Oral health in an urban slum, Nigeria: residents' perceptions, practices and care-seeking experiences.

BACKGROUND/INTRODUCTION: One of the key recommendations for the new WHO global strategy for oral health is inclusion of disadvantaged populations and their engagement in policy dialogues such that their needs and views are addressed in policy decisions. OBJECTIVES: This study explored oral health perceptions, practices and care-seeking experiences of slum residents in Ibadan, Nigeria. METHOD: Focus group discussions (FGD) were conducted with family health-decision makers in an urban slum site. Oral health perceptions, practices, and care-seeking experiences were discussed. FGDs were recorded, transcribed, and translated. ATLAS.ti qualitative research software was deployed for analysis using thematic analysis. RESULTS: Six FGD sessions, divided by gender and age, were conducted between September-October 2019, (N = total 58 participants, aged 25 to 59 years). Common dental ailments mentioned were dental pain, tooth sensitivity, bleeding gums, tooth decay, mouth odor, gum disease, and tooth fracture. Perceived causes of dental conditions included poor dental hygiene and habits, sugary diets, ignorance, and supernatural forces. Mouth cleaning was mostly done once daily using toothbrush and paste. Other cleaning tools were ground glass, wood ash, charcoal, "epa Ijebu" (a dentrifice), and "orin ata" (a type of chewing stick). Remedies for relieving dental pain included over-the-counter medicines, warm salted water, gin, tobacco (snuff/powdered), cow urine/dung, battery fluid, and various mixtures/ concoctions. Visits to the dentists were mentioned by a few but this was usually as last resort. Main barriers to accessing care from dental care facilities were unaffordability of service charges and fear of extreme treatment measures (extraction). Suggested measures to improve timely access to dental health care included reducing/subsidizing costs of treatments and medications, offering non-extraction treatment options, and oral health education programmes. CONCLUSION: The slum residents experience various forms of dental ailments mostly pain-related. The residents perceived formal dental clinics as unaffordable, thereby engaging in self-care remedies and harmful oral health practices before seeking professional help. Policymakers and decision-makers may leverage this empirical evidence for the people's education on early dental care and address challenges to affordable, available, and acceptable oral healthcare services among slum residents to improve access to care facilities.

Implementation of research evidence in orthopaedics: a tale of three trials.

OBJECTIVE: To examine implementation of evidence in orthopaedic practice following publication of the results of three pivotal clinical trials. DESIGN: Case studies based on three orthopaedic trials funded in sequence by the National Institute for Health Research Health Technology Assessment (HTA) programme. These trials dealt with treatment of fractures of the humerus, radius and ankle, respectively. For each case study, we conducted time-series analyses to examine the relationship between publication of findings and the implementation (or not) of the findings. RESULTS: The results of all three trials favoured the less expensive and less invasive option. In two cases, a change of practice, in line with the evidence that eventually emerged, preceded publication. Furthermore, the upturn in use of the intervention most supported by each of these two trials corresponded to the start of recruitment to the respective trial. The remaining trial failed to influence practice despite yielding clear-cut evidence. CONCLUSIONS: Implementation of results of all three HTA orthopaedic trials favoured the less expensive and less invasive option. In two of the three studies, a change in practice, in line with the evidence that eventually emerged, preceded publication of that evidence. A trend or a change in practice, at around the start of the trial, indicates that the direction of causation opposes our hypothesis that publication of trial findings would lead to changes in practice. Our results provide provocative insight into the nuanced topic of research and practice, but further qualitative work is needed to fully explain what led to the pre-emptive change in practice we observed and why there was no change in the third case.

Removal of all ovarian tissue versus conserving ovarian tissue at time of hysterectomy in premenopausal patients with benign disease: study using routine data and data linkage.

