No. of practices per adverse event they are aiming to prevent/reduce.
\r\n\tThis book aims to explore the issues around the rheology of polymers, with an emphasis on biopolymers as well as the modification of polymers using reactive extrusion.
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She was discharged from hospital the following day, but within the first week, she felt unwell and had fever. She saw her general practitioner (GP) twice during that week, but he did not notice anything wrong. Later that week, she was admitted to hospital with abdominal pain and septic shock. Her condition worsened rapidly and, despite the excellent inpatient care, she died shortly afterward.
Despite the fact that maternal mortality rate in Italy is one of the lowest in Europe [1], sepsis remains one of the leading causes of preventable maternal death [2]. The body is vulnerable after pregnancy. Resources are depleted, and whether the birth was natural or surgical, large areas of the body are exposed and vulnerable to infection. To end preventable mortality, every pregnant woman needs skilled care at birth. Furthermore, it is crucial for a safe childbirth that continuity of care is ensured.
To prevent the occurrence of adverse events such as the one described above, the Local Health Authority of Treviso (Italy) has set up a multidisciplinary working group (gynecologists, obstetricians, nurses, anesthesiologists, and neonatologists) that has been mapping the whole path toward childbirth, from pregnancy to delivery, with the aim of ensuring (1) continuity of care before, during, and after childbirth, (2) uniform services are delivered, and (3) appropriate care based on the assessment of pregnancy-related risks regarding the case at hand. Besides the above, an analysis of adverse events and near misses has been carried out and situations that may influence the decision-making of professionals—such as confidence in own skills and lack of or excessive consideration of the patient’s perspective—identified. Therefore, the following actions have been carried out:
Identification of a suitable space for handover, possibly in front of a board so as to ensure that the professionals have all relevant information at the moment of taking charge.
Definition and adoption of strategies aimed at promoting dialog between professionals in specific situations that are potentially at risk due to human or environment factors.
Drafting an updated list of procedures already in place within the organization.
Participation of all the professionals involved in childbirth is a key strength of the practice outlined, as it led to the definition of shared procedures and improved the information flow from one step to another.
The importance of safe practices to improve quality not only in maternal care but also in patient care, in general, has been put in the spotlight by the publication of the report by the Institute of Medicine, “To err is human” [3]. The need “to promote safe practices to prevent the most commonly occurring adverse events such as medication-related events, healthcare-associated infections, and complications during or after surgery” has been highlighted by the Council Recommendation on patient safety [4] and, more recently, by the European Parliament Resolution on a safer healthcare in Europe [5].
In Italy, some actions, within a specific national program, have been launched to improve quality and safety in childbirth and maternal care. They are also inspired by what the OECD highlighted in the Review of Health Care Quality: Italy 2014. Raising Standards [6]: “a range of quality-related activities have been developed in Italy, with varying depth and scope, and with little co-ordination across these approaches by central agencies.” This situation was a result of the organization of the Italian Healthcare System, which is a regional-based system that provides universal coverage free of charge at the point of use. The wide autonomy granted to the Regions and Autonomous Provinces (R&APs) has led to a huge heterogeneity in the quality and safety of the services provided [6–8]. The need for a nationwide initiative to improve patient safety, coordinated at central level, was translated into an agreement between the Italian government and the R&APs, which entrusted the National Agency for Regional Healthcare Services (Agenas) with the task of monitoring, promoting, and supporting regional and local initiatives on clinical risk and patient safety, with a focus on monitoring and promoting dissemination of good practices for patient safety. Based on this mandate, the National Observatory on Good Practices for Patient Safety was established as a national program to improve patient safety by promoting diffusion and active dissemination of evidence-based practices.
The general aim of the Observatory is to ensure that the care every patient receives is as safe as the state-of-the-art of knowledge allows by stimulating local governments, healthcare organizations, and professionals to implement evidence-based safe practices. Its activities are based on the belief that top-down and bottom-up actions are complementary in order to achieve continuous quality and safety improvement in healthcare [7–10]. Drawing on this belief, multiple stakeholders have been involved in the Observatory’s scope definition, design, and implementation (Ministry of Health, R&APs, Agenas, healthcare organizations, and professionals).
The Observatory’s scope was defined on the basis of a restricted survey among the leading experts in quality and safety at international level in order to define what a good practice is. The result of the survey was the following definition of good practices for patient safety: evidence-based interventions, sustainable over time and potentially transferable, that have been implemented at regional/local level and proved to be effective in improving patient safety.
The Observatory’s activities are implemented through a cyclic model shaped on the PDSA cycle, whose main steps are [7] (Figure 1):
The Observatory model of intervention.
The Observatory model of intervention is based on five main phases that are sequential from a logical and temporal point of view: after defining/updating and sharing models and tools, good practices are identified and collected in a web database; they are evaluated, classified, and subjected to dissemination actions while priorities are set for the next cycle. These phases are annually covered in a spiral process tending to continuous improvement.
1. Defining and sharing the models and tools among all stakeholders
As mentioned, the Observatory has been designed and implemented based on the input of multiple stakeholders. Furthermore, stakeholders are periodically asked to provide feedback on the tools used to collect and share patient safety practices so as to revise them accordingly.
2. Identification and collection of patient safety practices
The tool used to collect patient safety practices is the Call for Good Practices, issued annually to invite regional health authorities to coordinate the collection of patient safety activities carried out at regional/local level.
Every year a focus on a specific safety-related problem is defined, so as to align the patient safety activities carried out at national level with the international ones. Therefore, over the years, the Call has been paying special attention to practices related to the following topics: surgical site infections, medication reconciliation, and hand hygiene. The focus of the 2016 edition of the Call has been defined based on the proposals made by the regional representatives who have been participating in the periodic survey aimed at collecting their feedback on the usability of the tools of the Observatory and on possible improvements to be implemented. As a result, childbirth and maternal care have been identified as an area where more needs to be done to ensure good quality care is delivered throughout childbirth and major complications are prevented.
Participation in the Call is fully web based and articulated in a three-level system: healthcare organizations/professionals (reporting); regional representatives—experts in patient safety appointed by the Regional Health Authorities (approval/validation); Agenas (collection/classification).
The Observatory developed and shared with the R&APs a standard form for reporting the practices consistent with Standard for Quality Improvement Reporting Excellence (SQUIRE—www.squire-statement.org) guidelines [11] and supported by a computer-based tool to help professionals calculate the implementation costs. In 2014, a revision was made to the reporting form to allow transfer of the practices at European level. Agenas, in fact, has been participating in and supporting the activities of the PaSQ Joint Action (co-funded and supported by the European Commission under the Public Health Programme, Agreement Number 20112101), whose main objective was to improve patient safety and quality of care through sharing information and experiences and implementing good practices. To do so, a form to collect patient safety practices (PSPs) has been developed and tested at European level [7]. It has then been translated into Italian and made available to healthcare organizations and professionals to report their PSPs to the Observatory.
The Call takes about 5 months, from mid-May to mid-October. The practices submitted, once validated by the regional representatives, feed an Internet archive (
3. Classification of practices
The practices submitted to the Observatory have been classified into three main categories until 2014:
Good practices: Experiences fully implemented which include a detailed evaluation of results (either by quantitative or qualitative analyses).
Potential good practices: Ongoing/not fully implemented experiences, with incomplete report of results.
Initiatives: Interventions not yet implemented or with very limited documentation about efficacy.
From 2014 onwards, the Observatory applies the classification model developed at European level (PaSQ Joint Action) [7]:
Safe practice: A practice that was implemented and the before and after measurement has documented that it enhanced one or more aspects of patient safety. The before and after evaluation could be qualitative as well as quantitative.
