Improving uptake of colorectal cancer screening by complex patients at an academic primary care practice: a feasibility study.

BACKGROUND: Regular screening reduces mortality from colorectal cancer (CRC). The Canton of Vaud, Switzerland, has a regional screening programme offering faecal immunochemical tests (FITs) or colonoscopy. Participation in the screening programme has been low, particularly among complex patients. Patient navigation has strong evidence for increasing the CRC screening rate. DESIGN AND OBJECTIVE: This feasibility study tested patient navigation performed by medical assistants for complex patients at an academic primary care practice. BASELINE MEASUREMENTS: A review of 328 patients' medical charts revealed that 51% were up-to-date with screening (16% within the programme), 24% were ineligible, 5% had a documented refusal and 20% were not up-to-date, of whom 58 (18%) were complex patients. INTERVENTION FEBRUARY 2023 TO MAY 2023: We tried to help complex patients participate in the screening programme using either in-person or telephone patient navigation. Each intervention was piloted by a physician-researcher and then performed by a medical assistant. Based on the reach, effectiveness, adoption, implementation, maintenance framework, we collected: Intervention participation and refusal, screening acceptance and completion and both patients and medical assistant acceptability (ie, qualitative interviews). RESULTS: Only 4/58 (7%) patients participated in the in-person patient navigation test phase due to scheduling problems. All four patients accepted a prescription and 2/4 (50%) completed their test. We piloted a telephone intervention to bypass scheduling issues but all patients refused a telephone discussion with the medical assistant. At two months after the last intervention, the proportion of patients up-to-date increased from 51% to 56%. CONCLUSION: Our overall approach was resource-intensive and had little impact on the overall participation rate. It was likely not sustainable. New approaches and reimbursement for a specific patient navigator role are needed to increase CRC screening of complex patients.

[2023 scientific breakthroughs in ambulatory general internal medicine]. / Avancées scientifiques de 2023 en médecine interne générale ambulatoire.

The timing of taking antihypertensive medication does not have an impact on the cardiovascular plan. Geniculate block is an alternative to oral analgesic treatment for knee osteoarthritis. Feedback and audits are ineffective in reducing the inappropriate prescription of antibiotics in Switzerland. The intervention of community health professionals in collaboration with general practitioners allows for the control of arterial hypertension. In the case of peripheral facial paralysis, it is relevant to systematically consider performing magnetic resonance imaging. Aspirin is an alternative to enoxaparin in thromboembolic prophylaxis after surgery for a traumatic fracture. Walking 8,000 steps a few days a week reduces mortality. Opioids are not effective for acute neck and lower back pain.

Le moment de prise des antihypertenseurs n'a pas d'impact sur le plan cardiovasculaire. Le bloc géniculé est une alternative au traitement antalgique oral de la gonarthrose. Le feedback et les audits sont inefficaces dans la diminution de la prescription inappropriée d'antibiotiques en Suisse. L'intervention de professionnelsa de santé communautaire en collaboration avec des généralistes permet de contrôler l'hypertension artérielle. Lors d'une paralysie faciale périphérique, il s'avère pertinent de réfléchir de manière systématique à la réalisation d'une IRM. L'aspirine est une alternative à l'énoxaparine dans la prophylaxie thromboembolique après la chirurgie d'une fracture traumatique. Marcher 8000 pas quelques jours par semaine diminue la mortalité. Les opioïdes ne sont pas efficaces pour les cervicalgies et les lombalgies aiguës.

[2022 scientific breakthroughs in ambulatory general internal medicine]. / Avancées scientifiques de 2022 en médecine interne générale ambulatoire.

In patients aged 65 or older, the risk of dementia decreases with cataract surgery. Mental stress doubles the risk of a cardiac event in patients with stable coronary artery disease. The one-legged stance performance estimates total mortality in patients 50 years or older. Patients with chronic pain benefit from treatment with dronabinol or nabiximols. Salt substitutes are an alternative to regular salt in hypertensive patients aged 60 years or more. The promotion of physical activity in the office is effective in reducing sedentary behavior. Music has a favorable impact on the mental dimensions of quality of life. Colonoscopies performed on patients aged 75 years or more have a higher risk of non-gastrointestinal complications than gastrointestinal complications.