OBJECTIVE:  To conduct a nationwide study of associations between removal of all ovarian tissue versus conservation of at least one ovary at the time of hysterectomy and important health outcomes (ischaemic heart disease, cancer, and all cause mortality). STUDY DESIGN AND SETTING:  Retrospective analysis of the English Hospital Episode Statistics database linked to national registers of deprivation indices and of deaths. PARTICIPANTS:  113 679 patients aged 35-45 who had had a hysterectomy for benign conditions between April 2004 and March 2014. EXPOSURES:  Bilateral ovarian removal versus no removal or unilateral ovarian removal (ovarian conservation). MAIN OUTCOME MEASURES:  Hospital admissions for ischaemic heart disease, cancer, or attempted suicide; deaths, overall and from heart disease, cancer, or suicide. Statistical adjustments were made using Cox regression and propensity score matching for potential confounders. RESULTS:  A third of patients had bilateral ovarian removal. Patients in the ovarian conservation group were less likely to be admitted for ischaemic heart disease after hysterectomy than were those in the bilateral removal group (adjusted hazard ratio 0.85, 95% confidence interval 0.77 to 0.93; P=0.001). They were also less likely to have a cancer related post-hysterectomy admission (adjusted hazard ratio 0.83, 0.78 to 0.89; P<0.001). A significant difference in all cause mortality was also seen: 0.60% (456/76 581) of patients with ovarian conservation compared with 1.01% (376/37 098) of patients with bilateral removal. Again, this difference in favour of ovarian conservation was significant (adjusted hazard ratio 0.64, 0.55 to 0.73; P<0.001). Fewer deaths related specifically to heart disease (adjusted hazard ratio 0.50, 0.28 to 0.90; P=0.02) and to cancer (0.54, 0.45 to 0.65; P<0.001) occurred in the ovarian conservation group than in the bilateral removal group. No significant difference between groups was found relating to suicide (attempted or completed). The results after propensity score matching were essentially unchanged. CONCLUSION:  Patients who had ovarian conservation had a significantly lower hazard of all cause mortality compared with those who had bilateral ovarian removal and also had lower death rates from ischaemic heart disease and cancer. Consistent with this observation, admissions to hospital for both ischaemic heart disease and cancer were also lower in the ovarian conservation group than in the bilateral removal group. Although removal of both ovaries protects against subsequent development of ovarian cancer, premenopausal women should be advised that this benefit comes at the cost of an increased risk of cardiovascular disease and of other (more prevalent) cancers and higher overall mortality.

Identification of Extracolonic Pathologies by Computed Tomographic Colonography in Colorectal Cancer Symptomatic Patients.

BACKGROUND & AIMS: Symptoms suggestive of colorectal cancer may originate outside the colorectum. Computed tomographic colonography (CTC) is used to examine the colorectum and abdominopelvic organs simultaneously. We performed a prospective randomized controlled trial to quantify the frequency, nature, and consequences of extracolonic findings. METHODS: We studied 5384 patients from 21 UK National Health Service hospitals referred by their family doctor for the investigation of colorectal cancer symptoms from March 2004 through December 2007. The patients were assigned randomly to groups that received the requested test (barium enema or colonoscopy, n = 3574) or CTC (n = 1810). We determined the frequency and nature of extracolonic findings, subsequent investigations, ultimate diagnosis, and extracolonic cancer diagnoses 1 and 3 years after testing patients without colorectal cancer. RESULTS: Extracolonic pathologies were detected in 959 patients by CTC (58.7%), in 42 patients by barium enema analysis (1.9%), and in no patients by colonoscopy. Extracolonic findings were investigated in 142 patients (14.2%) and a diagnosis was made for 126 patients (88.1%). Symptoms were explained by extracolonic findings in 4 patients analyzed by barium enema (0.2%) and in 33 patients analyzed by CTC (2.8%). CTC identified 72 extracolonic neoplasms, however, barium enema analysis found only 3 (colonoscopy found none). Overall, CTC diagnosed extracolonic neoplasms in 72 of 1634 patients (4.4%); 26 of these were malignant (1.6%). There were significantly more extracolonic malignancies detected than expected 1 year after examination, but these did not differ between patients evaluated by CTC (22.2/1000 person-years), barium enema (26.5/1000 person-years; P = .43), or colonoscopy (32.0/1000 person-years; P = .88). CONCLUSIONS: More than half of the patients with symptoms of colorectal cancer are found to have extracolonic pathologies by CTC analysis. However, the proportion of patients found to have extracolonic malignancies after 1 year of CTC examination is not significantly greater than after barium enema or colonoscopy examinations. International Standard Randomised Controlled Trials no: 95152621.isrctn.com.

