Do patient-reported outcomes offer a more sensitive method for comparing the outcomes of consultants than mortality? A multilevel analysis of routine data.

BACKGROUND: Patient-reported outcome measures (PROM) might be better for comparing consultant surgeons' outcomes than mortality. OBJECTIVES: To describe variation in outcomes between consultants, compare the number of outlying consultants according to different measures, explore the effect that the hospital in which a consultant works has on their outcomes and determine the scope for improving outcomes by reducing variation between consultants. METHOD: Consultants performing hip replacement (n=948), knee replacement (1130) and hernia repair (974) in National Health Service hospitals in England in 2009-2012; disease-specific and generic PROMs and complications; fixed-effects and multilevel models to assess consultant outcomes, were all compared. Influence of patient factors and hospital factors was assessed. RESULTS: Fixed-effects models showed that most consultants are 'as or better than expected'. However, unlike with mortality, some consultants are more than three SDs 'worse than expected' according to disease-specific PROMs (2.4% for hip and 1.2% for knee replacement), generic PROMs (1.2% and 1.0%) and incidence of complications (1.8% and 0.8%). The proportion of consultants worse than expected is less with random-effects models. Controlling for hospital factors reduced the proportion further. After controlling for known patient characteristics, consultants and hospitals contribute little towards variation in patient outcomes. CONCLUSIONS: PROMs offer a more appropriate and sensitive method for comparing consultants' outcomes. The influence of hospitals must be considered to ensure comparisons are meaningful. Improvements will be achieved by shifting the distribution of consultants rather than by reducing variation between them

Coding of Barrett's oesophagus with high-grade dysplasia in national administrative databases: a population-based cohort study.

OBJECTIVES: The International Classification of Diseases 10th Revision (ICD-10) system used in the English hospital administrative database (Hospital Episode Statistics (HES)) does not contain a specific code for oesophageal high-grade dysplasia (HGD). The aim of this paper was to examine how patients with HGD were coded in HES and whether it was done consistently. SETTING: National population-based cohort study of patients with newly diagnosed with HGD in England. The study used data collected prospectively as part of the National Oesophago-Gastric Cancer Audit (NOGCA). These records were linked to HES to investigate the pattern of ICD-10 codes recorded for these patients at the time of diagnosis. PARTICIPANTS: All patients with a new diagnosis of HGD between 1 April 2013 and 31 March 2014 in England, who had data submitted to the NOGCA. OUTCOMES MEASURED: The main outcome assessed was the pattern of primary and secondary ICD-10 diagnostic codes recorded in the HES records at endoscopy at the time of diagnosis of HGD. RESULTS: Among 452 patients with a new diagnosis of HGD between 1 April 2013 and 31 March 2014, Barrett's oesophagus was the only condition coded in 200 (44.2%) HES records. Records for 59 patients (13.1%) contained no oesophageal conditions. The remaining 193 patients had various diagnostic codes recorded, 93 included a diagnosis of Barrett's oesophagus and 57 included a diagnosis of oesophageal/gastric cardia cancer. CONCLUSIONS: HES is not suitable to support national studies looking at the management of HGD. This is one reason for the UK to adopt an extended ICD system (akin to ICD-10-CM)

Evaluating the care received by patients with oesophago-gastric (OG) cancer: the richer picture provided by linked datasets

ABSTRACT Objectives The national oesophago-gastric cancer audit evaluates the care given to patients with OG cancer diagnosed in England and Wales, identifying areas for local services to improve and so achieve better patient outcomes. While the audit follows a standard approach by collecting a core dataset, it extends this by linking to other national databases in order to (1) reduce the burden of data collection, (2) add data that could not otherwise be obtained, (3) verify the quality of audit data. This presentation will provide an overview of the modern approach to national clinical audits and introduce anticipated future developments. Approach The data collected by hospitals and submitted to the audit is expanded by linkage to radiotherapy data (RTDS), date of death from the Office for National Statistics and administrative hospital admission data (HES). The linked data enables the Audit to: (1) examine whether radiotherapy regimens used in definitive oncology comply with guideline recommendations, using dosage information drawn from RTDS; (2) publish comparative short-term survival figures for NHS trusts and surgeons using ONS date of death; and (3) assess the quality of data submitted from hospitals by comparing coded procedural information in HES and the audit dataset. Results The analysis of the linked data has led to several important audit findings, namely: (1) Access to RTDS data confirmed reasonable compliance with official guidelines on recommended radiotherapy dosing schedules. (2) Linked mortality data has provided robust and credible estimates of surgical outcomes and is a critical output to NHS trusts and surgeons, as well as the wider public. Our analysis has highlighted a gradual decline in post-operative mortality. (3) Linkage of audit and HES data identified gaps in the recording of endoscopic stenting, with many procedures not being submitted by participating trusts. These diverse results underline the usefulness of linked data in revealing a more complete picture of the care received by OG cancer patients. Conclusion Linked data has become integral for the successful implementation of a national clinical audit, supplementing the core dataset with information that would otherwise be unavailable or difficult and costly to collect. Linkage enhances the audit’s ability to assess health services’ compliance with professional standards and to give service providers the opportunity to benchmark their performance. Future developments are expected to expand on this by including primary care service use before diagnosis