Potentially safe practice: A practice that was implemented and a before measure was established. However, no after measure is reported.
Not proven effective practice: A practice that was implemented, but the before and after measure did not show improvements.
Not implemented practice: A practice that was not implemented yet. This could be the case, e.g., if the practice is under development or it is just an idea.
Not evaluated practice: A practice that was implemented, but before measure was not established.
4. Exploitation, dissemination, and promotion of transfer of safe practices—priority settings of next call
The Observatory approach was aimed at setting up actions for gradual transition from passive spread of safe practices to active and planned adoption in a sustainable way [6, 7, 9, 12, 13]. Therefore, further to web diffusion and traditional dissemination tools (presentations in national and international conferences, brochures, and scientific papers), some specific tools have been tested to disseminate and promote the transfer of safe practices. As a part of an increasingly widespread dissemination of good practices, a model for inter-regional transfer of safe practices has been tested. The model is based on the exchange of experiences and knowledge between three groups of Regions (Northern, Central, and Southern) that are contiguous from the geographical and cultural point of view and their models for clinical risk management have similar organizational features [7]. The tool consists of a standard workshop format that is reproducible and adaptable to different contexts. The strengths of this tool, as declared by professionals, health organizations, and regions involved, lie in the fact that it enables an open and direct discussion between organizations sharing similar problems and allows a more widespread dissemination of the safe practices.
A peer review program for promoting transfer of safe practices at inter-regional level has been developed and tested. For the first test, the peer review program has been focused on good practice for safe surgery (to answer to specific needs expressed by professionals and to keep the Observatory aligned with the international indications). In collaboration with the Association of Italian Hospital Surgeons (ACOI), the Italian Society of Anesthesia Analgesia and Intensive Care (SIAARTI), and the Association of Operating Room Nurses (AICO), the specific model of intervention and procedures have been developed and tested at the Day Surgery Unit of the Niguarda Ca’ Granda Hospital in Milan. The program is still ongoing in the Lombardy Region.
The main result of the activities described in this chapter is a publicly available database of patient safety improvement interventions including 2628 experiences (Figure 2).
Number of practices reported to the Observatory per year.
An average of 300 practices per year has been submitted to the Observatory. The number ranged from a maximum of 358 in 2008 to a minimum of 230 in 2013. Since 2014, the trend is in the direction of a recovery.
This year’s focus is on experiences aimed at improving quality of maternal care that resulted in submission of the 43 practices some of which are briefly outlined in the box (titles are provided for all of them); they represent evidence-based, implemented real solutions to the problem presented in the beginning of this chapter.
Patient safety practices aimed at improving quality of maternal care. Titles and abstracts are taken from the Observatory on Good Practice for Patient Safety (
The application of the National Recommendations for the healthcare safety: a questionnaire for the internal monitoring in the Clinical Units of the University Hospital of Parma [14]
Parma Hospital—Emilia Romagna Region
Aiming to improve: (1) Analyze the applicability, relevance, and effective implementation of each National Recommendation within all the clinical units of the University Hospital of Parma. (2) Assess whether the training events for the dissemination of all National Recommendations have had repercussions in the clinical care practice. (3) Check whether the tools provided for the spreading of the specific contents of the National Recommendations are actually considered useful by the chiefs of clinical units. (4) Identify suggestions for improvement in order to increase the safety culture in the University Hospital.
Description of PSP: (1) The Clinical Governance Structure of the University Hospital of Parma has promoted an internal survey, in all clinical units, for monitoring the application of National Recommendations for the Clinical Risk Management. The monitoring has included: (1) The creation of the questionnaire, developed by the professionals of the Clinical Governance Structure in collaboration with the Nursing Directorate (time required 3 months). The questionnaire, prepared in a pdf mode, had “forms” fillable directly online by the managers of all clinical units. The compilation of “filter” questions has allowed managers to bypass entire sections of the questionnaire if they have evaluated one or more Recommendations as “not applicable” in their clinical units. The questionnaire has allowed to automate the insertion phase of data. (2) Sending the online questionnaire by email to all clinical units’ chiefs/coordinators evaluated as eligible to the survey. The questionnaire has been accompanied by an introductory note that has explained the survey’s objectives and the methodology used. All clinical units have been represented by one or more questionnaires compiled by their representatives (chief of clinical unit or coordinator). (3) Results’ processing (time required 3 months). (4) Dissemination of the final report to the chiefs/coordinators through the Intranet site and use of the results for the 3-year program of safety management (time required 3 months).
Methods used for evaluating results: Process indicators—Coordinators participated in 75% of cases, whereas chiefs of clinical unit doctors responded in the remaining 25% of cases. About 81% of clinical units that were eligible for detection has joined the survey (N = 59). The departments that have joined more to the survey were the General and Specialist Surgery Department and the Geriatric Department. Outcome indicators: The National Recommendations that have been highlighted as more applicable in the clinical units are (1) the 9th, regarding the malfunctioning of electromedical devices: 100 of clinical units, (2) the 13th about the falls prevention: 89.8% of clinical units, (3) the 8th for the prevention of violence against healthcare workers: 88.1% of clinical units, and (4) the 17th, regarding the drugs reconciliation 86.4% of clinical units. The more a recommendation has contents that concern all clinical units, much less was found to be homogeneous in its effective dissemination/application in the teaching hospital. In fact, the recommendations, whose contents are general and applicable for 60–100% of clinical units of the teaching hospital, were found to have a non homogeneous application: in fact, except for the two recommendations on the safety of drugs use (the 7th and the 12th), applied in 100% of the clinical units, all the other remaining recommendations have achieved the levels of application inferior to 8.5%. Instead, the National Recommendations whose content was “specific” or limited to specific clinical areas (e.g., the prevention of maternal or neonatal death) have obtained 100% of application in the few clinical units concerned.—An average of 8% of clinical units has evaluated “scarce” the utility of the training events and of the tools made available by the Clinical Governance Structure, in particular for the 9th and 4th Recommendations (regarding “the malfunctioning of electromedical devices” and “the prevention of patient’s suicide,” respectively), also by considering them highly relevant.—37.5% of the structures in which the Recommendation n.10 is considered has highly relevant, has evaluated the specific tools made available by the Clinical Governance structure as not useful in which the Recommendation 10 (focused on “Prevention of bisphosphonates-induced osteonecrosis”) is considered highly relevant, also has evaluated as not useful the specific tools and training events made available by the Clinical Governance Structure to improving safety. These recommendations will, therefore, be the subject of specific projects within the three-year planning (Plan on the Safety of Care Program 2016–2018) in the Parma Teaching Hospital. An average of 8.7 suggestions/proposals for the improvement of the local application of each among the 17 National Recommendations has been obtained.
Newborn Emergency Transport Service (NETS): the experience in the Province of Reggio Emilia [15]
Local Health Authority of Reggio Emilia—Emilia Romagna Region
Nursing skills video-tutorial (infant/child 0–3) [16]
University Hospital of Trieste—Friuli Venezia Giulia Region
Aiming to improve:Keywords: maternal and child nursing skills, simulations, safe care, and effective communication. The training of nursing staff in maternal and childcare must take place in the safest possible manner. The simulation provides a solution for safe learning, offering to those who practice two major advantages: on the one hand, the “permission to make mistakes” and, on the other, the opportunity to learn through clinical experience. Building on the experience of the laboratory, 2nd year CDL Nursing 2012–2013 AA will be implementing further simulations for learning in a safe environment with the aim of improving the clinical learning of nursing students within maternal and childcare. To test the possible improvement of the practice, it will compare the performance of students of 2012–2013 AA with those of 2016–2017 AA (CDL Nursing—Department of Medical, Surgical and Health Sciences-University of Trieste).
