Trends in low-value GP care during the COVID-19 pandemic: a retrospective cohort study.

BACKGROUND: Several studies showed that during the pandemic patients have refrained from visiting their general practitioner (GP). This resulted in medical care being delayed, postponed or completely forgone. The provision of low-value care, i.e. care which offers no net benefit for the patient, also could have been affected. We therefore assessed the impact of the COVID-19 restrictions on three types of low-value GP care: 1) imaging for back or knee problems, 2) antibiotics for otitis media acuta (OMA), and 3) repeated opioid prescriptions, without a prior GP visit. METHODS: We performed a retrospective cohort study using registration data from GPs part of an academic GP network over the period 2017-2022. The COVID-19 period was defined as the period between April 2020 to December 2021. The periods before (January 2017 to April 2020) and after the COVID-19 period (January 2022 to December 2022) are the pre- and post-restrictions periods. The three clinical practices examined were selected by two practicing GPs from a top 30 of recommendations originating from the Dutch GP guidelines, based on their perceived prevalence and relevance in practice (van Dulmen et al., BMC Primary Care 23:141, 2022). Multilevel Poisson regression models were built to examine changes in the incidence rates (IR) of both registered episodes and episodes receiving low-value treatment. RESULTS: During the COVID-19 restrictions period, the IRs of episodes of all three types of GP care decreased significantly. The IR of episodes of back or knee pain decreased by 12%, OMA episodes by 54% and opioid prescription rate by 13%. Only the IR of OMA episodes remained significantly lower (22%) during the post-restrictions period. The provision of low-value care also changed. The IR of imaging for back or knee pain and low-value prescription of antibiotics for OMA both decreased significantly during the COVID-restrictions period (by 21% and 78%), but only the low-value prescription rate of antibiotics for OMA remained significantly lower (by 63%) during the post-restrictions period. The IR of inappropriately repeated opioid prescriptions remained unchanged over all three periods. CONCLUSIONS: This study shows that both the rate of episodes as well as the rate at which low-value care was provided have generally been affected by the COVID-19 restrictions. Furthermore, it shows that the magnitude of the impact of the restrictions varies depending on the type of low-value care. This indicates that deimplementation of low-value care requires tailored (multiple) interventions and may not be achieved through a single disruption or intervention alone.

[Plans of the Rutte IV administration: more control by the government, less personnel, lower budget]. / De zorgplannen van Rutte IV.

The Rutte IV administration can and will spend much less on healthcare than its predecessor. A difficult task. Providing less low-value care, that is healthcare with no or little benefit for the patient given the alternatives, by physicians is one way to improve quality and reduce costs. Less low-value care will therefore play a crucial role in the plans of the Rutte IV administration. Low-value care is attractive on paper, but radical implementation will lead to new dilemmas. The government must therefore be prepared to make and manage more choices itself. Besides tension on professional autonomy, there is also the risk of (even) more administrative burdens for healthcare professionals, which has a bad effect on captivating and retaining healthcare professionals. How to keep the intrinsic motivation of professionals intact within the paradigm of appropriate care could well become the real dilemma for the new administration of Mark Rutte.

Cost-effectiveness of Restrictive Strategy Versus Usual Care for Cholecystectomy in Patients With Gallstones and Abdominal Pain (SECURE-trial).

OBJECTIVE: To perform a cost-effectiveness analysis of restrictive strategy versus usual care in patients with gallstones and abdominal pain. SUMMARY OF BACKGROUND DATA: A restrictive selection strategy for surgery in patients with gallstones reduces cholecystectomies, but the impact on overall costs and cost-effectiveness is unknown. METHODS: Data of a multicentre, randomized-controlled trial (SECURE-trial) were used. Adult patients with gallstones and abdominal pain were included. Restrictive strategy was economically evaluated against usual care from a societal perspective. Hospital-use of resources was gathered with case-report forms and out-of-hospital consultations, out-of-pocket expenses, and productivity loss were collected with questionnaires. National unit costing was applied. The primary outcome was the cost per pain-free patient after 12 months. RESULTS: All 1067 randomized patients (49.0 years, 73.7% females) were included. After 12 months, 56.2% of patients were pain-free in restrictive strategy versus 59.8% after usual care. The restrictive strategy significantly reduced the cholecystectomy rate with 7.7% and reduced surgical costs with €160 per patient, €162 was saved from a societal perspective. The cost-effectiveness plane showed that restrictive strategy was cost saving in 89.1%, but resulted in less pain-free patients in 88.5%. Overall, the restrictive strategy saved €4563 from a societal perspective per pain-free patient lost. CONCLUSIONS: A restrictive selection strategy for cholecystectomy saves €162 compared to usual care, but results in fewer pain-free patients. The incremental cost per pain-free patient are savings of €4563 per pain-free patient lost. The higher societal willingness to pay for 1 extra pain-free patient, the lower the probability that the restrictive strategy will be cost-effective. TRIAL REGISTRATION: The Netherlands National Trial Register NTR4022. Registered on 5 June 2013.

