The Role of Preoperative and Postoperative Transversus Abdominis Plane and Rectus Sheath Block in Patients Undergoing Total Laparoscopic Hysterectomy.

PURPOSE: This study was performed to assess the efficacy of a preoperative and postoperative transversus abdominis plane (TAP) and rectus sheath (RS) block compared with no TAP and RS block in patients undergoing total laparoscopic hysterectomy (TLH). DESIGN: Prospective observational cohort study. METHODS: From January 2014 to December 2017, 195 women undergoing TLH were categorized into three groups based on their perioperative analgesia: no TAP + RS block (n = 88), preoperative TAP + RS block + systemic analgesia (n = 68), and postoperative TAP + RS block + systemic analgesia (n = 39). We evaluated use of nonsteroidal anti-inflammatory drugs (NSAIDs) and NSAID consumption within the first 12 hours postoperatively and the numerical rating scale score at 0, 12, and 24 hours postoperatively. FINDINGS: Women with a preoperative TAP + RS block had a significantly lower utilization rate of NSAIDs within the first 12 hours postoperatively (54.4% vs 75.0%; P = .007), lower postoperative flurbiprofen dose (45.5 vs 62.0 mg; P = .048), and lower numerical rating scale score at 12 hours postoperatively (1.63 vs 2.20; P = .002) compared with women with no TAP + RS block. CONCLUSIONS: A preoperative TAP + RS block provided superior postoperative analgesia in patients undergoing TLH and reduced analgesic consumption during the first 12 hours postoperatively.

Liberal versus restrictive red blood cell transfusion strategy in sepsis or septic shock: a systematic review and meta-analysis of randomized trials.

BACKGROUND: We assessed the effect of liberal versus restrictive red blood cell transfusion strategy on survival outcome in sepsis or septic shock by systematically reviewing the literature and synthesizing evidence from randomized controlled trials (RCTs). METHODS: We searched the MEDLINE, Cochrane Central Register of Controlled Trials, and Web of Science databases. We included RCTs that compared mortality between a liberal transfusion strategy with a hemoglobin threshold of 9 or 10 g/dL and a restrictive transfusion strategy with a hemoglobin threshold of 7 g/dL in adults with sepsis or septic shock. Two investigators independently screened citations and conducted data extraction. The primary outcome was 28- or 30-day mortality. Secondary outcomes were 60- and 90-day mortality, use of life support at 28 days of admission, and number of patients transfused during their intensive care unit stay. DerSimonian-Laird random-effects models were used to report pooled odds ratios (ORs). RESULTS: A total of 1516 patients from three RCTs were included; 749 were randomly assigned to the liberal transfusion group and 767 to the restrictive strategy group. Within 28-30 days, 273 patients (36.4%) died in the liberal transfusion group, while 278 (36.2%) died in the restrictive transfusion group (pooled OR, 0.99; 95% confidence interval [CI], 0.67-1.46). For the primary outcome, heterogeneity was observed among the studies (I2 = 61.0%, χ2 = 5.13, p = 0.08). For secondary outcomes, only two RCTs were included. There were no significant differences in secondary outcomes between the two groups. CONCLUSIONS: We could not show any difference in 28- or 30-day mortality between the liberal and restrictive transfusion strategies in sepsis or septic shock patients by meta-analysis of RCTs. Our results should be interpreted with caution due to the existence of heterogeneity. As sepsis complicates a potentially wide range of underlying diseases, further trials in carefully selected populations are anticipated. TRIAL REGISTRATION: This present study was registered in the PROSPERO database (CRD42018108578).

Postoperative administration of dienogest for suppressing recurrence of disease and relieving pain in subjects with ovarian endometriomas.

To assess the effect of dienogest on recurrence of ovarian endometriomas and severity of pain after laparoscopic surgery, a retrospective study of 81 patients was performed at three institutions in Osaka, Japan. Patients had a six-month minimum follow-up after laparoscopic surgery for ovarian endometriomas performed between June 2012 and August 2014. Patients who chose to receive 2 mg dienogest daily and those who were managed expectantly postoperatively were included. Recurrence was defined as the presence of endometriomas of more than 2 cm. A visual analog scale (VAS) was used to score the intensity of pelvic pain. The cumulative recurrence rate and absolute VAS score changes between the baseline and at 6, 12, 18 and 24 months after the start of administration were evaluated in both groups. The recurrence rate was 16.5% and 24.0% in the expectant management group at 12 and 24 months, respectively. No recurrences occurred in the dienogest treatment group. The rate of VAS score reduction was significantly higher in the dienogest than in the expectant management group. Dienogest is effective on the recurrence of ovarian endometrioma and relieving pelvic pain after laparoscopic surgery.