Attrition revisited:adherence and retention in a web-based alcohol trial

BACKGROUND: Attrition is a noted feature of eHealth interventions and trials. In 2005, Eysenbach published a landmark paper calling for a "science of attrition," suggesting that the 2 forms of attrition--nonusage attrition (low adherence to the intervention) and dropout attrition (poor retention to follow-up)--may be related and that this potential relationship deserved further study.  OBJECTIVE: The aim of this paper was to use data from an online alcohol trial to explore Eysenbach's hypothesis, and to answer 3 research questions: (1) Are adherence and retention related? If so, how, and under which circumstances? (2) Do adherence and retention have similar predictors? Can these predictors adequately explain any relationship between adherence and retention or are there additional, unmeasured predictors impacting on the relationship? (3) If there are additional unmeasured predictors impacting on the relationship, are there data to support Eysenbach's hypothesis that these are related to overall levels of interest?  METHODS: Secondary analysis of data from an online trial of an online intervention to reduce alcohol consumption among heavy drinkers. The 2 outcomes were adherence to the intervention measured by number of log-ins, and retention to the trial measured by provision of follow-up data at 3 months (the primary outcome point). Dependent variables were demographic and alcohol-related data collected at baseline. Predictors of adherence and retention were modeled using logistic regression models.  RESULTS: Data were available on 7932 participants. Adherence and retention were related in a complex fashion. Participants in the intervention group were more likely than those in the control group to log in more than once (42% vs 28%, P<.001) and less likely than those in the control group to respond at 3 months (40% vs 49%, P<.001). Within each randomized group, participants who logged in more frequently were more likely to respond than those who logged in less frequently. Response rates in the intervention group for those who logged in once, twice, or ≥3 times were 34%, 46%, and 51%, respectively (P<.001); response rates in the control group for those who logged in once, twice, or ≥3 times were 44%, 60%, and 67%, respectively (P<.001). Relationships between baseline characteristics and adherence and retention were also complex. Where demographic characteristics predicted adherence, they tended also to predict retention. However, characteristics related to alcohol consumption and intention or confidence in reducing alcohol consumption tended to have opposite effects on adherence and retention, with factors that predicted improved adherence tending to predict reduced retention. The complexity of these relationships suggested the existence of an unmeasured confounder.  CONCLUSIONS: In this dataset, adherence and retention were related in a complex fashion. We propose a possible explanatory model for these data.  TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 31070347; http://www.controlled-trials.com/ISRCTN31070347 (Archived by WebCite at http://www.webcitation.org/6IEmNnlCn)

The role of salt intake and salt sensitivity in the management of hypertension in South Asian people with chronic kidney disease:a randomised controlled trial

