The use of PROMs and shared decision-making in medical encounters with patients: An opportunity to deliver value-based health care to patients.

BACKGROUND: The recent emphasis on value-based health care (VBHC) is thought to provide new opportunities for shared decision-making (SDM) in the Netherlands, especially when using patient-reported outcome measures (PROMs) in routine medical encounters. It is still largely unclear about how PROMs could be linked to SDM and what we expect from clinicians in this respect. AIM: To describe approaches and lessons learned in the fields of SDM and VBHC implementation that converge in using PROMs in medical encounters. APPROACH: Based on input from three Dutch forerunner case examples and available evidence about SDM and VBHC, we describe barriers and facilitators regarding the use of PROMs and SDM in the medical encounter. Barriers and facilitators were structured according to a conversational model that included monitoring and managing, team talk, option talk, choice talk, and decision talk. Key lessons learned and recommendations were synthesized. RESULTS: The use of individual, N = 1 PROMs scores in the medical encounter has been largely achieved in the forerunner projects. Conversation on monitoring and managing is relatively well implemented, and option talk to some extent, unlike team talk, and decision talk. Aggregated PROMs information describing outcomes of treatment options seemed to be scarcely used. Experienced barriers largely corresponded to what is known from the literature, eg, perceived lack of time and lack of tools summarizing the options. Some concerns were identified about increasing health care consumption as a result of using PROMs and SDM in the medical encounter. CONCLUSION: Successful implementation of SDM within VBHC initiatives may not be self-evident, even though individual, N = 1 PROMs scores are being used in the medical encounter. Education and staff resources on meso and macro levels may facilitate the more time-consuming SDM aspects. It seems fruitful to especially target team talk and choice talk in redesigning clinical pathways.

Economic outcomes in clinical studies assessing hyperbaric oxygen in the treatment of acute and chronic wounds.

INTRODUCTION: Hyperbaric oxygen treatment (HBOT) is used to treat acute and chronic wounds. This systematic review was conducted to summarise and evaluate existing evidence on the costs associated with HBOT in the treatment of wounds. METHODS: We searched multiple electronic databases in March 2015 for cohort studies and randomised clinical trials (RCTs) that reported on the clinical effectiveness and treatment costs of HBOT in the treatment of acute or chronic wounds. RESULTS: One RCT and three cohort studies reported on economic as well as clinical outcomes. These studies comprised different disorders (ischaemic diabetic foot ulcers, thermal burns, Fournier's gangrene and necrotising soft tissue infections) and employed different clinical and economic outcome measures. Only the RCT had a good methodological quality. Three of the included studies reported that their primary clinical outcomes (wound healing, hospital stay, complications) improved in the HBOT group. The effects of HBOT on costs were variable. CONCLUSIONS: Currently, there is little direct evidence on the cost-effectiveness of HBOT in the treatment of acute and chronic wounds. Although there is some evidence suggesting effectiveness of HBOT, further studies should include economic outcomes in order to make recommendations on the cost-effectiveness of applying HBOT in wound care.

Hospital costs of complications after a pancreatoduodenectomy.

BACKGROUND: A pancreatoduodenectomy (PD) is a highly advanced procedure associated with considerable post-operative complications and substantial costs. In this study the hospital costs associated with complications after PD were assessed. METHODS: A retrospective cohort study was conducted on 100 consecutive patients who underwent a pylorus-preserving (PP)PD between January 2012 and July 2013. Per patient, all complications occurring during admission or in the 30-day period after discharge were documented. All hospital costs related to the (PP)PD were defined as the costs of all medical interventions and resources during the hospitalisation period as recorded by the electronic supply tracking system. RESULTS: The median hospital costs ranged from €17 482 for a patient without complications to €55 623 for a patient with a post-operative haemorrhage. A post-operative haemorrhage was associated with a 39.6% increase in total hospital costs after adjusting for patient characteristics. Other factors significantly associated with an increase in total hospital costs were: the presence of a malignancy other than a pancreatic adenocarcinoma (29.4% cost increase), the severity grade of a complication (34.3-70.6% increase) and the presence of a post-operative infection (32.4% increase). CONCLUSIONS: This study provides an in-depth analysis of hospital costs and identifies factors that are associated with substantial cost consequences of specific complications occurring after a PD.