Assessment of age-specific safety of laparoscopic surgery in elderly patients with ovarian tumors.

AIM: We assessed the age-specific safety of laparoscopic surgery in elderly patients with ovarian tumors. MATERIAL AND METHODS: We performed a retrospective analysis of 55 elderly patients treated by laparoscopic salpingo-oophorectomy under the diagnosis of an ovarian tumor between January 2009 and December 2014. We divided patients into three groups: "young-elderly" (aged 65-74), "old-elderly" (aged 75-84), and "super-elderly" (aged 85-105) and assessed clinical characteristics, surgical results and postoperative course. Statistical significance of categorical variables was examined by the Student's t-test, Mann-Whitney U test, or Fisher's exact test. Multiple regression analysis was used for multivariate analysis. RESULTS: Of a total of 55 patients who underwent laparoscopic surgery, there were 36 patients in the young-elderly group, 17 in the old-elderly group, and two in the super-elderly group. Statistical analysis was performed between the young-elderly and the old-elderly groups because of the small number in the super-elderly group. More frequent comorbidities were found in the patients in the old-elderly than in the young-elderly group (Fisher's exact test, P = 0.007). There were no significant differences in operative time, estimated blood loss and postoperative hospital stay between the young-elderly and old-elderly groups. Intraoperative complications only occurred in the young-elderly group. Postoperative complications occurred in all groups. CONCLUSIONS: Although patients in the old-elderly group had a significantly higher risk for surgery, they had equivalent surgical results to the young-elderly group for laparoscopic salpingo-oophorectomy.

Use of preoperative contrast-enhanced computed tomography in damage control strategy for blunt liver injury: A case report.

For patients with unstable abdominal trauma unresponsive to initial transfusion, the damage control strategy includes prompt hemostasis by open surgery and packing. Recently, a hybrid treatment that combines packing and transcatheter arterial embolization as a damage control strategy was reported to be effective; however, the indications and techniques are yet to be established. A 25-year-old male patient who was in shock due to severe liver injury after a traffic accident was brought to our emergency room by emergency services. After initial resuscitation, including resuscitative endovascular balloon occlusion of the aorta and blood transfusion, preoperative contrast-enhanced computed tomography indicated grade IV liver injury with active bleeding from the right hepatic artery. Damage control strategy with packing and subsequent transcatheter arterial embolization was determined to be useful. During treatment, bile leakage was observed. An endoscopic nasobiliary drainage tube was inserted, and the patient was treated conservatively. He was discharged on day 83 of hospitalization. Although using preoperative contrast-enhanced computed tomography before damage control surgery remains controversial, it can provide useful information to determine damage control strategy, including morphological evaluation of the injured area and the presence of active bleeding.

Current status of active cooling, deep body temperature measurement, and face mask wearing in heat stroke and heat exhaustion patients in Japan: a nationwide observational study based on the Heatstroke STUDY 2020 and 2021.

Aim: The study aimed to determine the current status of face mask use, deep body temperature measurement, and active cooling in patients suffering from heat stroke and heat exhaustion in Japan. Methods: This was a prospective, observational, multicenter study using data from the Heatstroke STUDY 2020-2021, a nationwide periodical registry of heat stroke and heat exhaustion patients. Based on the Bouchama heatstroke criteria, we classified the patients into two groups: severe and mild-to-moderate. We compared the outcomes between the two groups and reclassified them into two subgroups according to the severity of the illness, deep body temperature measurements, and face mask use. Cramer's V was used to determine the effect sizes for a comparison between groups. Results: Almost all patients in this study were categorized as having degree III based on the Japanese Association for Acute Medicine heatstroke criteria (JAAM-HS). However, the severe group was significantly worse than the mild-to-moderate group in outcomes like in-hospital death and modified Rankin Scale scores, when discharged. Heat strokes had significantly higher rates of active cooling and lower mortality rates than heat stroke-like illnesses. Patients using face masks often use them during labor, sports, and other exertions, had less severe conditions, and were less likely to be young male individuals. Conclusions: It is suggested that severe cases require a more detailed classification of degree III in the JAAM-HS criteria, and not measuring deep body temperature could have been a factor in the nonperformance of active cooling and worse outcomes.

