Development of a Core Outcome Set for studies evaluating the effects of anaesthesia on perioperative morbidity and mortality following hip fracture surgery.

BACKGROUND: Perioperative studies of patients following hip fracture have large heterogeneity within their reported outcomes. This study aimed to develop a core outcome set for use in perioperative studies comparing the types of anaesthesia for hip fracture surgery. METHODS: The consensus process consisted of a systematic review of the literature, three rounds of a Delphi survey, two consensus webinars, and face-to-face patient meetings. RESULTS: The Delphi participants represented nine stakeholder groups. The numbers of participants completing Rounds 1-3 were 242, 186, and 169, respectively. Seventeen outcomes that met the predefined consensus criteria were considered at two consensus meetings. A final set of 10 core outcomes was agreed: mortality, time from injury to surgery, acute coronary syndrome, hypotension, acute kidney injury, delirium, pneumonia, orthogeriatric input, being out of bed at day 1, and pain. CONCLUSIONS: We generated a consensus-based set of core outcomes recommended for use in all perioperative trials evaluating the effects of anaesthesia for hip fracture surgery. An important next step is developing consensus-based consistency on how they should be measured. CLINICAL TRIAL REGISTRATION: http://www.comet-initiative.org/studies/details/757.

Influence of surgical rate on patients' reported clinical need and outcomes in English NHS.

BACKGROUND: To determine if higher rates of surgery are associated with lower levels of need (patients' pre-operative reports of their symptoms, functional status and quality of life) and with less benefit (patients' post-operative reports). METHODS: Patient-reported outcome measures (PROMs) collected before and after joint replacement, hernia repair or varicose vein (VV) surgery in National Health Service (NHS)-funded patients (2009/11). Regression analysis for associations between 10% increase in rates and mean PROM score for Primary Care Trust (PCT) populations. RESULTS: National rate for hip and knee replacement increased by 6%, unchanged for hernia repair and decreased by 26% for VV surgery. Changes in PCT rates varied but had little or no association with the mean level of need of patients: 10% increase in the rate was associated with only 0.3% decline in the pre-operative PROM score for knee replacement (P < 0.05) and VV surgery (P < 0.001) and no significant change for other procedures. There was no significant association between a 10% change in the rate and the amount of benefit from surgery apart from a slight reduction (0.46%; P < 0.001) in the disease-specific PROM score for VV surgery. CONCLUSION: Policies by commissioners to reduce surgical rates in the English NHS cannot be justified on the grounds of avoiding inappropriate operations or increasing cost-utility.

Socioeconomic differences in patient-reported outcomes after a hip or knee replacement in the English National Health Service.

BACKGROUND: We investigated socioeconomic differences in patient-reported outcomes after a hip or knee replacement and the contribution of health differences beforehand. METHODS: Our sample included 121 983 patients in England who had an operation in 2009-2011. Socioeconomic status was measured with quintiles of the ranking of areas by the English Index of Multiple Deprivation. Outcomes at 6 months were the Oxford hip or knee score (OHS or OKS) that measure pain and disability on a scale from 0 (worst) to 48 (best), and the percentage reporting no improvement in problems. Adjustment was made for age, sex, ethnicity, comorbidity, general health, revision surgery, primary diagnosis, preoperative OHS or OKS and having longstanding problems. RESULTS: Comparing the most- with the least-deprived group, the mean OHS was 5.0 points lower and the OKS 5.4 lower. Adjusted differences, reflecting the differences in improvement in the condition, were 2.8 [95% confidence interval (CI): 2.5-3.0] on OHS and 2.4 (95% CI: 2.2-2.7) on OKS. Adjusted odds ratios for reporting no improvement were 1.4 (1.2-1.6) for the hip and 1.4 (1.3-1.5) for the knee. CONCLUSIONS: On average, patients living in socioeconomically deprived areas had worse outcomes after surgery, partly related to preoperative differences in health and disease severity and partly to less postoperative improvement.

Relationship between patients' reports of complications and symptoms, disability and quality of life after surgery.