Description of PSP: Simulation Design Scale (Student Version)
Methods used for evaluating results: Simulation Design Scale (Student Version) and compare the performance of students of 2012–2013 AA with those of 2016–2017 AA (CDL Nursing—Department of Medical, Surgical and Health Sciences, University of Trieste)
“Dry cord care” in the treatment of the neonatal cord stump [17–19]
University Hospital of Udine—Friuli Venezia Giulia Region
HFMEA applied to >24 weeks pregnant patients’ pathway [20]
University Hospital of Udine—Friuli Venezia Giulia Region
Aiming to improve: To ensure safer care, we decided to apply HFMEA to our 24th week pregnant patients’ pathway. Our analysis started from patient acceptance and ended in temporary observation (before hospitalization).
Description of PSP: First of all, the multiprofessional team was assembled. The team analyzed the entire pathway, describing 6 main phases, 28 activities, and 45 potential failure modes (PFM). For each PFM, the professionals assigned a numerical value, risk priority number (RPN) to identify activities at risk, in accordance with literature. To establish the priority of interventions, we decided to put in place corrective actions for PFM with RPN numerical values > the third quartile.
Methods used for evaluating results: We assigned new RPN scores for PFM > the cut-off and analyzed the improvements through Wilcoxon test: we obtained a statistically significant decrease of the RPN values (p = 0.0009).
Continuing education on prevention and treatment of postpartum hemorrhage [21]
IRCCS S. Raffaele—Milano—Lombardy Region
Aiming to improve: The first official Italian guidelines on postpartum hemorrhage (PPH) prevention and treatment were published in November 2016. Our clinical practice has, therefore, been updated, and its compliance to these national guidelines verified. The department’s internal guidelines, albeit updated earlier this year, have also been integrated with the newest indications regarding the use and dosage of uterotonic medications. We aim to keep training our obstetric staff and younger physicians, in particular, to face PPH with effectiveness and celerity. We recently introduced the ROTEM analysis for patients undergoing severe blood loss, as this proved to be fundamental in order to guide the utilization of blood product transfusion.
Description of PSP: Thanks to the experience gained during a practical course using a mannequin (Noelle®), we decided to focus on patients who most rapidly reach 1500 ml of blood loss. We trained on positioning intrauterine hemostatic balloons and most specifically on uterine sparing compressive surgical techniques, as our primary objective is the conservation of young patients’ subsequent fertility. To improve our further education, we organized audits in order to discuss clinical scenarios that included PPH complications.
Methods used for evaluating results: We have always divulged monthly statistical analyses of PPH cases to our clinical staff in order to raise awareness and stimulate the individual’s revision of the adverse event. We also re-examined each single severe PPH case with the obstetric staff, on call at the time, to identify and discuss inconsistencies in different clinicians’ approach to the matter. Great effort is implied in supporting the patient and her relatives after PPH. In fact, some patients risk PTSD after such a complication, and we offer an appropriate psychological—behavioral aid to prevent this disorder. Among our PPH patients, none presented this problematic.
Intensive management of pregnant women with HELLP syndrome [22]
ASREM—Molise Region
Good practices in obstetrics: the value of Audit in healthcare [23]
Local Health Authority of Asti—Piedmont Region
Aiming to improve:Postpartum hemorrhage is a major cause of mortality and maternal morbidity: it occurs at a rate varying between 5 and 22% of total deliveries and implies a mortality rate of 1:1000 in developing countries and of 3–5:100,000 in industrialized countries. A total of 60–70% of deaths by postpartum hemorrhage is due to nonoptimal treatment. Hence, the need to apply the strategy of an “Active Management” of the third stage able to reduce the incidence of 40–50% hemorrhage. We worked according to the principles of clinical risk management, analyzing and activating adequate proceedings to restrict adverse events.
Description of PSP: The verification on the data collected allowed to confirm the goodness of our practice of active management of the third stage by oxytocin prophylactic administration to all patients. The frequency of postpartum hemorrhage in our ward seems to be comparable to that of other Centres of Excellence in Italy. In all cases of more serious hemorrhage (>1000 ml), the treatment was rapid and an integrated multiprofessional and multidisciplinary approach that allowed us to quickly identify the cause and provide suitable therapeutic measures.
Methods used for evaluating results: examination of medical records
Prevention and management of postpartum hemorrhage in Obstetrics and Gynecology [24]
Local Health Authority of Prato—Tuscany Region
Aiming to improve: Postpartum hemorrhage is one of the most frequent causes of maternal death. More than half of the cases occur within 24 hours of delivery. Good practice calls for actions and tools for better prevention and management of this event. Practice realized in collaboration with Italian Association of Hospital Gynecologists.
Description of PSP: As a part of the project for patient safety, the Regional Center for Clinical Risk Management of Tuscany has launched a campaign on the prevention and management of postpartum hemorrhage. In order to provide a guide to individual health structures for the implementation of interventions that might lead to better prevention and management of this event, it has developed a guidance document “Best Practices for prevention and management of postpartum hemorrhage” (Chapter 2.2 Best Practices for patient Safety in Obstetrics and Gynecology, published in No. 1 of Notebooks of laboratories for patient safety). Based on the indications suggested by the Regional Good Practice LHA 4 of Prato has (1) implemented the dissemination of the document to address GRC Regional Centre to all relevant staff; (2) provided a procedure for the adoption of formalized good practice; and (3) applied the regional indications for the prevention and management of postpartum, according to the responsibilities identified, and in particular: the prevention of post-partum hemorrhage through the active management of postpartum; the timely diagnosis of postpartum hemorrhage (procedure for the estimation of blood loss), the search for the cause of bleeding, and the immediate availability of tools and materials (Kit hemorrhage); coordinated multidisciplinary management of cases of postpartum hemorrhage through the implementation of an operating instruction for the management of hemorrhagic shock; sharing with anesthetists and the blood centers operation instruction for the management of hemorrhagic shock; the planning and execution of training events on laparotomy techniques in postpartum hemorrhage; the implementation of the default grid for the documentation of cases of postpartum hemorrhage; programming an audit of any postpartum hemorrhage.
Methods used for evaluating results: The implementation is evaluated through clinical Audit and periodical internal checks on the correct application of the good practice. INDICATORS—Presence of a procedure for the formal adoption of good practice; certificates on periodic training of the surgical team; presence of a board/grid for the documentation of cases of postpartum hemorrhage; presence of alert reports about systemic analysis of cases reported with postpartum hemorrhage; availability of postpartum hemorrhage kit in the delivery room; and presence of the poster “postpartum hemorrhage” in the delivery room.
Pregnancy and delivery of a cardiopathic fetus [25]
Gabriele Monasterio Foundation Hospital—Tuscany Region
Aiming to improve: The finding of a heart defect in the fetus has significant implications for pregnancy management, delivery planning, and diagnosis of abnormalities in other organs. Fetal echocardiography can help detect fetal heart abnormalities before birth, allowing for faster medical or surgical intervention once the baby is born if needed. This improves the chance of survival after delivery for babies with serious heart defects. Some heart defects will not require immediate intervention, and the baby can be followed at the delivery hospital and as an outpatient after discharge. Other defects are more serious and require pediatric cardiac surgical services immediately after delivery. In some cases, the condition may be severe enough for the pediatric cardiologist to recommend delivery at a pediatric heart center so that an intervention can be performed within minutes of life. In all cases, these issues should be discussed and planned for during the fetal echocardiography visits. Keyword: baby childbirth birth path cardiopathy.