Prediction, based on resection margins, of long-term outcome of cervical intraepithelial neoplasia 3 treated by Shimodaira-Taniguchi conization.

PURPOSE: The aim of the present study was to analyze the long-term outcome of cervical intraepithelial neoplasia 3 (CIN 3) after treatment with the Shimodaira-Taniguchi conization procedure, based on the status of the resection margins. METHODS: In the Osaka University Hospital, conization using the Shimodaira-Taniguchi procedure has been routinely performed for CIN 3. Medical records of patients during the period from 2001 to 2008, whose post-conization diagnosis was CIN 3, were retrospectively analyzed for outcome versus margin status. RESULTS: During the median follow-up period of 565 days (range 34-3,013), CIN disease was again detected in 14 of 243 patients; it was found in 7 patients among 198 margin-negative cases, and in 7 patients among 45 margin-positive cases. There was a significant difference in the reappearance rate demonstrated between the cases with positive and negative margins (p = 0.0018). Among the patients whose first follow-up post-conization cytology was normal, recurrence-free probability was significantly higher in margin-negative cases than in margin-positive ones (hazard ratio, 5.19; 95% CI, 1.175-22.994; p = 0.0041). CONCLUSION: For the first time, we demonstrate that after treatment of CIN 3 lesions by Shimodaira-Taniguchi conization the status of the resection margin was a significant predictor for long-term outcome.

Complement Activation in Patients With Heat-Related Illnesses: Soluble CD59 Is a Novel Biomarker Indicating Severity of Heat-Related Illnesses.

OBJECTIVES: Although multiple organ dysfunction syndrome (MODS) is the main cause of death in patients with heat-related illnesses, its underlying pathophysiological mechanism remains elusive. Complement activation is considered one of the main causes of MODS in patients with sepsis and trauma. Considering the pathophysiological similarity of heat related-illnesses with sepsis and trauma, the complement system might be activated in patients with heat-related illnesses as well. Our aim was to investigate whether excessive complement activation occurs in patients with heat-related illnesses. DESIGN: Prospective observational study. SETTING: Emergency department in the university hospital. PATIENTS: Thirty-two patients with heat-related illnesses and 15 age-matched healthy controls were enrolled in this study. INTERVENTIONS: Blood samples were collected from the study subjects for the measurement of complement factors. MEASUREMENTS AND MAIN RESULTS: Complement component 3a (C3a), complement component 5a (C5a), C5b-9, complement factor B (Ba), Factor H, and soluble CD59 in plasma were measured. The levels of C3a, C5a, C5b-9, and Ba significantly increased in patients with heat-related illnesses on day 0 compared with those in the healthy controls. Soluble CD59 was significantly high in patients with heat-related illnesses on day 0 and showed a correlation with the severity of the condition (Acute Physiology and Chronic Health Evaluation II, Sequential Organ Failure Assessment, and staging scores), Japanese Association for Acute Medicine disseminated intravascular coagulation scores, and the coagulation system (prothrombin time and fibrin degradation products). CONCLUSIONS: The complement system was activated in patients with heat-related illnesses, suggesting that it is one of the causes of MODS. Soluble CD59 may be a potent biomarker for the severity of heat-related illnesses.

Recurrent endometrial carcinoma: prognosis for patients with recurrence within 6 to 12 months is worse relative to those relapsing at 12 months or later.

OBJECTIVE: We evaluated association of prognosis of endometrial carcinoma patients and treatment-free intervals (TFIs). STUDY DESIGN: We compared the effectiveness of second-line chemotherapy performed for patients with TFIs of 6-12 months and 12 or more months following a first-line chemotherapy based on taxane (paclitaxel) and carboplatin, with or without the anthracycline (TC). RESULTS: Progression-free and overall survivals were significantly shorter in patients with TFIs of 6-12 months than those with TFIs of 12 or more months. Among the patients who received similar second-line chemotherapy, response rates of 15 patients with TFIs of 12 or more months and 7 patients with TFIs of 6-12 months were 67% and 43%, respectively. Progression-free survival was significantly worse in those with TFIs of 6-12 months (median, 7 months) than those with TFIs of 12 or more months (median, 12 months). CONCLUSION: Our small retrospective analysis suggests that recurrent endometrial carcinomas with TFIs of 6-12 months can be regarded as being partially sensitive to TC-based chemotherapy.

