Experiences in Monitoring and Assessment of Sustainable Land Management

Although sustainable land management (SLM) is widely promoted to prevent and mitigate land degradation and desertification, its monitoring and assessment (M&A) has received much less attention. This paper compiles methodological approaches which to date have been little reported in the literature. It draws lessons from these experiences and identifies common elements and future pathways as a basis for a global approach. The paper starts with local level methods where the World Overview of Conservation Approaches and Technologies (WOCAT) framework catalogues SLM case studies. This tool has been included in the local level assessment of Land Degradation Assessment in Drylands (LADA) and in the EU-DESIRE project. Complementary site-based approaches can enhance an ecological process-based understanding of SLM variation. At national and sub-national levels, a joint WOCAT/LADA/DESIRE spatial assessment based on land use systems identifies the status and trends of degradation and SLM, including causes, drivers and impacts on ecosystem services. Expert consultation is combined with scientific evidence and enhanced where necessary with secondary data and indicator databases. At the global level, the Global Environment Facility (GEF) knowledge from the land (KM:Land) initiative uses indicators to demonstrate impacts of SLM investments. Key lessons learnt include the need for a multi-scale approach, making use of common indicators and a variety of information sources, including scientific data and local knowledge through participatory methods. Methodological consistencies allow cross-scale analyses, and findings are analysed and documented for use by decision-makers at various levels. Effective M&A of SLM [e.g. for United Nations Convention to Combat Desertification (UNCCD)] requires a comprehensive methodological framework agreed by the major players.

Risk factors for geriatric patient falls in rehabilitation hospital settings: a systematic review

Objective: To review the literature to identify and synthesize the evidence on risk factors for patient falls in geriatric rehabilitation hospital settings. Data sources: Eligible studies were systematically searched on 16 databases from inception to December 2010. Review methods: The search strategies used a combination of terms for rehabilitation hospital patients, falls, risk factors and older adults. Cross-sectional, cohort, case-control studies and randomized clinical trials (RCTs) published in English that investigated risks for falls among patients ≥65 years of age in rehabilitation hospital settings were included. Studies that investigated fall risk assessment tools, but did not investigate risk factors themselves or did not report a measure of risk (e.g. odds ratio, relative risk) were excluded. Results: A total of 2,824 references were identified; only eight articles concerning six studies met the inclusion criteria. In these, 1,924 geriatric rehabilitation patients were followed. The average age of the patients ranged from 77 to 83 years, the percentage of women ranged from 56% to 81%, and the percentage of fallers ranged from 15% to 54%. Two were case-control studies, two were RCTs and four were prospective cohort studies. Several intrinsic and extrinsic risk factors for falls were identified. Conclusion: Carpet flooring, vertigo, being an amputee, confusion, cognitive impairment, stroke, sleep disturbance, anticonvulsants, tranquilizers and antihypertensive medications, age between 71 and 80, previous falls, and need for transfer assistance are risk factors for geriatric patient falls in rehabilitation hospital settings.

Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool

With the publication of the quality guideline ICH Q9 "Quality Risk Management" by the International Conference on Harmonization, risk management has already become a standard requirement during the life cycle of a pharmaceutical product. Failure mode and effect analysis (FMEA) is a powerful risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to biopharmaceutical processes brings about some difficulties. The proposal presented here is intended to serve as a brief but nevertheless comprehensive and detailed guideline on how to conduct a biopharmaceutical process FMEA. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. The application for such a biopharmaceutical process FMEA is widespread. It can be useful whenever a biopharmaceutical manufacturing process is developed or scaled-up, or when it is transferred to a different manufacturing site. It may also be conducted during substantial optimization of an existing process or the development of a second-generation process. According to their resulting risk ratings, process parameters can be ranked for importance and important variables for process development, characterization, or validation can be identified. LAY ABSTRACT: Health authorities around the world ask pharmaceutical companies to manage risk during development and manufacturing of pharmaceuticals. The so-called failure mode and effect analysis (FMEA) is an established risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to pharmaceutical processes that use modern biotechnology (biopharmaceutical processes) brings about some difficulties, because those biopharmaceutical processes differ from processes in mechanical and electrical industries. The proposal presented here explains how a biopharmaceutical process FMEA can be conducted. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. With the help of this guideline, different details of the manufacturing process can be ranked according to their potential risks, and this can help pharmaceutical companies to identify aspects with high potential risks and to react accordingly to improve the safety of medicines.