Key Factors that Promote Low-Value Care: Views of Experts From the United States, Canada, and the Netherlands.

BACKGROUND: Around the world, policies and interventions are used to encourage clinicians to reduce low-value care. In order to facilitate this, we need a better understanding of the factors that lead to low-value care. We aimed to identify the key factors affecting low-value care on a national level. In addition, we highlight differences and similarities in three countries. METHODS: We performed 18 semi-structured interviews with experts on low-value care from three countries that are actively reducing low-value care: the United States, Canada, and the Netherlands. We interviewed 5 experts from Canada, 6 from the United States, and 7 from the Netherlands. Eight were organizational leaders or policy-makers, 6 as low-value care researchers or project leaders, and 4 were both. The transcribed interviews were analyzed using inductive thematic analysis. RESULTS: The key factors that promote low-value care are the payment system, the pharmaceutical and medical device industry, fear of malpractice litigation, biased evidence and knowledge, medical education, and a 'more is better' culture. These factors are seen as the most important in the United States, Canada and the Netherlands, although there are several differences between these countries in their payment structure, and industry and malpractice policy. CONCLUSION: Policy-makers and researchers that aim to reduce low-value care have experienced that clinicians face a mix of interdependent factors regarding the healthcare system and culture that lead them to provide low-value care. Better awareness and understanding of these factors can help policy-makers to facilitate clinicians and medical centers to deliver high-value care.

Budget Impact of Restrictive Strategy Versus Usual Care for Cholecystectomy (SECURE-Trial).

OBJECTIVES: A cost-effectiveness analysis of a multicenter randomized-controlled trial comparing restrictive strategy versus usual care in patients with gallstones showed that savings by restrictive strategy could not compensate for the lower proportion of pain-free patients. However, four subgroups based on combined stratification factors resulted in less cholecystectomies and more pain-free patients in restrictive strategy (female-low volume-BMI > 30, female-low volume-BMI25-30, female-high volume-BMI25-30, and male-low volume-BMI < 25). The aim of this study was to explore the budget impact from a hospital healthcare perspective of implementation of restrictive strategy in these subgroups. METHODS: Data of the SECURE-trial were used to calculate the hospital budget impact with a time horizon of four years. Based on a study into practice variation, about 19% of hospitals treat patients according restrictive strategy. This represents the proportion of patients treated according restrictive strategy at the start of budget period. Three subanalyses were performed: a scenario analysis in which 30% of patients fall under a restrictive strategy in clinical practice, a sensitivity analysis in which we calculated the budget impact with the low and high 95% confidence limits of the expected future number of patients, a subgroup analysis in which restrictive strategy was also implemented in two additional subgroups (male-high volume-BMI < 25 and female-high volume-BMI >30). RESULTS: Budget impact analysis showed savings of €6.7-€15.6 million (2.2%-5.6%) for the period 2021-2024/2025 by implementing the restrictive strategy in the four subgroups and provision of usual care in other patients. Sensitivity analysis with 30% of patients already in the restrictive strategy at the start of the budget period, resulted in savings between €5.4 million and €14.0 million (1.7%-5.0%). CONCLUSION: Performing a restrictive strategy for selection of cholecystectomy in subgroups of patients and provision of usual care in other patients will result in a lower overall hospital budget needed to treat patients with abdominal pain and gallstones. TRIAL REGISTRATION: The Netherlands National Trial Register NTR4022. Registered on June 5, 2013.

Measuring Patient-Reported Shared Decision-Making to Promote Performance Transparency and Value-Based Payment: Assessment of collaboRATE's Group-Level Reliability.

