIVES: To determine the effectiveness and safety of laparoscopic ovarian drilling compared with ovulation induction for subfertile women with clomiphene-resistant PCOS. SEARCH STRATEGY: We used the search strategy of the Menstrual Disorders and Subfertility Group. SELECTION CRITERIA: We included randomised controlled trials of subfertile women with clomiphene-resistant PCOS that undertook laparoscopic ovarian drilling in order to induce ovulation. DATA COLLECTION AND ANALYSIS: Fifteen trials were identified and six were included in the review. All trials were assessed for quality criteria. The primary outcomes were live birth, ovulation and pregnancy rates and the secondary outcomes were rates of miscarriage, multiple pregnancy, ovarian hyperstimulation syndrome and cost. MAIN RESULTS: There was no evidence of a difference in live births or ongoing pregnancies between LOD and gonadotrophins and the pooled Odds Ratio (OR) (all studies) was 1.04 (95% CI 0.74, 1.99) and 1.16 (95% CI 0.72, 1.86) respectively. Multiple pregnancy rates were lower with ovarian drilling than with gonadotrophins (1% vs 16%, OR: 0.13, 95% CI: 0.03 to 0.59). There was no evidence of a difference in miscarriage rates between the two groups (OR 0.81, 955% 0.36, 1.86). AUTHORS' CONCLUSIONS: There was no evidence of a difference in the live birth rate and miscarriage rate in women with clomiphene resistant PCOS undergoing LOD compared to gonadotrophin treatment. The reduction in multiple pregnancy rates in women undergoing LOD makes this option attractive. However, there are ongoing concerns about long term effects of LOD on ovarian function.

Anovulation↗
PubMed2005

Incidental lesions found on CT colonography: their nature and frequency.

CT colonography has been used to detect colonic polyps and cancers, but its effect in practice will also be influenced by the frequency with which extracolonic lesions of various types are detected. We performed a systematic review of the types of incidental lesions found on CT colonography. This is necessary to model the benefits and harms of detecting extracolonic lesions. Primary clinical studies of extracolonic findings on CT colonography were identified from electronic databases, scanning reference lists and hand searches of relevant journals and conference proceedings. A data collection proforma was used to collect information on extracolonic findings. 17 discreet studies were identified, involving 3488 patients. In total 40% of patients were recorded to have abnormalities and many had more than one abnormality. Nearly 14% of patients had further investigations and 0.8% were given immediate treatment. Extracolonic cancers were detected in 2.7% (0.9% had N0M0 cancers) and 0.9% had an aortic aneurysm. The number of extracolonic findings was high in all studies. While only a small population were judged "important", the prevalence of serious lesions outside the colon was nevertheless higher than in many other screening programs.

Adult↗
PubMed2005

Lay public's understanding of equipoise and randomisation in randomised controlled trials.

