Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement

Background: In clinical trials, at the group level, results are usually reported as mean and standard deviation of the change in score, which is not meaningful for most readers. Objective: To determine the minimal clinically important improvement (MCII) of pain, patient's global assessment of disease activity, and functional impairment in patients with knee and hip osteoarthritis (OA). Methods: A prospective multicentre 4 week cohort study involving 1362 outpatients with knee or hip OA was carried out. Data on assessment of pain and patient's global assessment, measured on visual analogue scales, and functional impairment, measured on the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) function subscale, were collected at baseline and final visits. Patients assessed their response to treatment on a five point Likert scale at the final visit. An anchoring method based on the patient's opinion was used. The MCII was estimated in a subgroup of 814 patients ( 603 with knee OA, 211 with hip OA). Results: For knee and hip OA, MCII for absolute ( and relative) changes were, respectively, ( a) -19.9 mm (-40.8%) and -15.3 mm (-32.0%) for pain; ( b) -18.3 mm ( - 39.0%) and -15.2 mm ( -32.6%) for patient's global assessment; ( c) -9.1 ( -26.0%) and -7.9 ( -21.1%) for WOMAC function subscale score. The MCII is affected by the initial degree of severity of the symptoms but not by age, disease duration, or sex. Conclusion: Using criteria such as MCII in clinical trials would provide meaningful information which would help in interpreting the results by expressing them as a proportion of improved patients.

Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state

Background: The patient acceptable symptom state ( PASS) is the value beyond which patients can consider themselves well. This concept can help in interpreting results of clinical trials. Objective: To determine the PASS estimate for patients with knee and hip osteoarthritis (OA) by assessing pain, patient's global assessment of disease activity, and functional impairment. Methods: A 4 week prospective multicentre cohort study of 1362 outpatients with knee or hip OA was carried out. Data on assessment of pain and patient's global assessment of disease, measured on visual analogue scales, and functional impairment, measured on the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) function subscale, were collected at baseline and final visits. The patients assessed their satisfaction with their current state at the final visit. An anchoring method based on the patient's opinion was used. Results: For patients with knee and hip OA, the estimates of PASS were, respectively, 32.3 and 35.0 mm for pain, 32.0 and 34.6 mm for patient global assessment of disease activity, and 31.0 and 34.4 points for WOMAC function score. The PASS varied moderately across the tertiles of baseline scores but not across age, disease duration, or sex. Conclusion: The use of PASS in clinical trials would provide more meaningful results expressed as a proportion of patients in an acceptable symptom state.

Measuring the assessment and counselling provided with the supply of non-prescription asthma reliever medication: a simulated patient study

BACKGROUND: Over one quarter of asthma reliever medications are provided without prescription by community pharmacies in Australia. Evidence that community pharmacies provide these medications with sufficient patient assessment and medication counseling to ensure compliance with the government's Quality Use of Medicines principles is currently lacking. OBJECTIVE: To assess current practice when asthma reliever medication is provided in the community pharmacy setting and to identify factors that correlate with assessment of asthma control. METHODS: Researchers posing as patients visited a sample of Perth metropolitan community pharmacies in May 2007. During the visit, the simulated patient enacted a standardized scenario of someone with moderately controlled asthma who wished to purchase a salbutamol (albuterol) inhaler without prescription. Results of the encounter were recorded immediately after the visit. Regression analysis was performed, with medication use frequency (a marker of asthma control) as the dependent variable. RESULTS: One hundred sixty community pharmacies in the Perth metropolitan area were visited in May 2007. Pharmacists and/or pharmacy assistants provided some form of assessment in 84% of the visits. Counseling was provided to the simulated patients in 24% of the visits. Only 4 pharmacy staff members asked whether the simulated patient knew how to use the inhaler. Significant correlation was found between assessment and/or counseling of reliever use frequency and 3 independent variables: visit length (p < 0.001), number of assessment questions asked (p < 0.001), and the simulated patient who conducted the visit (p < 0.02). CONCLUSIONS: Both patient assessment and medication counseling were suboptimal compared with recommended practice when nonprescription asthma reliever medication was supplied in the community pharmacy setting. Pharmacy and pharmacist demographic variables do not appear to affect assessment of asthma control. This research indicates the need for substantial improvements in practice in order to provide reliever medication in line with Quality Use of Medication principles of ensuring safe and effective use of medication.