Shared decision-making (SDM) between clinicians and patients is a key component of patient experience, but measurement efforts have been hampered by a lack of valid and reliable measures that are feasible for routine use. In this study, we aim to investigate collaboRATE's reliability, calculate required sample sizes for reliable measurement, and compare Consumer Assessment of Healthcare Providers and Systems (CAHPS) patient experience survey items to collaboRATE. CollaboRATE's provider group-level reliability reached acceptable reliability at 190 patient reports, while the CAHPS SDM measure demonstrated similar reliability at a sample size of 124. The CAHPS communication measure reached acceptable reliability with 55 patient reports. A strong correlation was observed between collaboRATE and CAHPS communication measures (r = 0.83). As a reliable measure of SDM, collaboRATE may be useful for both building payment models that support shared clinical decision-making and encouraging data transparency with regard to provider group performance.

Do collaboRATE Scores Reflect Differences in Perceived Shared Decision-Making Across Diverse Patient Populations? Evidence From a Large-Scale Patient Experience Survey in the United States.

Patient characteristics have been linked to prevalence and quality of shared decision-making (SDM) behaviors across diverse studies of varied size and focus. We aim to evaluate the extent to which patient characteristics are associated with patient-rated SDM scores as measured by collaboRATE and whether or not collaboRATE varies at the provider group level. We used the 2017 California Patient Assessment Survey data set, which included adult patients of 153 California-based medical groups receiving services between January and October 2016. Mixed-effects logistic regression evaluated relationships between collaboRATE scores and patient characteristics. We analyzed 31 265 total survey responses. Among included covariates, patients' health status, race, primary language, and mode of survey response were significantly associated with collaboRATE scores. Case-mix adjustment is common in healthcare quality measurement and can be useful in pay-for-performance systems. For those use cases, we recommend adjusting collaboRATE scores by patients' age, health status, gender, race, and language spoken at home, and survey response mode. However, when case-mix adjustment is not required, we suggest highlighting observed disparities across diverse patient populations to improve attention to inequities in patient experience.

Reducing work pressure and IT problems and facilitating IT integration and audit & feedback help adherence to perioperative safety guidelines: a survey among 95 perioperative professionals.

BACKGROUND: To improve perioperative patient safety, guidelines for the preoperative, peroperative, and postoperative phase were introduced in the Netherlands between 2010 and 2013. To help the implementation of these guidelines, we aimed to get a better understanding of the barriers and drivers of perioperative guideline adherence and to explore what can be learned for future implementation projects in complex organizations. METHODS: We developed a questionnaire survey based on the theoretical framework of Van Sluisveld et al. for classifying barriers and facilitators. The questionnaire contained 57 statements derived from (a) an instrument for measuring determinants of innovations by the Dutch Organization for Applied Scientific Research, (b) interviews with quality and safety policy officers and perioperative professionals, and (c) a publication of Cabana et al. The target group consisted of 232 perioperative professionals in nine hospitals. In addition to rating the statements on a five-point Likert scale (which were classified into the seven categories of the framework: factors relating to the intervention, society, implementation, organization, professional, patients, and social factors), respondents were invited to rank their three most important barriers in a separate, extra open-ended question. RESULTS: Ninety-five professionals (41%) completed the questionnaire. Fifteen statements (26%) were considered to be barriers, relating to social factors (N = 5), the organization (N = 4), the professional (N = 4), the patient (N = 1), and the intervention (N = 1). An integrated information system was considered an important facilitator (70.4%) as well as audit and feedback (41.8%). The Barriers Top-3 question resulted in 75 different barriers in nearly all categories. The most frequently reported barriers were as follows: time pressure (16% of the total number of barriers), emergency patients (8%), inefficient IT structure (4%), and workload (3%). CONCLUSIONS: We identified a wide range of barriers that are believed to hinder the use of the perioperative safety guidelines, while an integrated information system and local data collection and feedback will also be necessary to engage perioperative teams. These barriers need to be locally prioritized and addressed by tailored implementation strategies. These results may also be of relevance for guideline implementation in general in complex organizations. TRIAL REGISTRATION: Dutch Trial Registry: NTR3568.

Selecting interventions to improve patient-relevant outcomes in health care for aortic valve disease - the Intervention Selection Toolbox.