The canine hair cycle - a guide for the assessment of morphological and immunohistochemical criteria

The hair follicle has a lifelong capacity to cycle through recurrent phases of controlled growth (anagen), regression (catagen) and quiescence (telogen), each associated with specific morphological changes. A comprehensive classification scheme is available for mice to distinguish the cycle stages anagen I-VI, catagen I-VIII and telogen. For dogs, such a classification system does not exist, although alopecia associated with hair cycle arrest is common. We applied analogous morphological criteria and various staining techniques to subdivide the canine hair cycle stages to the same extent as has been done in mice. Of all the staining techniques applied, haematoxylin and eosin stain, Sacpic, Masson Fontana and immunohistochemistry for vimentin and laminin proved to be most useful. To evaluate the applicability of our criteria, we investigated skin biopsies from healthy beagle dogs (n=20; biopsies from shoulder and thigh) kept in controlled conditions. From each biopsy, at least 50 hair follicles were assessed. Statistical analysis revealed that 30% of the follicles were in anagen (12% early and 18% late), 8% in catagen (2% early, 5% late and 1% not determinable) and 27% in telogen. Thirty-five per cent of hair follicles could not be assigned to a specific cycle stage because not all follicles within one biopsy were oriented perfectly. In conclusion, this guide will not only be helpful for the investigation of alopecic disorders and possibly their pathogenesis, but may also serve as a basis for research projects in which the comparison of hair cycle stages is essential, e.g. comparative analysis of gene expression patterns.

Towards dynamics in flood risk assessment

As a consequence of flood impacts, communities inhabiting mountain areas are increasingly affected by considerable damage to infrastructure and property. The design of effective flood risk mitigation strategies and their subsequent implementation is crucial for a sustainable development in mountain areas. The assessment of the dynamic evolution of flood risk is the pillar of any subsequent planning process that is targeted at a reduction of the expected adverse consequences of the hazard impact. Given these premises, firstly, a comprehensive method to derive flood hazard process scenarios for well-defined areas at risk is presented. Secondly, conceptualisations of a static and dynamic flood risk assessment are provided. These are based on formal schemes to compute the risk mitigation performance of devised mitigation strategies within the framework of economic cost-benefit analysis. In this context, techniques suitable to quantify the expected losses induced by the identified flood impacts are provided.

Geriatric Pain Measure short form: development and initial evaluation

OBJECTIVES: To develop and evaluate a short form of the 24-item Geriatric Pain Measure (GPM) for use in community-dwelling older adults. DESIGN: Derivation and validation of a 12-item version of the GPM in a European and an independent U.S. sample of community-dwelling older adults. SETTING: Three community-dwelling sites in London, United Kingdom; Hamburg, Germany; Solothurn, Switzerland; and two ambulatory geriatrics clinics in Los Angeles, California. PARTICIPANTS: European sample: 1,059 community-dwelling older persons from three sites (London, UK; Hamburg, Germany; Solothurn, Switzerland); validation sample: 50 persons from Los Angeles, California, ambulatory geriatric clinics. MEASUREMENTS: Multidimensional questionnaire including self-reported demographic and clinical information. RESULTS: Based on item-to-total scale correlations in the European sample, 11 of 24 GPM items were selected for inclusion in the short form. One additional item (pain-related sleep problems) was included based on clinical relevance. In the validation sample, the Cronbach alpha of GPM-12 was 0.92 (individual subscale range 0.77-0.92), and the Pearson correlation coefficient (r) between GPM-12 and the original GPM was 0.98. The correlation between the GPM-12 and the McGill Pain Questionnaire was 0.63 (P<.001), similar to the correlation between the original GPM and the McGill Pain Questionnaire (Pearson r=0.63; P<.001). Exploratory factor analysis indicated that the GPM-12 covers three subfactors (pain intensity, pain with ambulation, disengagement because of pain). CONCLUSION: The GPM-12 demonstrated good validity and reliability in these European and U.S. populations of older adults. Despite its brevity, the GPM-12 captures the multidimensional nature of pain in three subscales. The self-administered GPM-12 may be useful in the clinical assessment process and management of pain and in pain-related research in older persons.

