Improving risk models for patients having emergency bowel cancer surgery using linked electronic health records: a national cohort study.

BACKGROUND: Life-saving emergency major resection of colorectal cancer (CRC) is a high-risk procedure. Accurate prediction of postoperative mortality for patients undergoing this procedure is essential for both healthcare performance monitoring and preoperative risk assessment. Risk-adjustment models for CRC patients often include patient and tumour characteristics, widely available in cancer registries and audits. The authors investigated to what extent inclusion of additional physiological and surgical measures, available through linkage or additional data collection, improves accuracy of risk models. METHODS: Linked, routinely-collected data on patients undergoing emergency CRC surgery in England between December 2016 and November 2019 were used to develop a risk model for 90-day mortality. Backwards selection identified a 'selected model' of physiological and surgical measures in addition to patient and tumour characteristics. Model performance was assessed compared to a 'basic model' including only patient and tumour characteristics. Missing data was multiply imputed. RESULTS: Eight hundred forty-six of 10 578 (8.0%) patients died within 90 days of surgery. The selected model included seven preoperative physiological and surgical measures (pulse rate, systolic blood pressure, breathlessness, sodium, urea, albumin, and predicted peritoneal soiling), in addition to the 10 patient and tumour characteristics in the basic model (calendar year of surgery, age, sex, ASA grade, TNM T stage, TNM N stage, TNM M stage, cancer site, number of comorbidities, and emergency admission). The selected model had considerably better discrimination compared to the basic model (C-statistic: 0.824 versus 0.783, respectively). CONCLUSION: Linkage of disease-specific and treatment-specific datasets allowed the inclusion of physiological and surgical measures in a risk model alongside patient and tumour characteristics, which improves the accuracy of the prediction of the mortality risk for CRC patients having emergency surgery. This improvement will allow more accurate performance monitoring of healthcare providers and enhance clinical care planning.

Linkage of multiple electronic health record datasets using a 'spine linkage' approach compared with all 'pairwise linkages'.

BACKGROUND: Methods for linking records between two datasets are well established. However, guidance is needed for linking more than two datasets. Using all 'pairwise linkages'-linking each dataset to every other dataset-is the most inclusive, but resource-intensive, approach. The 'spine' approach links each dataset to a designated 'spine dataset', reducing the number of linkages, but potentially reducing linkage quality. METHODS: We compared the pairwise and spine linkage approaches using real-world data on patients undergoing emergency bowel cancer surgery between 31 October 2013 and 30 April 2018. We linked an administrative hospital dataset (Hospital Episode Statistics; HES) capturing patients admitted to hospitals in England, and two clinical datasets comprising patients diagnosed with bowel cancer and patients undergoing emergency bowel surgery. RESULTS: The spine linkage approach, with HES as the spine dataset, created an analysis cohort of 15 826 patients, equating to 98.3% of the 16 100 patients identified using the pairwise linkage approach. There were no systematic differences in patient characteristics between these analysis cohorts. Associations of patient and tumour characteristics with mortality, complications and length of stay were not sensitive to the linkage approach. When eligibility criteria were applied before linkage, spine linkage included 14 509 patients (90.0% compared with pairwise linkage). CONCLUSION: Spine linkage can be used as an efficient alternative to pairwise linkage if case ascertainment in the spine dataset and data quality of linkage variables are high. These aspects should be systematically evaluated in the nominated spine dataset before spine linkage is used to create the analysis cohort.

Probabilistic linkage without personal information successfully linked national clinical datasets.