BACKGROUND: Patient-reported complications are increasingly being used to compare the performance of surgical departments. The objectives of this study were to explore the validity of patient-reported complications and to determine their influence on patients' reports of the benefits of surgery (health gain). METHODS: This was an observational study of patients in England who underwent hip replacement (68,391), knee replacement (77,705), inguinal hernia repair (48,199) or varicose vein surgery (16,535) during 2009-2011. Health gain was assessed with condition-specific measures of symptoms and disability (Oxford Hip Score, Oxford Knee Score, Aberdeen Varicose Vein Questionnaire), health-related quality of life (EQ-5D™ index) and a single item on the success of surgery. Adverse outcomes included four complications, readmission and further surgery. RESULTS: There was evidence that patient-reported complications were valid. Patients with three or more co-morbid conditions reported more complications, whereas age, sex and socioeconomic status (adjusted for co-morbidity) had little, or no association. Complications were strongly associated with readmission and further surgery. Among patients reporting a complication, the Oxford Hip Score or Oxford Knee Score was about 3 points (or 15 per cent) lower than the value in patients not reporting a complication. The EQ-5D™ score was about 0·07 lower for joint replacement, 0·06 lower for hernia repair and 0·04 lower for varicose vein surgery. CONCLUSION: Patients' reports of complications can be used for statistical comparisons of surgical departments. If the relationship between complications and health gain is causal, there is scope for improving health gain indicators after surgery by minimizing the risk of a complication.

[The need for palliative care treatment in pneumology in non-malignant diseases--a case report]. / Bedarf für eine palliativmedizinische Versorgung in der Pneumologie bei nicht malignen Erkrankungen--ein Fallbericht.

A 70-year-old pneumological patient with a COLD for many years, who was using long-term oxygen therapy, developed a complex clinical presentation. During his inpatient course over several weeks we treated severe physical symptoms such as shortness of breath, anxiety and pain. After the transfer to the palliative care ward only an inpatient final accompaniment was possible. In this case the palliative care expertise was integrated too late into the process of the therapy. The delay led to a poorer control of severe physical symptoms such as those named above. Also, the patients request for comprehensive ambulant care could not be realised because the severity of the disease was not detected soon enough. Instruments for the evaluation of the need for an additional palliative care treatment in patients with a non-malignant pneumological disease have not been established sufficiently.

Sociodemographic differences in the severity and duration of disease amongst patients undergoing hip or knee replacement surgery.

BACKGROUND: Differences in the use of hip and knee replacement by sex, age, ethnicity or socioeconomic status may lead to differences in disease severity between those who have surgery. METHODS: Analyses used data collected from 117,736 patients in 2009-10 via the Patient Reported Outcome Measures (PROMs) programme in England. Adjusted differences were estimated in the Oxford Hip Score (OHS) or the Oxford Knee Score (OKS), both expressed on a scale from 0 to 48, and the proportion with longstanding problems (>5 years), expressed as odds ratios (ORs). RESULTS: Women had more severe pain and disability than men on average (difference OHS 2.3 and OKS 3.3), but less often longstanding problems. Compared with white patients, average severity was higher in South Asian patients (difference OHS 2.7 and OKS 3.0) and in black patients (difference OHS 0.9 and OKS 1.6), who also more often had longstanding problems (OR 1.40 for hip and 1.54 for knee). Patients from deprived areas had more severe disease (difference OHS 3.6 and OKS 3.3 between least and most deprived quintile). CONCLUSIONS: There is evidence that non-white and deprived patients tend to have hip and knee replacement surgery at a later stage in the course of their disease.

Outcomes of elective surgery undertaken in independent sector treatment centres and NHS providers in England: audit of patient outcomes in surgery.