BACKGROUND: Measuring and improving outcomes is a central element of value-based health care. However, selecting improvement interventions based on outcome measures is complex and tools to support the selection process are lacking. The goal was to present strategies for the systematic identification and selection of improvement interventions applied to the case of aortic valve disease and to combine various methods of process and outcome assessment into one integrated approach for quality improvement. METHODS: For this case study a concept-driven mixed-method approach was applied for the identification of improvement intervention clusters including: (1) benchmarking outcomes, (2) data exploration, (3) care delivery process analysis, and (4) monitoring of ongoing improvements. The main outcome measures were long-term survival and 30-day mortality. For the selection of an improvement intervention, the causal relations between the potential improvement interventions and outcome measures were quantified followed by a team selection based on consensus from a multidisciplinary team of professionals. RESULTS: The study resulted in a toolbox: the Intervention Selection Toolbox (IST). The toolbox comprises two phases: (a) identifying potential for improvement, and (b) selecting an effective intervention from the four clusters expected to lead to the desired improvement in outcomes. The improvements identified for the case of aortic valve disease with impact on long-term survival in the context of the studied hospital in 2015 include: anticoagulation policy, increased attention to nutritional status of patients and determining frailty of patients before the treatment decision. CONCLUSIONS: Identifying potential for improvement and carefully selecting improvement interventions based on (clinical) outcome data demands a multifaceted approach. Our toolbox integrates both care delivery process analyses and outcome analyses. The toolbox is recommended for use in hospital care for the selection of high-impact improvement interventions.

Regional variation in hospital care at the end-of-life of Dutch patients with lung cancer exists and is not correlated with primary and long-term care.

OBJECTIVE: To examine the regional variation in hospital care utilization in the last 6 months of life of Dutch patients with lung cancer and to test whether higher degrees of hospital utilization coincide with less general practitioner (GP) and long-term care use. DESIGN: Cross-sectional claims data study. SETTING: The Netherlands. PARTICIPANTS: Patients deceased in 2013-2015 with lung cancer (N = 25 553). MAIN OUTCOME MEASURES: We calculated regional medical practice variation scores, adjusted for age, gender and socioeconomic status, for radiotherapy, chemotherapy, CT-scans, emergency room contacts and hospital admission days during the last 6 months of life; Spearman Rank correlation coefficients measured the association between the adjusted regional medical practice variation scores for hospital admissions and ER contacts and GP and long-term care utilization. RESULTS: The utilization of hospital services in high-using regions is 2.3-3.6 times higher than in low-using regions. The variation was highest in 2015 and lowest in 2013. For all 3 years, hospital care was not significantly correlated with out-of-hospital care at a regional level. CONCLUSIONS: Hospital care utilization during the last 6 months of life of patients with lung cancer shows regional medical practice variation over the course of multiple years and seems to increase. Higher healthcare utilization in hospitals does not seem to be associated with less intensive GP and long-term care. In-depth research is needed to explore the causes of the variation and its relation to quality of care provided at the level of daily practice.

Care trajectories of chronically ill older adult patients discharged from hospital: a quantitative cross-sectional study using health insurance claims data.

BACKGROUND: For older adults, a good transition from hospital to the primary or long-term care setting can decrease readmissions. This paper presents the 6-month post-discharge healthcare utilization of older adults and describes the numbers of readmissions and deaths for the most frequently occurring aftercare arrangements as a starting point in optimizing the post-discharge healthcare organization. METHODS: This cross-sectional study included older adults insured with the largest Dutch insurance company. We described the utilization of healthcare within 180 days after discharge from their first hospital admission of 2015 and the most frequently occurring combinations of aftercare in the form of geriatric rehabilitation, community nursing, long-term care, and short stay during the first 90 days after discharge. We calculated the proportion of older adults that was readmitted or had died in the 90-180 days after discharge for the six most frequent combinations. We performed all analyses in the total group of older adults and in a sub-group of older adults who had been hospitalized due to a hip fracture. RESULTS: A total of 31.7% of all older adults and 11.4% of the older adults with a hip fracture did not receive aftercare. Almost half of all older adults received care of a community nurse, whereas less than 5% received long-term home care. Up to 18% received care in a nursing home during the 6 months after discharge. Readmissions were lowest for older adults with a short stay and highest in the group geriatric rehabilitation + community nursing. Mortality was lowest in the total group of older aldults and subgroup with hip fracture without aftercare. CONCLUSIONS: The organization of post-discharge healthcare for older adults may not be organized sufficiently to guarantee appropriate care to restore functional activity. Although receiving aftercare is not a clear predictor of readmissions in our study, the results do seem to indicate that older adults receiving community nursing in the first 90 days less often die compared to older adults with other types of aftercare or no aftercare. Future research is necessary to examine predictors of readmissions and mortality in both older adult patients discharged from hospital.