BACKGROUND: Probabilistic linkage can link patients from different clinical databases without the need for personal information. If accurate linkage can be achieved, it would accelerate the use of linked datasets to address important clinical and public health questions. OBJECTIVE: We developed a step-by-step process for probabilistic linkage of national clinical and administrative datasets without personal information, and validated it against deterministic linkage using patient identifiers. STUDY DESIGN AND SETTING: We used electronic health records from the National Bowel Cancer Audit and Hospital Episode Statistics databases for 10,566 bowel cancer patients undergoing emergency surgery in the English National Health Service. RESULTS: Probabilistic linkage linked 81.4% of National Bowel Cancer Audit records to Hospital Episode Statistics, vs. 82.8% using deterministic linkage. No systematic differences were seen between patients that were and were not linked, and regression models for mortality and length of hospital stay according to patient and tumour characteristics were not sensitive to the linkage approach. CONCLUSION: Probabilistic linkage was successful in linking national clinical and administrative datasets for patients undergoing a major surgical procedure. It allows analysts outside highly secure data environments to undertake linkage while minimizing costs and delays, protecting data security, and maintaining linkage quality.

Patients' satisfaction with the reconstructive options provided to them measured 18 months after mastectomy surgery for breast cancer.

INTRODUCTION: Mastectomy patients' satisfaction with reconstructive options has not been examined. METHODS: A national study measured 18-month satisfaction with reconstructive options and collected case-mix and reconstructive offer and uptake data on breast cancer patients having mastectomy with or without immediate reconstruction (IR) in England between January 2008 and March 2009. Multivariable logistic regression examined the relationship between satisfaction, age, IR offer and uptake, and clinical suitability. RESULTS: Of 4796 patients, 1889 were not offered IR, 1489 declined an offer and 1418 underwent it. Women not offered IR were more likely older, obese or smokers and had higher ASA grades, ECOG scores, tumour burdens and adjuvant chemotherapy and radiotherapy likelihoods (9% of lowest suitability group offered IR; 81% in highest suitability group). 83.7% were satisfied with their reconstructive options, varying significantly by IR offer and uptake (76.1% for those not offered IR; 85.8% for those who declined IR; 91.7% following IR). Older women and women deemed more suitable for IR were more often satisfied (p-values <0.001). CONCLUSIONS: Satisfaction varied by offer and uptake status, age and suitability score. Clinicians should target equity for women deemed unsuitable by exploring their needs and desired outcomes, standardising operative fitness assessments and utilising shared decision-making aids.

Geographical variation in rates of surgical treatment for female stress urinary incontinence in England: a national cohort study.

OBJECTIVE: To examine geographic variation in use of surgery for female stress urinary incontinence (SUI), mainly midurethral mesh tape insertions, in the English National Health Service (NHS). DESIGN: National cohort study. SETTING: NHS hospitals. PARTICIPANTS: 27 997 women aged 20 years or older who had a first SUI surgery in an English NHS Hospital between April 2013 and March 2016 and a diagnosis of SUI at the same time as the procedure. METHODS: Multilevel Poisson regression was used to adjust for geographic differences in age, ethnicity, prevalence of long-term illness and socioeconomic deprivation. PRIMARY OUTCOME MEASURE: Rate of surgery for SUI per 100 000 women/year at two geographic levels: Clinical Commissioning Group (CCG; n=209) and Sustainability and Transformation Partnership (STP; n=44). RESULTS: The rate of surgery for SUI was 40 procedures per 100 000 women/year. Risk-adjusted rates ranged from 20 to 106 procedures per 100 000 women/year across CCGs and 24 to 69 procedures per 100 000 women/year across the STP areas. These regional differences were only partially explained by demographic characteristics as adjustment reduced variance of surgery rates by 16% among the CCGs and 35% among the STPs. CONCLUSIONS: Substantial geographic variation exists in the use of surgery for female SUI in the English NHS, suggesting that women in some areas are more likely to be treated compared with women with the same condition in other areas. The variation reflects differences in how national guidelines are being interpreted in the context of the ongoing debate about the safety of SUI surgery.

Impact of patient choice and hospital competition on patient outcomes after prostate cancer surgery: A national population-based study.