Quantifying the demand for hospital care services: a time and motion study.

BACKGROUND: The actual amount of care hospitalised patients need is unclear. A model to quantify the demand for hospital care services among various clinical specialties would avail healthcare professionals and managers to anticipate the demand and costs for clinical care. METHODS: Three medical specialties in a Dutch university hospital participated in this prospective time and motion study. To include a representative sample of patients admitted to clinical wards, the most common admission diagnoses were selected from the most recent update of the national medical registry (LMR) of ICD-10 admission diagnoses. The investigators recorded the time spent by physicians and nurses on patient care. Also the costs involved in medical and nursing care, (surgical) interventions, and diagnostic procedures as an estimate of the demand for hospital care services per hospitalised patient were calculated and cumulated. Linear regression analysis was applied to determine significant factors including patient and healthcare outcome characteristics. RESULTS: Fifty patients on the Surgery (19), Pediatrics (17), and Obstetrics & Gynecology (14) wards were monitored during their hospitalization. Characteristics significantly associated with the demand for healthcare were: polypharmacy during hospitalization, complication severity level, and whether a surgical intervention was performed. CONCLUSIONS: A set of predictors of the demand for hospital care services was found applicable to different clinical specialties. These factors can all be identified during hospitalization and be used as a managerial tool to monitor the patients' demand for hospital care services and to detect trends in time.

Is additional hyperbaric oxygen therapy cost-effective for treating ischemic diabetic ulcers? Study protocol for the Dutch DAMOCLES multicenter randomized clinical trial?

BACKGROUND: The value of hyperbaric oxygen therapy (HBOT) in the treatment of diabetic ulcers is still under debate. Available evidence suggests that HBOT may improve the healing of diabetic ulcers, but it comes from small trials with heterogeneous populations and interventions. The DAMOCLES-trial will assess the (cost-)effectiveness of HBOT for ischemic diabetic ulcers in addition to standard of care. METHODS: In a multicenter randomized clinical trial, including 30 hospitals and all 10 HBOT centers in the Netherlands, we plan to enroll 275 patients with Types 1 or 2 diabetes, a Wagner 2, 3 or 4 ulcer of the leg present for at least 4 weeks, and concomitant leg ischemia, defined as an ankle systolic blood pressure of <70 mmHg, a toe systolic blood pressure of <50 mmHg or a forefoot transcutaneous oxygen tension (TcpO2) of <40 mmHg. Eligible patients may be candidates for revascularization. Patients will be randomly assigned to standard care with or without 40 HBOT-sessions. RESULTS: Primary outcome measures are freedom from major amputation after 12 months and achievement of, and time to, complete wound healing. Secondary endpoints include freedom from minor amputations, ulcer recurrence, TcpO2 , quality of life, and safety. In addition, we will assess the cost-effectiveness of HBOT for this indication. CONCLUSION: The DAMOCLES trial will be the largest trial ever performed in the realm of HBOT for chronic ulcers, and it is unique for addressing patients with ischemic diabetic foot ulcers who may also receive vascular reconstructions. This matches the treatment dilemma in current clinical practice.

Factors and models associated with the amount of hospital care services as demanded by hospitalized patients: a systematic review.

BACKGROUND: Hospitals are constantly being challenged to provide high-quality care despite ageing populations, diminishing resources, and budgetary restraints. While the costs of care depend on the patients' needs, it is not clear which patient characteristics are associated with the demand for care and inherent costs. The aim of this study was to ascertain which patient-related characteristics or models can predict the need for medical and nursing care in general hospital settings. METHODS: We systematically searched MEDLINE, Embase, Business Source Premier and CINAHL. Pre-defined eligibility criteria were used to detect studies that explored patient characteristics and health status parameters associated to the use of hospital care services for hospitalized patients. Two reviewers independently assessed study relevance, quality with the STROBE instrument, and performed data analysis. RESULTS: From 2,168 potentially relevant articles, 17 met our eligibility criteria. These showed a large variety of factors associated with the use of hospital care services; models were found in only three studies. Age, gender, medical and nursing diagnoses, severity of illness, patient acuity, comorbidity, and complications were the characteristics found the most. Patient acuity and medical and nursing diagnoses were the most influencing characteristics. Models including medical or nursing diagnoses and patient acuity explain the variance in the use of hospital care services for at least 56.2%, and up to 78.7% when organizational factors were added. CONCLUSIONS: A larger variety of factors were found to be associated with the use of hospital care services. Models that explain the extent to which hospital care services are used should contain patient characteristics, including patient acuity, medical or nursing diagnoses, and organizational and staffing characteristics, e.g., hospital size, organization of care, and the size and skill mix of staff. This would enable healthcare managers at different levels to evaluate hospital care services and organize or reorganize patient care.

Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study).

OBJECTIVE: To investigate which perioperative treatment, ie, laparoscopic or open surgery combined with fast track (FT) or standard care, is the optimal approach for patients undergoing segmental resection for colon cancer. SUMMARY BACKGROUND DATA: Important developments in elective colorectal surgery are the introduction of laparoscopy and implementation of FT care, both focusing on faster recovery. METHODS: In a 9-center trial, patients eligible for segmental colectomy were randomized to laparoscopic or open colectomy, and to FT or standard care, resulting in 4 treatment groups. Primary outcome was total postoperative hospital stay (THS). Secondary outcomes were postoperative hospital stay (PHS), morbidity, reoperation rate, readmission rate, in-hospital mortality, quality of life at 2 and 4 weeks, patient satisfaction and in-hospital costs. Four hundred patients were required to find a minimum difference of 1 day in hospital stay. RESULTS: Median THS in the laparoscopic/FT group was 5 (interquar-tile range: 4-8) days; open/FT 7 (5-11) days; laparoscopic/standard 6 (4.5-9.5) days, and open/standard 7 (6-13) days (P < 0.001). Median PHS in the laparoscopic/FT group was 5 (4-7) days; open/FT 6 (4.5-10) days; laparoscopic/standard 6 (4-8.5) days and open/standard 7 (6-10.5) days (P < 0.001). Secondary outcomes did not differ significantly among the groups. Regression analysis showed that laparoscopy was the only independent predictive factor to reduce hospital stay and morbidity. CONCLUSIONS: Optimal perioperative treatment for patients requiring segmental colectomy for colon cancer is laparoscopic resection embedded in a FT program. If open surgery is applied, it is preferentially done in FT care. This study was registered under NTR222 (www.trialregister.nl).

Occlusive vs gauze dressings for local wound care in surgical patients: a randomized clinical trial.

OBJECTIVE: To compare effectiveness and costs of gauze-based vs occlusive, moist-environment dressing principles. DESIGN: Randomized clinical trial. SETTING: Academic Medical Center, Amsterdam, the Netherlands. PATIENTS: Two hundred eighty-five hospitalized surgical patients with open wounds. INTERVENTION: Patients received occlusive (ie, foams, alginates, hydrogels, hydrocolloids, hydrofibers, or films) or gauze-based dressings until their wounds were completely healed. MAIN OUTCOME MEASURES: Primary end points were complete wound healing, pain during dressing changes, and costs. Secondary end point was length of hospital stay. RESULTS: Time to complete wound healing did not differ significantly between occlusive (median, 66 days; interquartile range [IQR], 29-133 days) and gauze-based dressing groups (median, 45 days; IQR, 26-106 days; log-rank P = .31). Postoperative wounds (62% of the wounds included) healed significantly (P = .02) quicker using gauze dressings (median, 45 days; IQR, 22-93 days vs median, 72 days; IQR, 36-132 days). Median pain scores were low and similar in the occlusive (0.90; IQR, 0.29-2.34) and the gauze (0.64; IQR, 0.22-1.95) groups (P = .32). Daily costs of occlusive materials were significantly higher (occlusive, euro6.34 [US $9.95] vs gauze, euro1.85 [US $2.90]; P < .001), but nursing time costs per day were significantly higher when gauze was used (occlusive, euro1.28 [US $2.01] vs gauze, euro2.41 [US $3.78]; P < .001). Total cost for local wound care per patient per day during hospitalization was euro7.48 (US $11.74) in the occlusive group and euro3.98 (US $6.25) in the gauze-based group (P = .002). CONCLUSIONS: The occlusive, moist-environment dressing principle in the clinical surgical setting does not lead to quicker wound healing or less pain than gauze dressings. The lower costs of less frequent dressing changes do not balance the higher costs of occlusive materials. Trial Registration trialregister.nl Identifier: 56264738.