Characteristics and health care utilization among patients with chronic heart failure: a longitudinal claim database analysis.

AIMS: This study aimed to determine the characteristics of patients with heart failure and high costs (top 1% and top 2-5% highest costs in perspective of the general population) and to explore the longitudinal health care utilization and persistency of high costs. METHODS AND RESULTS: Longitudinal observational study using claims data from 2006 to 2014 in the Netherlands. We identified all patients that received a hospital treatment for chronic heart failure between 1 January 2008 and 31 December 2010. Of each selected patient, all claims from the Dutch curative health system and with a starting date between 1 January 2006 and 31 December 2014 were extracted. Pharmaceutical and hospital claims were used to establish characteristics and indicators for health care utilization. Descriptive analyses and generalized estimating equation models were used to analyse characteristics, longitudinal health care utilization and to identify factors associated with high costs. Our findings revealed that the difference in costs between top 1%, top 2-5%, and bottom 95% patients with heart failure was mainly driven by hospital costs; and the top 1% group experienced a remarkable increase of mental health costs. Top 1% and top 2-5% patients with heart failure differed from lower cost patients in their higher rate of chronic conditions, excessive polypharmacy, hospital admissions, and heart-related surgeries. Heart-related surgeries contributed to the incidental high costs in 54% of top 1% patients, and the costs of the remaining top 1% patients were driven by mental health and pharmaceuticals use and rates of chronic conditions and multimorbidity. Top 1% patients were relatively young. Anaemia, dementia, diseases of arteries, veins and lymphatic vessels, influenza, and kidney failure were significantly associated with high costs. The end-of-life period was predictive of top 1% and top 5% costs. More than 90% of the population incurred at least one top 5% year during follow-up, and 31.8% incurred at least one top 1% year. Fifty-seven per cent incurred multiple top 5% years whereas only 8.6% incurred multiple top 1% years. Top 5% years were more frequently consecutive than top 1% years. CONCLUSIONS: Top 1% utilization occurs predominantly incidentally and among less than a third of patients with heart failure, whereas almost all patients with heart failure experience at least one top 5% year, and more than half experience two or more top 5% years. Both medical and psychiatric/psychosocial needs contribute to high costs in heart failure patients. Comprehensive and integrated efforts are needed to further improve quality of care and reduce unnecessary costs.

The implementation of change model adds value to value-based healthcare: a qualitative study.

BACKGROUND: Value-based healthcare (VBHC) is a concept that focuses on outcome measurement to contribute to quality improvement. However, VBHC does not offer a systematic approach for implementing improvement as implementation science does. The aim is to, firstly, investigate the implementation of improvement initiatives in the context of VBHC and secondly, to explore how implementation science could be of added value for VBHC and vice versa. METHODS: A case study with two cases in heart care was conducted; one without the explicit use of a systematic implementation method and the other one with the use of the Implementation of Change Model (ICM). Triangulation of data from document research, semi-structured interviews and a focus group was applied to evaluate the degree of method uptake. Interviews were held with experts involved in the implementation of Case 1 (N = 4) and Case 2 (N = 7). The focus group was held with experts also involved in the interviews (N = 4). A theory-driven qualitative analysis was conducted using the ICM as a framework. RESULTS: In both cases, outcome measures were seen as an important starting point for the implementation and for monitoring change. Several themes were identified as most important: support, personal importance, involvement, leadership, climate and continuous monitoring. Success factors included intrinsic motivation for the change, speed of implementation, complexity and continuous evaluation. CONCLUSION: Application of the ICM facilitates successful implementation of quality- improvement initiatives within VBHC. However, the practical use of the ICM shows an emphasis on processes. We recommend that monitoring of outcomes be added as an essential part of the ICM. In the discussion, we propose an implementation model that integrates ICM within VBHC.

What is the impact on the readmission ratio of taking into account readmissions to other hospitals? A cross-sectional study.