Chez les patients de 65 ans ou plus, le risque de démence diminue après une chirurgie de la cataracte. Le stress mental double le risque d'événements cardiaques chez des patients avec une coronaropathie stable. La station monopodale effectuée au cabinet permet d'estimer la mortalité totale chez les patients de 50 ans ou plus. Ceux souffrant de douleurs chroniques bénéficient d'un traitement par dronabinol ou nabiximols. Les substituts de sel sont une alternative au sel ordinaire chez les hypertendus de 60 ans ou plus. La promotion de l'activité physique au cabinet est efficace dans la diminution de la sédentarité. La musique a un impact favorable sur les dimensions mentales de la qualité de vie. Les coloscopies effectuées chez les patients de 75 ans ou plus présentent un risque supérieur de complications non gastro-intestinales comparativement à celles gastro-intestinales.

Adverse events in deceased hospitalised cancer patients as a measure of quality and safety in end-of-life cancer care.

BACKGROUND: Anticancer treatment exposes patients to negative consequences such as increased toxicity and decreased quality of life, and there are clear guidelines recommending limiting use of aggressive anticancer treatments for patients near end of life. The aim of this study is to investigate the association between anticancer treatment given during the last 30 days of life and adverse events contributing to death and elucidate how adverse events can be used as a measure of quality and safety in end-of-life cancer care. METHODS: Retrospective cohort study of 247 deceased hospitalised cancer patients at three hospitals in Norway in 2012 and 2013. The Global Trigger Tool method were used to identify adverse events. We used Poisson regression and binary logistic regression to compare adverse events and association with use of anticancer treatment given during the last 30 days of life. RESULTS: 30% of deceased hospitalised cancer patients received some kind of anticancer treatment during the last 30 days of life, mainly systemic anticancer treatment. These patients had 62% more adverse events compared to patients not being treated last 30 days, 39 vs. 24 adverse events per 1000 patient days (p < 0.001, OR 1.62 (1.23-2.15). They also had twice the odds of an adverse event contributing to death compared to patients without such treatment, 33 vs. 18% (p = 0.045, OR 1.85 (1.01-3.36)). Receiving follow up by specialist palliative care reduced the rate of AEs per 1000 patient days in both groups by 29% (p = 0.02, IRR 0.71, CI 95% 0.53-0.96). CONCLUSIONS: Anticancer treatment given during the last 30 days of life is associated with a significantly increased rate of adverse events and related mortality. Patients receiving specialist palliative care had significantly fewer adverse events, supporting recommendations of early integration of palliative care in a patient safety perspective.

Contribution of adverse events to death of hospitalised patients.

Background: There is no standardised method to investigate death as a patient safety indicator and we need valid and reliable measurements to use adverse events contributing to death as a quality measure. Objective: To investigate the contribution of severe adverse events to death in hospitalised patients and clarify methodological differences using the Global Trigger Tool method on all inpatient deaths compared with a sample of general hospitalised patients. Method: Retrospective records reviewing using the Global Trigger Tool method. Results: In 0.3% of hospital admissions, adverse events contribute to inpatient death. Patients who die in hospital have twice the rate of adverse events per 1000 patient days compared with general patients, 76.7 vs 36.5 (p<0.001, RR 2.10, 95% CI 1.79 to 2.47). Patients dying in hospital experience seven times the rate of severe adverse events, 38.4% vs 5.2% (p<0.001, RR 2.10, 95% CI 1.79 to 2.47). For 86 out of 377 inpatient deaths, the adverse event is so severe that it contributes to death. 27.9% of severe adverse events contributing to death originate in primary care. Lower respiratory infections (p<0.001, RR 2.81, 95% CI 1.76 to 4.51), medication harm (p<0.001, RR 5.21, 95% CI 3.04 to 8.94) and pressure ulcers (p=0.04, RR 2.23, 95% CI 1.03 to 4.85) are significantly more frequent for inpatient deaths than in the general sample of hospital patients. Conclusions: Patients dying in hospitals experience seven times the rate of severe adverse events. Reviewing all inpatient death by the Global Trigger Tool method discloses new valid and reliable data of severe adverse events contributing to death which otherwise would be undetected.