Knowing about a potential heart problem prior to delivery also gives a family a chance to learn more about the problem which can help themselves prepare psychologically for dealing with the extra challenges they may face following birth, such as surgery or other interventions the child may require. A coordinated fetal team that includes pediatric cardiologists, genetics counselors, obstetricians, perinatologists, neonatologists, nurses, and other subspecialists should work closely.
Description of PSP: A clinical pathway was designed in Fondazione Toscana “G. Monasterio” together with Nassau Hospital for precocious diagnosis of fetal congenital heart disease and for the rest of pregnancy and delivery management. Fetal heart abnormalities are detected before birth, allowing for faster medical or surgical intervention once the baby is born in order to improve chance of survival. After in-womb diagnosis, several meetings before delivery with parents, midwife, psychologist, pediatric cardiologist, and neonatologist are planned. Delivery is planned and performed in a special, dedicated area of Pediatric Cardiology/Cardiac Surgery Department, where the presence of specifically trained obstetricians, neonatologists, midwives, and anesthesiologists together with highly trained nurses is guaranteed all over 24 hours. After birth, the baby is transferred to a dedicated Newborn Intensive Care Unit for the first interventions, where she is evaluated also by a pediatric cardiologist and a pediatric cardiac surgeon.
Methods used for evaluating results: Nonquantitative methods are now in use
Prevention and management of shoulder dystocia in Obstetrics and Gynecology [26]
Local Health Authority of Prato—Tuscany Region
Aiming to improve: Shoulder dystocia is a complication associated with childbirth for which the shoulders of the fetus do not come out spontaneously after the escape of the head and require additional obstetric maneuvers. The good practice developed at regional level provides a series of actions and instruments, consistent with international guidelines, aimed at better prevention and management of this event. Made in collaboration with Italian Association of Hospital Gynecologists.
Description of PSP: As a part of the campaign for patient safety, the Regional Center for Clinical Risk Management (RCCRM) of Tuscany has launched a campaign on the prevention and management of shoulder dystocia. In order to provide a guide to individual health agencies for the implementation of interventions that might lead to better prevention and management of this event, the RCCRM has developed a guidance document “Best Practices for the prevention and management of shoulder dystocia” (Chapter 2.1 of the best practices for patient safety in Obstetrics and Gynecology, published in No. 1 of the Notebooks of laboratories for patient safety). Based on the indications suggested by the Regional Good Practice, the Trust of Prato: implemented the dissemination of the document to address GRC Regional Centre to all relevant staff; set up a general procedure for the adoption of formalized good practice; ensured the prevention, when possible, through proper identification of risk factors for antepartum and intrapartum both at the time of taking over of the woman in labor (shared procedures and protocols for the management of all phases of childbirth); ensured adequate treatment of cases by carrying out the maneuvers required by good practice and coordinate the multidisciplinary management of cases; ensured the competence of healthcare professionals (knowledge, skills, and interpersonal skills) through training and simulation; made available the presence of a poster in all venues of labor and of childbirth aid to remember the maneuvers to be carried out; implemented a default grid for the documentation of cases of shoulder dystocia; and ensured the conduct of an audit on all cases of dystocia.
Methods used for evaluating results: The actual implementation of the provisions of good practice is periodically checked: presence of a company procedure for the formal adoption of good practice; presence of the partogram in the medical record; presence of the poster in all rooms of labor and childbirth; presence of analysis of detected cases of shoulder dystocia, with relative alert report; and presence of certificates of training with simulation.
Activation of labor analgesia in first-level structure within 24 hours [27]
Local Health Authority of Mirano—Veneto Region
Aiming to improve: Modern anesthesiology allows women to control pain during labor and delivery through epidural analgesia, a safe and effective technique that ensures the possibility of a spontaneous delivery and at the same time the complete participation of the woman during the birth of her baby. In Italy, this kind of analgesia is not yet a widespread technique, even if it is provided by the most recent Essential Levels of Care. The reasons for this lack in popularity are many: (1) cultural barriers among both professionals and patients, who are often not well informed on the procedure; (2) organizational problems such as the lack of well-trained professionals and the lack of an on-call anesthetist during the 24 hours; and (3) an increasing request of analgesia during labor as a result of safer anesthesiological and pharmacological techniques used. For all these reasons, professionals working in obstetrics and gynecology and resuscitation units of Dolo and Mirano hospitals in the latest years have made a great effort to ensure analgesia during labor to all women who deliver there 24/7 (and not only 12 hours/day as provided by the current Essential Levels of Care). In this way, every woman who desires analgesia during labor can have access to it, if the clinical situation allows it, independently of the time of the request. Specific objectives: to ensure every pregnant woman, the possibility to have analgesia during labor 24/7, by the continuous presence of an on-call anesthetist; to reduce intrapartum complications, thanks to a specialized assistance; to reduce the number of complications after the birth, thanks to a dedicated and specialist level of assistance; to reduce the number of cesarean sections; and to increase professionals’ and patients’ knowledge and awareness about pain in labor.
Description of PSP: (1) Information about analgesia during labor is given during childbirth classes and obstetric visits, focusing on the technique, the risks, and the benefits for the mother and the baby and on how to access to the service, giving the pregnant women the specific forms to fill. (2) The anesthesiological visit is offered after 35 weeks of pregnancy, and it is necessary for the clinical evaluation of the pregnant woman and to explain her the technique. (3) The woman is invited to fill in the specific forms for epidural analgesia and to sign the informed consent for the procedure. (4) The working shifts guarantee there is an on-call anesthetist 24/7. (5) Daily briefing and multidisciplinary meetings are fundamental to discuss about organizational problems on the analgesia service and solve them. (6) The data on the anesthesiological chart are important for a quantitative analysis of the service. (7) It is important to evaluate the pain before and after the analgesia, using visual analog scale of pain (VAS) and to collect opinions of the patients about the assistance offered. These two parameters allow doing a qualitative analysis of the service.
Methods used for evaluating results: Evaluation of the results based on the detection of pain before and after analgesia with validated method visual analog scale of pain (VAS). Bromage scale to assess the motor blockade of the lower limbs. APGAR index of newborn.
ST analysis of fetal ECG reduce cesarean section rate for fetal distress [28]
Nursing Home Abano Terme—Veneto Region
Decreasing AUR (antibiotic use rate) in infants = 35 weeks in community-based neonatal intensive care unit (NICU) [29]
Local Health Authority of Vicenza—Veneto Region
Clinical birth pathways: new uncertainties and “error traps” in the risk assessment [30]
Local Health Authority of Treviso
Early identification and treatment of sepsis in pregnancy [31]
Hospital of Feltre
Aiming to improve: Sepsis protocol describes clinical and instrumental methods to early identify the risk of sepsis in pregnant women. The aim is to prevent the onset of sepsis and its complications.
Description of PSP: Healthcare Practitioners evaluate pregnant woman on her symptoms/signs, her risk factors to develop sepsis, and on the Quick-sepsis-related organ failure assessment (SOFA). If there is only a single symptom/sign positive, and all other parameters are negative, woman is monitored for 6–12 hours with re-evaluating of all parameters at least one time every 3 hours, carrying out specific blood chemical tests indicated in the protocol. If the parameters are positive (one or more symptoms and/or one or more risk factors and/or the Quick-SOFA is positive), woman is monitored for 12–24 hours with re-evaluating of all parameters at least one time on every 2 hours, carrying out specific blood chemical tests indicated in the protocol, including a blood gas analysis viewed by anesthetist. The gynecologist explains to the patient and her family the risk of possible sepsis diagnosis. If parameters go down, healthcare practitioners activate a series of countermeasures including the pregnant woman transfer to the intensive care.
