Early intervention with erythropoietin does not affect the outcome of acute kidney injury (the EARLYARF trial)

We performed a double-blind placebo-controlled trial to study whether early treatment with erythropoietin could prevent the development of acute kidney injury in patients in two general intensive care units. As a guide for choosing the patients for treatment we measured urinary levels of two biomarkers, the proximal tubular brush border enzymes γ-glutamyl transpeptidase and alkaline phosphatase. Randomization to either placebo or two doses of erythropoietin was triggered by an increase in the biomarker concentration product to levels above 46.3, with a primary outcome of relative average plasma creatinine increase from baseline over 4 to 7 days. Of 529 patients, 162 were randomized within an average of 3.5 h of a positive sample. There was no difference in the incidence of erythropoietin-specific adverse events or in the primary outcome between the placebo and treatment groups. The triggering biomarker concentration product selected patients with more severe illness and at greater risk of acute kidney injury, dialysis, or death; however, the marker elevations were transient. Early intervention with high-dose erythropoietin was safe but did not alter the outcome. Although these two urine biomarkers facilitated our early intervention, their transient increase compromised effective triaging. Further, our study showed that a composite of these two biomarkers was insufficient for risk stratification in a patient population with a heterogeneous onset of injury.

Effectiveness of pain management in hospital in the home programs

Objectives: The objective of the study was to examine patients’ experiences of pain in Hospital in the Home (HITH) programs and
identify the issues related to providing optimal pain management for acute care patients in the home environment.
Methods: A descriptive survey of patients’ experience of pain and pain management in 3 HITH programs in metropolitan Melbourne,
Australia (n=359). Data were collected by telephone interview using a modified version of The American Pain Society’s Patient Outcome Questionnaire. Patients were interviewed 48 to 72 hours after admission to the HITH program. Consecutive, adult, acute care patients were invited to participate in the study. Patients who had previously participated or had communication difficulties unable to be overcome with the assistance of an interpreter were excluded.
Results: Sixty-nine percent of patients interviewed experienced pain at home and 86% of these patients had experienced pain in the 24 hours before the interview. Over half (56%) of the patients had experienced moderate-to-severe worst pain in the previous 24 hours and 33% reported moderate-to-severe pain as their average pain experience. Two hundred thirty-two (93.2%) of the 250 patients who experienced pain had pain in hospital before being transferred to HITH. Of these patients, 52.2% (n=132) were prescribed analgesics to take home with them; the remaining 118 patients experiencing pain were not prescribed analgesics and either sourced analgesics once home (n=81, 68.1%) or did not take any analgesics (n=38, 31.9%).
Discussion: Treatment of pain at home was suboptimal with patients experiencing moderate-to-severe pain and discomfort during the treatment phase of their illness. Lack of appropriate discharge planning strategies meant that patients went home without adequate analgesia and use of non prescribed pain medication was common. The number of patients transferred home without analgesics indicates a worrying under recognition of the need for analgesia in this care context and poses a risk to patient safety that is no less significant because patients are at home.

Patient use of smartphones to communicate subjective data in clinical trials

Purpose. Various methods have been used in clinical trials to collect time-sensitive subjective responses, including study diaries, telephone interviews, and use of text messaging. However, all of these methods are limited by the uncertainty of when the participants enrolled in the study actually record their responses. This technical note reports on the utility of the BlackBerry smartphone to collect such data and why such a system provides advantages over other methods to report subjective ratings in clinical studies.

Methods. The Centre for Contact Lens Research developed an on-line web-enabled system that permits participants to record and immediately transmit subjective rating scores in numerical form directly into a web-enabled database. This, combined with the utility of BlackBerrys, enabled time-specific e-mail requests to be sent to the study participants and then for that data to be simultaneously transmitted to the web-enabled database. This system has been used in several clinical trials conducted at the Centre for Contact Lens Research, in which data were collected at various times and in several specific locations or environments.

Results. In the clinical trials conducted using this system, participants provided responses on 97.5% of occasions to the requests for data generated by the automated system. When the request was for data on a set date, this method resulted in responses of 84.1% of the time.

Conclusions. The series of clinical trials reported here show the benefits of the utilization of the BlackBerry to collect time- or environment-sensitive data via a web-enabled system.

Primary hemiarthroplasty for treatment of proximal humeral fractures

Background: Primary hemiarthroplasty of the shoulder is used to treat complex proximal humeral fractures, although the reported functional results following this method of treatment have varied widely. The aim of this study was to prospectively assess the prosthetic survival and functional outcomes in a large series of patients treated with shoulder hemiarthroplasty for a proximal humeral fracture. By determining the factors that affected the outcome, we also aimed to produce models that could be used clinically to estimate the functional outcome at one year following surgery.