From text to codings: intercoder reliability assessment in qualitative content analysis

BACKGROUND: High intercoder reliability (ICR) is required in qualitative content analysis for assuring quality when more than one coder is involved in data analysis. The literature is short of standardized procedures for ICR procedures in qualitative content analysis. OBJECTIVE: To illustrate how ICR assessment can be used to improve codings in qualitative content analysis. METHODS: Key steps of the procedure are presented, drawing on data from a qualitative study on patients' perspectives on low back pain. RESULTS: First, a coding scheme was developed using a comprehensive inductive and deductive approach. Second, 10 transcripts were coded independently by two researchers, and ICR was calculated. A resulting kappa value of .67 can be regarded as satisfactory to solid. Moreover, varying agreement rates helped to identify problems in the coding scheme. Low agreement rates, for instance, indicated that respective codes were defined too broadly and would need clarification. In a third step, the results of the analysis were used to improve the coding scheme, leading to consistent and high-quality results. DISCUSSION: The quantitative approach of ICR assessment is a viable instrument for quality assurance in qualitative content analysis. Kappa values and close inspection of agreement rates help to estimate and increase quality of codings. This approach facilitates good practice in coding and enhances credibility of analysis, especially when large samples are interviewed, different coders are involved, and quantitative results are presented.

A semi-structured interview to assess visual hallucinations in older people

OBJECTIVE: Visual hallucinations are under-reported by patients and are often undiscovered by health professionals. There is no gold standard available to assess hallucinations. Our objective was to develop a reliable, valid, semi-structured interview for identifying and assessing visual hallucinations in older people with eye disease and cognitive impairment. METHODS: We piloted the North-East Visual Hallucinations Interview (NEVHI) in 80 older people with visual and/or cognitive impairment (patient group) and 34 older people without known risks of hallucinations (control group). The informants of 11 patients were interviewed separately. We established face validity, content validity, criterion validity, inter-rater agreement and the internal consistency of the NEVHI, and assessed the factor structure for questions evaluating emotions, cognitions, and behaviours associated with hallucinations. RESULTS: Recurrent visual hallucinations were common in the patient group (68.8%) and absent in controls (0%). The criterion, face and content validities were good and the internal consistency of screening questions for hallucinations was high (Cronbach alpha: 0.71). The inter-rater agreements for simple and complex hallucinations were good (Kappa 0.72 and 0.83, respectively). Four factors associated with experiencing hallucinations (perceived control, pleasantness, distress and awareness) were identified and explained a total variance of 73%. Informants gave more 'don't know answers' than patients throughout the interview (p = 0.008), especially to questions evaluating cognitions and emotions associated with hallucinations (p = 0.02). CONCLUSIONS: NEVHI is a comprehensive assessment tool, helpful to identify the presence of visual hallucinations and to quantify cognitions, emotions and behaviours associated with hallucinations.

The self-administered 24-item geriatric pain measure (GPM-24-SA): psychometric properties in three European populations of community-dwelling older adults

OBJECTIVE: To explore the feasibility and psychometric properties of a self-administered version of the 24-item Geriatric Pain Measure (GPM-24-SA). DESIGN: Secondary analysis of baseline data from the Prevention in Older People-Assessment in Generalists' practices trial, an international multi-center study of a health-risk appraisal system. PARTICIPANTS: One thousand seventy-two community dwelling nondisabled older adults self-reporting pain from London, UK; Hamburg, Germany; and Solothurn, Switzerland. OUTCOME MEASURES: GPM-24-SA as part of a multidimensional Health Risk Appraisal Questionnaire including self-reported demographic and health-related information. RESULTS: Among the 1,072 subjects, 655 had complete GPM-24-SA data, 404 had 30% missing GPM-24-SA data. In psychometric analyses across the three European populations with complete GPM-24-SA data, the measure exhibited stable internal consistency, good convergent, divergent and discriminant validity, and produced stable pain measurements. However, factor analysis indicated differences in the GPM-24-SA across sites with discrepancies mainly related to items of a single subscale that failed to load appropriately. Analyses including imputation for subjects with assessment of pain in community dwelling older adults. However, because of incomplete response and uncertainty in factor structure, further refinement and psychometric evaluation of the GPM-24-SA is needed before it could be recommended for widespread use.

