Do pressure ulcer risk assessment scales improve clinical practice?

Standardized assessment instruments are deemed important for estimating pressure ulcer risk. Today, more than 40 so-called pressure ulcer risk assessment scales are available but still there is an ongoing debate about their usefulness. From a measurement point of view pressure ulcer (PU) risk assessment scales have serious limitations. Empirical evidence supporting the validity of PU risk assessment scale scores is weak and obtained scores contain varying amounts of measurement error. The concept of pressure ulcer risk is strongly related to the general health status and severity of illness. A clinical impact due do the application of these scales could also not be demonstrated. It is questionable whether completion of standardized pressure ulcer risk scales in clinical practice is really needed

Falls prevention for the elderly

Background: An ageing population, a growing prevalence of chronic diseases and limited financial resources for health care underpin the importance of prevention of disabling health disorders and care dependency in the elderly. A wide variety of measures is generally available for the prevention of falls and fall-related injuries. The spectrum ranges from diagnostic procedures for identifying individuals at risk of falling to complex interventions for the removal or reduction of identified risk factors. However, the clinical and economic effectiveness of the majority of recommended strategies for fall prevention is unclear. Against this background, the literature analyses in this HTA report aim to support decision-making for effective and efficient fall prevention.Research questions: The pivotal research question addresses the effectiveness of single interventions and complex programmes for the prevention of falls and fall-related injuries. The target population are the elderly (> 60 years), living in their own housing or in long term care facilities. Further research questions refer to the cost-effectiveness of fall prevention measures, and their ethical, social and legal implications. Methods: Systematic literature searches were performed in 31 databases covering the publication period from January 2003 to January 2010. While the effectiveness of interventions is solely assessed on the basis of randomised controlled trials (RCT), the assessment of the effectiveness of diagnostic procedures also considers prospective accuracy studies. In order to clarify social, ethical and legal aspects all studies deemed relevant with regard to content were taken into consideration, irrespective of their study design. Study selection and critical appraisal were conducted by two independent assessors. Due to clinical heterogeneity of the studies no meta-analyses were performed.Results: Out of 12,000 references retrieved by literature searches, 184 meet the inclusion criteria. However, to a variable degree the validity of their results must be rated as compromised due to different biasing factors. In summary, it appears that the performance of tests or the application of parameters to identify individuals at risk of falling yields little or no clinically relevant information. Positive effects of exercise interventions may be expected in relatively young and healthy seniors, while studies indicate opposite effects in the fragile elderly. For this specific vulnerable population the modification of the housing environment shows protective effects. A low number of studies, low quality of studies or inconsistent results lead to the conclusion that the effectiveness of the following interventions has to be rated unclear yet: correction of vision disorders, modification of psychotropic medication, vitamin D supplementation, nutritional supplements, psychological interventions, education of nursing personnel, multiple and multifactorial programs as well as the application of hip protectors. For the context of the German health care system the economic evaluations of fall prevention retrieved by the literature searches yield very few useful results. Cost-effectiveness calculations of fall prevention are mostly based on weak effectiveness data as well as on epidemiological and cost data from foreign health care systems. Ethical analysis demonstrates ambivalent views of the target population concerning fall risk and the necessity of fall prevention. The willingness to take up preventive measures depends on a variety of personal factors, the quality of information, guidance and decision-making, the prevention program itself and social support. The analysis of papers regarding legal issues shows three main challenges: the uncertainty of which standard of care has to be expected with regard to fall prevention, the necessity to consider the specific conditions of every single case when measures for fall prevention are applied, and the difficulty to balance the rights to autonomous decision making and physical integrity. Discussion and conclusions: The assessment of clinical effectiveness of interventions for fall prevention is complicated by inherent methodological problems (esp. absence of blinding) and meaningful clinical heterogeneity of available studies. Therefore meta-analyses are not appropriate, and single study results are difficult to interpret. Both problems also impair the informative value of economic analyses. With this background it has to be stated that current recommendations regarding fall prevention in the elderly are not fully supported by scientific evidence. In particular, for the generation of new recommendations the dependency of probable effects on specific characteristics of the target populations or care settings should be taken into consideration. This also applies to the variable factors influencing the willingness of the target population to take up and pursue preventive measures. In the planning of future studies equal weight should be placed on methodological rigour (freedom from biases) and transferability of results into routine care. Economic analyses require input of German data, either in form of a “piggy back study“ or in form of a modelling study that reflects the structures of the German health care system and is based on German epidemiological and cost data

Enhancing SKIN health and safety in aged CARE (SKINCARE Trial): a study protocol for an exploratory cluster-randomized pragmatic trial