OBJECTIVES: To research the lay public's understanding of equipoise and randomisation in randomised controlled trials (RCTs) and to look at why information on this may not be not taken in or remembered, as well as the effects of providing information designed to overcome barriers. DESIGN: Investigations were informed by an update of systematic review on patients' understanding of consent information in clinical trials, and by relevant theory and evidence from experimental psychology. Nine investigations were conducted with nine participants. SETTING: Access (return to education), leisure and vocational courses at Further Education Colleges in the Midlands, UK. PARTICIPANTS: Healthy adults with a wide range of educational backgrounds and ages. INVESTIGATIONS: Participants read hypothetical scenarios and wrote brief answers to subsequent questions. Sub-samples of participants were interviewed individually to elaborate on their written answers. Participants' background assumptions concerning equipoise and randomisation were examined and ways of helping participants recognise the scientific benefits of randomisation were explored. MAIN OUTCOME MEASURES: Judgments on allocation methods; treatment preferences; the acceptability of random allocation; whether or not individual doctors could be completely unsure about the best treatment; whether or not doctors should reveal treatment preferences under conditions of collective equipoise; and how sure experts would be about the best treatment following random allocation vs doctor/patient choice. Assessments of understanding hypothetical trial information. RESULTS: Recent literature continues to report trial participants' failure to understand or remember information about randomisation and equipoise, despite the provision of clear and readable trial information leaflets. In current best practice, written trial information describes what will happen without offering accessible explanations. As a consequence, patients may create their own incorrect interpretations and consent or refusal may be inadequately informed. In six investigations, most participants identified which methods of allocation were random, but judged the random allocation methods to be unacceptable in a trial context; the mere description of a treatment as new was insufficient to engender a preference for it over a standard treatment; around half of the participants denied that a doctor could be completely unsure about the best treatment. A majority of participants judged it unacceptable for a doctor to suggest letting chance decide when uncertain of the best treatment, and, in the absence of a justification for random allocation, participants did not recognise scientific benefits of random allocation over normal treatment allocation methods. The pattern of results across three intervention studies suggests that merely supplementing written trial information with an explanation is unlikely to be helpful. However, when people manage to focus on the trial's aim of increasing knowledge (as opposed to making treatment decisions about individuals), and process an explanation actively, they may be helped to understand the scientific reasons for random allocation. CONCLUSIONS: This research was not carried out in real healthcare settings. However, participants who could correctly identify random allocation methods, yet judged random allocation unacceptable, doubted the possibility of individual equipoise and saw no scientific benefits of random allocation over doctor/patient choice, are unlikely to draw upon contrasting views if invited to enter a real clinical trial. This suggests that many potential trial participants may have difficulty understanding and remembering trial information that conforms to current best practice in its descriptions of randomisation and equipoise. Given the extent of the disparity between the assumptions underlying trial design and the assumptions held by the lay public, the solution is unlikely to be simple. Nevertheless, the results suggest that including an accessible explanation of the scientific benefits of randomisation may be beneficial provided potential participants are also enabled to reflect on the trial's aim of advancing knowledge, and to think actively about the information presented. Further areas for consideration include: the identification of effective combinations of written and oral information; helping participants to reflect on the aim of advancing knowledge; and an evidence-based approach to leaflet construction.

Adolescent↗
PubMed2003

Organizing patient safety research to identify risks and hazards.

Patient safety has become an international priority with major research programmes being carried out in the USA, UK, and elsewhere. The challenge is how to organize research efforts that will produce the greatest yield in making health care safer for patients. Patient safety research initiatives can be considered in three different stages: (1) identification of the risks and hazards; (2) design, implementation, and evaluation of patient safety practices; and (3) maintaining vigilance to ensure that a safe environment continues and patient safety cultures remain in place. Clearly, different research methods and approaches are needed at each of the different stages of the continuum. A number of research approaches can be used at stage 1 to identify risks and hazards including the use of medical records and administrative record review, event reporting, direct observation, process mapping, focus groups, probabilistic risk assessment, and safety culture assessment. No single method can be universally applied to identify risks and hazards in patient safety. Rather, multiple approaches using combinations of these methods should be used to increase identification of risks and hazards of health care associated injury or harm to patients.

Health Services Research↗
PubMed2003

The measurement of active errors: methodological issues.

The value of research in any topic area turns on its validity. Patient safety research has revealed--or, at least, given renewed urgency to--a raft of methodological issues. The meaning and thus the value of empirical research in this field is contingent on getting the methodology right. The need for good methods for the measurement of error is necessary whenever an inference is intended and, since inferences lie at the heart of research and management, there is a huge need to understand better how to make measurements that are meaningful, precise, and accurate. In this paper we consider issues relating to the measurement of error and the need for more research.

Empirical Research↗
PubMed2003

Top-rated British business research: has the emperor got any clothes?

Business schools have great prestige and charge large amounts of money for their courses. But how good is the science on which they base their prescriptions for action? To find out we examined the published output from the only three British business schools with the highest (5*) research assessment ranking at the time the articles were published. We conclude that theory development and model construction are often elegant. However, the methods used to obtain primary empirical information to confirm or refute the theories or populate models are poor, at least from a positivist or pragmatic ontological perspective. Large scale comparative studies made up only a small proportion of research output from the business schools. Literature reviews were not systematic. The sampling frame and rationale for selection of cases for study are inadequately described. The methods of data collection were frequently not given in sufficient detail to enable the study to be replicated and the conclusions tended to go far beyond what the data by themselves could support. However, this does not have to be the case-there are excellent examples of research in social sciences. We conclude, therefore, that top-rated British business research is a scantily clad emperor.