OBJECTIVES: Readmissions are used widespread as an indicator of the quality of care within hospitals. Including readmissions to other hospitals might have consequences for hospitals. The aim of our study is to determine the impact of taking into account readmissions to other hospitals on the readmission ratio. DESIGN AND SETTING: We performed a cross-sectional study and used administrative data from 77 Dutch hospitals (2 333 173 admissions) in 2015 and 2016 (97% of all hospitals). We performed logistic regression analyses to calculate 30-day readmission ratios for each hospital (the number of observed admissions divided by the number of expected readmissions based on the case mix of the hospital, multiplied by 100). We then compared two models: one with readmissions only to the same hospital, and another with readmissions to any hospital in the Netherlands. The models were calculated on the hospital level for all in-patients and, in more detail, on the level of medical specialties. MAIN OUTCOME MEASURES: Percentage of readmissions to another hospital, readmission ratios same hospital and any hospital and C-statistic of each model in order to determine the discriminative ability. RESULTS: The overall percentage of readmissions was 10.3%, of which 91.1% were to the same hospital and 8.9% to another hospital. Patients who went to another hospital were younger, more often men and had fewer comorbidities. The readmission ratios for any hospital versus the same hospital were strongly correlated (r=0.91). There were differences between the medical specialties in percentage of readmissions to another hospital and C-statistic. CONCLUSIONS: The overall impact of taking into account readmissions to other hospitals seems to be limited in the Netherlands. However, it does have consequences for some hospitals. It would be interesting to explore what causes this difference for some hospitals and if it is related to the quality of care.

Value based competition in health care's ethical drawbacks and the need for a values-driven approach.

Value Based competition in Health Care (VBHC) has become a guiding principle in the quest for high quality health care for acceptable costs. Current literature lacks substantial ethical evaluation of VBHC.In this paper we describe how a single-minded focus on VBHC may cause serious infringements upon at least four medical ethical principles: 1) it tends to neglect patients' personal values; 2) it ignores the intrinsic value of the caring act; 3) it disproportionately replaces trust in professionals with accountability, and 4) it undermines solidarity.Health care needs a next step in VBHC. We suggest a 'Values-Driven Health Care' (VDHC) approach that a) takes patients' personal values as prescriptive and guiding; b) holds a value account that encompasses health care's intrinsic (gift) values; c) is based upon intelligent accountability that supports trust in trustworthy professionals, and d) encourages patients to raise their voices for the shared good of health care.

Re-admission patterns in England and the Netherlands: a comparison based on administrative data of all hospitals.

BACKGROUND: Examining variation in patterns of re-admissions between countries can be valuable for mutual learning in order to reduce unnecessary re-admissions. The aim of this study was to compare re-admission rates and reasons for re-admissions between England and the Netherlands. METHODS: We used data from 85 Dutch hospitals (1 355 947 admissions) and 451 English hospitals (5 260 227 admissions) in 2014 (96% of all Dutch hospitals and 100% of all English NHS hospitals). Re-admission data from England and the Netherlands were compared for all hospital patients and for specific diagnosis groups: pneumonia, urinary tract infection, chronic obstructive pulmonary disease, coronary atherosclerosis, biliary tract disease, hip fracture and acute myocardial infarction. Re-admissions were categorized using a classification system developed on administrative data. The classification distinguishes between potentially preventable re-admissions and other reasons for re-admission. RESULTS: England had a higher 30-day re-admission rate (adjusted for age and gender) compared to the Netherlands: 11.17% (95% CI 11.14-11.20%) vs. 9.83% (95% CI 9.77-9.88%). The main differences appeared to be in re-admissions for the elderly (England 17.2% vs. the Netherlands 10.0%) and in emergency re-admissions (England 85.3% of all 30-day re-admissions vs. the Netherlands 66.8%). In the Netherlands, however, more emergency re-admissions were classified as potentially preventable compared to England (33.8% vs. 28.8%). CONCLUSIONS: The differences found between England and the Netherlands indicate opportunities to reduce unnecessary re-admissions. For England this concerns more expanded palliative care, integrated social care and reduction of waiting times. In the Netherlands, the use of treatment plans for daily life could be increased.

Statistical analysis plan of a randomized controlled trial to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy (SECURE trial).