OBJECTIVE: To compare characteristics of patients and outcomes after elective surgery in independent sector treatment centres (ISTCs) and NHS providers. DESIGN: Follow-up study with outcomes reported by patients three to six months after surgery. SETTING: 25 ISTCs and 72 NHS providers in England. Population Consecutive patients undergoing hip or knee replacement (5671 in ISTCs and 14,292 in NHS), inguinal hernia repair (640 and 2023, respectively), or surgery for varicose veins (248 and 1336, respectively). MAIN OUTCOMES: Symptoms and disability reported by patients (Oxford hip and knee scores on a 48 point scale; Aberdeen varicose vein questionnaire) and quality of life (EuroQol EQ-5D score). RESULTS: Patients in ISTCs were healthier than those in NHS providers, had less severe preoperative symptoms, and were more affluent, though the differences were small. With adjustment, patients undergoing joint replacements in NHS providers had poorer outcomes: difference of -1.7 (95% confidence interval -2.5 to -0.9) on the Oxford hip score and -0.9 (-1.6 to -0.2) on the Oxford knee score. They more often reported complications: odds ratio 1.3 (95% confidence interval 1.1 to 1.5) for hip and 1.4 (1.2 to 1.6) for knee. There were no significant differences in outcomes after surgery for hernia or varicose veins, except that NHS patients more often reported poor results after hernia repair (1.4, 1.0 to 1.9) and additional surgery after varicose vein surgery (2.8, 1.2 to 6.8). CONCLUSION: Patients undergoing surgery in ISTCs were slightly healthier and had less severe conditions than those undergoing surgery in NHS providers. Some outcomes were better in ISTCs, but differences were small compared with the impact ISTCs could have on the provision of elective services.

Is there value in routine screening for Cushing's syndrome in patients with diabetes?

CONTEXT: Subclinical Cushing's syndrome has been described among diabetic populations in recent years, but no consensus has emerged about the value of screening. METHODS: We enrolled 201 consecutive patients attending our diabetes clinic and 79 controls. Patients with at least two of the following three criteria were offered screening using a 2300 h salivary cortisol test: glycosylated hemoglobin of at least 7%, body mass index of at least 25 kg/m(2), and a history of hypertension or blood pressure of at least 140/90 mm Hg. Results are expressed as mean +/- sem. RESULTS: Mean nighttime salivary cortisol levels were similar in the two groups (8.5 +/- 1.0 nmol/liter for diabetic patients vs. 5.8 +/- 1.0 nmol/liter for controls). Forty-seven patients (23%) had a value of at least 10 nmol/liter, which was set as a conservative threshold above which further investigation would be performed. Thirty-five (75%) agreed to further testing with a 1-mg overnight dexamethasone test. Of the remaining 12 patients, 10 were followed up clinically for at least 1 yr, and no evidence was found of the syndrome evolving. In 28 patients, serum cortisol suppressed to 60 nmol/liter or less. Of the seven patients who failed this test, four agreed to a 2 mg/d 48-h dexamethasone test, with serum cortisol suppressing to 60 nmol/liter or less in all four. Three declined this test but had normal 24-h urinary free cortisol levels. No patient had clinical features of hypercortisolism. CONCLUSIONS: The 1-3% detection rates of three recently published series have not been realized at our center where we studied a group using criteria making patients more likely to have hypercortisolism. Our results do not support the validity of screening patients without clinical features of Cushing's syndrome in the diabetes clinic.

Is there overutilisation of cataract surgery in England?

