Proxy reporting of health-related quality of life for people with dementia: a psychometric solution.

BACKGROUND: The growing move towards personalised health and social care systems means that every effort needs to be made to generate patient-reported outcome data. However, the deteriorating nature of dementia can make it difficult for people with dementia to complete self-reported questionnaires and it is often necessary to rely on a family member (proxy) to report on their behalf. There is little evidence to guide how the difference between self- and proxy-reports of health reported quality of life (HRQL) in dementia can be interpreted. METHODS: We recruited people with dementia and their family carers from 78 memory Assessment Services in the UK. We used Rasch measurement methods to investigate whether a HRQL questionnaire known as DEMQOL (self-reported by the person with dementia) and DEMQOL-Proxy (proxy-reported by a family carer) can be placed on the same continuum and whether a revised scoring algorithm, based on this equated model, can be developed that takes account of the relationship between self- and proxy-reports. RESULTS: In a sample of 1434 patients and 1030 carers, our findings supported equating DEMQOL/DEMQOL-Proxy (overall fit to the model; no mis-fitting items) after addressing specific issues (eight disordered items requiring re-scoring, four pairs locally dependent items, and five items showing DIF). Cross walk tables have been produced. CONCLUSIONS: We have established for the first time that DEMQOL and DEMQOL-Proxy can be placed on the same continuum and that patients and carer proxies are reporting on the same construct when they complete these questionnaires. Where possible both DEMQOL and DEMQOL-Proxy should still be administered together, using the improved scoring algorithm reported here. Where only DEMQOL-Proxy is available, the cross walk tables provide an estimate of DEMQOL for a particular person from their DEMQOL-Proxy score.

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.

TBX18 overexpression enhances pacemaker function in a rat subsidiary atrial pacemaker model of sick sinus syndrome.

KEY POINTS: The sinoatrial node (SAN) is the primary pacemaker of the heart. SAN dysfunction, or 'sick sinus syndrome', can cause excessively slow heart rates and pauses, leading to exercise limitation and syncope, currently treated by implantation of an electronic pacemaker. 'Biopacemaking' utilises gene therapy to restore pacemaker activity by manipulating gene expression. Overexpressing the HCN pacemaker ion channel has been widely used with limited success. We utilised bradycardic rat subsidiary atrial pacemaker tissue to evaluate alternative gene targets: the Na+ /Ca2+ exchanger NCX1, and the transcription factors TBX3 and TBX18 known to be involved in SAN embryonic development. TBX18 overexpression restored normal SAN function, as assessed by increased rate, improved heart rate stability and restoration of isoprenaline response. TBX3 and NCX1 were not effective in accelerating the rate of subsidiary atrial pacemaker tissue. Gene therapy targeting TBX18 could therefore have the potential to restore pacemaker function in human sick sinus syndrome obviating electronic pacemakers. ABSTRACT: The sinoatrial node (SAN) is the primary pacemaker of the heart. Disease of the SAN, sick sinus syndrome, causes heart rate instability in the form of bradycardia and pauses, leading to exercise limitation and syncope. Biopacemaking aims to restore pacemaker activity by manipulating gene expression, and approaches utilising HCN channel overexpression have been widely used. We evaluated alternative gene targets for biopacemaking to restore normal SAN pacemaker physiology within bradycardic subsidiary atrial pacemaker (SAP) tissue, using the Na+ /Ca2+ exchanger NCX1, and the transcription factors TBX3 and TBX18. TBX18 expression in SAP tissue restored normal SAN function, as assessed by increased rate (SAN 267.5 ± 13.6 bpm, SAP 144.1 ± 8.6 bpm, SAP-TBX18 214.4 ± 14.4 bpm; P < 0.001), improved heart rate stability (standard deviation of RR intervals fell from 39.3 ± 7.2 ms to 6.9 ± 0.8 ms, P < 0.01; root mean square of successive differences of RR intervals fell from 41.7 ± 8.2 ms to 6.1 ± 1.2 ms, P < 0.01; standard deviation of points perpendicular to the line of identity of Poincaré plots (SD1) fell from 29.5 ± 5.8 ms to 7.9 ± 2.0 ms, P < 0.05) and restoration of isoprenaline response (increases in rates of SAN 65.5 ± 1.3%, SAP 28.4 ± 3.4% and SAP-TBX18 103.3 ± 10.2%; P < 0.001). These changes were driven by a TBX18-induced switch in the dominant HCN isoform in SAP tissue, with a significant upregulation of HCN2 (from 1.01 × 10-5  ± 2.2 × 10-6 to 2.8 × 10-5  ± 4.3 × 10-6 arbitrary units, P < 0.001). Biophysically detailed computer modelling incorporating isoform-specific HCN channel electrophysiology confirmed that the measured changes in HCN abundance could account for the observed changes in beating rates. TBX3 and NCX1 were not effective in accelerating the rate of SAP tissue.