Commerce↗
PubMed2003

Redesigning postnatal care: a randomised controlled trial of protocol-based midwifery-led care focused on individual women's physical and psychological health needs.

OBJECTIVES: To develop, implement and test the cost-effectiveness of redesigned postnatal care compared with current care on women's physical and psychological health. DESIGN: A cluster randomised controlled trial, with general practice as the unit of randomisation. Recruited women were followed up by postal questionnaire at 4 and 12 months postpartum and further data collected from midwife and general practice sources. SETTING: Thirty-six randomly selected general practice clusters in the West Midlands Health Region, UK. PARTICIPANTS: All women expected to be resident within recruited practices for postnatal care were eligible for inclusion. Attached midwives recruited 1087 women in the intervention and 977 in the control practice clusters. INTERVENTIONS: The systematic identification and management of women's health problems, led by midwives with general practitioner contact only when required. Symptom checklists and the Edinburgh Postnatal Depression Scale (EPDS) were used at various times to maximise the identification of problems, and individual care and visit plans based on needs. Evidence-based guidelines were used to manage needs. Care was delivered over a longer period. MAIN OUTCOME MEASURES: Women's health at 4 and 12 months, assessed by the Physical and Mental Component Scores (PCS and MCS) of the Short-Form 36 (SF-36) and the EPDS. Women's views about care, reported morbidity at 12 months, health service usage during the year, 'good practice' indicators and health professionals' views about care were secondary outcomes. RESULTS: At 4 and 12 months postpartum the mean MCS and EPDS scores were significantly better in the intervention group and the proportion of women with an EPDS score of 13+ (indicative of probable depression) was significantly lower relative to controls. The physical health score (PCS) did not differ. Health service usage was significantly less in the intervention group as well as reported psychological morbidity at 12 months. Women's views about care were either more positive or did not differ. Intervention midwives were more satisfied with redesigned care than control midwives were with standard care. Intervention care was cost-effective since outcomes were better and costs did not differ substantially. CONCLUSIONS: The redesigned community postnatal care led by midwives and delivered over a longer period, resulted in an improvement in women's mental health at 4 months postpartum, which persisted at 12 months and at equivalent overall cost. It is suggested that further research should focus on: the identification of postnatal depression through screening; whether fewer adverse longer term effects might be demonstrated among the children of the women who had the intervention care relative to the controls; testing interventions to reduce physical morbidity, including studies to validate measures of physical health in postpartum women. Further research is also required to investigate appropriate postnatal care for ethnic minority groups.

Adolescent↗
PubMed2002

Different perspectives of patients and health care professionals on the potential benefits and risks of blastocyst culture and multiple embryo transfer.

BACKGROUND: A trade-off exists between the risk of multiple pregnancy and prospects of pregnancy itself in assisted reproduction. Blastocyst culture and embryo transfer after approximately 5 days may be one method of reconciling this dilemma, although a controversial one. METHODS AND RESULTS: We presented a questionnaire to groups of patients, embryologists and clinicians to solicit views on the potential benefits and risks of blastocyst culture and multiple pregnancy. The results indicate that patients are more accepting of multiple pregnancy as a prospective outcome of treatment than those involved in their treatment, despite awareness of the risks. Our data tend to support a genuine difference in values on this point. We also sought views on the patient selection criteria and treatment protocols which should apply in a planned randomized controlled trial comparing blastocyst culture with cleaving embryo transfer (e.g. numbers of embryos to transfer, acceptable levels of risk of twin and triplet pregnancy, the proportion of patients who would be put off from entering the trial by the risk of no embryo transfer). These are presented and discussed with reference to their likely impact on trial recruitment, highlighting differences in perspective between patients and professionals. CONCLUSIONS: We conclude that there are differences among patients, embryologists and clinicians in their perceptions of the desirability of multiple pregnancy, their preferences in certain practical aspects of treatment such as embryo transfer numbers, and their ideas on blastocyst culture and its prospective outcomes and risks.