BACKGROUND: Policies that encourage patient choice and hospital competition have been introduced across several countries with the purpose of improving the quality of health care services. The objective of the current national cohort study was to analyze the correlation between choice and competition on outcomes after cancer surgery using prostate cancer as a case study. METHODS: The analyses included all men who underwent prostate cancer surgery in the United Kingdom between 2008 and 2011 (n = 12,925). Multilevel logistic regression was used to assess the effect of a radical prostatectomy center being located in a competitive environment (based on the number of centers within a threshold distance) and being a successful competitor (based on the ability to attract patients from other hospitals) on 3 patient-level outcomes: postoperative length of hospital stay >3 days, 30-day emergency readmissions, and 2-year urinary complications. RESULTS: With adjustment for patient characteristics, men who underwent surgery in centers located in a stronger competitive environment were less likely to have a 30-day emergency readmission, irrespective of the type or volume of procedures performed at each center (odds ratio, 0.46; 95% confidence interval, 0.36-0.60; P = .005). Men who received treatment at centers that were successful competitors were less likely to have a length of hospital stay >3 days (odds ratio, 0.49; 95% confidence interval, 0.25-0.94; P = .02). CONCLUSIONS: The current results suggest for the first time that hospital competition improves short-term outcomes after prostate cancer surgery. Further evaluation of the potential role of patient choice and hospital competition is required to inform health service design in contrast to the role of top-down-driven approaches, which have focused on centralization of services.

The association between complications and quality of life after mastectomy and breast reconstruction for breast cancer.

BACKGROUND: Medical treatment for breast cancer is associated with substantial toxicity and patient burden. There is less known about the impact of surgical complications. Understanding this impact could provide important information for patients when they are considering surgical options. METHODS: Between 2008 and 2009, the UK National Mastectomy and Breast Reconstruction Audit recorded surgical complications for a prospective cohort of 17,844 women treated for breast cancer at 270 hospitals; 6405 of these women were surveyed about their quality of life 18 months after surgery. Breast appearance, emotional well-being, and physical well-being were quantified on 0- to 100-point scales. Linear multiple regression models, controlling for a range of baseline prognostic factors, were used to compare the scores of patients who had complications with the scores of those who did not. RESULTS: The overall complication rate was 10.2%. Complications were associated with little or no impairment in women undergoing mastectomy without reconstruction or with delayed reconstruction. The association was much larger for flap-related complications suffered during immediate reconstruction. The breast-appearance scores (adjusted mean difference, -23.8; 95% confidence interval [CI], -31.0 to -16.6) and emotional well-being scores (adjusted mean difference, -14.0; 95% CI, -22.0 to -6.0) of these patients were much lower than those of any other patient group. Implant-related complications were not associated with a lower quality of life in any surgical group. CONCLUSIONS: There is a strong case for prospectively collecting flap-complication rates at the surgeon and surgical unit level and for allowing patients to access these data when they make choices about their breast cancer surgery. Cancer 2017;123:3460-7. © 2017 American Cancer Society.

Surgical Determinants of Patient-Reported Outcomes following Postmastectomy Reconstruction in Women with Breast Cancer.

BACKGROUND: This national prospective cohort study compared the patient-reported outcomes of breast cancer patients undergoing postmastectomy autologous reconstruction to those who had breast implants, in terms of aesthetic appearance; levels of psychological, physical, and sexual well-being; and overall satisfaction. METHODS: Of 5063 women who underwent immediate reconstruction (n = 3349) or delayed reconstruction (n = 1714) between January 1, 2008, and March 31, 2009, in England, 2923 women who gave informed consent were sent validated, procedure-specific, 18-month follow-up questionnaires. Outcome scale scores ranged from 0 (poor) to 100 (excellent); multiple linear regression was used to adjust scores for patient and treatment characteristics. RESULTS: Two thousand two hundred eighty-nine women (78 percent) returned completed questionnaires (immediate reconstruction, n = 1528; delayed reconstruction, n = 761). For immediate reconstruction, mean overall satisfaction scores for the various techniques ranged from 67 to 85 (median, 67 to 93). For delayed reconstruction, mean overall satisfaction scores ranged from 70 to 85 (median, 75 to 100). For both groups, similar gradients were observed for the other outcome scales across techniques. Reconstruction using patients' own tissues tended to have higher mean adjusted scores compared with those techniques using implants alone (p < 0.0001 for aesthetic appearance, psychological well-being, sexual well-being, and satisfaction with outcomes for immediate and delayed reconstruction groups). CONCLUSIONS: Women who underwent autologous reconstruction tended to report greater satisfaction than those who underwent implant reconstruction. These results can inform patients of the anticipated outcomes of their selected surgery, but further research is required to confirm whether autologous reconstruction is superior in general. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Grommet Surgery in Children With Orofacial Clefts in England.

