The characteristics of leadership and their effectiveness in quality management in healthcare - A systematic literature review and a content analysis.

Effective quality leadership is identified as a critical factor for organisational success. Leadership style has an important role in the implementation of quality management. This systematic review describes the characteristics of leadership in quality management in healthcare, and analyses their association with successful or unsuccessful quality management by using content analysis. Papers published in peer-reviewed journals between 2011 and June 2023 were selected by exploring the Abi/Inform, Business Source Complete, Cinahl, Pubmed and Web of Science electronic databases. Altogether 3014 records were found. PRISMA-protocol was used for selection of studies. 12 original and three review articles were included. Six leadership characteristics were identified that were linked to successful or unsuccessful implementation of quality management. The six categories were strategic, knowledge-oriented, value-based, supportive, participatory and communicative leadership. Supercategories and subcategories of successful and unsuccessful implementation are described. The results can be used to identify the leadership characteristics that promote successful quality management in healthcare organisations. In education for leaders and managers, attention should be in the characteristics and style of leadership and their impact on the effectiveness of quality management.

Medical Device Safety Training by Using Quick Response Codes and Extended Reality-Based Technologies.

This article describes the results of three different study settings where the use of QR codes and XR technologies were tested for medical device training among 132 social and health care professionals. Data from three types of learning events and different contents of training indicated that the professionals considered these novel technologies both beneficial for learning and useful in their working environments for training safe use of medical devices. Based on the collected data, these technologies can be considered prospective options for medical device training.

Extended Reality Is Underutilized in Medical Device Training: A Descriptive Literature Review.

This descriptive review provides a synthesis of existing literature about the use of extended reality (XR) including virtual (VR) and augmented reality (AR) technology solutions for competence assurance, training and orientation regarding digital skills and medical device training. From the literature, only few original studies were recognized with a study question or aim to assess medical device training as the target of virtual training modalities. XR methods could provide potential useful solutions to improve medical device competence. Based on the literature, it was evident that further studies are required to research the possibilities of XR technologies to improve medical device training.

Medical Device Incident Reports by Professional Users in Finland 2014-2021.

Medical Device incident reporting is a legal obligation for professional users in Finland. We analyzed all medical device incident reports recorded into the national incident repository from January 2014 to August 2021. Among the total 5,897 records, annual numbers of incident reports varied between 463 and 1,190. Approximately 80% of the medical device incident reports were near misses, 18.7% were person injuries and 1.3% deaths. The number of annual medical device incident reports between hospital districts varied more than expected when related to the population of catchment area. There was a tendency towards lesser reports per population from smaller hospital districts. In conclusion, medical device incident reporting activity of the professional user varied both annually and geographically. A high number of incidents caused person injuries or even death, which arouses safety concerns. A further analysis is required to explore the causes behind our findings.

Electronic Health Records on the Top of Medical Device Incident Reports.

Medical Device incident reporting is a legal obligation for professional users in Finland. We analyzed all medical device incident reports recorded into the national incident repository from January 2014 to August 2021. Almost 30% of the total of 5,897 recorded incidents were caused by top ten devices, of which electronic health records were the most common (332 incidents). High number of incidents caused by electronic health records arouses safety concerns. A further analysis is required to explore the causes of findings.

The Need for Surgical Safety Checklists in Neurosurgery Now and in the Future-A Systematic Review.

Safety checklists have been studied among various surgical patient groups, but evidence of their benefits in neurosurgery remains sparse. Since the implementation of the World Health Organization's Surgical Safety Checklist, their use has become widespread. The aim of this review was to systematically review the state of the literature on surgical safety checklists in neurosurgery. Also, in the new era of robotics and artificial intelligence, there is a need to re-evaluate patient safety procedures in neurosurgery. A systematic review was conducted on PubMed, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials, Embase, and MEDLINE for articles published between 2008 and 2016 using MeSH (medical subject heading) terms and keywords describing postoperative complications and surgical adverse events, and some additional searches were carried out until January 2019. Twenty-six original studies or reviews were eligible for this review. They were categorized into studies with patient-related outcomes, personnel-related outcomes, or previous reviews. Checklist use in neurosurgery was found to reduce hospital-acquired infectious complications and to enhance operating room safety culture. Checklists seem to improve patient safety in neurosurgery, although the amount of evidence is still limited. Despite their shortcomings, checklists are here to stay, and new research is required to update checklists to meet the requirements of the transforming working environment of the neurosurgery operating room.