Laparoscopic approach in abdominal emergencies: a 5-year experience at a single center

Background. Laparoscopy is ever more common in both elective and emergency surgery. In fact, in abdominal emergencies it enables the resolution of preoperative diagnostic doubts as well as treatment of the underlying disease. We present a retrospective study of the results of a 5-year experience at a single center. Patients and methods. Between September 2006 and August 2011, 961 patients were treated via laparoscopy, including 486 emergency cases (15 gastroduodenal perforation; 165 acute cholecystitis; 255 acute appendicitis; 15 pelvic inflammatory disease and non-specific abdominal pain [NSAP]; 36 small bowel obstruction). All procedures were conducted by a team trained in laparoscopic surgery. Results. The conversion rate was 22/486 patients (4.53%). A definitive laparoscopic diagnosis was possible in over 96% of cases, and definitive treatment via laparoscopy was possible in most of these. Conclusions Our own experience confirms the literature evidence that laparoscopy is a valid option in the surgical treatment of abdominal emergencies. In any case, it must be performed by a dedicated and highly experienced team. Correct patient selection is also important, to enable the most suitable approach for each given situation.

A case of extraovarian primary peritoneal carcinoma in an oophorectomized-hysterectomized patient: a diagnostic dilemma

Extra Ovarian Primary Peritoneal Carcinoma (EOPPC) is a rare type of adenocarcinoma of the pelvic and abdominal peritoneum. The objective examination and the histological aspect of the neoplasia virtually overlaps with that of ovarian carcinoma. The reported case is that of a 72 year-old patient who had undergone a total hysterectomy with bilateral annessiectomy surgery 20 years earlier subsequently to a diagnosis for uterine leiomyomatosis. The patient came to our attention presenting recurring abdominal pain, constipation, weight loss, severe asthenia and fever. Her blood test results showed hypochromic microcytic anemia and a remarkable increase CA125 marker levels. Instrumental diagnostics with Ultrasound (US) and CT scans indicated the presence of a single peritoneal mass (10-12 cm diameter) close to the great epiploon. The patient was operated through a midline abdominal incision and the mass was removed with the great omentum. No primary tumor was found anywhere else in the abdomen and in the pelvis. The operation lasted approximately 50 minutes. The post-operative course was normal and the patient was discharged four days later. The histological exam of the neoplasia, supported by immunohistochemical analysis, showed a significant positivity for CA 125, vimentin and cytocheratin, presence of psammoma bodies, and cytoarchitectural pattern resembling that of a serous ovarian carcinoma even in absence of primitiveness, leading to a final diagnosis of EOPPC. The patient later underwent six cycles of chemotherapy with paclitaxel (135 mg/m2/24 hr) in association with cisplatin (75mg/m2). At the fourth year follow-up no sign of relapse was observed. .

Objective Structured Clinical Examinations (OSCE) improved communication skills of student of Pharmacology in Medicine and Podiatry degree.

Objective Structured Clinical Examinations (OSCE) improved communication skills of student of Pharmacology in Medicine and Podiatry degree. Bellido I, Blanco E, Gomez-Luque A. D. Pharmacology and Clinical Therapeutic. Medicine School. University of Malaga. IBIMA. Malaga, Spain. Objective Structured Clinical Examinations (OSCEs) are versatile multipurpose evaluative tools that can be utilized to assess health care professionals in a clinical setting including communication skills and ability to handle unpredictable patient behavior, which usually are not included in the traditional clinical exam. To designee and perform OSCEs by student is a novelty that really like to the students and may improve their arguing and planning capacities and their communication skills. Aim: To evaluate the impact of designing, developing and presenting Objective Structured Clinical Examinations (OSCE) by student in the communication skills development and in the learning of medicines in Medicine and Podiatry undergraduate students. Methods: A one-year study in which students were invited to voluntarily form groups (4 students maximum). Each group has to design and perform an OSCE (10 min maximum) showing a clinical situation/problem in which medicines’ use was needed. A clinical history, camera, a mobile-phone's video editor, photos, actors, dolls, simulators or whatever they may use was allowed. The job of each group was supervised and helped by a teacher. The students were invited to present their work to the rest of the class. After each OSCE performance the students were encouraged to ask questions if they wanted to do it. After all the OSCEs performances the students voluntarily answered a satisfaction survey. Results: Students of Pharmacology of Medicine degree and Podiatry degree, N=80, 53.75% female, 21±2.3 years old were enrolled. 26 OSCEs showing a clinical situation or clinical problem were made. The average time spent by students in making the OSCE was 21.5±9 h. The percentage of students which were satisfied with this way of presentation of the OSCE was 89.7%. Conclusion: Objective Structured Clinical Examinations (OSCE) designed and performed by student of Pharmacology of the Medicine and Podiatry Degree improved their communication skills.

