Cautionary tales in the interpretation of observational studies of effects of clinical interventions.

Observational studies of the effectiveness of clinical interventions are proliferating as more 'real-world' clinical data (so called 'big data') are gathered from clinical registries, administrative datasets and electronic health records. While well-conducted randomised controlled trials (RCT) remain the scientific standard in assessing the efficacy of clinical interventions, well-designed observational studies may add to the evidence base of effectiveness in situations where RCT are of limited value or very difficult to perform. Rather than dismissing observational studies, we need to determine what circumstances may justify doing an observational study and when the study is sufficiently rigorous to be considered reasonably trustworthy. This article proposes criteria by which users of the literature might make such determinations.

A medication review and deprescribing method for hospitalised older patients receiving multiple medications.

BACKGROUND: Prescribing of multiple medications in older patients poses risk of adverse drug events. AIM: To determine whether a structured approach to deprescribing - identifying and discontinuing unnecessary medications - in the inpatient setting is feasible and reduces medication burden. METHODS: Prospective pilot study of a convenience sample of patients aged ≥65 years admitted acutely to general medicine units in a tertiary hospital and receiving eight or more regular medications on presentation. The intervention comprised an education programme and a paper-based or computerised proforma listing clinical and medication data linked with a five-step decision support tool for selecting drugs eligible for discontinuation, which were then ceased or were being weaned by the time of discharge. RESULTS: Among 50 patients of median age 82.5 years and six co-morbidities, 186 of 542 (34.3%) regular medications were discontinued, representing a significant decrease in the median (interquartile range) number of medications per patient at discharge compared with presentation (7 (5-9) vs 10 (9-12), P < 0.001). Medication lists were reduced by at least two medications in 84% of patients, and by four or more in 50%. Statins, gastric acid suppressive agents, angiotensin-converting enzyme inhibitors/angiotensin receptor antagonists and inhaled bronchodilators were the most frequently ceased medications. Of 39 patients in whom follow-up status at a median of 78 days was ascertained, only 5 of 413 (1.2%) ceased medications were recommenced among three patients because of symptom relapse. CONCLUSION: A standardised method of medication review and deprescribing may significantly reduce medication burden in a cohort of older hospitalised patients.

Patient characteristics, interventions and outcomes of 1151 rapid response team activations in a tertiary hospital: a prospective study.

BACKGROUND: The characteristics of mature contemporary rapid response systems are unclear. AIM: To determine the patient characteristics, processes and outcomes, both in-hospital and post-discharge, of a well-established rapid response system in a tertiary adult hospital. METHODS: This is a prospective study of consecutive rapid response team (RRT) activations between 1 July and 25 November 2015. Variables included patient characteristics, timing, location and triggers of RRT activations, interventions undertaken, mortality and readmission status at 28 days post-discharge. RESULTS: A total of 1151 RRT activations was analysed (69.1 per 1000 admissions), involving 800 patients, of whom 81.5% were emergency admissions. A total of 351 (30.5%) activations comprised repeat activations for the same patient. Most activations (723; 62.8%) occurred out of hours, and 495 (43%) occurred within 48 h of admission. Hypotension, decreased level of consciousness and oxygen desaturation were the most common triggers. Advanced life support was undertaken in less than 7%; 198 (17.2%) responses led to transfer to higher-level care units. Acute resuscitation plans were noted for only 29.1% of RRT activations, with 80.3% stipulating supportive care only. A total of 103 (12.6%) patients died in hospital, equalling 14 deaths per 100 RRT activations. At 28 days, 150 (18.8%) patients had died, significantly more among those with multiple versus single RRT activations (24.9 vs 16.6%; odds ratio 1.66, 95% confidence interval 1.31-2.44; P = 0.013). CONCLUSION: Relatively few RRT activations are associated with acute resuscitation plans, and most interventions during RRT responses are low level. The high rate of post-RRT deaths and transfers to higher-level care units calls for the prospective identification of such patients in targeting appropriate care.

Rapid response teams in adult hospitals: time for another look?