Analysis of hospital infection register indicates that the implementation of WHO surgical safety checklist has an impact on early postoperative neurosurgical infections.

WHO surgical safety checklist has been proven to reduce postoperative infections in several studies. The aim of our study was to focus on surgical site infections (SSIs) after neurosurgical operations, and to determine whether the checklist implementation would have an impact on the reported SSIs. We used hospital-acquired infection (HAI) register to evaluate the effects of WHO surgical safety checklist in neurosurgery. The HAI register was searched for superficial and deep SSIs, deep organ SSIs, infections following orthopaedic implantation, and other surgical infections of 4678 neurosurgical patients operated on between 2007 and 2011. The data analysis consisted of 95 and 104 neurosurgical postoperative infections before and after the checklist implementation. Time from operation to infection was shorter before than after checklist implementation (p = 0.039), indicating a positive effect of the checklist use in the onset of early HAIs. The overall incidence of SSIs of all neurosurgical patients did not differ (4.1% and 4.5%, respectively) and no differences were noticed in the incidences of the subgroups of superficial SSIs, deep SSIs, and deep organ SSIs. The reduction in early postoperative infection rate along with checklist implementation, but not in the long run indicates the complexity of preventing HAIs in neurosurgical patients and need for a multistep infection control approach.

SUCCESSFUL IMPLEMENTATION OF LEAN AS A MANAGERIAL PRINCIPLE IN HEALTH CARE: A CONCEPTUAL ANALYSIS FROM SYSTEMATIC LITERATURE REVIEW.

PURPOSE: The aim of this study was to identify and analyze the characteristics of leadership and management associated with a successful Lean thinking adaptation in healthcare. DESIGN: A systematic literature review was undertaken using electronic databases: PubMed, PubMed Systematic Review, ABI/INFORM, Business Source Complete, Emerald, JBI, and Cinahl. Inclusion criteria were: (i) a description of Lean management or leadership in health care, (ii) a reference to Lean thinking, (iii) a peer-reviewed original research article or a literature review, and (iv) a full text article available in English. Among the 1,754 peer-reviewed articles identified, nine original articles and three systematic reviews met the inclusion criteria. Data on informants, methods, and settings were extracted and collated. Content analysis was used to conduct a review of the nine original studies describing and analyzing the success factors of Lean adaptation. The characteristics of leadership and management were analyzed by using the concept of a managerial windshield that divides leadership and management into four ontological dimensions: activities, style, focus, and purpose, each with typical developmental stages of skills and capabilities. The current study has some limitations: some papers from the journals not indexed in the searched databases may have been overlooked and the literature searches were carried out only for a 5-year period. FINDINGS: Considering the results using the windshield concept emphasizes the philosophy, principles, and tools of Lean thinking. Lean leadership and management factors in health care were mainly conceptualized as skills and capabilities such as problem solving, making changes occur, empowering, communicating, coaching, supporting, facilitating, being democratic, organizational learning, and organizational success, all of which represented middle-stage or advanced managerial skills and capabilities. PRACTICAL IMPLICATIONS: A conceptual analysis of systematically reviewed studies of Lean leadership and management point to certain traits as being typical when adapting Lean thinking to health care. The concept of a managerial windshield is useful when categorizing and analyzing essential managerial skills and capabilities for Lean implementation. Findings are beneficial when learning and educating the skills required for Lean transformation in healthcare organizations.

IMPLEMENTING HEALTH TECHNOLOGY ASSESSMENT-BASED RECOMMENDATIONS IN FINLAND: MANAGED UPTAKE OF MEDICAL METHODS.

OBJECTIVES: The Managed Uptake of Medical Methods Program (MUMM) started 10 years ago as a joint venture of the Finnish Office for Health Technology Assessment (Finohta) and the twenty hospital districts in Finland. The aim is to offer information on the effectiveness, safety, organizational effects, and costs of new medical methods to support decisions concerning their uptake in secondary care. In this article, we discuss the successes and challenges of implementing the MUMM program. METHODS: A study of awareness and use of five MUMM recommendations for various medical specialties with short-form web-based surveys to hospitals. RESULTS: The recommendations were noticed and considered relevant. In overall assessment they received a mean rating of 8.4 (range: 4 to 10). Two thirds of the respondents thought MUMM recommendations were useful for practice, but only a third had actually used them in decision making. CONCLUSIONS: HTA-based MUMM recommendations were well received by physicians but in practice they are less used than clinical practice guidelines. Short-form electronic surveys were a useful way of gathering information about awareness and implementation. The surveys also functioned as another method of informing key physicians about the recommendations.