Can Memory Assessment Services (MAS) in England be categorized? A national survey.

Background: The effectiveness and efficiency of memory assessment services (MASs) is unknown. Our aim was to determine if a typology can be constructed, based on shared structural and process characteristics, as a basis for a non-randomized evaluation of their effectiveness and cost-effectiveness. Methods: Survey of random sample of 73 MASs in 2015; comparison of characteristics and investigation of inter-correlation. Results: It was not possible to group characteristics to form the basis of a typology of MASs. However, there was considerable variation in staff numbers (20-fold), new patients per whole-time equivalent (WTE) staff (20-fold), skill mix and the nurse:doctor ratio (1-10). The operational performance also varied: first appointments (50-120 minutes); time for first follow-up (2-12 weeks); frequency of follow-up in first year (1-5). These differences were not associated with the number of new patients per WTE staff or the accreditation status of the MAS. Post diagnosis, all MASs provided pharmacological treatment but the availability of non-pharmacological support varied, with half providing none or only one intervention while others providing four or more. Conclusions: In the absence of any clear typology, evaluation of MASs will need to focus on the impact of individual structural and process characteristics on outcomes.

Patient-reported outcomes: pathways to better health, better services, and better societies.

While the use of PROs in research is well established, many challenges lie ahead as their use is extended to other applications. There is consensus that health outcome evaluations that include PROs along with clinician-reported outcomes and administrative data are necessary to inform clinical and policy decisions. The initiatives presented in this paper underline evolving recognition that PROs play a unique role in adding the patient perspective alongside clinical (e.g., blood pressure) and organizational (e.g., admission rates) indicators for evaluating the effects of new products, selecting treatments, evaluating quality of care, and monitoring the health of the population. In this paper, we first explore the use of PRO measures to support drug approval and labeling claims. We critically evaluate the evidence and challenges associated with using PRO measures to improve healthcare delivery at individual and population levels. We further discuss the challenges associated with selecting from the abundance of measures available, opportunities afforded by agreeing on common metrics for constructs of interest, and the importance of establishing an evidence base that supports integrating PRO measures across the healthcare system to improve outcomes. We conclude that the integration of PROs as a key end point within individual patient care, healthcare organization and program performance evaluations, and population surveillance will be essential for evaluating whether increased healthcare expenditure is translating into better health outcomes.

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.

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.

[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.

Preparedness for the prevention and control of influenza outbreaks on passenger ships in the EU: the SHIPSAN TRAINET project communication.

Passenger ships carry a large number of people in confined spaces. A case of the new influenza A (H1N1) virus aboard a passenger ship is an expected event and would lead to rapid spread of the virus, if preventive measures are not in place. However, many cruise lines have detailed policies and procedures to deal with cases of influenza like illness (ILI). The EU SHIPSAN and SHIPSAN TRAINET projects include in their objectives guidelines for the prevention and control of communicable diseases aboard passenger ships. A literature review showed that from 1997 to 2005, nine confirmed outbreaks of influenza were linked to passenger ships, with attack rates up to 37%. It is important to establish and maintain a surveillance system for ILI aboard passenger ships, in order to systematically collect data that can help to determine the baseline illness levels. Monitoring these will enable early identification of outbreaks and allow timely implementation of control measures.