Adverse events in hospitalised cancer patients: a comparison to a general hospital population.

BACKGROUND: Patients with cancer are often treated by many healthcare providers, receive complex and potentially toxic treatments that can increase the risk for iatrogenic harm. The aim of this study is to investigate whether hospitalised cancer patients are at higher risk of adverse events (AEs) compared to a general hospital population. MATERIAL AND METHODS: A total of 6720 patient records were retrospectively reviewed comparing AEs in hospitalised cancer patients to a general hospital population in Norway, using the IHI Global Trigger Tool method. RESULTS: 24.2 percent of admissions for cancer patients had an AE compared to 17.4% of admissions of other patients (p < .001, rr 1.39, 95% CI 1.19-1.62). However, cancer patients did not have a higher rate of AEs per 1000 patient days compared to other patients, 37.1 vs. 36.0 (p = .65, rr 0.94, 95% CI 0.90-1.18). No particular cancer category is at higher risk. The rate of AEs increases by 1.05 times for each day spent in hospital. For every year increase in age, the risk for AEs increases by 1.3%. Cancer patients more often have hospital-acquired infections, other surgical complications and AEs related to medications. CONCLUSIONS: Because of higher age, longer length of stay and surgical treatment, hospitalised cancer patients experience AEs more often than other patients.

Talking about quality: exploring how 'quality' is conceptualized in European hospitals and healthcare systems.

BACKGROUND: Conceptualization of quality of care - in terms of what individuals, groups and organizations include in their meaning of quality, is an unexplored research area. It is important to understand how quality is conceptualised as a means to successfully implement improvement efforts and bridge potential disconnect in language about quality between system levels, professions, and clinical services. The aim is therefore to explore and compare conceptualization of quality among national bodies (macro level), senior hospital managers (meso level), and professional groups within clinical micro systems (micro level) in a cross-national study. METHODS: This cross-national multi-level case study combines analysis of national policy documents and regulations at the macro level with semi-structured interviews (383) and non-participant observation (803 hours) of key meetings and shadowing of staff at the meso and micro levels in ten purposively sampled European hospitals (England, the Netherlands, Portugal, Sweden, and Norway). Fieldwork at the meso and micro levels was undertaken over a 12-month period (2011-2012) and different types of micro systems were included (maternity, oncology, orthopaedics, elderly care, intensive care, and geriatrics). RESULTS: The three quality dimensions clinical effectiveness, patient safety, and patient experience were incorporated in macro level policies in all countries. Senior hospital managers adopted a similar conceptualization, but also included efficiency and costs in their conceptualization of quality. 'Quality' in the forms of measuring indicators and performance management were dominant among senior hospital managers (with clinical and non-clinical background). The differential emphasis on the three quality dimensions was strongly linked to professional roles, personal ideas, and beliefs at the micro level. Clinical effectiveness was dominant among physicians (evidence-based approach), while patient experience was dominant among nurses (patient-centered care, enough time to talk with patients). Conceptualization varied between micro systems depending on the type of services provided. CONCLUSION: The quality conceptualization differed across system levels (macro-meso-micro), among professional groups (nurses, doctors, managers), and between the studied micro systems in our ten sampled European hospitals. This entails a managerial alignment challenge translating macro level quality definitions into different local contexts.

Six versus fewer planned cycles of first-line platinum-based chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual patient data.