Endometrial carcinoma: better prognosis for asymptomatic recurrences than for symptomatic cases found by routine follow-up.

BACKGROUND: The aim of this study was to determine if there is a prognostic value for the presence of symptoms at the time of recurrence detection in surgically resected endometrial carcinoma patients. METHODS: During the study period of 2000-2006, complete surgical removal of endometrial carcinoma was achieved in 271 stage I-IV endometrial cancer cases at the Department of Obstetrics and Gynecology of Osaka University Hospital, Osaka, Japan. A subsequent recurrence was detected in 29 (11%) of these cases. Patient characteristics and clinicopathological features were retrospectively reviewed utilizing their clinical records. RESULTS: Among the 29 cases with a recurrence, 13 (45%) had symptoms, whereas in the other 16 cases (55%) the recurrent disease was found only during routine follow-up procedures. Although the time to detection of recurrence was similar for both asymptomatic and symptomatic cases, progression-free survival after detection in the 16 asymptomatic patients was significantly longer than for the 13 symptomatic patients (P = 0.017); this was found to be especially true in those who underwent chemotherapy as their adjuvant therapy (P = 0.023). CONCLUSIONS: A better prognosis after recurrence was demonstrated in cases that were asymptomatic at the time of recurrence detection than in those in which the tumor was symptomatic. This finding implies that, after the initial surgical resection, intensive follow-up intervention looking for asymptomatic recurrences may significantly improve the prognosis of endometrial carcinoma patients. A further in-depth prospective study is required to establish a standard strategy of follow-up care for endometrial cancer patients.

Characteristics, injuries, and clinical outcomes of geriatric trauma patients in Japan: an analysis of the nationwide trauma registry database.

Geriatric trauma is a major socio-economic problem, especially among the aging Japanese society. Geriatric people are more vulnerable to trauma than younger people; thus, their outcomes are often severe. This study evaluates the characteristics of geriatric trauma divided by age in the Japanese population. We evaluated trauma characteristics in patients (n = 131,088) aged ≥ 65 years by segregating them into 2 age-based cohorts: age 65-79 years (65-79 age group; n = 70,707) and age ≥ 80 years (≥ 80 age group; n = 60,381). Clinical characteristics such as patient background, injury mechanism, injury site and severity, treatment, and outcome were examined. Injuries among men were more frequent in the 65-79 age group (58.6%) than in the ≥ 80 age group (36.3%). Falls were the leading cause of trauma among the 65-79 age group (56.7%) and the ≥ 80 age group (78.9%). In-hospital mortality was 7.7% in the 65-79 age group and 6.6% in the ≥ 80 age group. High fall in the ≥ 80 age group showed 30.5% mortality. The overall in-hospital mortality was 11.8% (the 65-79 age group, 12.3%; the ≥ 80 age group, 11.2%). Most hospitalized patients were transferred to another hospital (the 65-79 age group, 52.5%; the ≥ 80 age group, 66.2%). We demonstrated the epidemiological characteristics of Japanese geriatric trauma patients. The overall in-hospital mortality was 11.8%, and fall injury in the ≥ 80 age group required caution of trauma care.

Effects of hypertonic saline versus mannitol in patients with traumatic brain injury in prehospital, emergency department, and intensive care unit settings: a systematic review and meta-analysis.

