The clinical applicability of sensor technology with body position detection to combat pressure ulcers in bedridden patients.

INTRODUCTION: Pressure Ulcers (PUs) are a major healthcare issue leading to prolonged hospital stays and decreased quality of life. Monitoring body position changes using sensors could reduce workload, improve turn compliance and decrease PU incidence. METHOD: This systematic review assessed the clinical applicability of different sensor types capable of in-bed body position detection. RESULTS: We included 39 articles. Inertial sensors were most commonly used (n = 14). This sensor type has high accuracy and is equipped with a 2-4 hour turn-interval warning system increasing turn compliance. The second-largest group were piezoresistive (pressure) sensors (n = 12), followed by load sensors (n = 4), piezoelectric sensors (n = 3), radio wave-based sensors (n = 3) and capacitive sensors (n = 3). All sensor types except inertial sensors showed a large variety in the type and number of detected body positions. However, clinically relevant position changes such as trunk rotation and head of bed elevation were not detected or tested. CONCLUSION: Inertial sensors are the benchmark sensor type regarding accuracy and clinical applicability but these sensors have direct patient contact and (re)applying the sensors requires the effort of a nurse. Other sensor types without these disadvantages should be further investigated and developed. We propose the Pressure Ulcer Position System (PUPS) guideline to facilitate this.

International study to develop the WOUND-Q patient-reported outcome measure for all types of chronic wounds.

Patient-reported outcome measures (PROMs) for chronic wounds mainly focus on specific types of wounds. Our team developed the WOUND-Q for use with all types of wounds in any anatomic location. We conducted 60 concept elicitation interviews with patients in Canada, Denmark, the Netherlands, and the United States. Analysis identified concepts of interest to patients and scales were formed and refined through cognitive interviews with 20 patients and input from 26 wound care experts. Scales were translated into Danish and Dutch. An international field-test study collected data from 881 patients (1020 assessments) with chronic wounds. Rasch measurement theory (RMT) analysis was used to refine the scales and examine psychometric properties. RMT analysis supported the reliability and validity of 13 WOUND-Q scales that measure wound characteristics (assessment, discharge, and smell), health-related quality of life (life impact, psychological, sleep impact, and social), experience of care (information, home care nurses, medical team, and office staff), and wound treatment (dressing and suction device). The WOUND-Q can be used to measure outcomes in research and clinical practice from the perspective of patients with any type of wound.

Patient-Reported Outcome Measures in Lymphedema: A Systematic Review and COSMIN Analysis.

BACKGROUND: Lymphedema is a chronic and debilitating condition that affects many cancer survivors. Patient-reported outcome measures (PROMs) can give valuable insight into the impact of lymphedema on a patient's quality of life and can play an essential role in treatment decisions. This study aims to (1) identify PROMs used to assess health-related quality of life (HRQoL) in patients with lymphedema; and (2) assess the quality of the lymphedema-specific PROMs. METHODS: We performed a systematic search to identify articles on lymphedema, quality of life, and PROMs. An overview was created of all PROMs used to assess HRQoL in patients with lymphedema. The methodological quality of the lymphedema-specific PROMs was assessed using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. RESULTS: A total of 235 articles met the inclusion criteria, of which 200 described studies using one or more PROMs as an outcome measure in patients with lymphedema. The other 35 studies described the development and/or validation of a lymphedema-specific PROM. The COSMIN assessment demonstrated that none of these PROMs met all quality standards for development. CONCLUSION: The use of PROMs in lymphedema is increasing; however, based on our findings, we cannot fully support the use of any of the existing instruments. A well-developed lymphedema-specific PROM, based on patient input, is needed to gain better insight into the impact of this condition, and can be used to measure the effect of possible medical and surgical treatments.

International mixed methods study protocol to develop a patient-reported outcome measure for all types of chronic wounds (the WOUND-Q).