BACKGROUND: Platinum-based chemotherapy is the standard first-line treatment for patients with advanced non-small-cell lung cancer. However, the optimum number of treatment cycles remains controversial. Therefore, we did a systematic review and meta-analysis of individual patient data to compare the efficacy of six versus fewer planned cycles of platinum-based chemotherapy. METHODS: All randomised trials comparing six versus fewer planned cycles of first-line platinum-based chemotherapy for patients with advanced non-small-cell lung cancer were eligible for inclusion in this systematic review and meta-analysis. The primary endpoint was overall survival. Secondary endpoints were progression-free survival, proportion of patients with an objective response, and toxicity. Statistical analyses were by intention-to-treat, stratified by trial. Overall survival and progression-free survival were compared by log-rank test. The proportion of patients with an objective response was compared with a Mantel-Haenszel test. Prespecified analyses explored effect variations by trial and patient characteristics. FINDINGS: Five eligible trials were identified; individual patient data could be collected from four of these trials, which included 1139 patients-568 of whom were assigned to six cycles, and 571 to three cycles (two trials) or four cycles (two trials). Patients received cisplatin (two trials) or carboplatin (two trials). No evidence indicated a benefit of six cycles of chemotherapy on overall survival (median 9·54 months [95% CI 8·98-10·69] in patients assigned to six cycles vs 8·68 months [8·03-9·54] in those assigned to fewer cycles; hazard ratio [HR] 0·94 [95% CI 0·83-1·07], p=0·33) with slight heterogeneity between trials (p=0·076; I(2)=56%). We recorded no evidence of a treatment interaction with histology, sex, performance status, or age. Median progression-free survival was 6·09 months (95% CI 5·82-6·87) in patients assigned to six cycles and 5·33 months (4·90-5·62) in those assigned to fewer cycles (HR 0·79, 95% CI 0·68-0·90; p=0·0007), and 173 (41·3%) of 419 patients assigned to six cycles and 152 (36·5%) of 416 patients assigned to three or four cycles had an objective response (p=0·16), without heterogeneity between the four trials. Anaemia at grade 3 or higher was slightly more frequent with a longer duration of treatment: 12 (2·9%) of 416 patients assigned to three-to-four cycles and 32 (7·8%) of 411 patients assigned to six cycles had severe anaemia. INTERPRETATION: Six cycles of first-line platinum-based chemotherapy did not improve overall survival compared with three or four courses in patients with advanced non-small-cell lung cancer. Our findings suggest that fewer than six planned cycles of chemotherapy is a valid treatment option for these patients. FUNDING: None.

Patient experiences with interventions to reduce surgery cancellations: a qualitative study.

BACKGROUND: The cancellation of planned surgery harms patients, increases waiting times and wastes scarce health resources. Previous studies have evaluated interventions to reduce cancellations from medical and management perspectives; these have focused on cost, length of stay, improved efficiency, and reduced post-operative complications. In our case a hospital had experienced high cancellation rates and therefore redesigned their pathway for elective surgery to reduce cancelations. We studied how patients experienced interventions to reduce cancellations. METHODS: We conducted a comparative, qualitative case study by interviewing 8 patients who had experienced the redesigned pathway, and 8 patients who had experienced the original pathway. We performed a content analysis of the interviews using a theory-based coding scheme. Through a process of coding and condensing, we identified themes of patient experience. RESULTS: We identified three common themes summarizing patients' positive experiences with the effects of the interventions: the importance of being involved in scheduling time for surgery, individualized preparation before the hospital admission, and relationships with few clinicians during their hospital stay. CONCLUSIONS: Patients appreciated the effects of interventions to reduce cancellations, because they increased their autonomy. Unanticipated consequences were that the telephone reminder created a personalized dialogue and centralization of surgical preparation and discharge processes improved continuity of care. Thus apart from improving surgical logistics, the pathway became more patient-centered.

[Patient safety can be ensured in clinical microsystems]. / Der kan skabes patientsikkerhed i kliniske mikrosystemer.