BACKGROUND: Intracranial pressure control has long been recognized as an important requirement for patients with severe traumatic brain injury. Hypertonic saline has drawn attention as an alternative to mannitol in this setting. The aim of this study was to assess the effects of hypertonic saline versus mannitol on clinical outcomes in patients with traumatic brain injury in prehospital, emergency department, and intensive care unit settings by systematically reviewing the literature and synthesizing the evidence from randomized controlled trials. METHODS: We searched the MEDLINE database, the Cochrane Central Register of Controlled Trials, and the Igaku Chuo Zasshi (ICHUSHI) Web database with no date restrictions. We selected randomized controlled trials in which the clinical outcomes of adult patients with traumatic brain injury were compared between hypertonic saline and mannitol strategies. Two investigators independently screened the search results and conducted the data extraction. The primary outcome was all-cause mortality. The secondary outcomes were 90-day and 180-day mortality, good neurological outcomes, reduction in intracranial pressure, and serum sodium level. Random effects estimators with weights calculated by the inverse variance method were used to determine the pooled risk ratios. RESULTS: A total of 125 patients from four randomized trials were included, and all the studies were conducted in the intensive care unit. Among 105 patients from three trials that evaluated the primary outcome, 50 patients were assigned to the hypertonic saline group and 55 patients were assigned to the mannitol group. During the observation period, death was observed for 16 patients in the hypertonic saline group (32.0%) and 21 patients in the mannitol group (38.2%). The risks were not significant between the two infusion strategies (pooled risk ratio, 0.82; 95% confidence interval, 0.49-1.37). There were also no significant differences between the two groups in the other secondary outcomes. However, the certainty of the evidence was rated very low for all outcomes. CONCLUSIONS: Our findings revealed no significant difference in the all-cause mortality rates between patients receiving hypertonic saline or mannitol to control intracranial pressure. Further investigation is warranted because we only included a limited number of studies.

Evaluating the risks of arrhythmia following electrical injury: Two cases of electrical injuries in the upper limbs.

Electrical injuries induce ventricular arrhythmias, which are lethal. Therefore, it is important to evaluate the risk of arrhythmias at initial presentation to the emergency department in cases of electrical injuries. Here, we report two cases with electrical injuries, where current flowed between the upper limbs, requiring 24-h hospitalization for arrhythmia monitoring. The patients were 57- and 30-year-old men, who sustained separate electrical injuries (6600 V, line voltage), with current flow from one hand to the other. They did not develop any ventricular arrhythmias during hospitalization and were discharged. The risk for ventricular arrhythmias is lower for electrical injuries occurring between the upper limbs than for those occurring between the upper and lower limbs. We conclude that 24-h hospitalization for monitoring of patients with electrical injuries of the upper limbs may be sufficient.

Influences of Total Laparoscopic Hysterectomy According to Body Mass Index (Underweight, Normal Weight, Overweight, or Obese).

STUDY OBJECTIVE: The aim of this study is to evaluate the effect of body mass index (BMI) on laparoscopic hysterectomy outcomes. DESIGN: This was retrospective study. SETTING: Minoh City Hospital, Japan. MATERIALS AND METHODS: Between January 1, 2014, and June 30, 2017, 183 patients underwent total laparoscopic hysterectomy (TLH) at our institution. INTERVENTION: Patients who underwent TLH were grouped according to BMI, as follows: underweight group (BMI <18.5 kg/m2), normal-weight group (18.5 ≤BMI <25 kg/m2), overweight group (25 ≤BMI <30 kg/m2), and obese group (BMI ≥30 kg/m2). MEASUREMENTS AND MAIN RESULTS: Information on patients' clinical characteristics and surgical results were collected retrospectively by medical record review. The severity of complications was graded according to the Clavien-Dindo classification. We assessed clinical characteristics, surgical results, and the perioperative complications in each BMI group. Surgical results included operation time, nonsurgical operating room time estimated blood loss, uterine weight, and postoperative hospital stay. Compared with the normal-weight group, the obese group had significantly more complications (P = 0.012) and longer operation time (P = 0.04). The underweight and overweight groups did not have significantly different surgical results than the normal-weight group. CONCLUSION: Underweight and overweight patients had no significant differences in surgical results, compared with patients of normal weight. Obese patients had significantly longer operation times and more perioperative complications than patients with normal weight. Laparoscopic hysterectomy has burdens and risks for obese patients. Our results suggest that appropriate weight control may decrease the risk of surgery for obese patients.

Development and process evaluation of the participatory and action-oriented empowerment model facilitated by occupational health nurses for workplace health promotion in small and medium-sized enterprises.