OBJECTIVES: Following a 3.7-fold increase in the rate of cataract surgery in the UK between 1989 and 2004, concern has been raised as to whether this has been accompanied by an excessive decline in the threshold such that some operations are inappropriate. The objective was to measure the impact of surgery on a representative sample of patients so as to determine whether or not overutilisation of surgery is occurring. DESIGN: Prospective cohort assessed before and 3 months after surgery. SETTING: Ten providers (four NHS hospitals, three NHS treatment centres, three independent sector treatment centres) from across England. PARTICIPANTS: 861 patients undergoing first eye (569) or second eye (292) cataract surgery provided preoperative data of whom 745 (87%) completed postoperative questionnaires. MAIN OUTCOME MEASURES: Patient-reported visual function (VF-14); general health status and quality of life (EQ5D); postoperative complications; overall view of the operation and its impact. RESULTS: Overall, visual function improved (mean VF-14 score increased from 83.2 (SD 17.3) to 93.7 (SD 13.2)). Self-reported general health status deteriorated (20.3% fair or poor before surgery compared with 25% afterwards) which was reflected in the mean EQ5D score (0.82 vs 0.79; p = 0.003). At least one complication was reported by 66 (8.9%) patients, though this probably overestimated the true incidence. If the appropriateness of surgery is based on an increase in VF-14 score of 5.5 (that corresponds to patients' reporting being "a little better"), 30% of operations would be deemed inappropriate. If an increase of 12.2 (patients' reports of being "much better") is adopted, the proportion inappropriate is 49%. Using a different approach to determining a minimally important difference, the proportion inappropriate would be closer to 20%. Although visual function (VF-14) scores were unchanged or deteriorated in 25% of patients, 93.1% rated the results of the operation as "good," "very good" or "excellent," and 93.5% felt their eye problem was "better." This partly reflects inadequacies in the validity of the VF-14. CONCLUSIONS: Improvement in the provision of cataract surgery has been accompanied by a reduction in the visual function threshold. However, methodological difficulties in measuring the impact of cataract surgery on visual function and quality of life mean it is impossible to determine whether or not overutilisation of cataract surgery is occurring.

The Patient Outcomes of Surgery-Head/Neck (POS-head/neck): a new patient-based outcome measure.

OBJECTIVES: To develop a new patient-based outcome measure in plastic surgery for head/neck skin lesions for use in audit, clinical trials and effectiveness studies. DESIGN AND SUBJECTS: Questionnaire development and validation study. Qualitative methods, including interviews with 27 patients, were carried out to develop a preliminary version of the questionnaire. The questionnaire was then field tested by postal survey of 141 pre- and 250 post-surgery patients to produce a shortened (item-reduced) questionnaire and to evaluate acceptability, reliability, validity and responsiveness. A second field test was carried out by postal survey in an independent sample of 67 pre-surgery patients to further evaluate the reliability and validity of the questionnaire. MAIN OUTCOME MEASURES: Psychometric properties of acceptability, reliability, validity, and responsiveness were assessed. RESULTS: We developed a new measure, the Patient Outcomes of Surgery-Head/Neck (POS-Head/Neck), which includes a six- and nine-item pre- and post-surgery questionnaire, respectively. Results confirmed the acceptability (missing data <10%, evenly distributed endorsement frequencies), reliability (Cronbach alphas >0.76, item-total correlations >0.22), validity (scale inter-correlations r=0.50, scaling assumptions, correlations with age and sex < -0.25) and responsiveness (effect size=0.63) of the questionnaire. CONCLUSIONS: The POS-Head/Neck is a new surgical outcome measure that can be used to evaluate outcomes in malignant and benign head/neck skin lesions before and after surgery is acceptable to patients and satisfies rigorous scientific criteria.

An experimental study of determinants of the extent of disagreement within clinical guideline development groups.

OBJECTIVE: To assess the effect of design features and clinical and social cues on the extent of disagreement among participants in a formal consensus development process. METHODS: Factorial design involving 16 groups consisting of 135 general practitioners (GPs) and 42 mental health professionals from England. The groups rated the appropriateness of four mental health interventions for three conditions (chronic back pain, irritable bowel syndrome, and chronic fatigue syndrome) in the context of various clinical and social cues. The groups differed in three design features: provision of a systematic literature review (versus not provided), group composition (mixed versus GP only), and assumptions about the healthcare resources available (realistic versus idealistic). Disagreement was measured using the mean absolute deviation from a group's median rating for a scenario. RESULTS: None of the design features significantly affected the extent of disagreement within groups (all p>0.3). Disagreement did differ between treatments (closer consensus for cognitive behavioural therapy and behavioural therapy than for brief psychodynamic intervention therapy and antidepressants) and cues (closer consensus for depressed patients and patients willing to try any treatment). CONCLUSION: In terms of the extent of disagreement in the groups in this study, formal consensus development was a robust technique in that the results were not dependent on the way it was conducted.

Grommets in otitis media with effusion: an individual patient data meta-analysis.