Aligning ICT in assessment with teaching and learning : enhancing student achievement in the middle years

Student underachievement in the middle years (typically Years 4 to 9) is a concern in education. Incorporating Information and Communication Technologies (ICT) in assessment that is aligned to teaching and learning has the potential to engage students in higher cognitive processes that lead to increased student achievement. To examine this proposition an investigation was undertaken into teachers’ perceptions of alignment and the implications of those for student achievement in ICT enhanced middle years assessment tasks. This investigation used a collective case study design underpinned by socio-cultural theory. Two methods were used for data collection, namely, semi-structured interviews with individual teachers and a focus group discussion with teachers and another with students. Findings revealed teachers’ perceptions that alignment: assists in mediating achievement of learning outcomes in quality middle years assessment tasks, assists in creating a challenging but supportive environment in which positive learning dispositions and success is encouraged for all students, and contributes to more rigorous use of ICT in assessment. The process of implementing alignment was found to be complex but assisted through prioritising particular practices. These findings enabled the development of eight steps which serve as a guide to the effective implementation of alignment in middle years assessment tasks.

Health Assessment and Physical Examination

"This first Australia and New Zealand edition of the comprehensive Estes’ Health Assessment and Physical Examination is designed to teach students to assess a patient’s physical, psychological, cultural and emotional dimensions of health as a foundation of nursing care. The skills of interviewing, inspection, percussion, palpation, auscultation, and documentation are defined to help students to make clinical assessments and promote healthy patient outcomes. A strong emphasis on science encompasses all the technical aspects of anatomy, physiology and assessment, while highlighting clinically relevant information. Emphasis on caring is displayed through themes of assessment of the whole person, which also encourages nurses to think about care for themselves as well as patients."--publisher website

Nurse-administered procedural sedation and analgesia in the cardiac catheterisation laboratory : a mixed methods study