Methods used for evaluating results: To evaluate the results, it will use patient’s clinical documents; in Italy, a specific information called “flusso SDO (Hospital Discharge Abstract)” is used to search for sepsis diagnosis in pregnant women and verify the sepsis protocol application.
Implementation of Safe Operating Rooms project by applying a surgical safety checklist tailored to the specific needs of cesarean delivery and evaluation of the impact on patient safety [32]
University Hospital of Modena—Emilia Romagna Region
Assisted Maternal Fetal Transport [33]
Local Health Authority of Piacenza—Emilia Romagna Region
Improving the management of shoulder dystocia by updating the knowledge of operators and the participation of pregnant women: health education project [34]
Local Health Authority ROMA E—Lazio Region
Protocol for assisting and surveilling newborns [35]
Local Health Authority ROMA B—Lazio Region
Presence of partner during childbirth [36]
Local Health Authority ROMA B—Lazio Region
Diagnostic-therapeutic pathways (DTPs) improve the affective-relational dimension between mother and baby through contact experiences [37]
Local Health Authority ROMA E—Lazio Region
Baby Friendly Community Initiative UNICEF Family Planners Centre EX ASL Roma B [38]
Local Health Authority ROMA B—Lazio Region
Development of integrated network for mother and child patient safety [39]
ASST Mantova—Lombardy Region
Strategies for reducing the number of cesarean sections as an indicator of quality of care in the delivery room [40]
ASST Valle Olona—Lombardy Region
Safe Delivery Room [41]
Local Health Authority of Bolzano—Autonomous Province of Bolzano
Childbirth checklist [42]
Local Health Authority CN1—Piedmont Region
Standardized procedures for the safety and appropriateness of neonatal emergency transport (STEN) and maternal-fetal assisted transport (STAM) in Piedmont Region [43]
Local Health Authority CN2
Procedure for assisting newborn with hypoxic-ischemic encephalopathy possible candidate for hypodermic treatment [44]
Local Health Authority BAT—Puglia Region
The childbirth from prenatal access to discharge from hospital [45]
Nursing Home Triolo Zancla—Sicily Region
Description of emergencies activities—gynecological-obstetric emergency [46]
Provincial Health Authority of Catania—Sicily Region
Implementation of good practices in relevant clinical obstetrics and gynecology through specific documentation integrated inside the obstetric assistance folder care [47]
Local Health Authority of Lucca—Tuscany Region
Prevention and management of shoulder dystocia [48]
University Hospital of Pisa—Tuscany Region
Prevention and management of postpartum hemorrhage [49]
University Hospital of Pisa—Tuscany Region
The checklist applied to the path medically assisted procreation [50]
Local Health Authority Versilia—Tuscany Region
Procedure for neonatal resuscitation [51]
Local Health Authority Rovigo—Veneto Region
The path leading to childbirth [52]
Local Health Authority of Thiene—Veneto Region
The autonomy of midwife in the management of labor and physiological delivery [53]
Local Health Authority of Mirano—Veneto Region
Safe childbirth [54]
Local Health Authority of Legnago—Veneto Region
Implementation of obstetrician triage at the clinic in midwifery acceptance [55]
Hospital of Padova
Assistance procedure in the postpartum hemorrhage [56]
Local Health Authority of Rovigo
Procedure for prevention of maternal death or serious illness related to labor and/or childbirth [57]
Local Health Authority of Rovigo
Guidelines for the management of sepsis in pregnancy and childbirth [58]
Local Health Authority of Rovigo
Below, we also report some of the results achieved by the Observatory by applying the logical model [59–61]. To do this, we performed a temporal analysis (2008–2014) of aggregated data collected through the annual calls for good practices. Over the years, the number of patient safety practices (PSPs) submitted to the Observatory ranged from a maximum of 361 in 2008 to a minimum of 230 in 2013 [7], while the absolute number of Health Providers who reported at least one good practice has had a fairly more stable trend. In particular, we can see an increase in the number of health providers participating in the Call from 2008 to 2010, and then a decrease from 2010 to 2014. The joint observation of this decrease and the number of good practices shows opposite patterns (an increase in the number of good practices from 2013 to 2014). This means that in 2014, a lower number of providers have been actually producing a higher number of good practices (Figure 3).
Number of patient safety practices and healthcare providers in the Italian Observatory 2008–2014.
Even though the number of professionals reporting patient safety practices has been decreasing over time, there is an increase in the number of experiences reported from 2013 to 2014. This means that a lower number of providers have been actually producing a higher number of good practices.
Since the practices reported could be at a different stage of development, we also looked at them according to their level of implementation and evaluation of results (Figure 4), as derived from the classification in good practice, potential good practice, and initiative. At a decreasing total number of practices reported in 2013 corresponds a more balanced proportion of fully implemented good practices with respect to potential good practices (40% each). This suggests that the quality of the experiences reported has improved over time.
Absolute number of patient safety practices (right axis) and percentage of practices per level of implementation (left axis) per year 2008–2014: Analysis of temporal trend in the level of implementation of patient safety practices.
It is interesting to look at the distribution of the practices according to the adverse events they focus on (the experiences reported to the Observatory have to specify one or more adverse events they aim to prevent/reduce). Adverse events have been selected among the most prevalent in literature and in the Italian context [62].
Table 1 shows the list of adverse events and the total number of good practices related to them over the whole period of 2008–2014.
COD | Adverse events | No. of practices |
---|---|---|
1 | Other clinical adverse events | 430 |
2 | Procedure on wrong patient/wrong side or body part or wrong procedure | 310 |
3 | Hospital-acquired infections | 298 |
4 | Death, coma or disability due to medication errors | 296 |
5 | Retention of material in surgical site | 181 |
6 | Death or severe adverse event unexpected after surgical intervention | 174 |
7 | Patient’s fall | 166 |
8 | Adverse events related to inadequate hand hygiene | 144 |
9 | Transfusion reaction due to AB0 incompatibility | 136 |
10 | Deep venous thrombosis | 128 |
11 | Pressure ulcers | 98 |
12 | Adverse events due to malfunctioning of transportation system | 90 |
13 | Death/permanent disability in healthy newborn (weight>2.500 gr) | 72 |
14 | Violence against healthcare workers | 68 |
15 | Maternal death or severe illness associated with labor and/or delivery | 65 |
16 | Prevention of adverse events related to incorrect attribution of triage code | 65 |
17 | Suicide or attempted suicide in hospitalized patients | 60 |
18 | Violence against patients | 48 |
No. of practices per adverse event they are aiming to prevent/reduce.
In general, the number of practices that related to prevention of the main surgical adverse events is very high (665). It is followed by the number of practices aimed at avoiding hospital infections (298) and those related to prevention of errors in pharmacological therapy (296). Many experiences are also aimed at avoiding patient’s fall (166), reported to be the most frequent event occurring in the last 7 years in Italy [62].
The evidence of the Observatory’s success in supporting and promoting regional monitoring of patient safety practices is in the participation rate in the calls: 100% (21/21) of Regions and Autonomous Provinces have been participating in the call for good practices and developed their own regional model for verification and evaluation of good practices for patient safety. However, participation rates were markedly differentiated among the regions.
Figure 5 highlights the high variability in geographical participation, with Tuscany and Lombardy regions covering together almost 50% of the overall number of practices submitted. As the practices are submitted to the Observatory using a standard form where authors are required to describe the methods they used to evaluate the results achieved using qualitative measures and quantitative indicators, the capacity of the Observatory to spread the culture of self-assessment is proved by the number of the collected practices.
Percentage of patient safety practices per regions/Autonomous Province in 2008–2014: there is high variability in geographical participation, with Tuscany and Lombardy covering together almost 50% of the overall number of practices submitted.
