Effect of adjunctive raloxifene therapy on severity of refractory schizophrenia in women: a randomized clinical trial

IMPORTANCE: A substantial proportion of women with schizophrenia experience debilitating treatment-refractory symptoms. The efficacy of estrogen in modulating brain function in schizophrenia has to be balanced against excess exposure of peripheral tissue. Raloxifene hydrochloride is a selective estrogen receptor modulator (mixed estrogen agonist/antagonist) with potential psychoprotective effects and fewer estrogenic adverse effects. OBJECTIVE: To determine whether adjunctive raloxifene therapy reduces illness severity in women with refractory schizophrenia. DESIGN, SETTING, AND PARTICIPANTS: This 12-week, double-blind, placebo-controlled, randomized clinical trial with fortnightly assessments was performed at an urban tertiary referral center and a regional center from January 1, 2006, to December 31, 2014. Participants included 56 women with schizophrenia or schizoaffective disorder and marked symptom severity despite substantial and stable antipsychotic doses. Data were analyzed using intention to treat as the basis. INTERVENTIONS: Adjunctive raloxifene hydrochloride, 120 mg/d, or placebo for 12 weeks. MAIN OUTCOMES AND MEASURES: The primary outcome was the change in the Positive and Negative Syndrome Scale (PANSS) total score. Clinical response (defined as a ≥20% decrease in PANSS total score from baseline) and change in PANSS subscale scores, mood, cognition, reproductive hormone levels, and adverse events were also assessed. RESULTS: Of the 56 participants (mean [SD] age, 53 [7.7] years; age range, 40-70 years; mean [SD] duration of psychotic illness, 24 [11] years), 26 were randomized to raloxifene and 30 were randomized to placebo. Raloxifene produced a greater reduction in the PANSS total score relative to placebo (β = -6.37; 95% CI, -11.64 to -1.10; P = .02) and resulted in an increased probability of a clinical response (hazard ratio, 5.79; 95% CI, 1.46 to 22.97; P = .01). A significant reduction was found in the PANSS general symptom scores for the raloxifene compared with the placebo (β = -3.72; 95% CI, -6.83 to -0.61; P = .02) groups. For patients who completed the full 12-week trial, there was not a statistically significant treatment effect on PANSS positive symptom scores (β for change in raloxifene vs placebo, -1.92; 95% CI, -3.83 to 0.00; P = .05). Change in mood, cognition, and reproductive hormone levels and the rate of adverse events did not differ between groups. CONCLUSIONS AND RELEVANCE: Raloxifene hydrochloride, 120 mg/d, reduces illness severity and increases the probability of a clinical response in women with refractory schizophrenia. This large trial of raloxifene in this patient population offers a promising, well-tolerated agent that has potential application in clinical practice. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00361543.

Changes in intravenous fluid use patterns in Australia and New Zealand: evidence of research translating into practice

OBJECTIVES: To describe changes in the use of intravenous (IV) fluid by quantity and type in different regions of Australia and New Zealand. DESIGN, SETTING AND PARTICIPANTS: We conducted a retrospective ecological study examining regional and temporal trends in IV fluid consumption across Australia and New Zealand over the periods 2012-2013 and 2013- 2014, using national proprietary sales data as a surrogate for consumption, and demographic data from the public domain. RESULTS: More than 13.3 million litres of IV fluid were consumed in Australia and New Zealand in 2012-2013, and more than 13.9 million litres in 2013-2014, with colloid solutions accounting for < 2%. There was marked regional variation in consumption of fluids, by volumes and proportions used, when standardised to overall Australian and New Zealand values. There was no significant change in the overall volume of crystalloid solutions consumed but there was a significant decrease (9%; P = 0.02) in the ratio of unbalanced to balanced crystalloid solutions consumed. Consumption of all forms of colloid solutions decreased, with a 12% reduction overall (P = 0.02), primarily driven by a 67% reduction in the consumption of hydroxyethyl starch (HES) solutions. CONCLUSIONS: The amount and type of IV fluid use, as determined by fluid sales, is highly variable across Australia and New Zealand. However, overall use of balanced crystalloid solutions is increasing and the use of HES has decreased dramatically.

Comparison of medication policies to guide nursing practice across seven Victorian health services

Objectives The objective of this paper is to review and compare the content of medication management policies across seven Australian health services located in the state of Victoria. Methods The medication management policies for health professionals involved in administering medications were obtained from seven health services under one jurisdiction. Analysis focused on policy content, including the health service requirements and regulations governing practice. Results and Conclusions The policies of the seven health services contained standard information about staff authorisation, controlled medications and poisons, labelling injections and infusions, patient self-administration, documentation and managing medication errors. However, policy related to individual health professional responsibilities, single- and double-checking medications, telephone orders and expected staff competencies varied across the seven health services. Some inconsistencies in health professionals' responsibilities among medication management policies were identified. What is known about the topic? Medication errors are recognised as the single most preventable cause of patient harm in hospitals and occur most frequently during administration. Medication management is a complex process involving several management and treatment decisions. Policies are developed to assist health professionals to safely manage medications and standardise practice; however, co-occurring activities and interruptions increase the risk of medication errors. What does this paper add? In the present policy analysis, we identified some variation in the content of medication management policies across seven Victorian health services. Policies varied in relation to medications that require single- and double-checking, as well as by whom, nurse-initiated medications, administration rights, telephone orders and competencies required to check medications. What are the implications for practitioners? Variation in medication management policies across organisations is highlighted and raises concerns regarding consistency in governance and practice related to medication management. Lack of practice standardisation has previously been implicated in medication errors. Lack of intrajurisdictional concordance should be addressed to increase consistency. Inconsistency in expectations between healthcare services may lead to confusion about expectations among health professionals moving from one healthcare service to another, and possibly lead to increased risk of medication errors.

A cognitive behavioural therapy booklet for anxiety in functional gastrointestinal disorders: patient and health practitioner perspectives

OBJECTIVE: Psychotherapy is commonly used to treat functional gastrointestinal disorders (FGiDs), yet face-to-face psychotherapy is 15 labour intensive, less convenient for patients as it involves travel to the practice, costly and not always easily available. Self-administered psychotherapies have not been extensively investigated in this population. This study aimed to examine the feasibility and acceptability of a self-administered cognitive behavioural therapy booklet to reduce anxiety in patients with FGiD.

METHOD: A mixed-methods study underpinned by the Health Belief Model was conducted.

RESULTS: The booklet has been well received by patients (n = 26) and doctors (n = 8) and its acceptability and feasibility confirmed.

CONCLUSIONS: The results of the study suggest that this self-help tool is acceptable by patients and doctors as part of treatment for anxiety in FGiDs and its effectiveness should be further tested in adequately powered studies.

Deconstructing pedagogies of professional practice and learning for police officers.

This research applied qualitative and narrative methodology to investigate police officers' professional practice and learning. Analysis of the data revealed three thematic frameworks of power-knowledge relations, practice and knowledge, and gender and (dis)embodied practice that harboured doubtful matters (aporias) and blind spots (lacunae). The potential for change and the possibility of different perspectives and new learning was evident. Paradigmatic shifts in thinking, learning and practice are needed for police officers to develop reflexive practice that is social, relational, agential, and embodied, however, limitations and constraints exist based on the strength and resilience of dominant pedagogies influenced by social, cultural, institutional and occupational practices and discourses.