Peri-operative pulse oximetry in low-income countries: a cost-effectiveness analysis.

OBJECTIVE: To evaluate the cost-effectiveness of pulse oximetry--compared with no peri-operative monitoring--during surgery in low-income countries. METHODS: We considered the use of tabletop and portable, hand-held pulse oximeters among patients of any age undergoing major surgery in low-income countries. From earlier studies we obtained baseline mortality and the effectiveness of pulse oximeters to reduce mortality. We considered the direct costs of purchasing and maintaining pulse oximeters as well as the cost of supplementary oxygen used to treat hypoxic episodes identified by oximetry. Health benefits were measured in disability-adjusted life-years (DALYs) averted and benefits and costs were both discounted at 3% per year. We used recommended cost-effectiveness thresholds--both absolute and relative to gross domestic product (GDP) per capita--to assess if pulse oximetry is a cost-effective health intervention. To test the robustness of our results we performed sensitivity analyses. FINDINGS: In 2013 prices, tabletop and hand-held oximeters were found to have annual costs of 310 and 95 United States dollars (US$), respectively. Assuming the two types of oximeter have identical effectiveness, a single oximeter used for 22 procedures per week averted 0.83 DALYs per annum. The tabletop and hand-held oximeters cost US$ 374 and US$ 115 per DALY averted, respectively. For any country with a GDP per capita above US$ 677 the hand-held oximeter was found to be cost-effective if it prevented just 1.7% of anaesthetic-related deaths or 0.3% of peri-operative mortality. CONCLUSION: Pulse oximetry is a cost-effective intervention for low-income settings.

A systematic review of systematic reviews and panoramic meta-analysis: staples versus sutures for surgical procedures.

OBJECTIVE: To systematically evaluate the evidence across surgical specialties as to whether staples or sutures better improve patient and provider level outcomes. DESIGN: A systematic review of systematic reviews and panoramic meta-analysis of pooled estimates. RESULTS: Eleven systematic reviews, including 13,661 observations, met the inclusion criteria. In orthopaedic surgery sutures were found to be preferable, and for appendicial stump sutures were protective against both surgical site infection and post surgical complications. However, staples were protective against leak in ilecolic anastomosis. For all other surgery types the evidence was inconclusive with wider confidence intervals including the possibly of preferential outcomes for surgical site infection or post surgical complication for either staples or sutures. Whilst reviews showed substantial variation in mean differences in operating time (I(2) 94%) there was clear evidence of a reduction in average operating time across all surgery types. Few reviews reported on length of stay, but the three reviews that did (I(2) 0%, including 950 observations) showed a non significant reduction in length of stay, but showed evidence of publication bias (P-value for Egger test 0.05). CONCLUSIONS: Evidence across surgical specialties indicates that wound closure with staples reduces the mean operating time. Despite including several thousand observations, no clear evidence of superiority emerged for either staples or sutures with respect to surgical site infection, post surgical complications, or length of stay.

What is the best strategy for investigating abnormal liver function tests in primary care? Implications from a prospective study.

OBJECTIVE: Evaluation of predictive value of liver function tests (LFTs) for the detection of liver-related disease in primary care. DESIGN: A prospective observational study. SETTING: 11 UK primary care practices. PARTICIPANTS: Patients (n=1290) with an abnormal eight-panel LFT (but no previously diagnosed liver disease). MAIN OUTCOME MEASURES: Patients were investigated by recording clinical features, and repeating LFTs, specific tests for individual liver diseases, and abdominal ultrasound scan. Patients were characterised as having: hepatocellular disease; biliary disease; tumours of the hepato-biliary system and none of the above. The relationship between LFT results and disease categories was evaluated by stepwise regression and logistic discrimination, with adjustment for demographic and clinical factors. True and False Positives generated by all possible LFT combinations were compared with a view towards optimising the choice of analytes in the routine LFT panel. RESULTS: Regression methods showed that alanine aminotransferase (ALT) was associated with hepatocellular disease (32 patients), while alkaline phosphatase (ALP) was associated with biliary disease (12 patients) and tumours of the hepatobiliary system (9 patients). A restricted panel of ALT and ALP was an efficient choice of analytes, comparing favourably with the complete panel of eight analytes, provided that 48 False Positives can be tolerated to obtain one additional True Positive. Repeating a complete panel in response to an abnormal reading is not the optimal strategy. CONCLUSIONS: The LFT panel can be restricted to ALT and ALP when the purpose of testing is to exclude liver disease in primary care.