By developing and testing a peer review program, the Observatory also contributed to spreading the culture of external evaluation of quality and safety, as confirmed by professionals in the feedback survey recently carried out by Agenas.
Hundred percent of the practices submitted to the Observatory and published in the web portal includes an abstract, whose aim is to communicate to nonprofessionals in a comprehensible way the intervention informing citizens about the resources used and the results achieved in order to establish transparency and accountability.
Data collected by the Observatory clearly depict its effectiveness as a tool for promotion, dissemination, and application in the Italian context of state-of-the-art of safe practices. The Observatory has also proved to be an effective tool for reducing heterogeneity in patient safety activities among the Italian regions.
The adoption of a bottom-up approach within a national improvement program has greatly contributed in Italy to spreading knowledge and experience to improve patient safety in the healthcare system. Both the patient and the GP from the vignette would have benefited from the knowledge-sharing platform provided by the Observatory. As pregnancy is fraught with potential for worry and confusion, the patient would have benefited from the experience of the professionals dealing with quality and safety issues in their everyday life. However, consultation of the Observatory’s database would have provided the GP with the chance of exchanging views with colleagues on the best way for a rapid identification of sepsis.
The Italian experience shows that key success factors of a national patient safety improvement program are a strong government mandate, solid scientific foundation and reference theories, inclusion of stakeholders, and continuous attention to the needs of those (professionals and health organizations) who are in charge of implementing the good practices for patient safety.
In the review carried out by the OECD on the quality of healthcare in Italy [6], the Italian Observatory was described as a “key action to improve patient safety” and as an “example to emulate.”
The Observatory has proved to be an effective strategy to overcome some of the main barriers to implementing evidence-based safe practices [63] at an individual level:
Lack of understanding of the organization or the structure of electronic databases, lack of search skills, lack of library/database: the Observatory database is searchable by simple search criteria and is dedicated exclusively to evidence-based safe practices.
Lack of knowledge about evidence-based safe practice: the Observatory is a free source of knowledge that is continuously updated by professionals themselves and at organization/institution level.
Organizational budget for acquisition of information resources.
Organizational budget for training in resource use: a survey recently carried out by Agenas confirmed that the Observatory free database is usable, used, and useful for professionals.
The debate about method for evaluating healthcare quality improvement and patient safety national programs is still very open [64, 65], whereas outcome evaluation is very complex (case—control studies and randomized control trials are not applicable); the process evaluation we used to assess the results of the Observatory is considered an important tool for describing the intervention and for explaining its success or lack of effect and to enable other people to replicate the intervention with the appropriate adaptations [66].
We applied the logical model that is commonly used in evaluating public health intervention as it grants transparency, accountability, and collaboration with stakeholders [67]. This model well fits for planning, managing, and evaluating quality and patient safety improvement programs [68] as it allows to evaluate, in a transparent and accountable way, whether the objectives for which the intervention had been planned have been achieved. From this perspective, the results achieved by the Observatory on Good Practices for Patient Safety—after 9 years of working—are very encouraging, allowing us to consider it an important lever with which to improve patient safety.
We would like to thank the authors of the practices reported in the chapter and all the professionals who have been reporting patient safety practices for contributing to the work of the Observatory, thus making it to be regarded as an example to be emulated by other countries. We are also thankful to the regional representatives for coordinating local collection of patient safety practices and for providing periodic feedback on the tools of the Observatory, thus contributing to its review and update. Finally, we would like to thank the Italian Ministry of Health for funding, through a research project, the start-up of the Observatory.
Research methodology is the path through which researchers need to conduct their research. It shows the path through which these researchers formulate their problem and objective and present their result from the data obtained during the study period. This research design and methodology chapter also shows how the research outcome at the end will be obtained in line with meeting the objective of the study. This chapter hence discusses the research methods that were used during the research process. It includes the research methodology of the study from the research strategy to the result dissemination. For emphasis, in this chapter, the author outlines the research strategy, research design, research methodology, the study area, data sources such as primary data sources and secondary data, population consideration and sample size determination such as questionnaires sample size determination and workplace site exposure measurement sample determination, data collection methods like primary data collection methods including workplace site observation data collection and data collection through desk review, data collection through questionnaires, data obtained from experts opinion, workplace site exposure measurement, data collection tools pretest, secondary data collection methods, methods of data analysis used such as quantitative data analysis and qualitative data analysis, data analysis software, the reliability and validity analysis of the quantitative data, reliability of data, reliability analysis, validity, data quality management, inclusion criteria, ethical consideration and dissemination of result and its utilization approaches. In order to satisfy the objectives of the study, a qualitative and quantitative research method is apprehended in general. The study used these mixed strategies because the data were obtained from all aspects of the data source during the study time. Therefore, the purpose of this methodology is to satisfy the research plan and target devised by the researcher.
The research design is intended to provide an appropriate framework for a study. A very significant decision in research design process is the choice to be made regarding research approach since it determines how relevant information for a study will be obtained; however, the research design process involves many interrelated decisions [1].
This study employed a mixed type of methods. The first part of the study consisted of a series of well-structured questionnaires (for management, employee’s representatives, and technician of industries) and semi-structured interviews with key stakeholders (government bodies, ministries, and industries) in participating organizations. The other design used is an interview of employees to know how they feel about safety and health of their workplace, and field observation at the selected industrial sites was undertaken.
Hence, this study employs a descriptive research design to agree on the effects of occupational safety and health management system on employee health, safety, and property damage for selected manufacturing industries. Saunders et al. [2] and Miller [3] say that descriptive research portrays an accurate profile of persons, events, or situations. This design offers to the researchers a profile of described relevant aspects of the phenomena of interest from an individual, organizational, and industry-oriented perspective. Therefore, this research design enabled the researchers to gather data from a wide range of respondents on the impact of safety and health on manufacturing industries in Ethiopia. And this helped in analyzing the response obtained on how it affects the manufacturing industries’ workplace safety and health. The research overall design and flow process are depicted in Figure 1.
Research methods and processes (author design).
To address the key research objectives, this research used both qualitative and quantitative methods and combination of primary and secondary sources. The qualitative data supports the quantitative data analysis and results. The result obtained is triangulated since the researcher utilized the qualitative and quantitative data types in the data analysis. The study area, data sources, and sampling techniques were discussed under this section.
According to Fraenkel and Warren [4] studies, population refers to the complete set of individuals (subjects or events) having common characteristics in which the researcher is interested. The population of the study was determined based on random sampling system. This data collection was conducted from March 07, 2015 to December 10, 2016, from selected manufacturing industries found in Addis Ababa city and around. The manufacturing companies were selected based on their employee number, established year, and the potential accidents prevailing and the manufacturing industry type even though all criterions were difficult to satisfy.
It was obtained from the original source of information. The primary data were more reliable and have more confidence level of decision-making with the trusted analysis having direct intact with occurrence of the events. The primary data sources are industries’ working environment (through observation, pictures, and photograph) and industry employees (management and bottom workers) (interview, questionnaires and discussions).
Desk review has been conducted to collect data from various secondary sources. This includes reports and project documents at each manufacturing sectors (more on medium and large level). Secondary data sources have been obtained from literatures regarding OSH, and the remaining data were from the companies’ manuals, reports, and some management documents which were included under the desk review. Reputable journals, books, different articles, periodicals, proceedings, magazines, newsletters, newspapers, websites, and other sources were considered on the manufacturing industrial sectors. The data also obtained from the existing working documents, manuals, procedures, reports, statistical data, policies, regulations, and standards were taken into account for the review.
In general, for this research study, the desk review has been completed to this end, and it had been polished and modified upon manuals and documents obtained from the selected companies.