Barriers and facilitators to the successful development, implementation and evaluation of care bundles in acute care in hospital: a scoping review.

BACKGROUND: Care bundles are small sets of evidence-based recommendations, designed to support the implementation of evidence-based best clinical practice. However, there is variation in the design and implementation of care bundles, which may impact on the fidelity of delivery and subsequently their clinical effectiveness. METHODS: A scoping review was carried out using the Arksey and O'Malley framework to identify the literature reporting on the design, implementation and evaluation of care bundles. The Embase, CINAHL, Cochrane and Ovid MEDLINE databases were searched for manuscripts published between 2001 and November 2017; hand-searching of references and citations was also undertaken. Data were initially assessed using a quality assessment tool, the Downs and Black checklist, prior to further analysis and narrative synthesis. Implementation strategies were classified using the Expert Recommendations for Implementing Change (ERIC) criteria. RESULTS: Twenty-eight thousand six hundred ninety-two publications were screened and 348 articles retrieved in full text. Ninety-nine peer-reviewed quantitative publications were included for data extraction. These consisted of one randomised crossover trial, one randomised cluster trial, one case-control study, 20 prospective cohort studies and 76 non-parallel cohort studies. Twenty-three percent of studies were classified as poor based on Downs and Black checklist, and reporting of implementation strategies lacked structure. Negative associations were found between the number of elements in a bundle and compliance (Spearman's rho = - 0.47, non-parallel cohort and - 0.65, prospective cohort studies), and between the complexity of elements and compliance (p < 0.001, chi-squared = 23.05). Implementation strategies associated with improved compliance included evaluative and iterative approaches, development of stakeholder relationships and education and training strategies. CONCLUSION: Care bundles with a small number of simple elements have better compliance rates. Standardised reporting of implementation strategies may help to implement care bundles into clinical practice with high fidelity. TRIAL REGISTRATION: This review was registered on the PROSPERO database: CRD 42015029963 in December 2015.

A biopsychosocial understanding of lower back pain: Content analysis of online information.

OBJECTIVES: (1) To develop a checklist to assess the representation of biopsychosocial lower back pain (LBP) online information; (2) to analyse publicly accessed online LBP information from a Google search for the degree that psychosocial contributors are described alongside the traditional biomedical approach to explaining LBP; (3) whether websites use information on pain biology to educate on LBP; (4) any inaccurate or false information regarding the mechanisms of LBP and; (5) the amount of websites certified by established benchmarks for quality health information. MATERIALS AND METHODS: An online search was conducted using the Google search engines of six major English-speaking countries. Website content was analysed using three checklists developed for the purpose of this study - Biopsychosocial information categorisation checklist and scoring criteria; pain biology information checklist; and the inaccurate information checklist. Website quality was identified by the presence of an Health on the Net certification (HONcode). RESULTS: Of the fifteen websites analysed, the content of 26.7% of websites was classified as 'biomedical', 60% 'limited psychosocial' and 13.3% 'reasonable psychosocial'; 20% included information on pain biology; 46.7% inaccurately implied pain to be equal to tissue damage and 46.7% implied pathways specific to pain transmission; 40% were HONcode certified. CONCLUSION: Online LBP information retrieved through a Google search has limited to no integration of psychosocial or pain biology information. The focus on tissue pathology is further supported by the inaccurate descriptions of pain as equal to tissue damage and as an input to the central nervous system (CNS). Online LBP information needs to be guided by criteria more sensitive to the psychosocial contributors to pain. SIGNIFICANCE: The online LBP information retrieved from a Google search needs to be guided by information more sensitive to the psychosocial contributors to pain and disability. This study also highlights the presence of inaccurate information that implied pain as a measure of tissue damage or as an input to the nervous system.

A case of infant botulism with a possible link to infant formula milk powder: evidence for the presence of more than one strain of Clostridium botulinum in clinical specimens and food.