Patients, health-care professionals and the public expect safe health care. The system, however, is not safe and patients are being harmed. Workplace and organizational conditions and human factors contribute to these harms and a system approach is needed to avoid them. In clinical microsystems (CMS), the frontline units of health care, staff and patients can make care safer by learning about their system, its processes, members and purposes. Approaches from patient safety should be integrated in the daily work of every member of the CMS to reduce risk, implement safe practices and learn from errors. We summarize methods for use in CMS and offer ideas for fostering a proactive culture of patient safety.

Sustainability of healthcare improvement: what can we learn from learning theory?

BACKGROUND: Changes that improve the quality of health care should be sustained. Falling back to old, unsatisfactory ways of working is a waste of resources and can in the worst case increase resistance to later initiatives to improve care. Quality improvement relies on changing the clinical system yet factors that influence the sustainability of quality improvements are poorly understood. Theoretical frameworks can guide further research on the sustainability of quality improvements. Theories of organizational learning have contributed to a better understanding of organizational change in other contexts. To identify factors contributing to sustainability of improvements, we use learning theory to explore a case that had displayed sustained improvement. METHODS: Førde Hospital redesigned the pathway for elective surgery and achieved sustained reduction of cancellation rates. We used a qualitative case study design informed by theory to explore factors that contributed to sustain the improvements at Førde Hospital. The model Evidence in the Learning Organization describes how organizational learning contributes to change in healthcare institutions. This model constituted the framework for data collection and analysis. We interviewed a strategic sample of 20 employees. The in-depth interviews covered themes identified through our theoretical framework. Through a process of coding and condensing, we identified common themes that were interpreted in relation to our theoretical framework. RESULTS: Clinicians and leaders shared information about their everyday work and related this knowledge to how the entire clinical pathway could be improved. In this way they developed a revised and deeper understanding of their clinical system and its interdependencies. They became increasingly aware of how different elements needed to interact to enhance the performance and how their own efforts could contribute. CONCLUSIONS: The improved understanding of the clinical system represented a change in mental models of employees that influenced how the organization changed its performance. By applying the framework of organizational learning, we learned that changes originating from a new mental model represent double-loop learning. In double-loop learning, deeper system properties are changed, and consequently changes are more likely to be sustained.

A new pathway for elective surgery to reduce cancellation rates.

BACKGROUND: The cancellation of planned surgeries causes prolonged wait times, harm to patients, and is a waste of scarce resources. To reduce high cancellation rates in a Norwegian general hospital, the pathway for elective surgery was redesigned. The changes included earlier clinical assessment of patients, better planning and documentation systems, and increased involvement of patients in the scheduling of surgeries. This study evaluated the outcomes of this new pathway for elective surgery and explored which factors affected the outcomes. METHODS: We collected the number of planned operations, performed operations, and cancellations per month from the hospital's patient administrative system. We then used Student's t-test to analyze differences in cancellation rates (CRs) before and after interventions and a u-chart to analyze whether the improvements were sustained. We also conducted semi-structured interviews with employees of the hospital to explore the changes in the surgical pathway and the factors that facilitated these changes. RESULTS: The mean CR was reduced from 8.5% to 4.9% (95% CI for mean reduction 2.6-4.5, p < 0.001). The reduction in the CR was sustained over a period of 26 months after the interventions. The median number of operations performed per month increased by 17% (p = 0.04). A clear improvement strategy, involvement of frontline clinicians, introduction of an electronic scheduling system, and engagement of middle managers were important factors for the success of the interventions. CONCLUSION: The redesign of the old clinical pathway contributed to a sustained reduction in cancellations and an increased number of performed operations.

[Palliative care of patients with terminal obstructive pulmonary disease]. / Palliativ behandling af patienter med terminal kronisk obstruktiv lungesygdom.

Terminal chronic obstructive pulmonary disease (COPD) and advanced cancer have similar prognosis and symptom burden. However, palliative care of patients with terminal COPD has been neglected in Denmark. We describe the symptoms of terminal COPD and suggest criteria for defining the palliative phase of the disease. Furthermore we discuss the prognostic and ethical challenges for patients, their families and their caregivers. Finally, we summarize the current evidence for palliative treatment of dyspnoea and ways to evaluate response to treatment.