Rapid response teams (RRT), alternatively termed medical emergency teams, have become part of the clinical landscape in the majority of adult hospitals throughout Australia and New Zealand. These teams aim to bring critical care expertise to the bedside of clinically deteriorating patients residing in general hospital wards with the aim of preventing adverse outcomes, in particular death or cardiorespiratory arrests. While the concept of RRT has considerable face validity, there is little high quality evidence of their effectiveness and much uncertainty as to the optimal methods for identifying patients in need of RRT and calling the RRT (afferent limb) and how, and with whom, the RRT should then respond (efferent limb). Adverse unintended consequences of RRT systems and the opportunity costs involved in maintaining such systems have not been subject to study, amid concerns RRT may be compensating for other potentially remediable system of care failures. This article presents an overview of the current state of play of RRT in hospital practice as they pertain to the care of adult patients and identifies several issues around their implementation and evaluation that should be subject to further research.

Physicians need to take the lead in deprescribing.

Inappropriate polypharmacy and its associated harm pose a significant threat to older patients. The prescribing decisions of physicians greatly influence what other practitioners prescribe. Minimising medication-related harm requires physicians to adopt a systematic approach to the deliberate and judicious deprescribing of potentially inappropriate medicines in at-risk individuals.

Quality of care factors associated with unplanned readmissions of older medical patients: a case-control study.

BACKGROUND: Unplanned readmissions befall up to 25% of acutely hospitalised older patients, and many may be potentially preventable. AIM: To assess the type and prevalence of quality of care factors associated with potentially preventable readmissions to a tertiary hospital general medicine service. METHODS: A retrospective case-control study was undertaken of hospital records of patients 65 years or older admitted acutely between 1 January 2005 and 31 December 2010. Readmissions up to 30 days postdischarge (cases) were purposively sampled according to frequencies of primary discharge diagnoses coded during the study period. Non-readmitted patients (controls), matched according to age, sex and primary discharge diagnosis on index admission, were selected in a 1.7:1 ratio. RESULTS: One hundred and thirteen cases and 198 controls were analysed, the former demonstrating a significantly higher comorbidity burden (mean (±standard deviation) comorbidity score 6.6 (±2.2) vs 5.6 (±2.4), P = 0.003) and a higher proportion of individuals with one or more hospitalisations over the preceding 6 months (55.7% vs 8.1%, P < 0.001). Among readmitted patients, 50 (44.3%) were associated with one or more quality factors versus 23 (11.6%) controls (P < 0.001). The most common were: failure to develop/activate an advance care plan (18, 15.9% vs 2, 1.0%; P < 0.001); suboptimal management of presenting illness (13, 11.4% vs 0, 0%; P < 0.001); inadequate assessment of functional limitations (11, 9.7% vs 0, 0%; P < 0.001); and potentially preventable complication of therapy (8, 7.1% vs 1, 0.5%, P = 0.002). CONCLUSIONS: Quality of care factors are more common among readmitted than among non-readmitted older patients suggesting potential for remedial strategies. Such strategies may still have limited effects as older, frail patients with advanced diseases and multimorbidity will likely retain a high propensity for readmission despite optimal care.

Prescribing for older people discharged from the acute sector to residential aged-care facilities.

For frail older people, admission to hospital is an opportunity to review the indications for specific medications. This research investigates prescribing for 206 older people discharged into residential aged care facilities from 11 acute care hospitals in Australia. Patients had multiple comorbidities (mean 6), high levels of dependency, and were prescribed a mean of 7.2 regular medications at admission to hospital and 8.1 medications on discharge, with hyper-polypharmacy (≥10 drugs) increasing from 24.3% to 32.5%. Many drugs were preventive medications whose time until benefit was likely to exceed the expected lifespan. In summary, frail patients continue to be exposed to extensive polypharmacy and medications with uncertain risk-benefit ratio.

Native aphids of New Zealand--diversity and host associations.

At least 15 species of aphids are now recognised as New Zealand natives and most of these are very likely to be endemic. Most native aphids belong in the subfamily Aphidinae (Aphidini), with a possible single species in Aphidinae-Macrosiphini, at least two in Neophyllaphidinae and one in Taiwanaphidinae. With one exception, native aphids are restricted to a single host plant genus, and these hosts are from 13 genera and 12 plant families in the Pinales and Angiospermae-Eudicotyledonae, suggesting that the aphids are a remnant fauna. No known native aphids have host plants from the Pteridophyta or Angiospermae-Monocotyledonae, with the possible exception of two possibly native species extracted from native tussock grassland turfs. Most host plant genera have some degree of Gondwanan distribution, but only two indigenous species are found on large forest trees and only one host is deciduous. Native aphids have been recorded from sea level to the subalpine zone, reflecting their host plant distributions. Sexual reproduction, followed by several parthenogenetic generations on the same host plant, appears to be the norm for most species. Eggs appear to be used for surviving winter conditions in some species and summer conditions in others. Native aphid distribution and abundance varies with five species considered to be scarce, one species localised, two species sparse and three relatively common based on current knowledge.