Computed tomographic colonography versus barium enema for diagnosis of colorectal cancer or large polyps in symptomatic patients (SIGGAR): a multicentre randomised trial.

BACKGROUND: Barium enema (BE) is widely available for diagnosis of colorectal cancer despite concerns about its accuracy and acceptability. Computed tomographic colonography (CTC) might be a more sensitive and acceptable alternative. We aimed to compare CTC and BE for diagnosis of colorectal cancer or large polyps in symptomatic patients in clinical practice. METHODS: This pragmatic multicentre randomised trial recruited patients with symptoms suggestive of colorectal cancer from 21 UK hospitals. Eligible patients were aged 55 years or older and regarded by their referring clinician as suitable for radiological investigation of the colon. Patients were randomly assigned (2:1) to BE or CTC by computer-generated random numbers, in blocks of six, stratified by trial centre and sex. We analysed the primary outcome-diagnosis of colorectal cancer or large (≥10 mm) polyps-by intention to treat. The trial is an International Standard Randomised Controlled Trial, number 95152621. FINDINGS: 3838 patients were randomly assigned to receive either BE (n=2553) or CTC (n=1285). 34 patients withdrew consent, leaving for analysis 2527 assigned to BE and 1277 assigned to CTC. The detection rate of colorectal cancer or large polyps was significantly higher in patients assigned to CTC than in those assigned to BE (93 [7.3%] of 1277 vs 141 [5.6%] of 2527, relative risk 1.31, 95% CI 1.01-1.68; p=0.0390). CTC missed three of 45 colorectal cancers and BE missed 12 of 85. The rate of additional colonic investigation was higher after CTC than after BE (283 [23.5%] of 1206 CTC patients had additional investigation vs 422 [18.3%] of 2300 BE patients; p=0.0003), due mainly to a higher polyp detection rate. Serious adverse events were rare. INTERPRETATION: CTC is a more sensitive test than BE. Our results suggest that CTC should be the preferred radiological test for patients with symptoms suggestive of colorectal cancer. FUNDING: NIHR Health Technology Assessment Programme, NIHR Biomedical Research Centres funding scheme, Cancer Research UK, EPSRC Multidisciplinary Assessment of Technology Centre for Healthcare, and NIHR Collaborations for Leadership in Applied Health Research and Care.

Computed tomographic colonography versus colonoscopy for investigation of patients with symptoms suggestive of colorectal cancer (SIGGAR): a multicentre randomised trial.

BACKGROUND: Colonoscopy is the gold-standard test for investigation of symptoms suggestive of colorectal cancer; computed tomographic colonography (CTC) is an alternative, less invasive test. However, additional investigation after CTC is needed to confirm suspected colonic lesions, and this is an important factor in establishing the feasibility of CTC as an alternative to colonoscopy. We aimed to compare rates of additional colonic investigation after CTC or colonoscopy for detection of colorectal cancer or large (≥10 mm) polyps in symptomatic patients in clinical practice. METHODS: This pragmatic multicentre randomised trial recruited patients with symptoms suggestive of colorectal cancer from 21 UK hospitals. Eligible patients were aged 55 years or older and regarded by their referring clinician as suitable for colonoscopy. Patients were randomly assigned (2:1) to colonoscopy or CTC by computer-generated random numbers, in blocks of six, stratified by trial centre and sex. We analysed the primary outcome-the rate of additional colonic investigation-by intention to treat. The trial is an International Standard Randomised Controlled Trial, number 95152621. FINDINGS: 1610 patients were randomly assigned to receive either colonoscopy (n=1072) or CTC (n=538). 30 patients withdrew consent, leaving for analysis 1047 assigned to colonoscopy and 533 assigned to CTC. 160 (30.0%) patients in the CTC group had additional colonic investigation compared with 86 (8.2%) in the colonoscopy group (relative risk 3.65, 95% CI 2.87-4.65; p<0.0001). Almost half the referrals after CTC were for small (<10 mm) polyps or clinical uncertainty, with low predictive value for large polyps or cancer. Detection rates of colorectal cancer or large polyps in the trial cohort were 11% for both procedures. CTC missed 1 of 29 colorectal cancers and colonoscopy missed none (of 55). Serious adverse events were rare. INTERPRETATION: Guidelines are needed to reduce the referral rate after CTC. For most patients, however, CTC provides a similarly sensitive, less invasive alternative to colonoscopy. FUNDING: NIHR Health Technology Assessment Programme, NIHR Biomedical Research Centres funding scheme, Cancer Research UK, EPSRC Multidisciplinary Assessment of Technology Centre for Healthcare, and NIHR Collaborations for Leadership in Applied Health Research and Care.

