Filling the Gap: A Feasibility Study of a COPD-Specific Breathlessness Service.

Refractory breathlessness is a devastating symptom in chronic obstructive pulmonary disease (COPD). Symptom-focused breathlessness services, involving palliative care teams, offer individualized support but are not yet widely available for people with nonmalignant disease among which COPD. Our primary aim was to demonstrate the feasibility of setting up a breathlessness service specifically for COPD patients within a respiratory outpatient clinic. Our secondary aims were to assess how many sessions patients need to complete the intervention; to obtain an indication of effect size (on the Chronic Respiratory Questionnaire (CRQ), subset mastery domain); and to evaluate patient and professional satisfaction. We conducted a non-randomized single-center feasibility study. Participants had COPD and refractory breathlessness. During at least one session with a respiratory nurse and a pulmonologist, and one session with a physiotherapist, patients learned non-pharmacological interventions to manage breathlessness. Of 34 screened patients, 19 were included. All completed the intervention. A median of two clinical visits and two telephone calls were needed to complete the intervention. The mean improvement of 1.55 in CRQ, mastery domain, significantly exceeded the clinically important difference of 0.5. The service was rated as excellent by the eight patients who completed the survey. The health professional team gave positive feedback on the experience of delivering the intervention. Delivery of a breathlessness service for COPD outpatients with refractory breathlessness appears feasible, easy to implement in a respiratory outpatient clinic, and has the potential to be effective. A randomized controlled clinical trial is needed to test effectiveness and cost-effectiveness in this context.

Life-sustaining treatment preferences in older patients when referred to the emergency department for acute geriatric assessment: a descriptive study in a Dutch hospital.

BACKGROUND: In many cases, life-sustaining treatment preferences are not timely discussed with older patients. Advance care planning (ACP) offers medical professionals an opportunity to discuss patients' preferences. We assessed how often these preferences were known when older patients were referred to the emergency department (ED) for an acute geriatric assessment. METHODS: We conducted a descriptive study on patients referred to the ED for an acute geriatric assessment in a Dutch hospital. Patients were referred by general practitioners (GPs), or in the case of nursing home residents, by elderly care physicians. The referring physician was asked if preferences regarding life-sustaining treatments were known. The primary outcome was the number of patients for whom preferences were known. Secondary outcomes included which preferences, and which variables predict known preferences. RESULTS: Between 2015 and 2017, 348 patients were included in our study. At least one preference regarding life-sustaining treatments was known at referral in 45.4% (158/348) cases. In these cases, cardiopulmonary resuscitation (CPR) policy was always included. Preferences regarding invasive ventilation policy and ICU admission were known in 17% (59/348) and 10.3% (36/348) of the cases respectively. Known preferences were more frequent in cases referred by the elderly care physician than the GP (P < 0.001). CONCLUSIONS: In less than half the patients, at least one preference regarding life-sustaining treatments was known at the time of referral to the ED for an acute geriatric assessment; in most cases it concerned CPR policy. We recommend optimizing ACP conversations in a non-acute setting to provide more appropriate, desired, and personalized care to older patients referred to the ED.

Measuring the Burden on Family Caregivers of People With Cancer: Cross-cultural Translation and Psychometric Testing of the Caregiver Reaction Assessment-Indonesian Version.