Improving chemotherapy for patients with advanced non-small cell lung cancer.

INTRODUCTION: Lung cancer is the third most common mortal disease in industrialised countries and the prognosis has been slow to improve. The largest subgroup has locally advanced or metastatic non-small cell lung cancer (NSCLC). Unfortunately, these patients can usually not be cured and the main treatment option is palliative chemotherapy. Given the palliative intention of the chemotherapy, it is clinically highly relevant to establish the optimal treatment duration. While chemotherapy prolongs survival and improves quality of life (QoL), it also has side effects and only a minority of patients achieve an objective treatment response. Clinicians need guidance on treatment duration from controlled trials to balance these aspects. Improvements of the conditions under which chemotherapy is given can increase patient and staff satisfaction and increase system performance. This is especially relevant to incurable patients who spend a lot of their limited time at oncology outpatient clinics. Staffing, infrastructure and organisation of these units are often suboptimal to serve patients with palliative needs and reports of improvement projects can inspire and guide clinicians in improving their microsystems of care. Clinicians, health care administrators and the public need knowledge about the outcomes of palliative chemotherapy in unselected patient populations. The efficacy of palliative chemotherapy for advanced NSCLC has been amply documented in controlled clinical trials. Meanwhile, the elderly and patients with higher performance status have usually been under-represented in these trials and population studies of the effectiveness of chemotherapy are needed. OBJECTIVES: (i) To establish the optimal duration of platinum-based first line chemotherapy for advanced NSCLC; (ii) To improve the care processes at an oncology outpatient clinical microsystem; (iii) To describe the use of chemotherapy in a national population and investigate associations between chemotherapy use and survival; and (iv) To explore approaches to improve the system of chemotherapy from the macro perspective of a whole country. MATERIALS AND METHODS: The thesis combines methods from different knowledge domains. In a randomised trial, we compared three with six courses of platinum-based chemotherapy for advanced NSCLC. In a quality improvement study, we used logistic improvement tools, qualitative and quantitative patient and staff satisfaction measurements. Finally using data from the Norwegian cancer and chemotherapy registries, we investigated temporary and geographical variations of chemotherapy use and correlations with the survival of patients with advanced NSCLC. Methods and findings from the three studies were explored to inform a national improvement strategy for the chemotherapy of advanced NSCLC. RESULTS: Survival and QoL were equal with three or six courses of chemotherapy for advanced NSCLC. Systematic process changes at the outpatient clinic led to increased patient and staff satisfaction. Furthermore, the study illustrates the application of established process improvement and evaluation tools in a clinical microsystem. In the registry study, we found delays of the introduction of palliative chemotherapy in Norway and significant associations between the use of chemotherapy and the survival of patients with advanced NSCLC. The general section of the thesis describes approaches to system-wide improvements and introduces a quality improvement matrix. CONCLUSION: We conclude from our randomised trial and related research that chemotherapy beyond three courses is not beneficial for patients with advanced NSCLC. The report from the oncology outpatient clinic illustrates the value of the clinical microsystem approach for quality improvement at the front line of care. Patient feedback through a focus group, simple methods of assessing and simplifying processes of care, as well as measuring results over time were effective tools in our project. The description of the experiences can serve as an example for the improvement of microsystems in settings with similar problems. Finally, in the registry study of Norwegian patients with lung cancer, we found significant geographical and temporal variations of the utilisation of chemotherapy that were related to survival. Potential areas of improvement in the system of care for lung cancer are recruitment of patients in clinical studies, standardisation of the processes of care in outpatient clinics, definition of strategic aims of quality, development of balanced quality indicators, as well as measuring and reporting of outcomes by means of a quality registry.

Phase III study by the Norwegian lung cancer study group: pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first-line chemotherapy in advanced non-small-cell lung cancer.