The cardiac catheterisation laboratory (CCL) is a specialised medical radiology facility where both chronic-stable and life-threatening cardiovascular illness is evaluated and treated. Although there are many potential sources of discomfort and distress associated with procedures performed in the CCL, a general anaesthetic is not usually required. For this reason, an anaesthetist is not routinely assigned to the CCL. Instead, to manage pain, discomfort and anxiety during the procedure, nurses administer a combination of sedative and analgesic medications according to direction from the cardiologist performing the procedure. This practice is referred to as nurse-administered procedural sedation and analgesia (PSA). While anecdotal evidence suggested that nurse-administered PSA was commonly used in the CCL, it was clear from the limited information available that current nurse-led PSA administration and monitoring practices varied and that there was contention around some aspects of practice including the type of medications that were suitable to be used and the depth of sedation that could be safely induced without an anaesthetist present. The overall aim of the program of research presented in this thesis was to establish an evidence base for nurse-led sedation practices in the CCL context. A sequential mixed methods design was used over three phases. The objective of the first phase was to appraise the existing evidence for nurse-administered PSA in the CCL. Two studies were conducted. The first study was an integrative review of empirical research studies and clinical practice guidelines focused on nurse-administered PSA in the CCL as well as in other similar procedural settings. This was the first review to systematically appraise the available evidence supporting the use of nurse-administered PSA in the CCL. A major finding was that, overall, nurse-administered PSA in the CCL was generally deemed to be safe. However, it was concluded from the analysis of the studies and the guidelines that were included in the review, that the management of sedation in the CCL was impacted by a variety of contextual factors including local hospital policy, workforce constraints and cardiologists’ preferences for the type of sedation used. The second study in the first phase was conducted to identify a sedation scale that could be used to monitor level of sedation during nurse-administered PSA in the CCL. It involved a structured literature review and psychometric analysis of scale properties. However, only one scale was found that was developed specifically for the CCL, which had not undergone psychometric testing. Several weaknesses were identified in its item structure. Other sedation scales that were identified were developed for the ICU. Although these scales have demonstrated validity and reliability in the ICU, weaknesses in their item structure precluded their use in the CCL. As findings indicated that no existing sedation scale should be applied to practice in the CCL, recommendations for the development and psychometric testing of a new sedation scale were developed. The objective of the second phase of the program of research was to explore current practice. Three studies were conducted in this phase using both quantitative and qualitative research methods. The first was a qualitative explorative study of nurses’ perceptions of the issues and challenges associated with nurse-administered PSA in the CCL. Major themes emerged from analysis of the qualitative data regarding the lack of access to anaesthetists, the limitations of sedative medications, the barriers to effective patient monitoring and the impact that the increasing complexity of procedures has on patients' sedation requirements. The second study in Phase Two was a cross-sectional survey of nurse-administered PSA practice in Australian and New Zealand CCLs. This was the first study to quantify the frequency that nurse-administered PSA was used in the CCL setting and to characterise associated nursing practices. It was found that nearly all CCLs utilise nurse-administered PSA (94%). Of note, by characterising nurse-administered PSA in Australian and New Zealand CCLs, several strategies to improve practice, such as setting up protocols for patient monitoring and establishing comprehensive PSA education for CCL nurses, were identified. The third study in Phase Two was a matched case-control study of risk factors for impaired respiratory function during nurse-administered PSA in the CCL setting. Patients with acute illness were found to be nearly twice as likely to experience impaired respiratory function during nurse-administered PSA (OR=1.78; 95%CI=1.19-2.67; p=0.005). These significant findings can now be used to inform prospective studies investigating the effectiveness of interventions for impaired respiratory function during nurse-administered PSA in the CCL. The objective of the third and final phase of the program of research was to develop recommendations for practice. To achieve this objective, a synthesis of findings from the previous phases of the program of research informed a modified Delphi study, which was conducted to develop a set of clinical practice guidelines for nurse-administered PSA in the CCL. The clinical practice guidelines that were developed set current best practice standards for pre-procedural patient assessment and risk screening practices as well as the intra and post-procedural patient monitoring practices that nurses who administer PSA in the CCL should undertake in order to deliver safe, evidence-based and consistent care to the many patients who undergo procedures in this setting. In summary, the mixed methods approach that was used clearly enabled the research objectives to be comprehensively addressed in an informed sequential manner, and, as a consequence, this thesis has generated a substantial amount of new knowledge to inform and support nurse-led sedation practice in the CCL context. However, a limitation of the research to note is that the comprehensive appraisal of the evidence conducted, combined with the guideline development process, highlighted that there were numerous deficiencies in the evidence base. As such, rather than being based on high-level evidence, many of the recommendations for practice were produced by consensus. For this reason, further research is required in order to ascertain which specific practices result in the most optimal patient and health service outcomes. Therefore, along with necessary guideline implementation and evaluation projects, post-doctoral research is planned to follow up on the research gaps identified, which are planned to form part of a continuing program of research in this field.

Quality of life and survival in patients treated with radical chemoradiation alone for oesophageal cancer

Aims: To report cancer-specific and health-related quality-of-life outcomes in patients undergoing radical chemoradiation (CRT) alone for oesophageal cancer. Materials and methods: Between 1998 and 2005, 56 patients with oesophageal cancer received definitive radical CRT, due to local disease extent, poor general health, or patient choice. Data from European Organization for Research and Treatment of Cancer quality-of-life questionnaires QLQ-30 and QLQ-OES24 were collected prospectively. Questionnaires were completed at diagnosis, and at 3, 6 and 12 months after CRT where applicable. Results: The median follow-up was 18 months. The median overall survival was 14 months, with a 51, 26 and 13% 1-, 3- and 5-year survival, respectively. At 12 months after treatment there was a significant improvement compared with before treatment with respect to dysphagia and pain. Global health scores were not significantly affected. Conclusions: Considering the relatively short long-term survival for this cohort of patients, maximising the quality of those final months should be very carefully borne in mind from the outset. The health-related quality-of-life data reported herein helps to establish benchmarks for larger evaluation within randomised clinical trials. © 2007 The Royal College of Radiologists.