BACKGROUND: The Caregiver Reaction Assessment (CRA) is considered one of the well-developed instruments for measuring the multidimensional burden of family caregivers. To date, there is no available validated instrument to assist healthcare professionals in measuring the caregiver's burden in Indonesia. OBJECTIVE: To translate the CRA from English into Indonesian and to conduct psychometric testing of this CRA-Indonesian version (CRA-ID) with family caregivers of patients with cancer. METHODS: Cross-cultural translation and psychometric testing were conducted. Confirmatory factor analysis and exploratory factor analysis were performed to check, explore, and confirm the best model for the CRA-ID; internal consistency was also measured. RESULTS: A total of 451 respondents participated, of whom 40 were involved in the feasibility testing. Confirmatory factor analysis with the original factors of the CRA revealed that the fit was not satisfactory, and adaptation was needed. Through exploratory factor analysis, the best model fit was developed, and confirmatory factor analysis was performed again. Five factors from the original instrument were confirmed with an explained variance of 54.89%. Almost all items in the CRA-ID appeared to have a similar structure as the original version. Cronbach's α's ranged between .64 and .81. CONCLUSIONS: The CRA-ID appeared to be feasible, valid, and reliable for measuring the burden of family caregivers of patients with cancer in Indonesia. IMPLICATIONS FOR PRACTICE: Nurses can use the CRA-ID to measure family caregivers' burden. Its availability in the Indonesian language enhances the opportunity to conduct international comparisons of family caregiver burden using the same instrument.

Decreased costs and retained QoL due to the 'PACE Steps to Success' intervention in LTCFs: cost-effectiveness analysis of a randomized controlled trial.

BACKGROUND: The number of residents in long-term care facilities (LTCFs) in need of palliative care is growing in the Western world. Therefore, it is foreseen that significantly higher percentages of budgets will be spent on palliative care. However, cost-effectiveness analyses of palliative care interventions in these settings are lacking. Therefore, the objective of this paper was to assess the cost-effectiveness of the 'PACE Steps to Success' intervention. PACE (Palliative Care for Older People) is a 1-year palliative care programme aiming at integrating general palliative care into day-to-day routines in LTCFs, throughout seven EU countries. METHODS: A cluster RCT was conducted. LTCFs were randomly assigned to intervention or usual care. LTCFs reported deaths of residents, about whom questionnaires were filled in retrospectively about resource use and quality of the last month of life. A health care perspective was adopted. Direct medical costs, QALYs based on the EQ-5D-5L and costs per quality increase measured with the QOD-LTC were outcome measures. RESULTS: Although outcomes on the EQ-5D-5L remained the same, a significant increase on the QOD-LTC (3.19 points, p value 0.00) and significant cost-savings were achieved in the intervention group (€983.28, p value 0.020). The cost reduction mainly resulted from decreased hospitalization-related costs (€919.51, p value 0.018). CONCLUSIONS: Costs decreased and QoL was retained due to the PACE Steps to Success intervention. Significant cost savings and improvement in quality of end of life (care) as measured with the QOD-LTC were achieved. A clinically relevant difference of almost 3 nights shorter hospitalizations in favour of the intervention group was found. This indicates that timely palliative care in the LTCF setting can prevent lengthy hospitalizations while retaining QoL. In line with earlier findings, we conclude that integrating general palliative care into daily routine in LTCFs can be cost-effective. TRIAL REGISTRATION: ISRCTN14741671 .

Integrating palliative care in long-term care facilities across Europe (PACE): protocol of a cluster randomized controlled trial of the 'PACE Steps to Success' intervention in seven countries.