Evaluation of iron deficiency anaemia in tertiary hospital settings: room for improvement?

BACKGROUND: Iron deficiency anaemia (IDA) is a marker of occult blood loss from gastrointestinal (GI) lesions and requires thorough GI evaluation. AIM: This study aimed to determine frequency and findings of GI endoscopy in patients with IDA attending a tertiary hospital, and associations of endoscopy with patient and clinician-related factors and results of faecal occult blood tests (FOBT). METHODS: Retrospective audit of 621 subjects identified with definite and probable IDA (serum ferritin ≤ 15 ug/L and 16-50 µg/L respectively) between 1 January 2006 and 31 December 31 2008. Subjects were analysed as males >18 years and females ≥ 45 years of age with definite (group A, n= 180) or probable (group B, n= 353) IDA, and females <45 years of age with definite or probable IDA (group C, n= 88). RESULTS: Endoscopy of any type was documented in 310 (50%) of patients with oesophagogastroduodenal endoscopy, and colonoscopy rates being significantly higher in group A patients (61% and 56% respectively) than in group B (39%, 37%) and group C (30%, 31%; P ≤ 0.01 for all comparisons). Endoscopy rates ranged from 96% of patients seeing gastroenterologists to 31% of those seeing nephrologists. In patients undergoing colonoscopy, cancer and high-risk adenomas were detected in 51 patients (20%), ranging from 27/100 (27%) of group A, 23/130 (18%) of group B and 1/27 (4%) of group C. Lesion prevalence was similar (19-24%) regardless of whether FOBT yielded positive or negative results or had not been performed. CONCLUSIONS: Almost one in two patients with IDA were not documented as undergoing GI endoscopy. More intense guideline promulgation, improved endoscopy access and ongoing practice audits are required to improve endoscopy rates.

Assessing individual clinical performance: a primer for physicians.

The assessment of individual physician performance has attracted interest from several quarters, including statutory licensing agencies and credentialing bodies of healthcare institutions. Performance measures and assessment methods have been developed, although their validity, reliability and feasibility in regards to physician specialty practice are open to challenge. Despite this, professional colleges and societies will be increasingly obliged to ensure their members are demonstrating high-quality performance on the basis of assessment methods viewed as being transparent, impartial and reproducible. This article provides an overview of the current state of the art which hopefully will serve to inform future debate both within and outside professional circles.

Cautionary tales in the clinical interpretation of trials assessing therapy-induced changes in health status.

Trials assessing the effects of therapies on symptoms, functional capacity, health-related quality of life and other aspects of health status are becoming more common in an era of chronic disease management. Such trials involve instruments for measuring health status whose reliability, validity and responsiveness need to be understood by clinicians and policy-makers in interpreting trial results. Deciding whether a treatment is clinically efficacious requires prior determination, based on empirical evidence, of what constitutes a minimal important difference (MID) between active treatment and control groups in the change in health status between study start and end. This MID should be used to calculate the sample size that will confer adequate power to detect a treatment effect if it truly exists. Many trials assessing health status have major methodological flaws: use of inappropriate or psychometrically unsound measurement instruments, lack of specification of MID, assumption that statistically significant results represent clinically significant treatment effects, and statement of conclusions inconsistent with observed results. This article provides guidance to clinicians in interpreting results of such trials in regard to clinical decision-making.

Cautionary tales in the interpretation of studies of tools for predicting risk and prognosis.

Assessing future risk or prognosis in individual subjects is an often difficult and humbling task for clinicians. In recent times numerous prediction tools have been developed to make the task more accurate and thereby render management decisions more appropriate. If these tools are to be used effectively, an understanding is needed of their method of development, performance characteristics, ease of use and applicability in clinical settings, and potential impact on clinical decision-making. In this fourth article in a series on critical appraisal, we discuss questions that need to be asked of any new risk prediction tool.

Chronic disease management: a primer for physicians.