OBJECTIVE: To assess grommet insertion practice in the first 5 years of life among children with an orofacial cleft in England. DESIGN: Analysis of national administrative data of hospital admissions. SETTING: National Health Service hospitals, England. PATIENTS: Patients born between 1997 and 2005 who underwent surgical cleft repair. INTERVENTION: Children receiving grommets before the age of 5 years. OUTCOME MEASURES: The proportion of children receiving grommets before the age of 5 years, the timing of the first grommet insertion, and the proportion of children having repeat grommet insertions were examined according to cleft type, the absence or presence of additional anomalies, socioeconomic deprivation, and region of residence. RESULTS: The study included 8,269 children. Before the age of 5 years, 3,015 (36.5%) children received grommets. Of these, 33.2% received their first grommets at primary cleft repair and 33.3% underwent multiple grommet insertion procedures. The most common age for the first procedure was between 6 and 12 months. Children with a cleft affecting the palate were more likely to receive grommets than children with a cleft lip alone (45.5% versus 4.5%). Grommet insertion practice also varied according to year of birth, absence or presence of additional anomalies, socioeconomic deprivation, and region of residence. CONCLUSION: Grommets practice in children with a cleft appears to vary according to their clinical characteristics. The differences in practice observed according to deprivation and region of residence need to be further explored.

Evaluating variation in use of definitive therapy and risk-adjusted prostate cancer mortality in England and the USA.

OBJECTIVES: Prostate cancer mortality (PCM) in the USA is among the lowest in the world, whereas PCM in England is among the highest in Europe. This paper aims to assess the association of variation in use of definitive therapy on risk-adjusted PCM in England as compared with the USA. DESIGN: Observational study. SETTING: Cancer registry data from England and the USA. PARTICIPANTS: Men diagnosed with non-metastatic prostate cancer (PCa) in England and the USA between 2004 and 2008. OUTCOME MEASURES: Competing-risks survival analyses to estimate subhazard ratios (SHR) of PCM adjusted for age, ethnicity, year of diagnosis, Gleason score (GS) and clinical tumour (cT) stage. RESULTS: 222,163 men were eligible for inclusion. Compared with American patients, English patients were more likely to present at an older age (70-79 years: England 44.2%, USA 29.3%, p<0.001), with higher tumour stage (cT3-T4: England 25.1%, USA 8.6%, p<0.001) and higher GS (GS 8-10: England 20.7%, USA 11.2%, p<0.001). They were also less likely to receive definitive therapy (England 38%, USA 77%, p<0.001). English patients were more likely to die of PCa (SHR=1.9, 95% CI 1.7 to 2.0, p<0.001). However, this difference was no longer statistically significant when also adjusted for use of definitive therapy (SHR=1.0, 95% CI 1.0 to 1.1, p=0.3). CONCLUSIONS: Risk-adjusted PCM is significantly higher in England compared with the USA. This difference may be explained by less frequent use of definitive therapy in England.

Findings of a national comparative audit of mastectomy and breast reconstruction surgery in England.