BACKGROUND: Several studies have highlighted the need for improvement in palliative care delivered to older people long-term care facilities. However, the available evidence on how to improve palliative care in these settings is weak, especially in Europe. We describe the protocol of the PACE trial aimed to 1) evaluate the effectiveness and cost-effectiveness of the 'PACE Steps to Success' palliative care intervention for older people in long-term care facilities, and 2) assess the implementation process and identify facilitators and barriers for implementation in different countries. METHODS: We will conduct a multi-facility cluster randomised controlled trial in Belgium, Finland, Italy, the Netherlands, Poland, Switzerland and England. In total, 72 facilities will be randomized to receive the 'Pace Steps to Success intervention' or to 'care as usual'. Primary outcome at resident level: quality of dying (CAD-EOLD); and at staff level: staff knowledge of palliative care (Palliative Care Survey). SECONDARY OUTCOMES: resident's quality of end-of-life care, staff self-efficacy, self-perceived educational needs, and opinions on palliative care. Economic outcomes: direct costs and quality-adjusted life years (QALYs). Measurements are performed at baseline and after the intervention. For the resident-level outcomes, facilities report all deaths of residents in and outside the facilities over a previous four-month period and structured questionnaires are sent to (1) the administrator, (2) staff member most involved in care (3) treating general practitioner, and (4) a relative. For the staff-level outcomes, all staff who are working in the facilities are asked to complete a structured questionnaire. A process evaluation will run alongside the effectiveness evaluation in the intervention group using the RE-AIM framework. DISCUSSION: The lack of high quality trials in palliative care has been recognized throughout the field of palliative care research. This cross-national cluster RCT designed to evaluate the impact of the palliative care intervention for long-term care facilities 'PACE Steps to Success' in seven countries, will provide important evidence concerning the effectiveness as well as the preconditions for optimal implementation of palliative care in nursing homes, and this within different health care systems. TRIAL REGISTRATION: The study is registered at www.isrctn.com - ISRCTN14741671 (FP7-HEALTH-2013-INNOVATION-1 603111) Registration date: July 30, 2015.

The use of Quality-Adjusted Life Years in cost-effectiveness analyses in palliative care: Mapping the debate through an integrative review.

BACKGROUND: In cost-effectiveness analyses in healthcare, Quality-Adjusted Life Years are often used as outcome measure of effectiveness. However, there is an ongoing debate concerning the appropriateness of its use for decision-making in palliative care. AIM: To systematically map pros and cons of using the Quality-Adjusted Life Year to inform decisions on resource allocation among palliative care interventions, as brought forward in the debate, and to discuss the Quality-Adjusted Life Year's value for palliative care. DESIGN: The integrative review method of Whittemore and Knafl was followed. Theoretical arguments and empirical findings were mapped. DATA SOURCES: A literature search was conducted in PubMed, EMBASE, and CINAHL, in which MeSH (Medical Subject Headings) terms were Palliative Care, Cost-Benefit Analysis, Quality of Life, and Quality-Adjusted Life Years. FINDINGS: Three themes regarding the pros and cons were identified: (1) restrictions in life years gained, (2) conceptualization of quality of life and its measurement, including suggestions to adapt this, and (3) valuation and additivity of time, referring to changing valuation of time. The debate is recognized in empirical studies, but alternatives not yet applied. CONCLUSION: The Quality-Adjusted Life Year might be more valuable for palliative care if specific issues are taken into account. Despite restrictions in life years gained, Quality-Adjusted Life Years can be achieved in palliative care. However, in measuring quality of life, we recommend to-in addition to the EQ-5D- make use of quality of life or capability instruments specifically for palliative care. Also, we suggest exploring the possibility of integrating valuation of time in a non-linear way in the Quality-Adjusted Life Year.

Comprehensive and Integrated Palliative Care for People With Advanced Chronic Conditions: An Update From Several European Initiatives and Recommendations for Policy.

The number of people in their last years of life with advanced chronic conditions, palliative care needs, and limited life prognosis due to different causes including multi-morbidity, organ failure, frailty, dementia, and cancer is rising. Such people represent more than 1% of the population. They are present in all care settings, cause around 75% of mortality, and may account for up to one-third of total national health system spend. The response to their needs is usually late and largely based around institutional palliative care focused on cancer. There is a great need to identify these patients and integrate an early palliative approach according to their individual needs in all settings, as suggested by the World Health Organization. Several tools have recently been developed in different European regions to identify patients with chronic conditions who might benefit from palliative care. Similarly, several models of integrated palliative care have been developed, some with a public health approach to promote access to all in need. We describe the characteristics of these initiatives and suggest how to develop a comprehensive and integrated palliative approach in primary and hospital care and to design public health and community-oriented practices to assess and respond to the needs in the whole population. Additionally, we report ethical challenges and prognostic issues raised and emphasize the need for research to test the various tools and models to generate evidence about the benefits of these approaches to patients, their families, and to the health system.