AIMS: To identify subgroups of children with otitis media with effusion (OME) that might benefit more than others from treatment with ventilation tubes. METHODS: An individual patient data (IPD) meta-analysis on seven randomised controlled trials (n = 1234 children in all), focusing on interactions between treatment and baseline characteristics--hearing level (HL), history of acute otitis media, common colds, attending day-care, gender, age, socioeconomic status, siblings, season, passive smoking, and history of breast feeding. Outcome measures that could be studied were mean time spent with effusion (n = 557), mean hearing levels (n = 557 in studies that randomised children, and n = 180 in studies that randomised ears), and language development (n = 381). RESULTS: In the trials that treated both ears the only significant interaction was between day-care and surgery, occurring where mean hearing level was the outcome measure. None of the other baseline variables showed an interaction effect with treatment that would justify subgrouping. In the trials that treated only one ear, the baseline hearing level showed a significant but not pervasive interaction with treatment-that is, only with a cut-off of 25 dB HL. CONCLUSIONS: The effects of conventional ventilation tubes in children studied so far are small and limited in duration. Observation (watchful waiting) therefore seems to be an adequate management strategy for most children with OME. Ventilation tubes might be used in young children that grow up in an environment with a high infection load (for example, children attending day-care), or in older children with a hearing level of 25 dB HL or greater in both ears persisting for at least 12 weeks.

The Patient Outcomes of Surgery-Hand/Arm (POS-Hand/Arm): a new patient-based outcome measure.

The purpose of this study was to develop and validate a new patient-based outcome measure for hand/arm disorders for use in audit, clinical trials and effectiveness studies. There were three stages. First, we carried out interviews with 40 patients with hand/arm disorders to develop and pilot questionnaire content. Second, in a postal survey with 165 pre- and 181 post-surgery patients, we reduced the number of items and identified scales. Third, in a postal survey with 132 pre- and 204 post-surgery patients we evaluated the psychometric properties of the measure. Findings confirmed the acceptability, reliability, validity and responsiveness to clinical change of the questionnaire. The Patient Outcomes of Surgery-Hand/Arm (POS-Hand/Arm) is a new surgical outcome measure that can be used before and after surgery (29 and 33 items, respectively) to evaluate and compare new techniques, surgical teams and units.

Reduction in the use of surgery for glue ear: did national guidelines have an impact?

BACKGROUND: It is widely accepted that the passive dissemination of national clinical guidance has little or no impact on practice. OBJECTIVE: To assess the impact in England of an Effective Health Care bulletin on childhood surgery for glue ear issued in 1992 and to understand the reasons for any change (or lack of change) in practice that ensued. METHOD: Time series analysis of the rate of use of surgery by children under 10 years of age from 1975 to 1997/8 in 13 English health districts. RESULTS: Following a rise in the rate of surgery in public (National Health Service) hospitals from 1975 to 1985, the rate declined by 1.6% a year from 1986 to 1992/3. Following publication of the guidelines in November 1992, the rate of decline increased to 10.1% a year. Even after allowing for a slight increase in the use of independent (private) hospitals between 1992/3 and 1997/8, the overall rate of decline was at least 7.9%. It appears that the rate of referral of cases by primary care physicians (general practitioners) halved during this period. Several contextual factors are thought to have contributed to the effect of the guidelines, including pre-existing professional concern about the value of surgery, the introduction of an internal market into the NHS, and growing apprehension among parents fuelled by scepticism in the mass media. During this unprecedented period of rapid change in usage, staff delivering the service remained unaware of the alterations in their own practice. CONCLUSIONS: Passive dissemination of national guidelines can accelerate an existing trend in clinical practice if the context is hospitable. Policy makers should identify and target such situations.

Gender differences in the management and outcome of patients with acute coronary artery disease.