OBJECTIVES: This paper summarises the findings of a national audit of mastectomy and breast reconstruction surgery carried out in England. It describes patterns of treatment, and the clinical and patient-reported quality of life outcomes associated with these types of procedure. DESIGN: Prospective cohort study. SETTING: All 150 National Health Service hospital groups (NHS trusts) in England that provided mastectomy or breast reconstruction surgery, along with six NHS trusts in Wales and Scotland and 114 independent hospitals. PARTICIPANTS: Women aged 16 years and over undergoing mastectomy with or without immediate breast reconstruction, or primary delayed breast reconstruction, between 1st January 2008 and 31st March 2009. MAIN OUTCOME MEASURES: Reconstructive utilisation, post-operative complications and sequelae, and patient-reported satisfaction and quality of life. RESULTS: Overall, 21% of the 16,485 women who had mastectomy underwent immediate reconstruction. However, the proportion varied between regions from 9% to 43% (p < 0.001). Levels of patient satisfaction with information, choice and the quality of care were high. The proportion of women who experienced local complications was 10.30% (95% CI 9.78-10.84) for mastectomy surgery, ranged from 11.02% (9.31-12.92) to 18.24% (14.80-22.10) for different immediate reconstructive procedures, and from 5.00% (2.76-8.25) to 19.86% (16.21-23.94) for types of delayed reconstruction. Breast appearance and overall well-being scores reported 18 months after surgery were higher among women having immediate breast reconstruction compared to mastectomy only. Postoperative outcomes were similar across providers.. CONCLUSIONS: The Audit found women were highly satisfied with their peri-operative care, with hospital providers achieving similar outcomes. English providers should examine how to reduce the variation in rates of immediate reconstruction.

Functional outcome, revision rates and mortality after primary total hip replacement--a national comparison of nine prosthesis brands in England.

BACKGROUND: The number of prosthesis brands used for hip replacement has increased rapidly, but there is little evidence on their effectiveness. We compared patient-reported outcomes, revision rates, and mortality for the three most frequently used brands within each prosthesis type: cemented (Exeter V40 Contemporary, Exeter V40 Duration and Exeter V40 Elite Plus Ogee), cementless (Corail Pinnacle, Accolade Trident, and Taperloc Exceed), and hybrid (Exeter V40 Trilogy, Exeter V40 Trilogy, and CPT Trilogy). METHODS AND FINDINGS: We used three national databases of patients who had hip replacements between 2008 and 2011 in the English NHS to compare functional outcome (Oxford Hip Score (OHS) ranging from 0 (worst) to 48 (best)) in 43,524 patients at six months. We analysed revisions and mortality in 187,201 patients. We used multiple regression to adjust for pre-operative differences. Prosthesis type had an impact on post-operative OHS and revision rates (both p<0.001). Patients with hybrid prostheses had the best functional outcome (mean OHS 39.4, 95%CI 39.1 to 39.7) and those with cemented prostheses the worst (37.7, 37.3 to 38.1). Patients with cemented prostheses had the lowest reported 5-year revision rates (1.3%, 1.2% to 1.4%) and those with cementless prostheses the highest (2.2%, 2.1% to 2.4%). Differences in mortality according to prosthesis type were small and not significant (p = 0.06). Functional outcome varied according to brand among cemented (p = 0.05, with Exeter V40 Duration having the best) and cementless prostheses (p = 0.01, with Corail Pinnacle having the best). Revision rates varied according to brand among hybrids (p = 0.05, with Exeter V40 Trident having the lowest). CONCLUSIONS: Functional outcomes were better with cementless cups and revision rates were lower with cemented stems, which underlies the good overall performance of hybrids. The hybrid Exeter V40 Trident seemed to produce the best overall results. This brand should be considered as a benchmark in randomised trials.

Trends in the use of bilateral mastectomy in England from 2002 to 2011: retrospective analysis of hospital episode statistics.