Background: Aged long-term care receivers are affected by various adverse skin conditions like pressure ulcers, incontinence-associated dermatitis, dryness, intertrigo, and many more. Prevention of these skin problems and the provision of general hygiene and skin care activities are key areas of nursing practice. Numerous condition-specific guidelines are available and are implemented separately. On the other hand, there is huge overlap in terms of etiology, pathogenesis, and prevention of the skin conditions mentioned above. This leads to fragmented practice neglecting shared etiologies and prevention and treatment principles. Methods: The overall aims of this trial are to test the feasibility and to estimate possible effects of the implementation of a comprehensive skin care and prevention strategy targeting main nursing-relevant skin problems at the same time. A two-arm cluster-randomized controlled trial will be performed in 20 nursing homes randomly selected from the population of nursing homes of the state of Berlin, comparing skin care according to the skin care and prevention strategy with standard skin care. Discussion: It is expected that the implementation of this evidence-based skin care and prevention strategy will reduce the incidence of pressure ulcers, incontinence dermatitis, and other skin problems frequently related to care dependency. This trial will benefit individual patients and aged nursing home residents in general given the high prevalence and incidence of the addressed skin conditions. Findings of this exploratory trial may lay the foundation for a change in the development and evaluation of clinical standards and practices in general as it moves the perspective from individual conditions to a more comprehensive view on overlapping or coexisting health problems, in this case common skin conditions, in old-age long-term care receivers

Clinical and virological characteristics of hospitalised COVID-19 patients in a German tertiary care centre during the first wave of the SARS-CoV-2 pandemic: a prospective observational study

Purpose: Adequate patient allocation is pivotal for optimal resource management in strained healthcare systems, and requires detailed knowledge of clinical and virological disease trajectories. The purpose of this work was to identify risk factors associated with need for invasive mechanical ventilation (IMV), to analyse viral kinetics in patients with and without IMV and to provide a comprehensive description of clinical course. Methods: A cohort of 168 hospitalised adult COVID-19 patients enrolled in a prospective observational study at a large European tertiary care centre was analysed. Results: Forty-four per cent (71/161) of patients required invasive mechanical ventilation (IMV). Shorter duration of symptoms before admission (aOR 1.22 per day less, 95% CI 1.10-1.37, p < 0.01) and history of hypertension (aOR 5.55, 95% CI 2.00-16.82, p < 0.01) were associated with need for IMV. Patients on IMV had higher maximal concentrations, slower decline rates, and longer shedding of SARS-CoV-2 than non-IMV patients (33 days, IQR 26-46.75, vs 18 days, IQR 16-46.75, respectively, p < 0.01). Median duration of hospitalisation was 9 days (IQR 6-15.5) for non-IMV and 49.5 days (IQR 36.8-82.5) for IMV patients. Conclusions: Our results indicate a short duration of symptoms before admission as a risk factor for severe disease that merits further investigation and different viral load kinetics in severely affected patients. Median duration of hospitalisation of IMV patients was longer than described for acute respiratory distress syndrome unrelated to COVID-19

analyses for the indirect and direct appraisal of the clinical benefits of standardised risk assessment compared to nurses' clinical judgement alone