Evaluation of a predevelopment service delivery intervention: an application to improve clinical handovers.

BACKGROUND: We developed a method to estimate the expected cost-effectiveness of a service intervention at the design stage and 'road-tested' the method on an intervention to improve patient handover of care between hospital and community. METHOD: The development of a nine-step evaluation framework: 1. Identification of multiple endpoints and arranging them into manageable groups; 2. Estimation of baseline overall and preventable risk; 3. Bayesian elicitation of expected effectiveness of the planned intervention; 4. Assigning utilities to groups of endpoints; 5. Costing the intervention; 6. Estimating health service costs associated with preventable adverse events; 7. Calculating health benefits; 8. Cost-effectiveness calculation; 9. Sensitivity and headroom analysis. RESULTS: Literature review suggested that adverse events follow 19% of patient discharges, and that one-third are preventable by improved handover (ie, 6.3% of all discharges). The intervention to improve handover would reduce the incidence of adverse events by 21% (ie, from 6.3% to 4.7%) according to the elicitation exercise. Potentially preventable adverse events were classified by severity and duration. Utilities were assigned to each category of adverse event. The costs associated with each category of event were obtained from the literature. The unit cost of the intervention was €16.6, which would yield a Quality Adjusted Life Year (QALY) gain per discharge of 0.010. The resulting cost saving was €14.3 per discharge. The intervention is cost-effective at approximately €214 per QALY under the base case, and remains cost-effective while the effectiveness is greater than 1.6%. CONCLUSIONS: We offer a usable framework to assist in ex ante health economic evaluations of health service interventions.

Efficacy of adjuvant chemotherapy after surgery when considered over all cancer types: a synthesis of meta-analyses.

BACKGROUND: Despite a large number of clinical trials having been conducted to assess the efficacy of adjuvant chemotherapy after surgery for various cancers, whether it is best to use this treatment remains a generally contentious issue for many common cancers. The purpose of this study was to ascertain whether any general conclusions can be drawn about the efficacy or inefficacy of this treatment within different cancer classifications. METHODS: Meta-analyses of randomized, controlled trials (RCTs) of adjuvant chemotherapy after surgery were synthesized over as many types of cancer as possible. Data sources were Medline, Embase, and the Cochrane library. Eligible meta-analyses were meta-analyses of RCTs for any type of cancer that compared surgery followed by adjuvant chemotherapy with surgery followed by no adjuvant chemotherapy. RESULTS: The literature search found 25 meta-analyses for 15 cancer types that satisfied the criteria necessary for detailed analysis within this study. The estimates of relative risk for all cause mortality were reported as being less than one (indicating adjuvant chemotherapy is beneficial) by all meta-analyses apart from a meta-analysis for colorectal cancer metastasized to the liver. Moreover, 15 of these meta-analyses also reported that the 95% confidence interval for this relative risk is less than one (indicating statistical significance at the 5% level). CONCLUSIONS: The results for all cancer types included in this study except for cancer metastasized to the liver can be thought of as supporting each other through the idea of there being a common treatment effect or at least a common range of effect across all (or most) of these cancer types. For example, with regard to cancer types where the evidence in favor of adjuvant chemotherapy after surgery is only moderately strong, the results of this study may encourage more clinicians to regard the use of this treatment as standard practice.

Patient acceptability and psychologic consequences of CT colonography compared with those of colonoscopy: results from a multicenter randomized controlled trial of symptomatic patients.