Attitude of Health Personnel↗
PubMed2002

The Leeds University Maternity Audit Project.

OBJECTIVES: To measure levels of and changes in compliance with evidence-based recommendations in obstetrics in the UK. To identify barriers to and factors associated with compliance. DESIGN: A quantitative case-note audit for 1988 and 1996, and a qualitative interview study of key staff. SETTING: Twenty maternity units, selected at random from all UK units SUBJECTS: Fifty consecutive cases of pre-term delivery (PTD), Caesarean section (CS), instrumental delivery (ID), and perineal repair (PR) operations in each period in each unit. The lead clinician, midwifery manager, a senior midwife, neonatologist, and middle-grade obstetrician in each unit. MAIN OUTCOME MEASURES: Maternal steroid use in PTD, antibiotic use in CS, use of the ventouse (vacuum extractor) rather than forceps as instrument of first choice for ID, and use of polyglycolic acid (PGA) sutures for PR in each time period. Facilities for implementing, staff attitudes to, and the degree of planning to follow each recommendation. MAIN RESULTS: The median proportion of ventouse as instrument of first choice in each unit was 8% (range 0-32%) in 1988, rising to 64% (range 0-98%) in 1996. PGA use for PR was 0% (range 0-30%) in 1988, and 72% (range 0-100%) in 1996. Steroid use for eligible PTD was median 0% (range 0-23%) in 1988, rising to 82% (range 63-95%) in 1996. Antibiotic use for CS was 7% (range 0-25%) rising to 84% (range 10-100%) in 1996. There was no relationship between unit size, type of unit, facilities, staff attitudes or degree of planning, and compliance with the recommendations, nor was the level of adherence to one standard typically correlated with adherence to the others. However, there was a positive correlation (R = 0.6, P < 0.005) between local availability of the Cochrane database of perinatal trials and unit compliance with the audit standards in the latter time period. CONCLUSIONS: We have documented a massive shift in practice in line with the evidence, although many units still have substantial room for improvement. About 2000 wound infections, 200 deaths due to prematurity, nearly 8000 women in pain from catgut sutures, and 1500 cases of severe perineal trauma from forceps remain preventable. The reasons why units vary remain obscure, although the qualitative interviews often revealed local factors such as key enthusiastic staff. There was no sign of evidence being positively driven into practice by any systematic managerial process. The relationship between Cochrane availability and high-standard care may be simply a marker of commitment to the evidence, but it remains plausible that if senior staff make Cochrane available for their juniors, audit compliance improves.

Adult↗
PubMed2001

Are randomized clinical trials good for us (in the short term)? Evidence for a "trial effect".

OBJECTIVE: To assess whether there is evidence that randomized controlled trials are systematically beneficial, or harmful, for patients. In other words, is there a "trial effect"? If so, to examine whether the evidence sheds light on the likely sources of the difference in outcomes. METHODS: Systematic review of the literature. RESULTS: We set out in some detail potential sources of a "trial effect" and potential biases. We found only 14 research articles (covering more than 21 trials) with relevant primary data. We extracted, with difficulty, quantitative data-sets from the articles, and classified these according to likely source of any apparent trial effect. The categories used were: differences in prognosis; superior treatment in the trial; and "protocol/Hawthorne effect" (benefit from improved routine care within a trial). ANALYSIS: The evidence available is limited in breadth (coming largely from cancer trials) and quality, as well as quantity. There is weak evidence to suggest that clinical trials have a positive effect on the outcome of participants. This does not appear to depend strongly on the trial demonstrating that an experimental treatment is superior. However, benefit to participants is less evident where scope for a "protocol/Hawthorne effect" was apparently limited (because there was no effective routine treatment or because the comparison group also received protocol care). A form of bias, arising if clinicians who tend to recruit to trials also tend to be better clinicians, could also explain these results. CONCLUSION: While the evidence is not conclusive, it is more likely that clinical trials have a positive rather than a negative effect on the outcome of patients. In the limited data available, the effect seems to be larger in trials where an effective treatment already exists and is included in the trial protocol. RECOMMENDATION: That carefully researched treatment protocols, and monitoring of outcomes, be used for all patients, not just those in trials.

Bias↗