Pain Assessment with Short Message Service and Interactive Voice Response in Outpatients with Cancer and Pain: A Feasibility Study.

BACKGROUND: Pain assessment and monitoring is a prerequisite for its adequate treatment in patients with cancer. We performed a feasibility study on the use of short message service (SMS) and interactive voice response (IVR) to improve pain management in patients with cancer, including terminally ill patients. METHODS: During 4 weeks, palliative patients received a daily IVR asking to provide their pain score on a numeric rating scale (NRS) with their mobile phone. If pain was moderate or high, the nurse contacted the patient the same day and, if required, adapted the treatment. RESULTS: Thirteen of the 17 invited patients agreed to participate (79%), four died during the study period. IVR/SMS provides a reliable assessment of the pain intensity, and if required, treatment can be rapidly adapted. All patients were satisfied with the intervention. There were no difficulties for the, mainly older, patients in handling this communication way on pain intensity. The mean pain score decreased from 4.78 to 3.33 (P = 0.07). The pain scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) decreased significantly from 56 to 35 (P = 0.047). DISCUSSION: Monitoring and managing pain with IVR/SMS in patients with cancer at home appeared acceptable and feasible, even in terminally ill patients. The reluctance for actively contacting the professional in case of increased pain intensity is circumvented in this setting. Further research, preferably in a controlled study, is needed to establish the use of this intervention in a larger patient population.

The Impact of a National Guideline on the Management of Cancer Pain on the Practice of Pain Assessment and Registration.

The Dutch clinical practice guideline on the diagnosis and management of pain in patients with cancer was published in 2008 and intensively promoted to healthcare professionals who see patients with cancer. One of the most important recommendations is the systematic registering of the pain and its intensity. To evaluate in which degree this part of the practice guideline is implemented, we analyzed the medical records of patients attending the outpatient oncological clinic in an academic hospital, a large teaching hospital, and 4 smaller peripheral hospitals. None of the participating hospitals assessed pain by a standardized scale. Reference to pain in the medical record happened more frequently in the academic hospital than in the other hospitals. The frequency of recording pain in the medical record in the academic hospital was much higher in this study than the one previously reported, whereas the findings in the other hospitals were comparable. There may be several reasons for the difference in reporting rate of pain in patients with cancer. Our findings indicate that the clinical practice guideline with regard to pain registration is poorly implemented in oncology outpatient clinics. More efforts should be made to generate the awareness for the need of pain registration.

Comparison of problems and unmet needs of patients with advanced cancer in a European country and an Asian country.

BACKGROUND: Patients with advanced cancer experience problems and unmet needs. However, we assume that patients with advanced cancer will have more problems and unmet needs in a country with a lower economic status than in an economically stronger country. We studied whether patients with advanced cancer in Indonesia have more problems and unmet needs than a similar group of patients in the Netherlands. METHODS: We performed a cross-sectional survey. We compared the data for 180 Indonesian and 94 Dutch patients relating to 24 items of the Problems and Needs in Palliative Care-short version questionnaire. We performed descriptive and χ(2) analysis with Bonferroni correction. RESULTS: The prevalence of most physical problems, including pain, was similar in the 2 groups. In Indonesia, financial problems were the most common: 70 to 80% vs. 30 to 42% in the Netherlands. In Indonesia, 25 to 50% of the patients reported psychological and autonomy problems versus 55 to 86% in the Netherlands. The Indonesian group had many more unmet needs for each problem (> 54%) than the Dutch group (< 35%). CONCLUSION: Apparently, economic and cultural differences hardly influence physical problems. Nonetheless, fewer Indonesian patients reported psychological and autonomy problems than Dutch patients. This difference contradicts our hypothesis. However, we found more unmet needs for professional attention in Indonesia than in the Netherlands, which is compatible with our hypothesis. These simple comparative data provide interesting insights into problems and unmet needs and give rise to our new hypothesis about cultural influences. This hypothesis should be studied in more depth.