OBJECTIVES: For healthy women at high risk of developing breast cancer, a bilateral mastectomy can reduce future risk. For women who already have unilateral breast cancer, removing the contralateral healthy breast is more difficult to justify. We examined trends in the number of women who had a bilateral mastectomy in England between 2002 and 2011. DESIGN: Retrospective cohort study using the Hospital Episode Statistics database. SETTING: NHS hospital trusts in England. PARTICIPANTS: Women aged between 18 and 80 years who had a bilateral mastectomy (or a contralateral mastectomy within 24 months of unilateral mastectomy) with or without a diagnosis of breast cancer. MAIN OUTCOME MEASURES: Number and incidence of women without breast cancer who had a bilateral mastectomy; number and proportion who had a bilateral mastectomy as their first breast cancer operation, and the proportion of those undergoing bilateral mastectomy who had immediate breast reconstruction. RESULTS: Among women without breast cancer, the number who had a bilateral mastectomy increased from 71 in 2002 to 255 in 2011 (annual incidence rate ratio 1.16, 95% CI 1.13 to 1.18). In women with breast cancer, the number rose from 529 to 931, an increase from 2% to 3.1% of first operations (OR for annual increase 1.07, 95% CI 1.05 to 1.08). Across both groups, rates of immediate breast reconstruction roughly doubled and reached 90% among women without breast cancer in 2011. CONCLUSIONS: The number of women who had a bilateral mastectomy nearly doubled over the last decade, and more than tripled among women without breast cancer. This coincided with an increase in the use of immediate breast reconstruction.

Evaluating maternity care using national administrative health datasets: how are statistics affected by the quality of data on method of delivery?

BACKGROUND: Information on maternity services is increasingly derived from national administrative health data. We evaluated how statistics on maternity care in England were affected by the completeness and consistency of data on "method of delivery" in a national dataset. METHODS: Singleton deliveries occurring between April 2009 and March 2010 in English NHS trusts were extracted from the Hospital Episode Statistics (HES) database. In HES, method of delivery can be entered twice: 1) as a procedure code in core fields, and 2) in supplementary maternity fields. We examined overall consistency of these data sources at a national level and among individual trusts. The impact of different analysis rules for handling inconsistent data was then examined using three maternity statistics: emergency caesarean section (CS) rate; third/fourth degree tear rate amongst instrumental deliveries, and elective CS rate for breech presentation. RESULTS: We identified 629,049 singleton deliveries. Method of delivery was not entered as a procedure or in the supplementary fields in 0.8% and 12.5% of records, respectively. In 545,594 records containing both data items, method of delivery was coded consistently in 96.3% (kappa = 0.93; p < 0.001). Eleven of 136 NHS trusts had comparatively poor consistency (<92%) suggesting systematic data entry errors. The different analysis rules had a small effect on the statistics at a national level but the effect could be substantial for individual NHS trusts. The elective CS rate for breech was most sensitive to the chosen analysis rule. CONCLUSIONS: Organisational maternity statistics are sensitive to inconsistencies in data on method of delivery, and publications of quality indicators should describe how such data were handled. Overall, method of delivery is coded consistently in English administrative health data.

Impact of route to diagnosis on treatment intent and 1-year survival in patients diagnosed with oesophagogastric cancer in England: a prospective cohort study.

OBJECTIVE: To investigate the relationship between the route to diagnosis, patient characteristics, treatment intent and 1 -year survival among patients with oesophagogastric (O-G) cancer. SETTING: Cohort study in 142 English NHS trusts and 30 cancer networks. PARTICIPANTS: Patients diagnosed with O-G cancer between October 2007 and June 2009. DESIGN: Prospective cohort study. Route to diagnosis defined as general practitioner (GP) referral-urgent (suspected cancer) or non-urgent, hospital consultant referral, or after an emergency admission. Logistic regression was used to estimate associations and adjust for differences in casemix. MAIN OUTCOME MEASURES: Proportion of patients diagnosed by route of diagnosis; proportion of patients selected for curative treatment; 1-year survival. RESULTS: Among 14 102 cancer patients, 66.3% were diagnosed after a GP referral, 16.4% after an emergency admission and 17.4% after a hospital consultant referral. Of the 9351 GP referrals, 68.8% were urgent. Compared to urgent GP referrals, a markedly lower proportion of patients diagnosed after emergency admission had a curative treatment plan (36% vs 16%; adjusted OR=0.62, 95% CI 0.52 to 0.74) and a lower proportion survived 1 year (43% vs 27%; OR 0.78; 95% CI 0.68 to 0.89). Urgency of GP referral did not affect treatment intent or survival. Routes to diagnosis varied across cancer networks, with the adjusted proportion of patients diagnosed after emergency admission ranging from 8.7 to 32.3%. CONCLUSIONS: Outcomes for cancer patients are worse if diagnosed after emergency admission. Primary care and hospital services should work together to reduce rates of diagnosis after emergency admission and the variation across cancer networks.