Combination therapy with gefitinib and rofecoxib in patients with platinum-pretreated relapsed non-small-cell lung cancer

Purpose: In non-small-cell lung cancer (NSCLC), the epidermal growth factor receptor (EGFR) and cyclooxygenase-2 (COX-2) play major roles in tumorigenesis. This phase I/II study evaluated combined therapy with the EGFR tyrosine kinase inhibitor (TKI) gefitinib and the COX-2 inhibitor rofecoxib in platinum-pretreated, relapsed, metastatic NSCLC (n = 45). Patients and Methods: Gefitinib 250 mg/d was combined with rofecoxib (dose escalated from 12.5 to 25 to 50 mg/d through three cohorts, each n = 6). Because the rofecoxib maximum-tolerated dose was not reached, the 50 mg/d cohort was expanded for efficacy evaluation (n = 33). Results: Among the 42 assessable patients, there was one complete response (CR) and two partial responses (PRs) and 12 patients with stable disease (SD); disease control rate was 35.7% (95% CI, 21.6% to 52.0%). Median time to tumor progression was 55 days (95% CI, 47 to 70 days), and median survival was 144 days (95% CI, 103 to 190 days). In a pilot study, matrix-assisted laser desorption/ionization (MALDI) proteomics analysis of baseline serum samples could distinguish patients with an objective response from those with SD or progressive disease (PD), and those with disease control (CR, PR, and SD) from those with PD. The regimen was generally well tolerated, with predictable toxicities including skin rash and diarrhea. Conclusion: Gefitinib combined with rofecoxib provided disease control equivalent to that expected with single-agent gefitinib and was generally well tolerated. Baseline serum proteomics may help identify those patients most likely to benefit from EGFR TKIs. © 2007 by American Society of Clinical Oncology.

Chemotherapy for upper gastrointestinal tumours

The aim of this review is to identify current chemotherapy treatment for tumours of the oesophagus, stomach, pancreas, and liver. The role of both neoadjuvant, adjuvant, and palliative chemotherapy regimens will be discussed. This review will be of interest to oncologists in clarifying current issues regarding chemotherapy, and to physicians in other medical specialties, to increase their general understanding of benefits and drawbacks of chemotherapy in this patient group.

What factors influence nurses’ assessment practices? Development of the Barriers to Nurses’ use of Physical Assessment Scale

Aim To develop and psychometrically test the Barriers to Nurses’ use of Physical Assessment Scale. Background There is growing evidence of failure to recognise hospitalised patients at risk of clinical deterioration, in part due to inadequate physical assessment by nurses. Yet, little is known about the barriers to nurses’ use of physical assessment in the acute hospital setting and no validated scales have been published. Design Instrument development study. Method Scale development was based on a comprehensive literature review, focus groups, expert review and psychometric evaluation. The scale was administered to 434 acute care registered nurses working at a large Australian teaching hospital between June and July 2013. Psychometric analysis included factor analysis, model fit statistics and reliability testing. Results The final scale was reduced to 38 items representing seven factors, together accounting for 57.7% of the variance: (1) reliance on others and technology, (2) lack of time and interruptions, (3) ward culture, (4) lack of confidence, (5) lack of nursing role models, (6) lack of influence on patient care, and; (7) specialty area. Internal reliability ranged from .70 to .86. Conclusion Findings provide initial evidence for the validity and reliability of the Barriers to Nurses’ use of Physical Assessment Scale and point to the importance of understanding the organisational determinants of nurses’ assessment practices. The new scale has potential clinical and research applications to support nursing assessment in acute care settings.

Too much knowledge for a nurse? Use of physical assessment by final-semester nursing students

There is debate around the scope of physical assessment skills that should be taught in undergraduate nursing programs. Yet this debate is largely uninformed by evidence on what is learned and practiced by nursing students. This study examined the pattern and correlates of physical assessment skill utilization by 208 graduating nursing students at an Australian university, including measures of knowledge, frequency of use and perceived barriers to physical assessment skills during clinical practice. Of the 126 skills surveyed, on average only five were used every time students practiced. Core skills reflected inspection or general observation of the patient; none involved complex palpation, percussion or auscultation. Skill utilization was also shaped by specialty area. Most skills (70%) were, on average, never performed or learned and students perceived nursing physical assessment was marginalized in both university and workplace contexts. Lack of confidence was thus a significant barrier to use of skills. Based on these findings we argue that the current debate must shift to how we might best support students to integrate comprehensive physical assessment into nursing practice.