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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 8  |  Issue : 3  |  Page : 186-197

Designing and evaluation of patient safety management questionnaire: A mixed method study


1 Department of Health Services Management, Faculty of Medical Sciences and Technologies, Science and Research, Islamic Azad University, Tehran, Iran
2 Community-Oriented Nursing Midwifery Research Center, Department of Adult and Geriatric Nursing, Nursing and Midwifery School, Shahr-e-Kord University of Medical Sciences, Shahr-e-Kord, IR Iran

Date of Submission16-Sep-2020
Date of Acceptance02-Jun-2021
Date of Web Publication19-Jul-2021

Correspondence Address:
Dr. Leila Riahi
Associate Professor, phD; Department of Health Services Management, Science and Research Branch, Islamic Azad University, Tehran
Iran
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jnms.jnms_127_20

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  Abstract 


Context: Health system managers have a responsibility to prioritize their policies, procedures, and guidelines to ensure patient safety.
Aim: Design and evaluation of patient safety management questionnaire in Shahrekord teaching hospitals.
Settings and Design: This study was a mixed and exploratory research.
Materials and Methods: This study was conducted in 2017–2019 in Shahrekord. To analyze the factor load, the entire study population participated including 450 manager, nurse manager, supervisors, head nurses, and patient safety practitioner.
Statistical Analysis Used: The scope and items of the questionnaire were confirmed by examining the face validity, content, and structure and its reliability by internal consistency and stability. After collecting data, SPSS software version 18 was used to analyze and evaluate the information.
Results: In the qualitative stage and interview professors and experts and reviewing scientific texts, 116 items were extracted in 8 dimension of patient safety management, which after reviewing the face and content validity, 19 items were removed. In the quantitative stage, in the content validity ratio study, two items were removed due to the ratio of< 0.56 and one item in the content validity index review was removed due to the ratio of <0.78, and 94 items were finalized. Evaluation result of structure validity with Kaiser-Meyer-Olkin index was 0.85 and Bartlett test was 7237.504 (P < 0.001).
Conclusions: Result showed that patient safety management questionnaire is an essential tool for use by hospital managers to evaluate patient safety management in the dimensions of planning, guidance and leadership, decision-making, organizing, information, communication, coordination, and control.

Keywords: Factor analysis, Health care, Patient safety, Psychometric, Reliability, Validity


How to cite this article:
Irani SJ, Riahi L, Komeili A, Masoudi R. Designing and evaluation of patient safety management questionnaire: A mixed method study. J Nurs Midwifery Sci 2021;8:186-97

How to cite this URL:
Irani SJ, Riahi L, Komeili A, Masoudi R. Designing and evaluation of patient safety management questionnaire: A mixed method study. J Nurs Midwifery Sci [serial online] 2021 [cited 2021 Oct 24];8:186-97. Available from: https://www.jnmsjournal.org/text.asp?2021/8/3/186/321731




  Introduction Top


Medical errors cause harm of patients and impose heavy financial costs on hospitals. The number and impact of errors are now thought provoking. Andel, Davido, Hollander, and Moreno report that more than 200,000 deaths occur each year due to medical errors. Researchers estimate that the annual cost of preventable errors is approximately $ 38 billion.[1] Estimation also shows that 7.4% of patients admitted to acute care centers in Canada experience injury or death due to health-care accidents, of which 38% are preventable.[2] Success in correcting and reducing medical errors indicates an important problem in health care. Therefore, there is a better understanding of the factors that lead to improved process quality and patient safety outcomes in hospitals.[3]

In order to increase patient safety, we need effective methods for risk management. The purpose of this work was to propose an integrated approach to risk management in the hospital. To improve patient safety, a flexible approach should be considered, in which different aspects of risk and type of information are considered.[4] To this end, reliable and up-to-date qualitative and quantitative information is essential for health-care leadership. Thus, a framework for measuring safety and monitoring in five dimensions; organizing, leadership, manpower, patients, and families are considered.[5]

Improving patient safety requires attention to knowledge management, which provides an appropriate and reliable structure for quality improvement.[6] Recent developments in health care, however, indicate that hospitals do not have good clinical governance and need to be improved. For example, it is important to gather adequate information, patient safety indicators, safety accident reports, patient satisfaction surveys, risk recording, and meetings related to rare safety events.[7]