Approximately one in three Australians or 6.8 million individuals suffer from one or more chronic diseases, the most prevalent being ischaemic heart disease, congestive heart failure, chronic obstructive lung disease, diabetes and renal disease. Potentially avoidable hospitalizations related to chronic disease comprise 5.5% of all admissions nationally and cluster in older age groups and socioeconomically disadvantaged regions. In an effort to reduce mortality and morbidity, programmes of chronic disease management have evolved with the aim of achieving formalized, population-wide implementation of elements of the chronic care model developed by Wagner et al. Results of rigorous evaluations of such programmes suggest improved survival and/or disease control with reductions in hospitalizations and adverse clinical events. This paper aims to provide an overview of available evidence for chronic disease management programmes for practising physicians who will be increasingly invited to take an active leadership role in designing and operationalizing such programmes.

Cautionary tales in the clinical interpretation of studies of diagnostic tests.

The use of investigational tests in making a diagnosis is a core activity of physicians and one that requires an understanding of the accuracy and usefulness of specific tests in discriminating between several diagnostic possibilities. Studies of diagnostic tests are frequently methodologically flawed and their results are often not well understood or applied in clinical practice. This article defines the performance characteristics of diagnostic tests, describes several commonly encountered deficiencies in study design which may invalidate reports of new diagnostic tests, and explains a Bayesian approach to interpreting test results in terms of disease probability.

Improving quality and safety of hospital care: a reappraisal and an agenda for clinically relevant reform.

Improving quality and safety of hospital care is now firmly on the health-care agenda. Various agencies within different levels of government are pursuing initiatives targeting hospitals and health professionals that aim to identify, quantify and lessen medical error and suboptimal care. Although not denying the value of such 'top-down' initiatives, more attention may be needed towards 'bottom-up' reform led by practising physicians. This article discusses factors integral to delivery of safe, high-quality care grouped under six themes: clinical workforce, teamwork, patient participation in care decisions, indications for health-care interventions, clinical governance and information systems. Following this discussion, a 20-point action plan is proposed as an agenda for future reform capable of being led by physicians, together with some cautionary notes about relying too heavily on information technology, use of non-clinical quality personnel and quantitative evaluative approaches as primary strategies in improving quality.

Evidence-based guide to perioperative medicine.

The discipline of perioperative medicine is assuming greater importance as increasing numbers of older patients with medical comorbidity undergo complex surgical procedures. If patient outcomes and use of limited hospital resources are to be optimized, physicians with skills and interest in perioperative risk assessment and therapeutic intervention are needed. This systematic review attempts to provide an evidence-based update in several key areas in the management of the perioperative patient.

Perioperative assessment of older surgical patients using a frailty index-feasibility and association with adverse post-operative outcomes.

This study aimed to examine the feasibility of using a frailty index (FI) based on comprehensive geriatric assessment (CGA), to assess the level of frailty in older surgical patients preoperatively and to evaluate the association of FI-CGA with poorer postoperative outcomes. Two hundred and forty-six patients aged ≥70 years undergoing intermediate- to high-risk surgery in a tertiary hospital were recruited. Frailty was assessed using a 57-item FI-CGA form, with fit, intermediate frail, and frail patients defined as FI ≤0.25, >0.25 to 0.4, and >0.4, respectively. Adverse outcomes were ascertained at 30 days and 12 months post-surgery. Logistic regression models assessed the relationship between FI and adverse outcomes, adjusting for age, gender and acuity of surgery. The mean age of the participants was 79 years (standard deviation [SD] 6.5%), 52% were female, 91% were admitted from the community, 43% underwent acute surgery, and 19% were assessed as frail. The FI-CGA form was reported as being easy to apply, with a low patient refusal rate (2.2%). The majority of items were easy to rate, although inter-rater reliability was not tested. In relation to outcomes, greater frailty was associated with increased 12-month mortality (6.4%, 15.6%, and 23% for fit, intermediate frail, and frail patients respectively, P=0.01) and 12-month hospital readmissions (33.9%, 48.9%, and 60% respectively, P=0.004). There were no statistically significant differences between fit, intermediate frail, and frail groups in perioperative adverse events (17.4%, 23.3%, and 19.1% respectively, P=0.577) or 30-day postoperative complications (35.8%, 47.8%, and 46.8% respectively, P=0.183). Our findings suggest that it is feasible to use the FI-CGA to assess frailty preoperatively, and that using the FI-CGA may identify patients at high risk of adverse long-term outcomes.