The study population consisted of manufacturing industries’ employees in Addis Ababa city and around as there are more representative manufacturing industrial clusters found. To select representative manufacturing industrial sector population, the types of the industries expected were more potential to accidents based on random and purposive sampling considered. The population of data was from textile, leather, metal, chemicals, and food manufacturing industries. A total of 189 sample sizes of industries responded to the questionnaire survey from the priority areas of the government. Random sample sizes and disproportionate methods were used, and 80 from wood, metal, and iron works; 30 from food, beverage, and tobacco products; 50 from leather, textile, and garments; 20 from chemical and chemical products; and 9 from other remaining 9 clusters of manufacturing industries responded.
A simple random sampling and purposive sampling methods were used to select the representative manufacturing industries and respondents for the study. The simple random sampling ensures that each member of the population has an equal chance for the selection or the chance of getting a response which can be more than equal to the chance depending on the data analysis justification. Sample size determination procedure was used to get optimum and reasonable information. In this study, both probability (simple random sampling) and nonprobability (convenience, quota, purposive, and judgmental) sampling methods were used as the nature of the industries are varied. This is because of the characteristics of data sources which permitted the researchers to follow the multi-methods. This helps the analysis to triangulate the data obtained and increase the reliability of the research outcome and its decision. The companies’ establishment time and its engagement in operation, the number of employees and the proportion it has, the owner types (government and private), type of manufacturing industry/production, types of resource used at work, and the location it is found in the city and around were some of the criteria for the selections.
The determination of the sample size was adopted from Daniel [5] and Cochran [6] formula. The formula used was for unknown population size Eq. (1) and is given as
where n = sample size, Z = statistic for a level of confidence, P = expected prevalence or proportion (in proportion of one; if 50%, P = 0.5), and d = precision (in proportion of one; if 6%, d = 0.06). Z statistic (Z): for the level of confidence of 95%, which is conventional, Z value is 1.96. In this study, investigators present their results with 95% confidence intervals (CI).
The expected sample number was 267 at the marginal error of 6% for 95% confidence interval of manufacturing industries. However, the collected data indicated that only 189 populations were used for the analysis after rejecting some data having more missing values in the responses from the industries. Hence, the actual data collection resulted in 71% response rate. The 267 population were assumed to be satisfactory and representative for the data analysis.
The sample size for the experimental exposure measurements of physical work environment has been considered based on the physical data prepared for questionnaires and respondents. The response of positive were considered for exposure measurement factors to be considered for the physical environment health and disease causing such as noise intensity, light intensity, pressure/stress, vibration, temperature/coldness, or hotness and dust particles on 20 workplace sites. The selection method was using random sampling in line with purposive method. The measurement of the exposure factors was done in collaboration with Addis Ababa city Administration and Oromia Bureau of Labour and Social Affair (AACBOLSA). Some measuring instruments were obtained from the Addis Ababa city and Oromia Bureau of Labour and Social Affair.
Data collection methods were focused on the followings basic techniques. These included secondary and primary data collections focusing on both qualitative and quantitative data as defined in the previous section. The data collection mechanisms are devised and prepared with their proper procedures.
Primary data sources are qualitative and quantitative. The qualitative sources are field observation, interview, and informal discussions, while that of quantitative data sources are survey questionnaires and interview questions. The next sections elaborate how the data were obtained from the primary sources.
Observation is an important aspect of science. Observation is tightly connected to data collection, and there are different sources for this: documentation, archival records, interviews, direct observations, and participant observations. Observational research findings are considered strong in validity because the researcher is able to collect a depth of information about a particular behavior. In this dissertation, the researchers used observation method as one tool for collecting information and data before questionnaire design and after the start of research too. The researcher made more than 20 specific observations of manufacturing industries in the study areas. During the observations, it found a deeper understanding of the working environment and the different sections in the production system and OSH practices.
Interview is a loosely structured qualitative in-depth interview with people who are considered to be particularly knowledgeable about the topic of interest. The semi-structured interview is usually conducted in a face-to-face setting which permits the researcher to seek new insights, ask questions, and assess phenomena in different perspectives. It let the researcher to know the in-depth of the present working environment influential factors and consequences. It has provided opportunities for refining data collection efforts and examining specialized systems or processes. It was used when the researcher faces written records or published document limitation or wanted to triangulate the data obtained from other primary and secondary data sources.
This dissertation is also conducted with a qualitative approach and conducting interviews. The advantage of using interviews as a method is that it allows respondents to raise issues that the interviewer may not have expected. All interviews with employees, management, and technicians were conducted by the corresponding researcher, on a face-to-face basis at workplace. All interviews were recorded and transcribed.
The main tool for gaining primary information in practical research is questionnaires, due to the fact that the researcher can decide on the sample and the types of questions to be asked [2].
In this dissertation, each respondent is requested to reply to an identical list of questions mixed so that biasness was prevented. Initially the questionnaire design was coded and mixed up from specific topic based on uniform structures. Consequently, the questionnaire produced valuable data which was required to achieve the dissertation objectives.
The questionnaires developed were based on a five-item Likert scale. Responses were given to each statement using a five-point Likert-type scale, for which 1 = “strongly disagree” to 5 = “strongly agree.” The responses were summed up to produce a score for the measures.
The data was also obtained from the expert’s opinion related to the comparison of the knowledge, management, collaboration, and technology utilization including their sub-factors. The data obtained in this way was used for prioritization and decision-making of OSH, improving factor priority. The prioritization of the factors was using Saaty scales (1–9) and then converting to Fuzzy set values obtained from previous researches using triangular fuzzy set [7].
The researcher has measured the workplace environment for dust, vibration, heat, pressure, light, and noise to know how much is the level of each variable. The primary data sources planned and an actual coverage has been compared as shown in Table 1.
Planned versus actual coverage of the survey.
The response rate for the proposed data source was good, and the pilot test also proved the reliability of questionnaires. Interview/discussion resulted in 87% of responses among the respondents; the survey questionnaire response rate obtained was 71%, and the field observation response rate was 90% for the whole data analysis process. Hence, the data organization quality level has not been compromised.
This response rate is considered to be representative of studies of organizations. As the study agrees on the response rate to be 30%, it is considered acceptable [8]. Saunders et al. [2] argued that the questionnaire with a scale response of 20% response rate is acceptable. Low response rate should not discourage the researchers, because a great deal of published research work also achieves low response rate. Hence, the response rate of this study is acceptable and very good for the purpose of meeting the study objectives.
The pretest for questionnaires, interviews, and tools were conducted to validate that the tool content is valid or not in the sense of the respondents’ understanding. Hence, content validity (in which the questions are answered to the target without excluding important points), internal validity (in which the questions raised answer the outcomes of researchers’ target), and external validity (in which the result can generalize to all the population from the survey sample population) were reflected. It has been proved with this pilot test prior to the start of the basic data collections. Following feedback process, a few minor changes were made to the originally designed data collect tools. The pilot test made for the questionnaire test was on 10 sample sizes selected randomly from the target sectors and experts.
The secondary data refers to data that was collected by someone other than the user. This data source gives insights of the research area of the current state-of-the-art method. It also makes some sort of research gap that needs to be filled by the researcher. This secondary data sources could be internal and external data sources of information that may cover a wide range of areas.
Literature/desk review and industry documents and reports: To achieve the dissertation’s objectives, the researcher has conducted excessive document review and reports of the companies in both online and offline modes. From a methodological point of view, literature reviews can be comprehended as content analysis, where quantitative and qualitative aspects are mixed to assess structural (descriptive) as well as content criteria.