Consensus on quality indicators to assess the organisation of palliative cancer and dementia care applicable across national healthcare systems and selected by international experts.

BACKGROUND: Large numbers of vulnerable patients are in need of palliative cancer and dementia care. However, a wide gap exists between the knowledge of best practices in palliative care and their use in everyday clinical practice. As part of a European policy improvement program, quality indicators (QIs) have been developed to monitor and improve the organisation of palliative care for patients with cancer and those with dementia in various settings in different European countries. METHOD: A multidisciplinary, international panel of professionals participated in a modified RAND Delphi procedure to compose a set of palliative care QIs based on existing sets of QIs on the organisation of palliative care. Panellists participated in three written rounds, one feedback round and one meeting. The panel's median votes were used to identify the final set of QIs. RESULTS: The Delphi procedure resulted in 23 useful QIs. These QIs represent key elements of the organisation of good clinical practice, such as the availability of palliative care teams, the availability of special facilities to provide palliative care for patients and their relatives, and the presence of educational interventions for professionals. The final set also includes QIs that are related to the process of palliative care, such as documentation of pain and other symptoms, communication with patients in need of palliative care and their relatives, and end-of-life decisions. CONCLUSION: International experts selected a set of 23 QIs for the organisation of palliative care. Although we particularly focused on the organisation of cancer and dementia palliative care, most QIs are generic and are applicable for other types of diseases as well.

Face-validation of quality indicators for the organization of palliative care in hospitals in Indonesia: a contribution to quality improvement.

PURPOSE: Quality indicators (QIs) for the organization of palliative care (PC) can contribute to quality improvement as they assess the key elements for adequate organization of care. They might differ between health care organization, cultures and economic resources. The aim of this study was face-validate an Indonesian set of QIs based on a European set, to compare the two sets of QIs and to test the applicability of Indonesian set. METHODS: A modified two-round RAND Delphi process was conducted in Indonesia. Twenty-four health care professionals from different disciplines were invited as panellists to rate clarity and usefulness of 98 QIs. Next, a applicability pilot test took place in five hospitals. RESULTS: A total of 21 panellists considered 76 QIs (78 %) face-valid and added two new ones. Of the QIs with the highest ratings, eight were evaluated by head nurses and two by reviewing 50 patient records. Each QI was met by at least two hospitals, and only one by all five. Regarding the two QIs on structured clinical record keeping, most medical records contained multidimensional aspects of care. CONCLUSIONS: We found that most QIs for the organization of PC developed for European countries were also considered face-valid for Indonesian hospitals. The top 10 QIs were applicable in Indonesia. This suggests that most of the organizational QIs are universal rather than country specific. The Indonesian set of QIs should be considered as a first step in developing, testing, and implementing a set of QIs for PC in Indonesia. We recommend validation in other Asian regions.

Assessment of neuropathic pain in patients with cancer: the interobserver reliability. An observational study in daily practice.