Infant botulism was confirmed in a 5-month-old female by both isolation of Clostridium botulinum type B and by detection of type B botulinum neurotoxin in rectal washout and faeces. DNA fingerprinting of nine isolates from faeces yielded two different amplified-fragment length polymorphism (AFLP) patterns. C. botulinum was isolated from two of 14 food and drink items from the patient's home: C. botulinum type A was recovered from an opened container of dried rice pudding and C. botulinum type B from opened infant formula milk powder. Ten C. botulinum type B isolates from the opened infant formula yielded four AFLP patterns, two of which were indistinguishable from the clinical isolates. Fifteen unopened foods were tested and C. botulinum type B of a unique AFLP pattern was recovered from one unopened infant formula of the same batch as the opened container. It is suggested that multiple C. botulinum were present in both food and the intestine during infant botulism.

Assessing symptom improvement after elective prostatectomy for benign prostatic hypertrophy.

BACKGROUND: Elective surgery for benign prostatic hypertrophy requires estimates of likely improvement. METHODS: Data are from a prospective study of all patients without cancer who underwent transurethral prostatectomy. After eliminating patients for whom surgery was not elective, we examined symptom improvement. RESULTS: Surgery was effective in reducing symptoms for all but those with very mild preoperative symptoms. For the remainder, the average level of postoperative outcomes achieved was independent of the initial symptom severity. CONCLUSIONS: Elective prostatectomy is effectiveness for improving symptoms. The improvement is typically sustained, and for some symptoms improvement continues during the first year after surgery. Patients with severe symptoms were as likely to achieve the same level of postoperative improvement as were patients with less severe problems initially. However, patients with very mild symptoms benefited little or none from surgery.

Position-sensing technologies for movement analysis in stroke rehabilitation.

Research has focused on improvement of the quality of life of stroke patients. Gait detection, kinematics and kinetics analysis, home-based rehabilitation and telerehabilitation are the areas where there has been increasing research interest. The paper reviews position-sensing technologies and their application for human movement tracking and stroke rehabilitation. The review suggests that it is feasible to build a home-based telerehabilitation system for sensing and tracking the motion of stroke patients.

Guns and suicide: possible effects of some specific legislation.

The authors describe suicide rates in Toronto and Ontario and methods used for suicide in Toronto for 5 years before and after enactment of Canadian gun control legislation in 1978. They also present data from San Diego, Calif., where state laws attempt to limit access to guns by certain psychiatric patients. Both sets of data indicate that gun control legislation may have led to decreased use of guns by suicidal men, but the difference was apparently offset by an increase in suicide by leaping. In the case of men using guns for suicide, these data support a hypothesis of substitution of suicide method.

A protocol-based treatment for intradialytic hypotension in hospitalized hemodialysis patients.

Human serum albumin is used in hemodialysis (HD) units as treatment for hypotension despite its high cost and undetermined efficacy. During a 4-month period in 1995, albumin was used in 22% of 1,296 consecutive HD treatments in the HD unit or intensive care units (ICUs) at our tertiary-care hospital. We evaluated the safety and efficacy of a protocol designed to minimize albumin use for treating HD-associated hypotension (HDAH). The protocol consisted of the stepwise use of saline, mannitol, and albumin for the purpose of achieving physician-determined ultrafiltration goals. Patients were exempted from receiving the protocol for age younger than 18 years, freshly declotted angioaccess, or cardiovascular instability. The protocol was evaluated prospectively in 2,559 consecutive dialysis sessions (15% in ICUs) in 442 patients. Hypotension occurred during 608 sessions (24%), and attending nephrologists elected to initiate the protocol in 71% of these cases. Of the 433 instances in which the protocol was begun, reversal of hypotension was achieved without the need for albumin in 91% and with the addition of albumin in an additional 2%. Protocol treatment was not completed because of nursing error in 1% or clotting of filter or angioaccess in 4%. Use of the protocol failed to reverse hypotension in only 2% of the cases in which it was completed. Albumin was administered in only 6% of the 2,559 HD treatments. In summary, our protocol-based approach to HDAH was effective, easy for nurses to use, albumin sparing, and cost reducing.