A literature search was conducted using the database sources like MEDLINE; Emerald; Taylor and Francis publications; EMBASE (medical literature); PsycINFO (psychological literature); Sociological Abstracts (sociological literature); accident prevention journals; US Statistics of Labor, European Safety and Health database; ABI Inform; Business Source Premier (business/management literature); EconLit (economic literature); Social Service Abstracts (social work and social service literature); and other related materials. The search strategy was focused on articles or reports that measure one or more of the dimensions within the research OSH model framework. This search strategy was based on a framework and measurement filter strategy developed by the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) group. Based on screening, unrelated articles to the research model and objectives were excluded. Prior to screening, researcher (principal investigator) reviewed a sample of more than 2000 articles, websites, reports, and guidelines to determine whether they should be included for further review or reject. Discrepancies were thoroughly identified and resolved before the review of the main group of more than 300 articles commenced. After excluding the articles based on the title, keywords, and abstract, the remaining articles were reviewed in detail, and the information was extracted on the instrument that was used to assess the dimension of research interest. A complete list of items was then collated within each research targets or objectives and reviewed to identify any missing elements.
Data analysis method follows the procedures listed under the following sections. The data analysis part answered the basic questions raised in the problem statement. The detailed analysis of the developed and developing countries’ experiences on OSH regarding manufacturing industries was analyzed, discussed, compared and contrasted, and synthesized.
Quantitative data were obtained from primary and secondary data discussed above in this chapter. This data analysis was based on their data type using Excel, SPSS 20.0, Office Word format, and other tools. This data analysis focuses on numerical/quantitative data analysis.
Before analysis, data coding of responses and analysis were made. In order to analyze the data obtained easily, the data were coded to SPSS 20.0 software as the data obtained from questionnaires. This task involved identifying, classifying, and assigning a numeric or character symbol to data, which was done in only one way pre-coded [9, 10]. In this study, all of the responses were pre-coded. They were taken from the list of responses, a number of corresponding to a particular selection was given. This process was applied to every earlier question that needed this treatment. Upon completion, the data were then entered to a statistical analysis software package, SPSS version 20.0 on Windows 10 for the next steps.
Under the data analysis, exploration of data has been made with descriptive statistics and graphical analysis. The analysis included exploring the relationship between variables and comparing groups how they affect each other. This has been done using cross tabulation/chi square, correlation, and factor analysis and using nonparametric statistic.
Qualitative data analysis used for triangulation of the quantitative data analysis. The interview, observation, and report records were used to support the findings. The analysis has been incorporated with the quantitative discussion results in the data analysis parts.
The data were entered using SPSS 20.0 on Windows 10 and analyzed. The analysis supported with SPSS software much contributed to the finding. It had contributed to the data validation and correctness of the SPSS results. The software analyzed and compared the results of different variables used in the research questionnaires. Excel is also used to draw the pictures and calculate some analytical solutions.
The reliability of measurements specifies the amount to which it is without bias (error free) and hence ensures consistent measurement across time and across the various items in the instrument [8]. In reliability analysis, it has been checked for the stability and consistency of the data. In the case of reliability analysis, the researcher checked the accuracy and precision of the procedure of measurement. Reliability has numerous definitions and approaches, but in several environments, the concept comes to be consistent [8]. The measurement fulfills the requirements of reliability when it produces consistent results during data analysis procedure. The reliability is determined through Cranach’s alpha as shown in Table 2.
Internal consistency and reliability test of questionnaires items.
K stands for knowledge; M, management; T, technology; C, collaboration; P, policy, standards, and regulation; H, hazards and accident conditions; PPE, personal protective equipment.
Cronbach’s alpha is a measure of internal consistency, i.e., how closely related a set of items are as a group [11]. It is considered to be a measure of scale reliability. The reliability of internal consistency most of the time is measured based on the Cronbach’s alpha value. Reliability coefficient of 0.70 and above is considered “acceptable” in most research situations [12]. In this study, reliability analysis for internal consistency of Likert-scale measurement after deleting 13 items was found similar; the reliability coefficients were found for 76 items were 0.964 and for the individual groupings made shown in Table 2. It was also found internally consistent using the Cronbach’s alpha test. Table 2 shows the internal consistency of the seven major instruments in which their reliability falls in the acceptable range for this research.
Face validity used as defined by Babbie [13] is an indicator that makes it seem a reasonable measure of some variables, and it is the subjective judgment that the instrument measures what it intends to measure in terms of relevance [14]. Thus, the researcher ensured, in this study, when developing the instruments that uncertainties were eliminated by using appropriate words and concepts in order to enhance clarity and general suitability [14]. Furthermore, the researcher submitted the instruments to the research supervisor and the joint supervisor who are both occupational health experts, to ensure validity of the measuring instruments and determine whether the instruments could be considered valid on face value.
In this study, the researcher was guided by reviewed literature related to compliance with the occupational health and safety conditions and data collection methods before he could develop the measuring instruments. In addition, the pretest study that was conducted prior to the main study assisted the researcher to avoid uncertainties of the contents in the data collection measuring instruments. A thorough inspection of the measuring instruments by the statistician and the researcher’s supervisor and joint experts, to ensure that all concepts pertaining to the study were included, ensured that the instruments were enriched.
Insight has been given to the data collectors on how to approach companies, and many of the questionnaires were distributed through MSc students at Addis Ababa Institute of Technology (AAiT) and manufacturing industries’ experience experts. This made the data quality reliable as it has been continually discussed with them. Pretesting for questionnaire was done on 10 workers to assure the quality of the data and for improvement of data collection tools. Supervision during data collection was done to understand how the data collectors are handling the questionnaire, and each filled questionnaires was checked for its completeness, accuracy, clarity, and consistency on a daily basis either face-to-face or by phone/email. The data expected in poor quality were rejected out of the acting during the screening time. Among planned 267 questionnaires, 189 were responded back. Finally, it was analyzed by the principal investigator.
The data were collected from the company representative with the knowledge of OSH. Articles written in English and Amharic were included in this study. Database information obtained in relation to articles and those who have OSH area such as interventions method, method of accident identification, impact of occupational accidents, types of occupational injuries/disease, and impact of occupational accidents, and disease on productivity and costs of company and have used at least one form of feedback mechanism. No specific time period was chosen in order to access all available published papers. The questionnaire statements which are similar in the questionnaire have been rejected from the data analysis.
Ethical clearance was obtained from the School of Mechanical and Industrial Engineering, Institute of Technology, Addis Ababa University. Official letters were written from the School of Mechanical and Industrial Engineering to the respective manufacturing industries. The purpose of the study was explained to the study subjects. The study subjects were told that the information they provided was kept confidential and that their identities would not be revealed in association with the information they provided. Informed consent was secured from each participant. For bad working environment assessment findings, feedback will be given to all manufacturing industries involved in the study. There is a plan to give a copy of the result to the respective study manufacturing industries’ and ministries’ offices. The respondents’ privacy and their responses were not individually analyzed and included in the report.
The result of this study will be presented to the Addis Ababa University, AAiT, School of Mechanical and Industrial Engineering. It will also be communicated to the Ethiopian manufacturing industries, Ministry of Labor and Social Affair, Ministry of Industry, and Ministry of Health from where the data was collected. The result will also be availed by publication and online presentation in Google Scholars. To this end, about five articles were published and disseminated to the whole world.
The research methodology and design indicated overall process of the flow of the research for the given study. The data sources and data collection methods were used. The overall research strategies and framework are indicated in this research process from problem formulation to problem validation including all the parameters. It has laid some foundation and how research methodology is devised and framed for researchers. This means, it helps researchers to consider it as one of the samples and models for the research data collection and process from the beginning of the problem statement to the research finding. Especially, this research flow helps new researchers to the research environment and methodology in particular.
There is no “conflict of interest.”
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