Methods: A thirteen-year observational cohort study of 163 consecutive patients treated with hemiarthroplasty for a proximal humeral fracture was performed. Twenty-five patients died or were lost to follow-up in the first year after treatment, leaving 138 patients who had assessment of shoulder function with use of the modified Constant score at one year postinjury.

Results: The overall rate of prosthetic survival was 96.9% at one year, 95.3% at five years, and 93.9% at ten years. The overall median modified Constant score was 64 points at one year, with a typically good score for pain relief (median, 15 points) and poorer scores, with a greater scatter of values, for function (median, 12 points), range of motion (median, 24 points), and muscle power (median, 14 points). Of the factors that were assessed immediately after the injury, only patient age, the presence of a neurological deficit, tobacco usage, and alcohol consumption were significantly predictive of the one-year Constant score (p < 0.05). Of the factors that were assessed at six weeks postinjury, those that predicted the one-year Constant score included the age of the patient, the presence of a persistent neurological deficit, the need for an early reoperation, the degree of displacement of the prosthetic head from the central axis of the glenoid seen radiographically, and the degree of displacement of the tuberosities seen radiographically.

Conclusions: Primary shoulder hemiarthroplasty performed for the treatment of a proximal humeral fracture in medically fit and cooperative adults is associated with satisfactory prosthetic survival at an average of 6.3 years. Although the shoulder is usually free of pain following this procedure, the overall functional result, in terms of range of motion, function, and power, at one year varies. A good functional outcome can be anticipated for a younger individual who has no preoperative neurological deficit, no postoperative complications, and a satisfactory radiographic appearance of the shoulder at six weeks. The results are poorer in the larger group of elderly patients who undergo this procedure, especially if they have a neurological deficit, a postoperative complication requiring a reoperation, or an eccentrically located prosthesis with retracted tuberosities.

Somatic symptoms, hypochondriasis and psychological distress: a study of somatisation in Australian general practice

Objective: To measure the prevalence of somatisation (multiple somatic symptoms and hypochondriasis) among Australian general practice attendees, its recognition by general practitioners, and its relationship with symptoms of depression and anxiety. Design, setting and participants: Self-reported questionnaires completed by 10 507 consecutive patients aged ≥18 years attending 340 GPs enrolled in a 6-hour national mental health program of continuing professional development who accepted invitations to participate; audit form completed by GPs for each patient during the period March 2004 to December 2006. Main outcome measures: Somatic symptom severity (measured with the 15-item Patient Health Questionnaire [PHQ-15]); hypochondriasis (measured with the Whiteley Index [Whiteley-7]; depression and anxiety (measured by the Kessler Psychological Distress scale [K10]); prevalence of “somatisers” (defined by medium to severe somatic symptom severity and hypochondriasis); GP recognition of somatisation (determined by their responses on audit forms to questions on whether patient’s complaints were most likely to have a physical or psychological explanation). Results: 18.5% of patients were classified as somatisers and 9.5% as probable cases of depression or anxiety. While 29.6% of somatisers had high anxiety or depression scores, 57.9% of people with anxiety or depression were also somatisers. Sex and age asserted significant but weak effects on psychometric scores. GPs identified somatic complaints as “mostly explained by a psychological disturbance” in 25.1% of somatisers. Conclusions: Somatisation is common in general practice, and more prevalent than depression or anxiety. While a minority of somatisers have significant anxiety and depression, most patients with depression and anxiety have a significant degree of somatisation. Recognition of depression and anxiety can be hindered by a somatic presentation and attribution. On the other hand, managing somatisation does not just involve recognising depression and anxiety, but also dealing with the health anxieties that underpin hypochondriasis.

The frontotemporal-orbitozygomatic approach : reconstructive technique and outcome