The objective of this study is to develop an available empowerment model for workplace health promotion (WHP) in small and medium-sized enterprises (SMEs) and to evaluate its applicability and feasibility. Semi-structured interviews with employers and workers in SMEs were conducted to assess their actual requirements for support. The structure of our new empowerment model was discussed and established through several rounds of focus group meetings with occupational safety and health researchers and practitioners on the basis of results of our interviews. We developed a new participatory and action-oriented empowerment model based on needs for support of employers and workers in SMEs. This new model consists of three originally developed tools: an action checklist, an information guidebook, and a book of good practices. As the facilitators, occupational health nurses (OHNs) from health insurance associations were trained to empower employers and workers using these tools. Approximately 80 SMEs (with less than 300 employees) were invited to participate in the model project. With these tools and continued empowerment by OHNs, employers and workers were able to smoothly work on WHP. This newly developed participatory and action-oriented empowerment model that was facilitated by trained OHNs appears to be both applicable and feasible for WHP in SMEs in Japan.

Spontaneous regression of FDG/PET positive lung adenocarcinoma in an elderly man.

Spontaneous cancer regression, either partial or complete, is a rare phenomenon, particularly in patients with lung cancer. The present paper is the case report of an elderly lung cancer patient aged 80 who exhibited spontaneous regression of the primary lesion, without receiving any treatment. Spontaneous regression commenced two years after obtaining pathological specimens by transbronchial biopsy from the pulmonary lesion. It is interesting that the tumor lesion had a strong uptake (standardized uptake value max: 26.3) in ¹8fluorodeoxyglucose positron-emission tomography before biopsy and that the regression occurred after a long interval after the biopsy, and that the regression developed in an elderly man. It is unknown why spontaneous regression was observed in this case and what kind of mechanism was involved in the phenomenon. Even in the elderly, as observed in our case, spontaneous regression can occur. The patient should be closely followed up to monitor the clinical course of such an unusual phenomenon.

Effectiveness of intraperitoneal or intrapleural administration of triamcinolone acetonide for the control of malignant ascites and pleural effusion (Kansai Clinical Oncology Group-G1102 study).

OBJECTIVES: We conducted a retrospective multi-institutional study to evaluate the efficacy and toxicity of intraperitoneal or intrapleural triamcinolone acetonide (TA), a slowly metabolized corticosteroid administration for the management of malignant ascites or pleural effusion. MATERIALS AND METHODS: The medical records of patients with gynecologic cancer who were treated with paracentesis or thoracocentesis followed by administration of 400 mg of TA between 2005 and 2014 were reviewed. RESULTS: The median age of the 74 eligible patients was 59 years. An Eastern Cooperative Oncology Group performance status 3-4 was present in 53 patients (73%), and 52 patients (70%) had ovarian cancer. Paracentesis followed by TA administration was performed in 65 patients (88%), and 37 patients (50%) were treated in a palliative setting. Chemotherapy or surgery after TA administration was performed in 37 patients (50%) in an aggressive setting, of which 14 patients (19%) were treated at the primary phase and 23 patients (31%) were treated at recurrent phase. The time interval of serial drainage was prolonged in 15 of 19 assessable patients, resulting in a response rate of 79% (95% confidence interval [95% CI]: 54-94%). Median overall survival after TA therapy in a palliative setting was 36 days (95% CI: 19-58 days). After TA therapy in a palliative setting, one patient complained of mild abdominal pain, two patients with advanced peritonitis carcinomatosis experienced bowel perforation, and three patients died within 7 days owing to disease progression. CONCLUSIONS: Intraperitoneal and intrapleural TA administration were feasible and effective in symptomatic control of ascites and pleural effusion.

Development of multi-dimensional action checklist for promoting new approaches in participatory occupational safety and health in small and medium-sized enterprises.

To meet diversified health needs in workplaces, especially in developed countries, occupational safety and health (OSH) activities should be extended. The objective of this study is to develop a new multi-dimensional action checklist that can support employers and workers in understanding a wide range of OSH activities and to promote participation in OSH in small and medium-sized enterprises (SMEs). The general structure of and specific items in the new action checklist were discussed in a focus group meeting with OSH specialists based upon the results of a literature review and our previous interviews with company employers and workers. To assure practicality and validity, several sessions were held to elicit the opinions of company members and, as a result, modifications were made. The new multi-dimensional action checklist was finally formulated consisting of 6 core areas, 9 technical areas, and 61 essential items. Each item was linked to a suitable section in the information guidebook that we developed concomitantly with the action checklist. Combined usage of the action checklist with the information guidebook would provide easily comprehended information and practical support. Intervention studies using this newly developed action checklist will clarify the effectiveness of the new approach to OSH in SMEs.