Improving patient safety must become an organizational concern, especially in hospitals where care, diagnosis, and treatment are becoming more complex. Thus, the risk of patient injury has become more tangible and a permanent issue for medical institutions.[8] Therefore, health system managers have a legal and moral obligation to ensure the safety and quality of patient care and to strive to improve care. They also have a responsibility to prioritize their policies, procedures, and guidelines to ensure patient safety. Accordingly, it is clear that health-care managers have an important and clear role in the quality of patient care and safety and are responsible for the results, quality, and safety of the patient.[9] In providing health care, medical errors are associated with many harmful, unwanted complications and consequences.[10] Such errors can occur at any stage of the patient management process, including diagnosis, treatment, and prevention, and may lead to adverse events. Medical errors endanger patients' health and lives and increase the cost of treatment and rehabilitation, leading to 210,000 deaths in the United States. In Australia, 18,000 preventable deaths and at least 50,000 disabled patients are the result of unsafe treatment and care. In Germany, there are 25,000 deaths due to 100,000 medical errors. In developing countries, there is no accurate estimate of deaths and disabilities. However, the rate of medical errors is thought to be very high. In Iran, it is estimated that between 3% and 17% of patients experience complications due to medical errors, of which 30%–70% are preventable.[11] Thus, health-care leaders around the world have worked to promote and develop patient safety, and steps have been taken to develop a conceptual framework for patient safety research. Among them, we can mention the involvement of physicians in improving the quality and safety of patients in academic medical centers, to reduce the number of injuries.[6] On the other hand, it should be acknowledged that measuring and evaluating patient's safety is related to the infrastructure of culture and society, and the role of each member of the treatment team can suggest new concepts about patient's safety.[12] Therefore, according to the studies and their emphasis on the role of planning, leadership, decision-making, organization, information, communication, coordination, and control in patient safety management and that there is no standard questionnaire in this area, designing an appropriate tool for the management evaluation. Patient safety is felt as an unavoidable necessity among managers and those involved in patient safety. Therefore, the present study was conducted to design and evaluate a patient safety management questionnaire.


  Materials and Methods Top


Design

This study is a practical, cross-sectional, mixed, and exploratory study that was conducted in 2017–2019 in Shahrekord (Eticla Code: IR.IAU.TMU.REC.1397.288). In the first step, to extract the items, interviews with twenty professors and patient safety experts and review of texts were used, which led to the compilation of 116 items. In the second step, in the quantitative analysis section, face validity, content, and structure of the questionnaire were confirmed through internal consistency. At this stage, 19 items were deleted. Furthermore, in content validity ratio (CVR), two items were removed, and in content validity index (CVI), one item was removed, and the final number of items reached 94. To perform exploratory factor analysis, the statistical population of the study was 450 people including heads, managers, nursing managers, supervisors, head nurses, and patient safety officials of teaching hospitals who were selected by census method. In this study, a patient safety questionnaire was designed based on the steps proposed by Schwab (2013). Schwab considers three basic steps including item development, scale development, and scale evaluation.[13]

Item development

In the first step, qualitative content analysis was used to extract the items. In the qualitative method, researchers formulate items based on experts' responses and review of texts that reflect their feelings and behaviors. The answers are then organized based on their type and content in different categories and dimensions. Qualitative data analysis at this stage was performed using conventional content analysis method and based on Graneheim and Lundman method.[14] The steps are as follows: the interviews were transcribed into words to obtain a clear questionnaire of the experts' thoughts, behaviors, ideas, and experiences. Scientific texts were read several times so that researchers could identify data and statements. These items were compiled using continuous data comparison. The selected items were carefully controlled and examined by the researchers. Similar items became themes or subcategories and were assigned to a single domain. The first stage involves the development of unique items, so due to the extensive knowledge that exists about patient safety, in this study, the reduction method has been used.[15] Furthermore, in this study, searches were made on library and electronic resources such as ISI (WOS), PubMed, Scopus, Google Science Direct, OVID, and Google Scholar to gain knowledge about patient safety frameworks and questionnaires. For searching the patient safety management content using keywords such as patient safety management, patient safety, patient safety monitoring and patient safety model in databases.

Combining concepts, using keywords, topic titles, synonymous keywords, being careful to link concepts correctly, and regularly evaluating search results to ensure focus on the topic was the strategy of searching in databases.

Scale development

At this stage, three important steps were taken to develop the questionnaire.