Background The frontotemporal-orbitozygomatic (FTOZ) approach, also known as "the workhorse of skull base surgery," has captured the interest of many researchers throughout the years. Most of the studies published have focused on the surgical technique and the gained exposure. However, few studies have described reconstructive techniques or functional and cosmetic outcomes. The goal of this study was to describe the surgical reconstruction after the FTOZ approach and analyze the functional and cosmetic outcomes. Methods Seventy-five consecutive patients who had undergone FTOZ craniotomy for different reasons were selected. The same surgical (one-piece FTOZ) and reconstructive techniques were applied in all patients. The functional outcome was measured by complications related to the surgical approach: retro-orbital pain, exophthalmos, enophthalmos, ocular movement restriction, cranial nerve injuries, pseudomeningocele (PMC) and secondary surgeries required to attain a reconstructive closure. The cosmetic outcome was evaluated by analyzing the satisfaction of the patients and their families. Questionnaires were conducted later in the postoperative period. A statistical analysis of the data obtained from the charts and questions was performed. Results Of the 75 patients studied, 59 had no complications whatsoever. Ocular movement restriction was found in two patients (2.4 %). Cranial nerve injury was documented in seven patients (8.5 %). One patient (1.2 %) underwent surgical repair of a cerebrospinal fluid (CSF) leak from the initial surgery. Two patients (2.4 %) developed delayed postoperative pseudomenigocele. One patient (1.2 %) developed intraparenchymal hemorrhage (IPH). Full responses to the questionnaires were collected from 28 patients giving an overall response rate of 34 %. Overall, 22 patients (78.5 %) were satisfied with the cosmetic outcome of surgery. Conclusion The reconstruction after FTOZ approach is as important as the performance of the surgical technique. Attention to anatomical details and the stepwise reconstruction are a prerequisite to the successful preservation of function and cosmesis. In our series, the orbitozygomatic osteotomy did not increase surgical complications or alter cosmetic outcomes.

Review of nursing care for patients undergoing percutaneous coronary intervention: a patient journey approach

Aim.  To evaluate the existing literature to inform nursing management of people undergoing percutaneous coronary intervention. Background.  Percutaneous coronary intervention is an increasingly important revascularisation strategy in coronary heart disease management and can be an emergent, planned or rescue procedure. Nurses play a critical role in delivering care in both the independent and collaborative contexts of percutaneous coronary intervention management. Design.  Systematic review. Method.  The method of an integrative literature review, using the conceptual framework of the patient journey, was used to describe existing evidence and to determine important areas for future research. The electronic data bases CINAHL, Medline, Cochrane and the Joanna Briggs data bases were searched using terms including: (angioplasty, transulminal, percutaneous coronary), nursing care, postprocedure complications (haemorrhage, ecchymosis, haematoma), rehabilitation, emergency medical services (transportation of patients, triage). Results.  Despite the frequency of the procedure, there are limited data to inform nursing care for people undergoing percutaneous coronary intervention. Currently, there are no widely accessible nursing practice guidelines focusing on the nursing management in percutaneous coronary intervention. Findings of the review were summarised under the headings: Symptom recognition; Treatment decision; Peri-percutaneous coronary intervention care, describing the acute management and Postpercutaneous coronary intervention management identifying the discharge planning and secondary prevention phase. Conclusions.  Cardiovascular nurses need to engage in developing evidence to support guideline development. Developing consensus on nurse sensitive patient outcome indicators may enable benchmarking strategies and inform clinical trial design. Relevance to clinical practice.  To improve the care given to individuals undergoing percutaneous coronary intervention, it is important to base practice on high-level evidence. Where this is lacking, clinicians need to arrive at a consensus as to appropriate standards of practice while also engaging in developing evidence. This must be considered, however, from the central perspective of the patient and their family.

Measuring self-care in chronic heart failure : a review of the psychometric properties of clinical instruments

Background : Improved self-care skills and behaviors are an important outcome of patient education and counseling. Both researchers and health professionals need to utilize instruments that are reliable and valid at measuring this outcome to advance our understanding as to the efficacy of clinical practice directed toward improving self-care.

Objective : The aim of this study was to identify instruments that measure chronic heart failure (CHF) self-care and demonstrate their psychometric properties.

Methods : A search of Medline, Cumulative Index to Nursing and Allied Health Literature, Medline, PsycArticles, Psychology and Behavioral Sciences Collection, and PsycINFO databases elucidated studies published between January 1980 and February 2009 that measure CHF self-care. The clinical instruments selected were disease-specific measures of CHF self-care behaviors that are promoted in best practice guidelines. Only instruments that reported estimates of reliability and validity were included in this review. Psychometric properties of the instruments were evaluated according to practice guidelines.

Results : The literature search identified 14 instruments published in peer-reviewed journals that measured constructs that predict or correlate to self-care rather than self-care itself. Only 2 disease-specific measures of self-care were identified (Self-care Heart Failure Index [SCHFI] and European Heart Failure Self-care Behavior Scale [EHFScBS]) that have undergone rigorous psychometric testing in CHF populations. Five aspects of validity had been demonstrated with EHFScBS, and 6 aspects of validity had been demonstrated with SCHFI. Two of 3 aspects of reliability have been demonstrated in both instruments.