BACKGROUND: Cholecystectomy is the preferred treatment for symptomatic cholecystolithiasis. However, persistent pain after cholecystectomy for symptomatic cholecystolithiasis is reported in up to 40% of patients. The aim of the SECURE trial is to compare the effectiveness of usual care with a restrictive strategy using a standardized work-up with stepwise selection for cholecystectomy in patients with gallstones and abdominal complaints. The SECURE trial is designed as a multicenter, randomized, parallel-arm, non-inferiority trial in patients with abdominal symptoms and ultrasound-proven gallstones or sludge. Randomization was performed to either usual care (standard practice, according to the physician's knowledge and experience, and physician's and patient's preference) or a restrictive standardized strategy: treated with interval evaluation and stepwise selection for laparoscopic cholecystectomy based on fulfilment of pre-specified criteria. This article presents in detail the statistical analysis plan (SAP) of this trial and was submitted before outcomes were available to the investigators. RESULTS: The primary end point of this trial is defined as the proportion of patients being pain-free at 12 months' follow-up. Pain will be assessed with the Izbicki Pain Score. Secondary endpoints will be the proportion of patients with complications due to gallstones or cholecystectomy, quality of life, the association between the patients' symptoms and treatment, work performance, and cost-effectiveness. DISCUSSION: The data from the SECURE trial will provide evidence whether or not a restrictive strategy in patients with symptomatic cholecystolithiasis is associated with similar patient reported outcomes and a reduction in the number of cholecystectomies compared to usual care. The data from this trial will be analyzed according to this pre-specified SAP. TRIAL REGISTRATION: The Netherlands National Trial Register NTR4022 . Registered on 5 June 2013.

Important factors for effective patient safety governance auditing: a questionnaire survey.

BACKGROUND: Audits are increasingly used for patient safety governance purposes. However, there is little insight into the factors that hinder or stimulate effective governance based on auditing. The aim of this study is to quantify the factors that influence effective auditing for hospital boards and executives. METHODS: A questionnaire of 32 factors was developed using influencing factors found in a qualitative study on effective auditing. Factors were divided into four categories. The questionnaire was sent to the board of directors, chief of medical staff, nursing officer, medical department head and director of the quality and safety department of 89 acute care hospitals in the Netherlands. RESULTS: We approached 522 people, of whom 211 responded. Of the 32 factors in the questionnaire, 30 factors had an agreement percentage higher than 50%. Important factors per category were 'audit as an improvement tool as well as a control tool', 'department is aware of audit purpose', 'quality of auditors' and 'learning culture at department'. We found 14 factors with a significant difference in agreement between stakeholders of at least 20%. Amongst these were 'medical specialist on the audit team', 'soft signals in the audit report', 'patients as auditors' and 'post-audit support'. CONCLUSION: We found 30 factors for effective auditing, which we synthesised into eight recommendations to optimise audits. Hospitals can use these recommendations as a framework for audits that enable boards to become more in control of patient safety in their hospital.

Systematic review of high-cost patients' characteristics and healthcare utilisation.

OBJECTIVES: To investigate the characteristics and healthcare utilisation of high-cost patients and to compare high-cost patients across payers and countries. DESIGN: Systematic review. DATA SOURCES: PubMed and Embase databases were searched until 30 October 2017. ELIGIBILITY CRITERIA AND OUTCOMES: Our final search was built on three themes: 'high-cost', 'patients', and 'cost' and 'cost analysis'. We included articles that reported characteristics and utilisation of the top-X% (eg, top-5% and top-10%) patients of costs of a given population. Analyses were limited to studies that covered a broad range of services, across the continuum of care. Andersen's behavioural model was used to categorise characteristics and determinants into predisposing, enabling and need characteristics. RESULTS: The studies pointed to a high prevalence of multiple (chronic) conditions to explain high-cost patients' utilisation. Besides, we found a high prevalence of mental illness across all studies and a prevalence higher than 30% in US Medicaid and total population studies. Furthermore, we found that high costs were associated with increasing age but that still more than halve of high-cost patients were younger than 65 years. High costs were associated with higher incomes in the USA but with lower incomes elsewhere. Preventable spending was estimated at maximally 10% of spending. The top-10%, top-5% and top-1% high-cost patients accounted for respectively 68%, 55% and 24% of costs within a given year. Spending persistency varied between 24% and 48%. Finally, we found that no more than 30% of high-cost patients are in their last year of life. CONCLUSIONS: High-cost patients make up the sickest and most complex populations, and their high utilisation is primarily explained by high levels of chronic and mental illness. High-cost patients are diverse populations and vary across payer types and countries. Tailored interventions are needed to meet the needs of high-cost patients and to avoid waste of scarce resources.