INTRODUCTION: Most patient-reported outcome measures (PROM) for chronic wounds are specific to a single wound type (eg, pressure ulcer) or part of the body. A barrier to outcome assessment in wound care and research is the lack of a rigorously designed PROM that can be used across wound types and locations. This mixed method study describes the protocol for an international collaboration to develop and validate a new PROM called the WOUND-Q for adults with chronic wounds. METHODS AND ANALYSIS: In phase I, the qualitative approach of interpretive description is used to elicit concepts important to people with wounds regarding outcome. Participants from Canada, Denmark, the Netherlands, and the USA are aged 18 years and older and have a wound that has lasted 3 months or longer. Interviews are digitally recorded, transcribed and coded. A conceptual framework and preliminary item pool are developed from the qualitative dataset. Draft scales are formed to cover important themes in the conceptual framework. These scales are refined using feedback from people with chronic wounds and wound care experts. After refinement, the scales are translated into Danish and Dutch, following rigorous methods, to prepare for an international field-test study. In phase II, data are collected in Canada, Denmark, the Netherlands, and the USA. An international sample of people with a large variety of chronic wounds complete the WOUND-Q. Rasch Measurement Theory analysis is used to identify the best subset of items to retain for each scale and to examine reliability and validity. ETHICS AND DISSEMINATION: This study is coordinated at Brigham and Women's Hospital (Boston, USA). Ethics board approval was received at each participating site for both study phases. Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.

Outcome predictors for wound healing in patients with a diabetic foot ulcer.

The aim of this study was to identify diabetic foot ulcer (DFU) patients at risk for the development of a hard-to-heal wound. This is a post-hoc analysis of a prospective cohort study including a total of 208 patients with a DFU. The primary endpoints were time to healing and the development of a hard-to-heal-wound. Univariable and multivariable logistic and Cox regression analysis were used to study the associations of patient characteristics with the primary endpoints. The number of previous DFUs [odds ratio (OR): 1.42, 95% confidence interval (CI): 1.01-1.99, P = .04], University of Texas (UT) classification grade 2 (OR: 2.93, 95% CI: 1.27-6.72, P = .01), UT classification grade 3 (OR: 2.80, 95% CI: 1.17-6.71, P = .02), and a diagnosis of foot stand deformation (OR: 1.54, 95% CI: 0.77-3.08, P = .05) were significantly associated with the development of a hard-to-heal wound. Only UT classification grade 3 (HR: 0.61, 95% CI: 0.41-0.90, P = .01) was associated with time to healing. The number of previous DFUs, UT classification grade, and a diagnosis of foot deformation are significantly associated with development of a hard-to-heal wound in patients with a DFU. The only predictor significantly associated with time to healing was UT classification grade 3. These patient characteristics can be used to identify patients at risk for the development of hard-to-heal wounds, who might need an early intervention to prevent wound problems.

Performance indicators; the association between the quality of preventive care and the prevalence of hospital-acquired skin lesions in adult hospital patients.

AIM: The aim of this study was to explore the relation between the occurrence of pressure ulcers or incontinence dermatitis and the quality of preventive care provided. BACKGROUND: Performance measurements using indicators has become standard practice in recent years. The prevalence of pressure ulcers with or without incontinence dermatitis is widely used as an indicator of the quality of nursing care. DESIGN: Matched case-control study. METHODS: We collected information on 132 patients selected from a prevalence study (April 2010). We matched 88 controls to 44 cases, controlling for duration of hospitalization and type of nursing unit. We wrote 132 patient reports, including patient factors and process criteria, using a chart review. Five expert teams assessed nine processes of care with guideline-based review criteria. The expert teams assessed the reports blinded for outcome. The care process was assessed using a four-point quality score ranging from optimal care to suboptimal care. RESULTS: In a multivariable analysis using conditional logistic regression, the pressure ulcer risk score and the quality score were associated with a poor outcome after adjustment for type of illness, age, care needs prior to hospitalization, intensive care stay during admission and the number of care problems. CONCLUSION: We found that the development of pressure ulcers or incontinence dermatitis was associated with the quality of the preventive care process, indicating that variation in their prevalence reflects variation in the quality of care.

Quality of measurements of acute surgical and traumatic wounds using a digital wound-analysing tool.