Einleitung Leitlinienempfehlungen variieren dahingehend, inwieweit Pflegende bei der Dekubitusrisikoeinschätzung Risikoskalen verwenden sollten. Um die Evidenzlage für die indirekte und direkte Bewertung des klinischen Nutzens dieser Instrumente zu verbessern, wurden folgende Fragestellungen untersucht: (1) Wie groß ist die diagnostische Genauigkeit von Risikoskalen bei der Identifizierung dekubitusgefährdeter Patienten im Vergleich zur Pflegeabhängigkeitsskala (PAS), einem generischen pflegebezogenen Assessmentinstrument? (2) Welche Patientenmerkmale berücksichtigen Pflegende bei der klinischen Einschätzung des Dekubitusrisikos von Krankenhauspatienten? (3) Welche Effekte hat die Anwendung einer Risikoskala gegenüber der klinischen Risikoeinschätzung auf die Dekubitusinzidenz von Krankenhauspatienten? Methodik (Zu 1) Auf der Basis der Daten von zwei Querschnittstudien mit Krankenhauspatienten wurde die diagnostische Genauigkeit verschiedener Risikoskalen und der PAS bei der Identifizierung dekubitusgefährdeter Patienten ermittelt. (Zu 2) In einer „mixed methods“-Studie wurden quantitative Daten zu den Prädiktoren der klinischen Risikoeinschätzung von Pflegenden mit Interviewdaten zur klinischen Einschätzung trianguliert. (Zu 3) Basierend auf einer kritischen Analyse publizierter randomisiert-kontrollierter Studien (RCT) zu der Forschungsfrage wurde ein methodisch robustes Cluster-RCT zum Vergleich der Braden-Skala mit der klinischen Einschätzung hinsichtlich der Effekte auf Dekubitusinzidenz bei Krankenhauspatienten geplant. Ergebnisse (Zu 1) In beiden Studien erwies sich die diagnostische Genauigkeit der PAS als ähnlich gut bzw. schlecht wie die der jeweils am besten diskriminierenden Risikoskala. (Zu 2) Bei der klinischen Einschätzung berücksichtigen Pflegende wichtige Risikofaktoren, aber auch protektive Faktoren, insbesondere die Selbstpflegefähigkeiten von Patienten. Einige Unsicherheiten in der Interpretation von Risikofaktoren wurden deutlich. (Zu 3) Verfügbare RCT (n=2) zeigen keine signifikanten klinischen Effekte für die Anwendung einer Risikoskala, jedoch ist ihre Beweiskraft stark limitiert. Das geplante methodisch robuste Cluster-RCT erwies sich wegen eines extrem hohen erforderlichen Stichprobenumfangs (>900 Cluster und >100.000 Patienten) als nicht durchführbar. Die indirekte Nutzenbewertung mittels sogenannter „evidence linkages“ wurde als bevorzugter alternativer Evaluationsansatz identifiziert. Hierfür sind jedoch einzelne Komponenten der Risikoeinschätzungs-Präventions-Wirkungskette noch besser zu untersuchen. Schlussfolgerung Die Ergebnisse liefern keine Hinweise auf eine Über- oder Unterlegenheit von Risikoskalen hinsichtlich des Informationsertrags im Vergleich zu anderen Einschätzungsverfahren (PAS, klinische Einschätzung). Der klinische Nutzen von Risikoskalen gegenüber der klinischen Einschätzung bleibt jedoch offen und lässt sich vermutlich nicht direkt mittels robuster experimenteller Untersuchungen bestimmen. Indirekte Nutzenbewertungen basierend auf dem „evidence linkages“-Ansatz erscheinen dagegen als machbar und geeignet, valide Effektschätzungen zu generieren. Dieser Ansatz bietet zudem einen Rahmen für die weitere Evidenzbildung zu wichtigen Komponenten der Risikoeinschätzungs-Präventions-Wirkungskette.Introduction Guideline recommendations vary concerning the role of pressure ulcer (PU) risk assessment scales (PURAS) in nurses’ risk assessment. To improve the evidence for indirect and direct assessment of these tools’ clinical benefits, following research questions were addressed: (1) What is the diagnostic accuracy of PURAS in identifying patients at PU compared to the Care Dependency Scale (CDS), a generic nursing assessment tool? (2) Which patient characteristics guide nurses’ clinical judgement on PU risk? (3) What are the effects of PURAS on the incidence of PUs in hospital patients compared to nurses’ clinical judgement? Methods (Ad 1) Based on cross-sectional data from two hospital samples, the diagnostic accuracy of several PURAS and the CDS was estimated. (Ad 2) Mixed methods study: Quantitative data on predictors of nurses’ clinical judgement on PU risk were triangulated with interview data on nurses’ clinical judgement. (Ad 3) Based on a critical review of available randomised-controlled trials (RCT) targeting the research question of interest, a methodologically robust cluster-RCT (cRCT) was planned to assess the Braden Scale’s impact on PU incidence compared to nurses’ clinical judgement. Results (Ad 1) In both studies, the CDS showed similar diagnostic accuracy compared to either best discriminating PURAS. (Ad 2) For their clinical judgement, nurses draw on well-established risk factors, but also on protective conditions, mainly patients’ self-care abilities. Some uncertainties concerning nurses’ interpretation of risk factors were noted. (Ad 3) Available trials (n=2) do not indicate a significant effect of PURAS on PU incidence, but results are limited through serious methodological weaknesses. A methodologically robust cRCT was found to be infeasible due to the sample size needed (>900 clusters, >100,000 patients). Alternatively, indirect assessment of clinical benefits using evidence linkages seems to be a promising way for further evaluation. However, to apply this method, more robust empirical data on single attributes of the risk assessment prevention pathway are needed. Conclusions With respect to the retrieval of diagnostic information, PURAS seem to be neither superior nor inferior to other risk assessment methods (CDS, clinical judgement). However, the clinical benefits of PURAS compared to nurses’ clinical judgement remain unclear and may be not amenable to direct evaluation using robust experimental trials. Instead, indirect evaluation using evidence linkages appears to be a feasible and suitable method for establishing valid effect estimates. This approach also offers an analytical framework for future research targeting the risk assessment-prevention pathway