Analysis of neurosurgical reoperations: use of a surgical checklist and reduction of infection-related and preventable complication-related reoperations.

OBJECT: Use of the WHO surgical checklist has been proven to reduce surgical morbidity and mortality, but its effect on surgical complications requiring reoperation has not been previously studied. The aim of this study was to determine whether the use of the WHO surgical checklist would have an impact on the number and causes of neurosurgical complications leading to a reoperation. METHODS: The authors retrospectively gathered information on all neurosurgical reoperations using hospital discharge data as well as the operations and procedures registry, and tracked all primary neurosurgical operations (n = 175) preceding a complication-related reoperation from 2007 to 2011. There were a total of 5418 neurosurgical operations during the study period. For further analysis of electronic patient records, the primary operations were divided into 2 groups based on the time of the WHO surgical checklist implementation in the authors' unit: 103 operations before and 72 after the introduction of the checklist. Observed adverse events and reoperations were categorized as preventable or unpreventable, and the actual use of the checklist during each operation was recorded. RESULTS: The overall rate of preventable complication-related neurosurgical reoperations decreased from 3.3% (95% CI 2.7%-4.0%) to 2.0% (95% CI 1.5%-2.6%) after the checklist implementation. The reoperations were mainly due to wound infections, 46% before and 39% after the checklist. All infection-related reoperations proportioned to all neurosurgical operations (2.5% before vs 1.6% after checklist implementation) showed a significant reduction (p = 0.02) after the implementation of the checklist. In particular, there was a significant decrease (p = 0.006) in the rate of preventable infections associated with reoperations, i.e., 2.2% before versus 1.2% after checklist implementation. The overall adherence to checklist use (the "time out" phase) in neurosurgical operations was 78%, and adherence was 70% in primary operations preceding a complication-related reoperation regarded as preventable. CONCLUSIONS: The implementation of the WHO surgical checklist in neurosurgery was associated with a decrease in complication-related reoperations, especially those due to preventable infection complications, the majority of which were wound infections. The adherence to checklist use in individual operations after the checklist implementation did not appear to have an impact on the results.

A systematic review and cost analysis of robot-assisted hysterectomy in malignant and benign conditions.

In order to assess the effectiveness and costs of robot-assisted hysterectomy compared with conventional techniques we reviewed the literature separately for benign and malignant conditions, and conducted a cost analysis for different techniques of hysterectomy from a hospital economic database. Unlimited systematic literature search of Medline, Cochrane and CRD databases produced only two randomized trials, both for benign conditions. For the outcome assessment, data from two HTA reports, one systematic review, and 16 original articles were extracted and analyzed. Furthermore, one cost modelling and 13 original cost studies were analyzed. In malignant conditions, less blood loss, fewer complications and a shorter hospital stay were considered as the main advantages of robot-assisted surgery, like any mini-invasive technique when compared to open surgery. There were no significant differences between the techniques regarding oncological outcomes. When compared to laparoscopic hysterectomy, the main benefit of robot-assistance was a shorter learning curve associated with fewer conversions but the length of robotic operation was often longer. In benign conditions, no clinically significant differences were reported and vaginal hysterectomy was considered the optimal choice when feasible. According to Finnish data, the costs of robot-assisted hysterectomies were 1.5-3 times higher than the costs of conventional techniques. In benign conditions the difference in cost was highest. Because of expensive disposable supplies, unit costs were high regardless of the annual number of robotic operations. Hence, in the current distribution of cost pattern, economical effectiveness cannot be markedly improved by increasing the volume of robotic surgery.

Amputations and socioeconomic position among persons with diabetes mellitus, a population-based register study.