The aim of this study was to assess the reliability of measurements using a wound-analysing tool and their interpretability. Wound surface areas and tissue types, such as granulation, slough and necrosis, in twenty digital photographs were measured using a specific software program. The ratio of these tissue types in a wound was calculated using a wound profile. We calculated the intraclass coefficient or κ for reliability, standard error of measurement (SEM) and smallest detectable change (SDC). The inter-rater reliability intraclass correlation coefficient (ICC) was 0·99 for surface area, 0·76 for granulation, 0·67 for slough and 0·22 for necrosis. The profiles gave an overall κ of 0·16. For test-retest reliability, the ICC was 0·99 for surface area, 0·81 for granulation, 0·80 for slough and 0·97 for necrosis. The agreement of the applied profiles in the test-retest was 66% (40-100). SEM and SDC for surface area were 0·10/0·27; for granulation, 6·88/19·08; for slough, 7·17/19·87; and for necrosis, 0·35/0·98, respectively. Measuring wound surface area and tissue types by means of digital photo analysis is a reliable and applicable method for monitoring wound healing in acute wounds in daily practice as well as in research.

Measuring Quality Improvement in Acute Ischemic Stroke Care: Interrupted Time Series Analysis of Door-to-Needle Time.

BACKGROUND: In patients with acute ischemic stroke, early treatment with recombinant tissue plasminogen activator (rtPA) improves functional outcome by effectively reducing disability and dependency. Timely thrombolysis, within 1 h, is a vital aspect of acute stroke treatment, and is reflected in the widely used performance indicator 'door-to-needle time' (DNT). DNT measures the time from the moment the patient enters the emergency department until he/she receives intravenous rtPA. The purpose of the study was to measure quality improvement from the first implementation of thrombolysis in stroke patients in a university hospital in the Netherlands. We further aimed to identify specific interventions that affect DNT. METHODS: We included all patients with acute ischemic stroke consecutively admitted to a large university hospital in the Netherlands between January 2006 and December 2012, and focused on those treated with thrombolytic therapy on admission. Data were collected routinely for research purposes and internal quality measurement (the Erasmus Stroke Study). We used a retrospective interrupted time series design to study the trend in DNT, analyzed by means of segmented regression. RESULTS: Between January 2006 and December 2012, 1,703 patients with ischemic stroke were admitted and 262 (17%) were treated with rtPA. Patients treated with thrombolysis were on average 63 years old at the time of the stroke and 52% were male. Mean age (p = 0.58) and sex distribution (p = 0.98) did not change over the years. The proportion treated with thrombolysis increased from 5% in 2006 to 22% in 2012. In 2006, none of the patients were treated within 1 h. In 2012, this had increased to 81%. In a logistic regression analysis, this trend was significant (OR 1.6 per year, CI 1.4-1.8). The median DNT was reduced from 75 min in 2006 to 45 min in 2012 (p < 0.001 in a linear regression model). In this period, a 12% annual decrease in DNT was achieved (CI from 16 to 8%). We could not find a significant association between any specific intervention and the trend in DNT. CONCLUSION AND IMPLICATIONS: The DNT steadily improved from the first implementation of thrombolysis. Specific explanations for this improvement require further study, and may relate to the combined impact of a series of structural and logistic interventions. Our results support the use of performance measures for internal communication. Median DNT should be used on a monthly or quarterly basis to inform all professionals treating stroke patient of their achievements.

[Transparency: can the effect of governmental surveillance be quantified?]. / Transparantie: is het effect van toezicht te meten?

OBJECTIVE: To explore the feasibility of using existing data to measure the impact of surveillance by the Health Care Inspectorate (IGZ) on public health. DESIGN: Retrospective, descriptive. METHOD: We examined the magnitude of the health problems of suicide, pressure ulcers and medication errors before and after surveillance by the IGZ. To do this, we used data from the IGZ, external data files and data from the literature. In addition, we assessed definitions and possible underreporting and overreporting of the results. We then determined whether an estimate could be made of the effect of the surveillance on the magnitude of the health problem using a time series design. RESULTS: Medication errors were not sufficiently defined to measure an effect of surveillance. The prevalence of pressure ulcers and the incidence of suicide could be quantified reliably using data from the Inspectorate. A time series design showed that both health problems declined after surveillance by the Inspectorate. However, these trends could not be attributed to the surveillance since there was no insight into the external factors that might have played a role. CONCLUSION: In case of clearly defined health problems, the extent of the problem can be defined using IGZ data and trends can be observed using a time series design. However, establishing a causal relationship between supervision and observed trends requires an experimental research design, such as a prospective randomized study or a stepped wedge design.