Centralisation of services for children with cleft lip or palate in England: a study of hospital episode statistics.

BACKGROUND: In 1998, a process of centralisation was initiated for services for children born with a cleft lip or palate in the UK. We studied the timing of this process in England according to its impact on the number of hospitals and surgeons involved in primary surgical repairs. METHODS: All live born patients with a cleft lip and/or palate born between April 1997 and December 2008 were identified in Hospital Episode Statistics, the database of admissions to English National Health Service hospitals. Children were included if they had diagnostic codes for a cleft as well as procedure codes for a primary surgical cleft repair. Children with codes indicating additional congenital anomalies or syndromes were excluded as their additional problems could have determined when and where they were treated. RESULTS: We identified 10,892 children with a cleft. 21.0% were excluded because of additional anomalies or syndromes. Of the remaining 8,606 patients, 30.4% had a surgical lip repair only, 41.7% a palate repair only, and 28.0% both a lip and palate repair. The number of hospitals that carried out these primary repairs reduced from 49 in 1997 to 13, with 11 of these performing repairs on at least 40 children born in 2008. The number of surgeons responsible for repairs reduced from 98 to 26, with 22 performing repairs on at least 20 children born in 2008. In the same period, average length of hospital stay reduced from 3.8 to 3.0 days for primary lip repairs, from 3.8 to 3.3 days for primary palate repairs, and from 4.6 to 2.6 days for combined repairs with no evidence for a change in emergency readmission rates. The speed of centralisation varied with the earliest of the nine regions completing it in 2001 and the last in 2007. CONCLUSIONS: Between 1998 and 2007, cleft services in England were centralised. According to a survey among patients' parents, the quality of cleft care improved in the same period. Surgical care became more consistent with current recommendations. However, key outcomes, including facial appearance and speech, can only be assessed many years after the initial surgical treatment.

Funnel plots for comparing provider performance based on patient-reported outcome measures.

BACKGROUND: Patient-reported outcome measures (PROMs) often produce skewed distributions of individual scores after a healthcare intervention. For health performance indicators derived from skewed distributions, funnel plots designed with symmetric control limits may increase the risk of false alarms about poor performance. AIM: To investigate the accuracy of funnel plots with symmetric control limits when comparing provider performance based on PROMs. METHODS: The authors used a database containing condition-specific PROMs for 17,453 hip replacements and 7656 varicose vein procedures performed by providers in the English NHS. The mean postoperative PROM score, adjusted for patient characteristics, was used as the measure of performance. To compare performance, symmetric 99.8% control limits were calculated on funnel plots, 3 SDs away from the overall mean on either side. These were compared to control limits derived directly from percentiles of simulated (bootstrap) distributions of mean scores. RESULTS: The simulated control limits on funnel plots for both procedures were asymmetric. The empirical probability of falling outside the symmetric 99.8% 'poor performance' control limit was inflated from the stipulated rate of 0.1% to 0.2-0.3% for provider sample sizes of up to 150 procedures. The authors observed that, out of 237 providers of hip replacement, eight had adjusted mean scores that exceeded the symmetric 'poor performance' limit compared with only five that exceeded the corresponding simulated limit. In other words, three (1.3%) were differently classified. For varicose vein surgery, five out of 160 providers exceeded the symmetric limit and four exceeded the simulated limit, that is, 1 (0.6%) was differently classified. CONCLUSIONS: When designing funnel plots for comparisons of provider performance based on highly skewed data, the use of simulated control limits should be considered.

Mathematical coupling may account for the association between baseline severity and minimally important difference values.