BACKGROUND: The effectiveness of salt restriction to lower blood pressure (BP) in Bangladeshi patients with chronic kidney disease (CKD) is uncertain. OBJECTIVE: To test the hypothesis that a tailored intervention intended to reduce salt intake in addition to standard care will achieve a greater reduction in BP in UK Bangladeshi patients with CKD than standard care alone. DESIGN: A randomised parallel-group controlled trial conducted over a 6 month period. SETTING: A tertiary renal unit based in acute care hospital in East London. PARTICIPANTS: 56 adult participants of Bangladeshi origin with CKD and BP >130/80 mm Hg or on antihypertensive medication. INTERVENTION: Participants were randomly allocated to receive a tailored low-salt diet or the standard low-salt advice. BP medication, physical activity and weight were monitored. MAIN OUTCOME MEASURES: The primary outcome was change in ambulatory BP. Adherence to dietary advice was assessed by measurement of 24 h urinary salt excretion. RESULTS: Of 56 participants randomised, six withdrew at the start of the study. During the study, one intervention group participant died, one control group participant moved to Bangladesh. Data were available for the primary endpoint on 48 participants. Compared with control group the intervention urinary sodium excretion fell from 260 mmol/d to 103 mmol/d (−131 to −76, p<0.001) at 6 months and resulted in mean (95% CI) falls in 24 h systolic/diastolic BP of −8 mm Hg (−11 to −5)/2 (−4 to −2) both p<0.001. CONCLUSIONS: A tailored intervention can achieve moderate salt restriction in patients with CKD, resulting in clinically meaningful falls in BP independent of hypertensive medication. TRIAL REGISTRATION: ClinicalTrials.gov NCT00702312

Bicarbonate Supplementation Slows Progression of CKD and Improves Nutritional Status

Bicarbonate supplementation preserves renal function in experimental chronic kidney disease (CKD), but whether the same benefit occurs in humans is unknown. Here, we randomly assigned 134 adult patients with CKD (creatinine clearance [CrCl] 15 to 30 ml/min per 1.73 m2) and serum bicarbonate 16 to 20 mmol/L to either supplementation with oral sodium bicarbonate or standard care for 2 yr. The primary end points were rate of CrCl decline, the proportion of patients with rapid decline of CrCl (>3 ml/min per 1.73 m2/yr), and ESRD (CrCl <10 ml/min). Secondary end points were dietary protein intake, normalized protein nitrogen appearance, serum albumin, and mid-arm muscle circumference. Compared with the control group, decline in CrCl was slower with bicarbonate supplementation (5.93 versus 1.88 ml/min 1.73 m2; P < 0.0001). Patients supplemented with bicarbonate were significantly less likely to experience rapid progression (9 versus 45%; relative risk 0.15; 95% confidence interval 0.06 to 0.40; P < 0.0001). Similarly, fewer patients supplemented with bicarbonate developed ESRD (6.5 versus 33%; relative risk 0.13; 95% confidence interval 0.04 to 0.40; P < 0.001). Nutritional parameters improved significantly with bicarbonate supplementation, which was well tolerated. This study demonstrates that bicarbonate supplementation slows the rate of progression of renal failure to ESRD and improves nutritional status among patients with CKD

Creatinine reduction ratio : a useful marker to identify medium and high-risk renal transplants

INTRODUCTION: Delayed graft function (DGF) has a major impact on long-term renal transplant survival. However, it is a diagnosis made retrospectively with little opportunity to modify treatment protocols. A classification based on creatinine reduction ratio between days 1 and 2 (CRR2) suggests that patients with CRR2 less than or equal to 30% (nondialysis requiring DGF [ND-DGF]) have similar outcomes to those with dialysis-requiring delayed graft function (D-DGF). We retrospectively applied this definition in our cohort of patients to examine outcomes. METHODS: We studied the association between CRR2 and graft outcomes in all 367 patients transplanted between 1996 and 2004 at our center. Patients were divided into the following three groups: IGF (immediate graft function; CRR2 >30%), D-DGF, and ND-DGF. Mean follow-up was 4.2 years. RESULTS: IGF accounted for 36% of patients, D-DGF for 22%, and ND-DGF for 42%. CRR2 was inversely correlated with serum creatinine on days 7, 30, 90, and 365 (r ranging from -0.65 to -0.22, P<0.001). Graft survival at 5 years was 98% (IGF), 74% (D-DGF), and 89% (ND-DGF). There was a significant difference in graft survival between IGF and D-DGF (P<0.001) and IGF and ND-DGF (P=0.005). In a multivariate analysis adjusting for recipient age and sex, donor age and sex, and human leukocyte antigen mismatch, graft failure was 2.4 times more likely to occur in patients with D-DGF than those with ND-DGF(P=0.02). CONCLUSIONS: Our study shows CRR2 influences long-term graft outcomes. Unlike the original description, patients with ND-DGF carry an intermediate risk and perhaps should be considered on day 2 for alternative treatment protocols.Peer reviewe