Conclusion : Only 2 reliable and valid tools have been developed to specifically measure CHF self-care. Further use of these instruments in the research arena may reduce gaps in our understanding of CHF self-care and further shape clinical practice directed at improving it.

Economic evaluation of adult rehabilitation: a systematic review and meta-analysis of randomized controlled trials in a variety of settings

Objectives:
To report if there is a difference in costs from a societal perspective between adults receiving rehabilitation in an inpatient rehabilitation setting versus an alternative setting. If there are cost differences, to report whether opting for the least expensive program setting adversely affects patient outcomes.

Data Sources:
Electronic databases from the earliest possible date until May 2011. All languages were included.

Study Selection
Multiple reviewers identified randomized controlled trials with a full economic evaluation that compared adult inpatient rehabilitation with an alternative. There were 29 included trials with 6746 participants.

Data Extraction
Multiple observers extracted data independently. Trial appraisal included a risk of bias assessment and a checklist to report the strength of the economic evaluation.

Data Synthesis:
Results were synthesized using standardized mean differences (SMDs) and meta-analyses for the primary outcome of cost. The Grading of Recommendations Assessment, Development, and Evaluation was applied to assess for risk of bias across studies for meta-analyses. There was high-quality evidence that cost was significantly reduced for rehabilitation in the home versus inpatient rehabilitation in a meta-analysis of 732 patients poststroke (pooled SMD [δ]=−.28; 95% confidence interval [CI], −.47 to −.09), without compromise to patient outcomes. Results of individual trials in other patient groups (orthopedic, rheumatoid arthritis, and geriatric) receiving rehabilitation in the home or community were generally consistent with the meta-analysis. There was moderate quality evidence that cost was significantly reduced for inpatient rehabilitation (stroke unit) versus general acute care in a meta-analysis of 463 patients poststroke (δ=.31; 95% CI, .15–.48), with improvement to patient outcomes. These results were not replicated in 2 individual trials with a geriatric and a mixed cohort, where costs did not differ between general acute care and inpatient rehabilitation. Three of the 4 individual trials, inclusive of a stroke or orthopedic population, reported less cost for an intensive inpatient rehabilitation program compared with usual inpatient rehabilitation. Sensitivity analysis included a health service perspective and varied inflation rates with no change to the significant findings of the meta-analyses.

Conclusions:
Based on this systematic review and meta-analyses, a single rehabilitation service may not provide health economic benefits for all patient groups and situations. For some patients, inpatient rehabilitation may be the most cost-effective method of providing rehabilitation; yet, for other patients, rehabilitation in the home or community may be the most cost-effective model of care. To achieve cost-effective outcomes, the ideal combination of rehabilitation services and patient inclusion criteria, as well as further data for nonstroke populations, warrants further research.

Undergraduate nursing students' performance in recognising and responding to sudden patient deterioration in high psychological fidelity simulated environments: an Australian multi-centre study

Objectives
This paper reports the quantitative findings of the first phase of a larger program of ongoing research: Feedback Incorporating Review and Simulation Techniques to Act on Clinical Trends (FIRST2ACTTM). It specifically aims to identify the characteristics that may predict primary outcome measures of clinical performance, teamwork and situation awareness in the management of deteriorating patients.

Design
Mixed-method multi-centre study.

Setting
High fidelity simulated acute clinical environment in three Australian universities.

Participants
A convenience sample of 97 final year nursing students enrolled in an undergraduate Bachelor of Nursing or combined Bachelor of Nursing degree were included in the study.

Method
In groups of three, participants proceeded through three phases: (i) pre-briefing and completion of a multi-choice question test, (ii) three video-recorded simulated clinical scenarios where actors substituted real patients with deteriorating conditions, and (iii) post-scenario debriefing. Clinical performance, teamwork and situation awareness were evaluated, using a validated standard checklist (OSCE), Team Emergency Assessment Measure (TEAM) score sheet and Situation Awareness Global Assessment Technique (SAGAT). A Modified Angoff technique was used to establish cut points for clinical performance.

Results
Student teams engaged in 97 simulation experiences across the three scenarios and achieved a level of clinical performance consistent with the experts' identified pass level point in only 9 (1%) of the simulation experiences. Knowledge was significantly associated with overall teamwork (p = .034), overall situation awareness (p = .05) and clinical performance in two of the three scenarios (p = .032 cardiac and p = .006 shock). Situation awareness scores of scenario team leaders were low overall, with an average total score of 41%.