STUDY OBJECTIVE: s: To compare the clinical management and health outcomes of men and women after admission with acute coronary syndromes, after adjusting for disease severity, sociodemographic, and cardiac risk factors. DESIGN: Prospective national survey of acute cardiac admissions followed up by mailed patient questionnaire two to three years after initial admission. SETTING: Random sample of 94 district general hospitals in the UK. PATIENTS: 1064 patients under 70 years old recruited between April 1995 and November 1996. MAIN RESULTS: Of the 1064 patients recruited, 126 (11.8%) died before follow up. Of the 938 survivors, 719 (76.7%) completed a follow up questionnaire. There were no gender differences in the use of cardiac investigations during the index admission or follow up period. However, male patients with hypertension were more likely to undergo rehabilitation compared with female hypertensive patients (OR 2.01, 95% CI 0.85 to 4.72). Men were also more likely to undergo coronary artery bypass grafting (CABG) than women (OR 1.90, 95%CI 1.21 to 3.00), but there was no gender difference in the use of revascularisation overall (p=0.14). An indirect indication that the gender differences in CABG were not attributable to bias was provided by the lack of gender differences in health outcomes, which implies that patients received the care they needed. CONCLUSIONS: Despite the extensive international literature referring to a gender bias in favour of men with coronary heart disease, this national survey found no gender differences in the use of investigations or in revascularisation overall. However, the criteria used for selecting percutaneous transluminal coronary angioplasty compared with CABG requires further investigation as does the use of rehabilitation. It is unclear whether the clinical decisions to provide these procedures are made solely on the basis of clinical need.

Surgery for stress incontinence: a non-randomised trial of colposuspension, needle suspension and anterior colporrhaphy.

OBJECTIVE: To compare the outcome, 12 months after surgery, of three principal categories of procedure (colposuspension, needle suspension and anterior colporrhaphy) used for treating stress incontinence. METHODS: A non-randomised trial design comparing 221 colposuspensions, 54 needle suspensions and 130 anterior colporrhaphies performed by 49 surgeons in 18 hospitals in the North Thames health region in 1993-1994. Four outcomes were considered: complications, severity of stress incontinence, social impact of incontinence, and activities of daily living score. Results were adjusted, using logistic regression, for 13 case-mix variables. RESULTS: Significant differences existed between the three procedures in the characteristics of the patients. The cure rate varied by procedure (colposuspension 34% dry; needle suspensions 13%; anterior colporrhaphy 19%). Two thirds of women, however, reported an improvement (colposuspension 75%; needle suspension 68%; anterior colporrhaphy 55%). After adjusting for confounders, colposuspension was significantly more likely to result in an improvement than anterior colporrhaphy (odds ratio 2.2). While this was reflected in improvements in the social life of the women, the difference between procedures did not reach statistical significance (p = 0.05). CONCLUSION: These results suggest surgery for stress incontinence in typical settings is not as good as reported in textbooks. This is mostly because this study was based on women's own reports (and not surgeons' reports) and partly because of the unselected nature of the patients. The information on outcomes given to patients should be reviewed and a large, pragmatic randomised trial including patient-assessed outcomes is needed.

Discovering relevance knowledge in data: a growing cell structures approach.

Both information retrieval and case-based reasoning systems rely on effective and efficient selection of relevant data. Typically, relevance in such systems is approximated by similarity or indexing models. However, the definition of what makes data items similar or how they should be indexed is often nontrivial and time-consuming. Based on growing cell structure artificial neural networks, this paper presents a method that automatically constructs a case retrieval model from existing data. Within the case-based reasoning (CBR) framework, the method is evaluated for two medical prognosis tasks, namely, colorectal cancer survival and coronary heart disease risk prognosis. The results of the experiments suggest that the proposed method is effective and robust. To gain a deeper insight and understanding of the underlying mechanisms of the proposed model, a detailed empirical analysis of the models structural and behavioral properties is also provided.

Improving clinical decision support through case-based data fusion.

This paper presents an information fusion technique based on a knowledge discovery model, and the case-based reasoning decision framework. Using signal data and database records from the heart disease risk estimation domain, three data fusion methods are discussed. Two of these methods combine information at the retrieval-outcome level, and one method merges data at the discovery-input level. The result of these three models are compared and evaluated against the performance of single-source models. It is shown that the methods that fuse information at the retrieval-outcome level are significantly superior.