PURPOSE To compare pemetrexed/carboplatin with a standard regimen as first-line therapy in advanced non-small-cell lung cancer NSCLC. PATIENTS AND METHODS Patients with stage IIIB or IV NSCLC and performance status of 0 to 2 were randomly assigned to receive pemetrexed 500 mg/m(2) plus carboplatin area under the curve (AUC) = 5 (Calvert's formula) on day 1 or gemcitabine 1,000 mg/m(2) on days 1 and 8 plus carboplatin AUC = 5 on day 1 every 3 weeks for up to four cycles. The primary end point was health-related quality of life (HRQoL) defined as global quality of life, nausea/vomiting, dyspnea, and fatigue reported on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and the lung cancer-specific module LC13 during the first 20 weeks. Secondary end points were overall survival and toxicity. Results Four hundred thirty-six eligible patients were enrolled from April 2005 to July 2006. Patients who completed the baseline questionnaire were analyzed for HRQoL (n = 427), and those who received > or = one cycle of chemotherapy were analyzed for toxicity (n = 423). Compliance of HRQoL questionnaires was 87%. There were no significant differences for the primary HRQoL end points or in overall survival between the two treatment arms (pemetrexed/carboplatin, 7.3 months; gemcitabine/carboplatin, 7.0 months; P = .63). The patients who received gemcitabine/carboplatin had more grade 3 to 4 hematologic toxicity than patients who received pemetrexed/carboplatin, including leukopenia (46% v 23%, respectively; P < .001), neutropenia (51% v 40%, respectively; P = .024), and thrombocytopenia (56% v 24%, respectively; P < .001). More patients on the gemcitabine/carboplatin arm received transfusions of RBCs and platelets, whereas the frequencies of neutropenic infections and thrombocytopenic bleedings were similar on both arms. CONCLUSION Pemetrexed/carboplatin provides similar HRQoL and survival when compared with gemcitabine/carboplatin with less hematologic toxicity and less need for supportive care.

Chemotherapy and quality of life in NSCLC PS 2 patients.

INTRODUCTION: Nearly 40% of patients with advanced NSCLC are in performance status (PS) 2. These patients have a shorter life expectancy than PS 0/1 patients and they are underrepresented in clinical trials. Data on how platinum-based combination chemotherapy affects Health Related Quality of Life (HRQOL) of patients with PS 2 are scarce and the treatment of this important group of patients is controversial. METHODS: A national multicenter phase III study on platinum based chemotherapy to 432 advanced NSCLC patients included 123 patients with PS 2. To explore the treatment impact on HRQOL, the development of HRQOL during the first nine weeks were compared between PS 2 and PS 0/1 patients. We used the EORTC QLQ-C30 and QLQ-LC13 questionnaires. Standardized area under the curve for all HRQOL items, and HRQOL responses classified as better, stable or worse, were compared between the groups. RESULTS: Whereas the demographic data at baseline were well balanced between the groups, the PS 2 patients had significantly worse function and more severe symptoms than the PS 0/1 patients. In response to combination chemotherapy, the PS 2 patients had a more profound improvement of global QOL, cognitive function, fatigue, dyspnea, sleeping problems and appetite loss in comparison to the PS 0/1 group. CONCLUSIONS: PS 2 NSCLC patients seem to achieve valuable HRQOL benefits from platinum-based combination therapy. Prospective clinical studies with predefined HRQOL outcomes in PS 2 patients are needed to confirm these findings.

A prospective phase II study: high-dose pemetrexed as second-line chemotherapy in small-cell lung cancer.