PURPOSE: To use a randomized design to compare patients' short- and longer-term experiences after computed tomographic (CT) colonography or colonoscopy. MATERIALS AND METHODS: After ethical approval, the trial was registered. Patients gave written informed consent. Five hundred forty-seven patients with symptoms suggestive of colorectal cancer who had been randomly assigned at a ratio of 2:1 to undergo either colonoscopy (n = 362) or CT colonography (n = 185) received a validated questionnaire to assess immediate test experience (including satisfaction, worry, discomfort, adverse effects) and a 3-month questionnaire to assess psychologic outcomes (including satisfaction with result dissemination and reassurance). Data were analyzed by using Mann-Whitney U, Kruskal-Wallis, and χ(2) test statistics. RESULTS: Patients undergoing colonoscopy were less satisfied than those undergoing CT colonography (median score of 61 and interquartile range [IQR] of 55-67 vs median score of 64 and IQR of 58-70, respectively; P = .008) and significantly more worried (median score of 16 [IQR, 12-21] vs 15 [IQR, 9-19], P = .007); they also experienced more physical discomfort (median score of 39 [IQR, 29-51] vs 35 [IQR, 24-44]) and more adverse events (82 of 246 vs 28 of 122 reported feeling faint or dizzy, P = .039). However, at 3 months, they were more satisfied with how results were received (median score of 4 [IQR, 3-4] vs 3 [IQR, 3-3], P < .0005) and less likely to require follow-up colonic investigations (17 of 230 vs 37 of 107, P < .0005). No differences were observed between the tests regarding 3-month psychologic consequences of the diagnostic episode, except for a trend toward a difference (P = .050) in negative affect (unpleasant emotions such as distress), with patients undergoing CT colonography reporting less intense negative affect. CONCLUSION: CT colonography has superior patient acceptability compared with colonoscopy in the short term, but colonoscopy offers some benefits to patients that become apparent after longer-term follow-up. The respective advantages of each test should be balanced when referring symptomatic patients.

Pooling systematic reviews of systematic reviews: a Bayesian panoramic meta-analysis.

Systematic reviews and meta-analyses usually synthesise evidence from studies reporting outcomes from particular interventions in specific diseases. For example, a meta-analysis of prophylactic antibiotics (intervention) in elective arterial reconstruction (disease) for rates of wound infection (outcome). However, because systematic reviews and meta-analyses are so widespread, a body of evidence often exists around specific intervention effects on particular outcomes over a range of diseases. So for example, a multitude of independent meta-analyses have evaluated rates of wound infection with and without the use of prophylactic antibiotics over multiple surgery types. A systematic review of systematic reviews is a means of synthesising evidence for the same intervention over multiple disease types. We propose a panoramic meta-analysis as a means of pooling effect estimates over systematic reviews of systematic reviews. We explore several methods ranging from a simple two-step approach, to a meta-regression or mixed effects approach, where variation between diseases are modelled as fixed covariate effects and between-study variation by random effects, and to a three-level hierarchical model in which exchangeability is assumed, which allows both a between-disease component of variance and a between-study (within disease) component of variance. In the surgery example, we pool 18 meta-analyses (each including between 4 and 26 studies) of prophylactic antibiotics reporting rates of wound infection from 18 different surgery sites to obtain a single pooled estimate of effect and estimates of between-disease, within-disease and within-study variability.

Estimating changes in overall survival using progression-free survival in metastatic breast and colorectal cancer.

OBJECTIVES: In clinical trials of new cancer drugs, reliable data for progression-free survival will often become available far sooner than reliable data for overall survival. The aim of this study was to determine how many months it would be expected that any given new drug for metastatic breast or colorectal cancer will add to overall survival times given that the number of months the drug adds to progression-free survival times relative to a standard drug is roughly already known. METHODS: A literature search was conducted over Medline for randomized controlled trials (RCTs) published between January 1980 and August 2008 that assessed the effect of a drug treatment in comparison to an alternative drug treatment on patients with either metastatic breast or metastatic colorectal cancer. RESULTS: The literature search found 95 and 74 RCTs for metastatic breast and colorectal cancer, respectively, that satisfied the study's inclusion criteria. The results from these trials are consistent, in the case of each of these two metastatic cancers, with gains in time to disease progression being generally associated with no gains or with very slight gains or losses in post-progression survival (i.e., the time between disease progression and death). CONCLUSIONS: It would appear that drugs for metastatic breast or colorectal cancer that extend, by a given amount, the time period between the start of treatment and disease progression (i.e., time to progression) have a strong tendency to extend, by roughly the same amount, the period between the start of treatment and death (i.e., overall survival).