OBJECTIVE: To generate anchor-based values for the "minimally important difference" (MID) for a number of commonly used patient-reported outcome (PRO) measures and to examine whether these values could be applied across the continuum of preoperative patient severity. STUDY DESIGN AND SETTING: Six prospective cohort studies of patients undergoing elective surgery at hospitals in England and Wales. Patients completed questionnaires about their health and health-related quality of life before and after surgery. MID values were calculated using the mean change score for a reference group of patients who reported they were "a little better" after surgery minus the mean change score for those who said they were "about the same." Pearson's correlation was used to examine the association between baseline severity and change scores in the reference group. Baseline severity was expressed in two ways: first in terms of preoperative scores and second in terms of the average of pre- and postoperative scores (Oldham's method). RESULTS: Of the 10 PRO measures examined, eight demonstrated a moderate or high positive association between preoperative scores and MID values. Only two measures demonstrated such an association when Oldham's measure of baseline severity was used. CONCLUSION: In general, there is little association between baseline severity and MID values. However, a moderate association persists for some measures, and it is recommended that researchers continue to test for this relationship when generating anchor-based MID values from change scores.

Trends in adult heart transplantation: a national survey from the United Kingdom Cardiothoracic Transplant Audit 1995-2007.

OBJECTIVE: The management of heart failure (HF), peri-transplant care and immunosuppression has changed in the last decade. Here we describe the changes that have occurred in the UK national programme of adult heart transplantation (HTx). METHODS: Using the data accrued with the UK Cardiothoracic Transplant Audit we undertook a prospective cohort study of 2958 consecutive adult patients listed for HTx and 2005 adult orthotopic HTx performed in three time periods - Era-1 (July 1995-March 1999, 1321 listed, 907 transplanted), Era-2 (April 1999-March 2003, 842 listed, 600 transplanted) and Era-3 (April 2003-March 2007, 795 listed, 498 transplanted). RESULTS: The median time on the waiting list reduced from 109 days in Era-1 to 40 days in Era-3. The proportion of HTx in non-ambulatory HF patients requiring inotropic or circulatory support increased from 12% in Era-1 to 35% in Era-3. The proportion undergoing HTx for non-ischaemic dilated cardiomyopathy increased from 40% in Era-1 to 58% in Era-3 while ischaemic cardiomyopathy decreased. Survival after HTx remained constant (81% (95% CI: 78-83%) at 1 year in Era-1 and 80% (95% CI: 77-84%) in Era-3). There was an increase in the use of mycophenolate and induction therapy and a reduction in rejection episodes over the eras. CONCLUSIONS: Although waiting list and HTx activity have declined, HTx continues to have an important role in the management of advanced HF, especially for patients on inotropic or circulatory support. Despite a deterioration of donor organ quality, survival after HTx has remained unchanged.

Diathermy power settings as a risk factor for hemorrhage after tonsillectomy.

OBJECTIVE: To investigate bipolar diathermy power settings as a risk factor for postoperative hemorrhage following tonsillectomy. STUDY DESIGN AND SETTING: A prospective cohort study was undertaken between July 2003 and September 2004 in National Health Service (NHS) and independent hospitals in England and Northern Ireland. Data were collected on patient characteristics, tonsillectomy technique, and postoperative hemorrhage within 28 days of surgery. RESULTS: Among the 9572 patients who had a tonsillectomy performed with bipolar diathermy dissection and hemostasis, the overall rate of hemorrhage was 4.6 percent and the risk of hemorrhage was not associated with the diathermy power setting. Among the 8465 patients who had tonsillectomy with cold steel dissection and bipolar diathermy hemostasis, the rate of hemorrhage increased from 1.8% in patients with the lowest power settings (6 to 8 watts) to 3.7% in those with settings above 18 watts (P value for trend = 0.005). CONCLUSION: In tonsillectomies using cold steel dissection and bipolar diathermy for hemostasis, the risk of postoperative hemorrhage becomes greater as diathermy power increases.