OBJECTIVE: Low socioeconomic position is a known health risk. Our study aims to evaluate the association between socioeconomic position (SEP) and lower limb amputations among persons with diabetes mellitus. DESIGN: Population-based register study. SETTING: Finland, nationwide individual-level data. PARTICIPANTS: All persons in Finland with any record of diabetes in the national health and population registers from 1991 to 2007 (FinDM II database). METHODS: Three outcome indicators were measured: the incidence of first major amputation, the ratio of first minor/major amputations and the 2-year survival with preserved leg after the first minor amputation. SEP was measured using income fifths. The data were analysed using Poisson and Cox regression as well as age-standardised ratios. RESULTS: The risk ratio of the first major amputation in the lowest SEP group was 2.16 (95% CI 1.95 to 2.38) times higher than the risk in the highest SEP group (p<0.001). The incidence of first major amputation decreased by more than 50% in all SEP groups from 1993 to 2007, but there was a stronger relative decrease in the highest compared with the lowest SEP group (p=0.0053). Likewise, a clear gradient was detected in the ratio of first minor/major amputations: the higher the SEP group, the higher the ratio. After the first minor amputation, the 2-year and 10-year amputation-free survival rates were 55.8% and 9.3% in the lowest and 78.9% and 32.3% in the highest SEP group, respectively. CONCLUSIONS: According to all indicators used, lower SEP was associated with worse outcomes in the population with diabetes. Greater attention should be paid to prevention of diabetes complications, adherence to treatment guidelines and access to the established pathways for early expert assessment when diabetic complications arise, with a special attention to patients from lower SEP groups.

Ethical issues of obesity surgery--a health technology assessment.

New surgical technologies may challenge societal values, and their adoption may lead to ethical challenges. Despite proven cost-effectiveness, obesity (bariatric) surgery and its public funding have been questioned on ethical arguments relating to, for example, the self-inflicted or non-disease nature of obesity. Our aim was to analyze the ethical issues relevant to bariatric surgery. A comprehensive health technology assessment was conducted on bariatric surgery for morbid obesity using the EUnetHTA method, including a fully integrated ethical analysis. The ethical arguments suggesting that obesity should not be surgically treated because it is self-inflicted were rejected. Medicalization of obesity may have both positive and negative effects that impact the various stakeholders differently, thus being difficult to balance. Informing bariatric surgery patients and actively supporting their autonomy is exceptionally important, as the benefits and harms of both obesity and bariatric surgery are complex, and the outcome depends on how well the patient understands and adheres to the life-long changes in eating habits required. Justice considerations are important in organizing surgical treatment of obesity, as the obese are discriminated against in many ways and obesity is more common in socioeconomically disadvantaged populations who might have problems of access to treatments. Obesity should be treated like other diseases in health care, and obesity surgery rationed like other cost-effective treatments. Positive actions to ensure patient autonomy and just access to surgical treatments may be warranted.

Fewer major amputations among individuals with diabetes in Finland in 1997-2007: a population-based study.

OBJECTIVE: Complications occur in diabetes despite rigorous efforts to control risk factors. Since 2000, the National Development Programme for the Prevention and Care of Diabetes has worked to halve the incidence of amputations in 10 years. Here we evaluate the impact of the efforts undertaken by analyzing the major amputations done in 1997-2007. RESEARCH DESIGN AND METHODS: All individuals with diabetes (n = 396,317) were identified from comprehensive national databases. Data on the first major amputations (n = 9,481) performed for diabetic and nondiabetic individuals were obtained from the National Hospital Discharge Register. RESULTS: The relative risk for the first major amputation was 7.4 (95% CI 7.2-7.7) among the diabetic versus the nondiabetic population. The standardized incidence of the first major amputation decreased among the diabetic and nondiabetic populations (48.8 and 25.2% relative risk reduction, respectively) over 11 years, and the time from the registration of diabetes to the first major amputation was significantly longer, on average 1.2 years more. The cumulative five-year postamputation mortality among diabetic individuals was 78.7%. CONCLUSIONS: In our nationwide diabetes database, the duration from the registration of diabetes to the first major amputation increased, and the incidence of major amputations decreased almost 50% in 11 years. Approximately half of this change was due to the increasing size of the diabetic population. The risk for major amputation is more than sevenfold that among the nondiabetic population. These results pose a continuous challenge to improve diabetes care.

Introducing new technology safely.

AIM: This report considers the introduction of new technology and the implications for patient safety. METHODS AND DISCUSSION: A distinction is made between 'conceptually' new and 'contextually' new technology. The life cycle of technology from development to routine use is discussed and the key role for regulation, health technology assessment, clinical engineering and surveillance in this life cycle considered. The limitations of each of these disciplines are also discussed. Special consideration is given to the needs of developing countries. Case study examples of particular challenges in the safe introduction of technology are presented.