Conclusions
Final year undergraduate nursing students may have difficulty recognising and responding appropriately to patient deterioration. Improving pre-requisite knowledge, rehearsal of first response and team management strategies need to be a key component of undergraduate nursing students' education and ought to specifically address clinical performance, teamwork and situation awareness.

Patient comfort in the intensive care unit : a multicentre, binational point prevalence study of analgesia, sedation and delirium management

Objective: To measure the prevalence of assessment and management practices for analgesia, sedation and delirium in patients in Australian and New Zealand intensive care units.
Materials and Methods: We developed survey items from a modified Delphi panel and included them in a binational, point prevalence study. We used a standard case report form to capture retrospective patient data on management of analgesia, sedation and delirium at the end of a 4-hour period on the study day. Other data were collected during independent assessment of patient status and medication requirements.
Results: Data were collected on 569 patients in 41 ICUs. Pain assessment was documented in the 4 hours before study observation in 46% of patients. Of 319 assessable patients, 16% had moderate pain and 6% had severe pain. Routine sedation assessment using a scale was recorded in 63% of intubated and ventilated patients. When assessed, 38% were alert and calm, or drowsy and rousable, 22% were lightly to moderately sedated, 31% were deeply sedated (66% of these had a documented indication), and 9% were agitated or restless. Sedatives were titrated to a target level in 42% of patients. Routine assessment of delirium occurred in 3%, and at study assessment 9% had delirium. Wrist or arm restraints were used for 7% of patients.
Conclusions: Only two-thirds of sedated patients had their sedation levels formally assessed, half had pain assessed and very few had formal assessment of delirium. Our description of current practices, and other observational data, may help in planning further research in this area.

A prospective analysis of pain experience, beliefs and attitudes, and pain management in a cohort of Danish surgical patients.

Background: 

Frequency of CSF oligoclonal banding in multiple sclerosis increases with latitude

With the advent of MRI scanning, the value of lumbar puncture to assess oligoclonal band (OCB) status-for the diagnosis of multiple sclerosis (MS) is increasingly uncertain. One major issue is that the reported frequency of cerebrospinal fluid (CSF)-restricted oligoclonal banding for the diagnosis of MS varies considerably in different studies. In addition, the relationship between OCB positivity and disease outcome remains uncertain, as reported studies are generally too small to assess comparative disability outcomes with sufficient power. In order to further investigate variation of OCB positivity in patients with MS, we utilized MSBase, a longitudinal, Web-based collaborative MS outcomes registry following clinical cohorts in several continents and latitudes. We also assessed whether OCB positivity affects long-term disability outcome. A total of 13,242 patient records were obtained from 37 MS specialist centres in 19 different countries. OCB status was documented in 4481 (34%) patients and 80% of these were OCB positive. The presence of OCB was associated with degree of latitude (p = 0.02). Furthermore, the outcome of patients negative for CSF-specific OCB was significantly better in comparison to the OCB positive patients, as assessed by Expanded Disability Status Scale change (p < 0.001). The results of this study indicate that latitude could explain some of the inconsistencies in OCB status reported in different populations. The study confirms that OCB positivity in MS is associated with a worse long-term prognosis.

Patient engagement strategies used for hypertension and their influence on self-management attributes

Background. Several effective methods to facilitate patient self-management of hypertension are available in primary care. These include direct support from community pharmacists and general practice, and the use of home blood pressure (BP) monitoring. The aim of this study is to establish the prevalence of use of key strategies and to determine their independent relationship with patient self-management attributes.

Methods. A survey of patients with treated hypertension was undertaken in 27 community pharmacies. This established recent use of BP monitoring and advice from health professionals. Patient awareness of BP and targets, appropriateness of BP targets and adherence to anti-hypertensive medications were assessed as indicative self-management outcomes. Predictors of outcomes were determined using binary logistic regression.

Results. Overall, 215 surveys were returned. Two-thirds of patients were aged >65 years, and 45% had conditions warranting tighter BP control (<130/80 mmHg). Almost all patients reported monitoring of their BP in the previous year and 63% could report their most recent BP reading. Just 36% reported knowing a target BP, and 78% of reported targets were within guidelines recommendations. One-fifth (22%) monitored their own BP, and 15% reported non-adherence to medication. Doctors provided the large majority of professional advice. Self-monitoring or documentation of BP readings was independently associated with increased likelihood of BP and target BP being known.

Conclusions. Regular monitoring of BP does not automatically translate to professional advice. Increased uptake of patient self-monitoring should be promoted as a means of enabling self-management.