PURPOSE: To investigate the efficacy and tolerability of high-dose pemetrexed as second-line chemotherapy in small cell lung cancer (SCLC). PATIENTS AND METHODS: Patients with verified SCLC who had received one prior chemotherapy regimen, aged 18-75 years, WHO Performance Status 0-2, no clinical signs of brain metastases and measurable disease were eligible. Patients received pemetrexed 900 mg/m(2) IV every 3 weeks. Four courses were planned for all patients. Patients with relapse later than 3 months since last course of first-line chemotherapy were defined as "sensitive", those with relapse within 3 months as "refractory". Toxicity was graded using the CTCAE v3.0. RESULTS: 36 patients were accrued, 34 received study treatment. Median age was 61 (range 43-74), 18 (53%) males and 16 (47%) females. Mean number of courses administered was 2.5. One patient (3%) had partial response, three (9%) had stable disease and 29 (85%) progressed. One patient (3%) was not evaluable for response. Median TTP (n=33) was 7.7 weeks ("sensitive": 8.4 weeks, "refractory": 5.1 weeks). Median OS (n=34) was 17.6 weeks ("sensitive": 22.6 weeks, "refractory": 15.3 weeks). Of grade 3-4 haematological toxicity, anemia was observed in 2 (6%) patients, leukopenia in 6 (18%), granulocytopenia in 9 (27%) and thrombocytopenia in 3 (9%). Febrile neutropenia occurred in 6 (18%) patients. There were no treatment related deaths. CONCLUSION: High-dose pemetrexed monotherapy to patients with recurrent SCLC yielded moderate toxicity, but limited treatment efficacy.

Treatment outcome in performance status 2 advanced NSCLC patients administered platinum-based combination chemotherapy.

BACKGROUND: There is no consensus regarding chemotherapy to patients with advanced NSCLC (ANSCLC) and performance status (PS) 2. Using data from a national multicenter study comparing two third-generation carboplatin-based regimens in ANSCLC patients, we evaluated the outcome of PS 2 patients. PATIENTS AND METHODS: The 123 PS 2 patients were compared to 309 PS 0/1 patients regarding survival, quality of life (QOL) and treatment toxicity. RESULTS: PS 2 patients had lower haemoglobin, lower global QOL and more pain, nausea/vomiting and dyspnea at inclusion. 68% of PS 2 patients received three chemotherapy courses vs. 85% in the PS 0/1 group (P<0.01). Median and 1-year survival were lower in the PS 2 group, 4.5 vs. 8.9 months and 10% vs. 37% (P<.01). More PS 2 patients needed blood transfusions (P=0.03) and hospitalization (P<0.01). In contrast, PS 2 patients had better relief of pain and dyspnea, and tended to a better global QOL and did not experience more leucopoenia, infections or bleeding. CONCLUSIONS: Despite shorter survival, treatment toxicity was acceptable and PS 2 patients achieved better improvement of pain and dyspnea and tended to better global QOL when compared to PS 0/1 patients.

Improving the quality of palliative care for ambulatory patients with lung cancer.

PROBLEM: Most patients with advanced lung cancer currently receive much of their health care, including chemotherapy, as outpatients. Patients have to deal with the complex and time consuming logistics of ambulatory cancer care. At the same time, members of staff often waste considerable time and energy in organisational aspects of care that could be better used in direct interaction with patients. DESIGN: Quality improvement study using direct observation and run and flow charts, and focus group meetings with patients and families regarding perceptions of the clinic and with staff regarding satisfaction with working conditions. SETTING: Thoracic oncology outpatient clinic at a Norwegian university hospital where patients receive chemotherapy and complementary palliative care. KEY MEASURES FOR IMPROVEMENT: Waiting time and time wasted during consultations; calmer working situation at the clinic; satisfaction among patients. STRATEGIES FOR CHANGE: Rescheduled patients' appointments, automated retrieval of blood test results, systematic reporting in patients' files, design of an information leaflet, and refurnishing of the waiting area at the clinic. EFFECTS OF CHANGE: Interventions resulted in increased satisfaction for patients and staff, reduced waiting time, and reduced variability of waiting time. LESSONS LEARNT: Direct observation, focus groups, questionnaires on patients' satisfaction, and measurement of process time were useful in systematically improving care in this outpatient clinic. The description of this experience can serve as an example for the improvement of a microsystem, particularly in other settings with similar problems.