Patient acceptability of CT colonography compared with double contrast barium enema: results from a multicentre randomised controlled trial of symptomatic patients.

OBJECTIVES: To determine patient acceptability of barium enema (BE) or CT colonography (CTC). METHODS: After ethical approval, 921 consenting patients with symptoms suggestive of colorectal cancer who had been randomly assigned and completed either BE (N = 606) or CTC (N = 315) received a questionnaire to assess experience of the clinical episode including bowel preparation, procedure and complications. Satisfaction, worry and physical discomfort were assessed using an adapted version of a validated acceptability scale. Non-parametric methods assessed differences between the randomised tests and the effect of patient characteristics. RESULTS: Patients undergoing BE were significantly less satisfied (median 61, interquartile range [IQR] 54-67 vs. median 64, IQR 56-69; p = 0.003) and experienced more physical discomfort (median 40, IQR 29-52 vs. median 35.5, IQR 25-47; p < 0.001) than those undergoing CTC. Post-test, BE patients were significantly more likely to experience 'abdominal pain/cramps' (68% vs. 57%; p = 0.007), 'soreness' (57% vs. 37%; p < 0.001), 'nausea/vomiting' (16% vs. 8%; p = 0.009), 'soiling' (31% vs. 23%; p = 0.034) and 'wind' (92% vs. 84%; p = 0.001) and in the case of 'wind' to also rate it as severe (27% vs. 15%; p < 0.001). CONCLUSION: CTC is associated with significant improvements in patient experience. These data support the case for CTC to replace BE.

Tracing the foundations of a conceptual framework for a patient safety ontology.

BACKGROUND: In work for the World Alliance for Patient Safety on research methods and measures and on defining key concepts for an International Patient Safety Classification (ICPS), it became apparent that there was a need to try to understand how the meaning of patient safety and underlying concepts relate to the existing safety and quality frameworks commonly used in healthcare. OBJECTIVES: To unfold the concept of patient safety and how it relates to safety and quality frameworks commonly used in healthcare and to trace the evolution of the ICPS framework as a basis of the electronic capture of the component elements of patient safety. CONCLUSION: The ICPS conceptual framework for patient safety has its origins in existing frameworks and an international consultation process. Although its 10 classes and their semantic relationships may be used as a reference model for different disciplines, it must remain dynamic in the ever-changing world of healthcare. By expanding the ICPS by examining data from all available sources, and ensuring rigorous compliance with the latest principles of informatics, a deeper interdisciplinary approach will progressively be developed to address the complex, refractory problem of reducing healthcare-associated harm.

Is antibiotic prophylaxis in surgery a generally effective intervention? Testing a generic hypothesis over a set of meta-analyses.