[Gerodontology consultation in geriatric facilities: general health status (I)]

Dental undertreatment is often seen in the older population. This is particularly true for the elderly living in nursing homes and geriatric hospitals. The progression of chronic diseases results in loss of their independence. They rely on daily support and care due to physical or mental impairment. The visit of a dentist in private praxis becomes difficult or impossible and is a logistic problem. These elderly patients are often not aware of oral and dental problems or these are not addressed. The geriatric hospital Bern, Ziegler, has integrated dental care in the concept of physical rehabilitation of geriatric patients. A total of 139 patients received dental treatment in the years 2005/2006. Their mean age was 83 years, but the segment with > 85 years of age amounted to 46%. The general health examinations reveald multiple and complex disorders. The ASA classification (American Society of Anesthesiologists, Physical Status Classification System) was applied and resulted in 15% = P2 (mild systemic disease, no functional limitation), 47% = P3 (severe systemic disease, definite functional limitations) and 38% = P4 (severe systemic disease, constant threat to life). Eighty-seven of the patients exhibited 3 or more chronic diseases with a prevalence of cardiovascular diseases, musculoskelettal disorders and dementia. Overall the differences between men and women were small, but broncho-pulmonary dieseases were significantly more frequent in women, while men were more often diagnosed with dementia and depression. Verbal communication was limited or not possible with 60% of the patients due to cognitive impairment or aphasia after a stroke. Although the objective treatment need is high, providing dentistry for frail and geriatric patients is characterized by risks due to poor general health conditions, difficulties in communication, limitations in feasibility and lack of adequate aftercare. In order to prevent the problem of undertreatment, elderly independently living people should undergo dental treatment regularly and in time. Training of nurses and doctors of geriatric hospitals in oral hygiene should improve the awareness. A multidisciplinary assessment of geriatric patients should include the oral and dental aspect if they enter the hospital.

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document

OBJECTIVES The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. BACKGROUND A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. METHODS AND RESULTS Two in-person meetings (held in September 2011 in Washington, DC, and in February 2012 in Rotterdam, The Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and noninterventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. CONCLUSIONS This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavors of applying definitions to other transcatheter valve therapies (for example, mitral valve repair).

Measuring mindfulness: first steps towards the development of a comprehensive mindfulness scale

The present study describes the development of and results obtained from the first version of a new mindfulness scale: the Comprehensive Inventory of Mindfulness Experiences beta (CHIME-β). The aim of the present analysis was to investigate two relevant open questions in mindfulness assessment: (1) the coverage of aspects of mindfulness and (2) the type of interrelationships among these aspects. A review of the aspects of mindfulness assessed by eight currently available mindfulness questionnaires led to the identification of nine aspects of mindfulness. The CHIME-β was constructed in order to cover each of these aspects in a balanced way. Initially, principal component and confirmatory factor analyses, as well as reliability and validity analyses, were performed in the entire sample (n = 313) of individuals from the general population and mindfulness-based stress reduction (MBSR) groups. The factor structure that emerged from this analysis was further investigated in meditation-trained individuals (n = 144) who had just completed an MBSR intervention. Results suggested a four-factor structure underlying the nine aspects proposed. The relationship between these mindfulness factors appears to be influenced by the degree of meditation experience. In fact, the mindfulness factors showed a greater interconnectedness among mediation-trained participants. Finally, data suggest that a non-avoidant stance plays a central role in mindfulness, while the capacity to put inner experiences into words may be related to mindfulness rather than a component of the construct.