BACKGROUND: Neuropathic pain (NeP) is a burdensome problem in all stages of cancer. Although clinical judgment is accepted as a surrogate for an objective gold standard in diagnosing NeP, no publications were found about its reliability. OBJECTIVES: Therefore, levels of agreement on the clinical examination of NeP were estimated by calculating kappa-value (K) and percentage of pair wise agreement (PA) to determine the interobserver reliability of diagnosing NeP. SETTING: The outpatient clinic of medical oncology of the Radboud University Nijmegen Medical Centre. METHODS: Patients with cancer with potential NeP complaints were recruited from the outpatient clinic of medical oncology. Physicians were recruited from the department of pain and palliative medicine. Physicians and patients were recruited for participation in an observational study in daily practice. Each patient (N = 34) was examined by 2 specialists via independent clinical assessment. All consultations were video recorded.  After each assessment, physicians were asked to indicate the most adequate characterization of the pain: pure NeP, pure nociceptive pain (NoP), mixed pain (MiP), or no pain (NP). RESULTS: Kappa (K) for the diagnosis of the most adequate pain characterization was 0.50, PA 64.7%. For diagnosing pure NeP k was 0.78 (PA 91.2%), for the NeP component (NeP + MiP)  and NoP component (NoP + MiP), it was respectively 0.52 (PA  76.5%) and 0.61 (PA 82.4%). For the diagnosis on the basis of the grading system between physicians, K was 0.34 (PA 52.9%). The intrarater reliability for the diagnosis of an NeP component on the basis of clinical assessment and the NeP component on the basis of the grading system, for pain specialists K was 0.69 (PA 85.3%) and for palliative care specialists K was 0.61 (PA 79.4%). LIMITATIONS: The values of K and the PA for the existence of an NeP component are not satisfying and the clinical agreement between physicians around findings from physical examination should encourage a better standardization of the clinical assessment and classification of pain in patients with cancer in respect with the identification of NeP.  CONCLUSIONS: A substantial level of agreement was found for the diagnosis of pure NeP and a moderate level of agreement for the diagnosis of the NeP component was found, both with a PA = 70%. There was only a fair agreement between the physicians regarding the grading system. However, there was a substantial level of (interrater) agreement for the diagnosis of an NeP component and the outcome of the grading system. The findings in this study also suggest that a better standardization of the clinical assessment and classification of pain in patients with cancer with respect to the identification of neuropathic pain is necessary.

Comparison of legislation, regulations and national health strategies for palliative care in seven European countries (Results from the Europall Research Group): a descriptive study.

BACKGROUND: According to EU policy, anyone in need of palliative care should be able to have access to it. It is therefore important to investigate which palliative care topics are subject to legislation and regulations in Europe and how these are implemented in (national) health care plans. This paper aims to deliver a structured overview of the legislation, existing regulations and the different health care policies regarding palliative care in seven European countries. METHODS: In 2008 an inventory of the organisation of palliative care was developed by the researchers of the Europall project. Included were two open questions about legislation, regulations, and health policy in palliative care. This questionnaire was completed using palliative care experts selected from Belgium, England, France, Germany, the Netherlands, Poland and Spain. Additionally, (grey) literature on palliative care health policy and regulations from the participating countries was collected to complete the inventory. Comparative analysis of country specific information was performed afterwards. RESULTS: In all countries palliative care regulations and policies existed (either in laws, royal decrees, or national policies). An explicit right to palliative care was mentioned in the Belgium, French and German law. In addition, access to palliative care was mentioned by all countries, varying from explicit regulations to policy intentions in national plans. Also, all countries had a national policy on palliative care, although sometimes mainly related to national cancer plans. Differences existed in policy regarding palliative care leave, advance directives, national funding, palliative care training, research, opioids and the role of volunteers. CONCLUSIONS: Although all included European countries have policies on palliative care, countries largely differ in the presence of legislation and regulations on palliative care as well as the included topics. European healthcare policy recommendations should support palliative care access across Europe.

What tools are available to identify patients with palliative care needs in primary care: a systematic literature review and survey of European practice.

BACKGROUND: It can be difficult to identify when a palliative care approach should be started both in malignant, and particularly, in non-malignant disease, ideally to run alongside disease-modifying care. A structured method or tool may be useful to help general practitioners (GPs) identify patients for early palliative care and trigger assessment and care planning. AIMS: To document what tools for identification of patients with palliative care needs are available in the published literature and to ascertain how GPs in Europe currently identify patients for palliative care. METHODS: A systematic literature search using PubMed and Embase, and a questionnaire survey among key informants in 14 European countries requesting data on methods used to identify patients with palliative care needs. RESULTS: The literature search identified four tools. The questionnaire survey identified a further three in current use and found that in current practice identification is largely based on a GP's own clinical judgement and information received from the hospital: tools are rarely used. CONCLUSIONS: Although several identification tools have been developed, none of these have been validated or widely implemented in Europe. Further collaborative international development, implementation and evaluation of such tools are recommended.