Random variation and rankability of hospitals using outcome indicators.

OBJECTIVE: There is a growing focus on quality and safety in healthcare. Outcome indicators are increasingly used to compare hospital performance and to rank hospitals, but the reliability of ranking (rankability) is under debate. This study aims to quantify the rankability of several outcome indicators of hospital performance currently used by the Dutch government. METHODS: From 52 indicators used by the Netherlands Inspectorate, the authors selected nine outcome indicators presenting a fraction and absolute numbers. Of these indicators, four were combined into two, resulting in seven indicators for analysis. The official data of 97 Dutch hospitals for the year 2007 were used. Uncertainty in the observed outcomes within the hospitals (within hospital variance, σ(2)) was estimated using fixed effect logistic regression models. Heterogeneity (between hospital variance, τ(2)) was measured with random effect logistic regression models. Subsequently, the rankability was calculated by relating heterogeneity to uncertainty within and between hospitals (τ(2)/(τ(2) +median σ(2))). RESULTS: Sample sizes varied but were typically around 200 per hospital (range of median 90-277) with a median of 2-21 cases, causing a substantial uncertainty in outcomes per hospital. Although fourfold to eightfold differences between hospitals were noted, the uncertainty within hospitals caused a poor (<50%) rankability in three indicators and moderate rankability (50-75%) in the other four indicators. CONCLUSION: The currently used Dutch outcome indicators are not suitable for ranking hospitals. When judging hospital quality the influence of random variation must be accounted for to avoid overinterpretation of the numbers in the quest for more transparency in healthcare. Adequate sample size is a prerequisite in attempting reliable ranking.

[Performance indicators: the role of 'task uncertainty']. / Prestatie-indicatoren: de rol van taakonzekerheid.

In recent years, quality of care has occupied a prominent place in health care. Different performance indicators are used to assess the quality of care. There is some debate about the value of outcome versus process indicators in measuring aspects of quality of care. Van de Geer et al. carried out a field study in a medical rehabilitation centre in the Netherlands in which four low task uncertainty teams ('hand trauma', 'heart failure', 'amputation', 'chronic pain'), and four high task uncertainty teams ('children with developmental coordination disorder', 'Parkinson disease', 'young children (aged 1-4 years) with developmental disorders', 'acquired brain injuries') participated in the development of performance indicators. They concluded that task uncertainty is an important factor to be considered in the development of indicators, and in the choice between the use of process and outcome indicators. Notably, outcome indicators are only useful in health problems with little variation and little task uncertainty, while many tasks are complex and uncertain. The participation of health care professionals in the development of quality indicators is, therefore, very important.

Reliable assessment of sedation level in routine clinical practice by adding an instruction to the Ramsay Scale.

OBJECTIVE: The level of sedation in mechanically ventilated patients is most often assessed with the Ramsay Scale. Its reliability, however, has never been evaluated in a large group of professionals using the Ramsay Scale in daily clinical practice, while differences in interpretations among professionals have been indicated. We developed a written stepwise instruction to optimize the inter-observer reliability of the Ramsay Scale within a large group of Intensive Care (IC) nurses. DESIGN: Reliability study. SETTING: The Intensive Care Cardiology (ICC) and the Intensive Care Thoracic surgery (ICT) units of a university hospital. PATIENTS AND PARTICIPANTS: The study population comprises randomly selected mechanically ventilated patients and IC nurses with a bachelor's degree in Nursing and an IC certification. In total 2x105 Ramsay measures were performed in 45 patients by 24 nurses. MEASUREMENT AND RESULTS: Analysis of 105 paired Ramsay scores showed an almost perfect agreement between observers (weighted K (Kw)=0.90). In both ICC patients and ICT patients, agreement between Ramsay scores was high (Kw=0.95 and Kw=0.86, respectively). CONCLUSION: By using a written stepwise instruction with the Ramsay Scale, the inter-observer reliability of the level of sedation measurements, performed in daily clinical practice within a large team of IC nurses, proved to be almost perfect.