Chlamydial lipopolysaccharide (cLPS) is present in atherosclerotic and aneurysmal arterial wall--cLPS levels depend on disease manifestation.

BACKGROUND: The role of Chlamydia pneumoniae in peripheral atherosclerosis disease and abdominal aortic aneurysm (AAA) remains unclear. Chlamydial lipopolysaccharide (cLPS) detection is a method used conventionally in routine chlamydial diagnosis of gynecological or ophthalmic samples. METHODS: We compared cLPS concentrations, as well as other markers of bacterial load, in plaques and sera of patients operated on for carotid artery stenosis (n=110), aorto-occlusive disease (n=22), or AAAs (n=50) at the Helsinki University Central Hospital. RESULTS: The median levels of cLPS in plaques were 2.28, 0.80, and 0.29 ng/ml in AAA, aorto-occlusive disease, and carotid artery stenosis patients, respectively (P<.001, Kruskal-Wallis). cLPS in serum correlated with LPS binding protein levels (Spearman's rho=0.52, P<.001), suggesting that the presence of chlamydiae is sufficient to produce an innate immune response reaction in these patients. Serum inflammatory markers interleukin 6 and highly sensitive C-reactive protein also correlate with cLPS (Spearman's rho=0.42 and 0.51, respectively, P<.001). CONCLUSIONS: cLPS is present in arterial disease, and the potential role of C. pneumoniae in the pathogenesis of both peripheral atherosclerosis disease and AAA should not be forgotten. cLPS has a positive correlation with serum inflammatory markers, but this is no proof of a causal association.

Testing the HTA core model: experiences from two pilot projects.

OBJECTIVES: The aim of this study was to analyze and describe process and outcomes of two pilot assessments based on the HTA Core Model, discuss the applicability of the model, and explore areas of development. METHODS: Data were gathered from HTA Core Model and pilot Core HTA documents, their validation feedback, questionnaires to investigators, meeting minutes, emails, and discussions in the coordinating team meetings in the Finnish Office for Health Technology Assessment (FINOHTA). RESULTS: The elementary structure of the HTA Core Model proved useful in preparing HTAs. Clear scoping and good coordination in timing and distribution of work would probably help improve applicability and avoid duplication of work. CONCLUSIONS: The HTA Core Model can be developed into a platform that enables and encourages true HTA collaboration in terms of distribution of work and maximum utilization of a common pool of structured HTA information for national HTA reports.

[Where does obesity stand in health care--every alternative into use]. / Lihavuuden asema terveydenhuollossa-- kaikki vaihtoehdot käyttöön.

Although intervention in obesity on a consultation visit, i.e. brief intervention, will only affect a portion of patients, it can reach large numbers of patients. Basic care of obesity, i.e. patient education in a group, leads to an average weight loss of 3 to 5 kg within one to two years. Basic care should be offered to patients having a condition that requires weight reduction during the treatment. In morbid obesity, surgical treatment should be promoted in Finland, although it can only be applied to a minor fraction of those requiring antiobesity treatment. Self-motivated weight control should thus be encouraged.

[Effectiveness and safety of bariatric surgery]. / Lihavuuskirurgian vaikuttavuus ja turvallisuus.

Evidence for the effectiveness of surgical treatment of morbid obesity on life span, quality of life and associated diseases proves it an applicable alternative for the morbidly obese in cases where other means of controlling obesity have remained ineffective. The operation causes significant weight reduction even within a 15-year follow-up. Surgical mortality after an endoscopic operation is usually less than 0.5%. After the operation, patients fairly often experience various symptoms of the digestive tract. Common complications include various infections and functional disturbances associated with the band.

[Provision of surgical treatment for the morbidly obese in Finland]. / Sairaalloisen lihavien leikkaushoidon järjestäminen Suomessa.

The number of and demand for surgical treatments of morbid obesity are quickly increasing in Finland. The resources and action models differ regionally. The position of antiobesity surgery among antiobesity treatments should be defined more clearly than is now the case in Finland. Also a decision should be made how these operations are included in the patient's treatment guarantee. There should be a public discussion on how to centralise the operations into sufficiently large units of expertise and availability of the treatment in various parts of Finland must be guaranteed. Treatment chains should be standardized, at the same time ascertaining adequate expertise of various health care providers.