The burden of non-acute dying on society: dying of cancer and chronic disease in the European Union.

OBJECTIVES: Due to the ageing of the European population, the burden of non-acute dying on society is expected to increase. The aim of this study is to estimate the number of persons dying of cancer and chronic disease in Europe, including regional differences. METHODS: Death certificates of deceased persons in the European Union (EU)-27 countries in 2007 (some countries 2006 or 2004) were analysed and primary death causes were listed. These data were prepared for the general population and for the population of 65 years and older. Crude death rates (CDRs) were calculated for both groups and for all included countries. RESULTS: Of 480 million deceased European people, 202 million died of cancer and chronic disease in 2007 (42%). The CDR of the EU-27 countries was 409 (95% CI 370 to 451) for cancer and other chronic diseases per 100 000 inhabitants in 2007. For the 65+ population, the CDR for the EU-27 was 1783 (95% CI 1701 to 1868) for cancer and chronic disease. Large differences across countries appeared. An inverse relationship was shown for country-specific CDRs for cancer and chronic disease versus CDRs for other death causes (R=-0.41; p=0.04). CONCLUSIONS: Dying of cancer and chronic diseases involves a considerable burden on the European society. Future research should relate this information to the prevalence of symptoms and the use of palliative care services. European policy makers should take into account regional variations in developing long- and short-term palliative care strategies.

Off-label use of drugs in pain medicine and palliative care: an algorithm for the assessment of its safe and legal prescription.

Off-label medication use is common practice, particularly in difficult to treat patients who have already tried commonly accepted medication unsuccessfully. Health authorities try to regulate this practice to protect the patient's safety and to prevent over consumption of new and more expensive drugs. Justified off-label drug use requires a thorough assessment. Physicians, in cooperation with formulary committees, need tools to structure this assessment. The evaluation algorithm for off-label prescription we present here, to be used after identification of a planned off-label application, consists of four steps. Step 1 indicates the extent of the problem and the need for further investigation. Step 2 is the decisional process evaluating the necessity of off-label use in identified prescriptions and confirmation as to what extent it needs further investigation. In step 3, the scientific knowledge to support the proposed off-label use is gathered in a short or extensive evaluation trajectory. The short trajectory consists of assembling the information approved in other countries or in accepted guidelines and textbooks, whereas the extensive trajectory is necessary when the indication, route, or formulation is not approved nationally or internationally. Assessment needs to be based on a literature research on the clinical and pharmacological information of the product. Step 4 is the acceptance or rejection of the off-label use of the drug for the indication at hand. Those four steps need to be carefully documented. Treatment outcome will then be closely monitored, documented, and made available to professionals, thus allowing for regular update of recommendations. This algorithm can help formulary committees to develop a strategy for evaluating off-label prescriptions in well-defined conditions, and help healthcare providers to develop protocols and guidelines.

Organizational assessment in general practice: a systematic review and implications for quality improvement.

BACKGROUND: Quality improvement of organizational aspects in general practice is receiving increasing attention. In particular, the impact of effective organization on preventative care has been recognized. Organizational assessments are typically used as part of professionally led accreditation schemes where there is a tension between externally led quality assurance and internally led quality improvement. The aim of this article is to inform the debate by reviewing the international-peer-reviewed literature on organizational assessments used in general practice settings. DESIGN: Systematic literature review. METHODS: The literature was searched for articles relating to organizational assessment. Titles and abstracts were examined by two independent reviewers and relevant articles obtained. Bibliographies were examined for follow-up references. Data were extracted on the development and use of assessment methods. RESULTS: Thirteen papers describing five organizational assessment instruments were included for detailed appraisal. CONCLUSION: This review discovered a developing field containing different approaches to the measurement of organizational aspects of general practice. Whilst professionally led accreditation is well-developed and dependent on externally led quality assurance, approaches to internally led quality improvement are less well-developed. There is a need for organizational assessment tools designed for the purpose of stimulating internal development.