CONTEXT: While the main focus of a meta-analysis is often to assess the effectiveness of a particular intervention in managing or curing a specific condition, there exists a substantial amount of information within published systematic reviews that could be used to assess the validity of a generic hypothesis about the effectiveness of an intervention across a range of different but related conditions. OBJECTIVE: To systematically search for and then collate the results of meta-analyses for the effectiveness of antibiotic prophylaxis in preventing postoperative wound infection across various types of surgery in order to assess generic hypotheses about the effectiveness of this intervention in surgery as a whole. With the relative risk of wound infection used as the measure of clinical effectiveness, the hypotheses to be assessed were first that antibiotic prophylaxis would be an effective intervention for preventing wound infection over a broad range of different surgical procedures, and second that there would be a substantial difference in the effectiveness of antibiotic prophylaxis between "clean" and "contaminated" surgical procedures. DATA SOURCES: Medline and the Cochrane Database of Systematic Reviews. STUDY SELECTION: Eligible meta-analyses were meta-analyses published between 1990 and 2006 of randomized controlled trials that looked at the effectiveness of prophylactic antibiotics versus no antibiotic or placebo in preventing postoperative wound infections. DATA EXTRACTION: Independent data extraction by multiple observers. RESULTS: The first hypothesis was strongly supported by the data as evidenced by the fact that the estimates of the relative risk of infection for the 23 types of surgery that were included in the study were all less than 1. However, there was no real evidence supporting the second hypothesis that the relative risk of wound infection would substantially vary over different levels of surgery cleanliness. CONCLUSION: : As well as antibiotic prophylaxis being a generally effective intervention for preventing postoperative wound infection, the level of this effectiveness would appear to be reasonably independent of what type of surgery is being considered. Therefore, the general prevailing attitude that antibiotic prophylaxis should be assumed to be ineffective unless its effectiveness has been experimentally proven beyond doubt for the specific type of surgery being considered, perhaps should be revised. In particular, perhaps a sensible philosophy would be to assume that antibiotic prophylaxis is effective in reducing the risk of wound infection for all types of surgery, even ones where no clinical trial data exists and make exceptions to this rule if, for certain types of surgery, it can be proved to the contrary.

Choosing between CT colonography and colonoscopy in the diagnostic context: a qualitative study of influences on patient preferences.

OBJECTIVE: To explore information needs and preferences on diagnostic bowel tests and elicit preferences for CT colonography (CTC) vs. colonoscopy (CC). BACKGROUND: CTC is a new technology for large-bowel imaging that has been widely assumed to be more acceptable than CC because it is non-invasive. DESIGN: Semi-structured focus groups discussing information choices and procedure preferences. SETTING AND PARTICIPANTS: Non-patient sample of 26 asymptomatic volunteers (mean age 64 years). MAIN OUTCOME MEASURES: Information choices and CC-vs.-CTC preferences were recorded following stepwise presentation of different test attributes. Qualitative thematic analysis was used to examine transcripts of group discussions. RESULTS: On the basis of minimal information about the two tests, a majority of participants preferred CTC to CC (65% vs. 11%), while 24% had no preference. However, once they had received information on all aspects, this was reversed, with 80% of participants preferring CC compared with 8% preferring CTC. Thematic analysis of the discussion showed that participants almost unanimously considered information about test sensitivity to be the most important feature, and perceived relatively modest differences in test sensitivity to be highly significant. Information about risks and side-effects was considered to be the second most important aspect and attracted questions about risks of bowel perforation and health consequences following exposure to radiation. CONCLUSIONS: Patients place high value on quality rather than comfort for medical investigations. This has important implications for the development of educational materials supporting informed choice as well as future directions in refinement of CTC technology.

The relationship between progression-free and post-progression survival in treating four types of metastatic cancer.

CONTEXT: A number of authors have found that there exists a positive relationship between progression-free survival and overall survival in clinical trials of cancer treatments for particular types of metastatic cancer. However, such an outcome is consistent with an increase in progression-free survival generally leading to an increase, a decrease or no change in survival following disease progression (post-progression survival) and which of these theories is valid has yet to be thoroughly investigated. OBJECTIVE: To test theories of this nature in relation to the use of chemotherapy in treating four different types of metastatic cancer by performing a systematic search of published clinical trials. The four types of metastatic cancer are metastatic breast cancer, colorectal cancer, hormone-refractory prostate cancer and non-small-cell lung cancer. METHODS: The data sources were systematic reviews of randomized controlled trials (RCTs) published between January 1990 and June 2007 that appear in Medline or the Cochrane Database of Systematic Reviews and the abstracts of articles referenced in such reviews. For an RCT to be included in the study, chemotherapy had to be administered to both the treatment and control groups and the chemical composition of the chemotherapy had to be different between the two groups. The median time to disease progression and the median overall survival time had to be reported in the data sources. RESULTS: The trial data found through the systematic search shows much greater support for the theory that, for all four types of metastatic cancer being considered, changes in post-progression survival are uncorrelated with changes in time to disease progression than for the theory that gains in post-progression survival are proportional to gains in time to progression. CONCLUSION: The theories about the relationship between progression-free and post-progression survival in cancer treatment that have been examined in this study are worthy of further investigation.