  1. Items were combined to design the questionnaire.[16] (The items extracted from the qualitative stage of the study were combined to go through a psychometric process in the form of a questionnaire)
  2. Researchers determined the adequacy of the number of variables. Cox (2019) describes drafts and plans as the main points for developing the questionnaire. Regular classification of variables makes it easier for people to respond[17]
  3. The 5-point Likert scale (strongly agree, agree, somewhat agree, disagree, and strongly disagree) was considered. A score of 5 was given for a strongly agree answer and a score of 1 was given for a strongly disagree answer.


Scale evaluation

This step includes determining the validity (face, content and structure) and reliability of the questionnaire, providing the characteristics of the research community and the method of Collecting, and analyzing quantitative data.

Face validity

Face validity can be measured both qualitatively and quantitatively. Qualitatively, the measurement criterion is how the questionnaire items relate to measurable variables. Quantitatively, face validity is determined by the score and through the following formula.

(%) × Frequency = Impact Score

Items with a score equal to or >1.5 were retained and other items were omitted.[18] In this study, to determine face quality validity, twenty professors and experts who were familiar with the concept of patient safety were asked to comment on the difficulty, appropriateness, ambiguity, and complexity of each item. Quantitative face validity was also determined by evaluating the importance and scoring of items.

Content validity

In this study, qualitative and quantitative methods have been used to examine the validity of the content. In the qualitative method, grammar, the use of correct words and sentences, and the placement of items in the appropriate place were done by professors and experts. CVR and CVI were measured in a quantitative method.

Content validity ratio

Lawshe's developed a content validity questionnaire that is provided to experts to comment on the need for its items.[19] In this study, a questionnaire was presented to twenty professors and patient safety experts and they were asked to rate the questionnaire items on a 3-part Likert scale (not necessary, useful but not necessary, and it is necessary) to evaluate. The obtained results were compared with the criteria of Lawshe's table.

Content validity index

CVI is the ratio of experts' agreement to the relationship and importance of each variable.[20] In this study, professors and experts were asked to determine the degree of relevance of each item to a four-part spectrum (unrelated, requires major revision, relevant but requires revision, and fully relevant). We divided the experts who chose options 3 and 4 by the total number of experts. Items larger than 0.79 were accepted.

Structure validity

In this study, the validity of the structure was determined by heuristic factor analysis. In exploratory factor analysis, the researcher does not expect much from the number or nature of structures or underlying factors.[21] Before factor extraction, Kaiser-Meyer-Olkin (KMO) sample adequacy test and Bartlett test were performed to ensure the suitability of domain components for principal component analysis. Bartlett test was also used to answer the question whether the obtained correlation matrix is different from zero and based on which factor analysis can be justified. It was found that among items of the questionnaire have sufficient integrity. In the exploratory factor analysis, 450 people in the target community, including heads, managers, nursing managers, supervisors, head nurses, and hospital safety officials, completed the designed questionnaire. Initially, the sample size adequacy index and the Bartlett test result showed that factor analysis could be used to analyze the data.

Reliability

In this study, internal stability was used to assess reliability. The most common method for assessing internal stability is to measure the Cronbach's alpha coefficient, which provides an indicator to determine the correlation between the items in the questionnaire.[22] To assess the stability of a criterion, the questionnaire is administered by the same people in two different situations.[23] In this study, to determine the reliability of the questionnaire, twenty professors and experts were asked to complete the final questionnaire within 2 weeks. Then, the internal correlation of the questionnaire domains was calculated.

Scoring method

In most cases, the format specified determines the overall scoring method. If the items are answered using the Likert scale, the total score is usually calculated by adding scores.[24] In this study, by collecting the answers, the total score was calculated. The questionnaire ranged from 94 to 470, with a higher score indicating greater safety for the patient.

Data analysis

For this purpose, by reviewing the texts, variables, and items of the questionnaires and different patient safety frameworks, the questionnaire was extracted, and its scope was summarized. In this study, the condition for transferring the studies to the table of comparative studies was the sharing of at least two variables of the questionnaire with each of the questionnaires and frameworks [Table 1].
Table 1: Comparative study of prescription pattern for patient safety management

Click here to view


In the quantitative part, after completing the questionnaires, the data were analyzed using SPSS version 18 software (SPSS software version 18, SPSS Inc, Chicago, Illinois). Absolute and relative frequencies of quantitative and qualitative variables were calculated. Spearman correlation coefficient was used to investigate the relationship between variables. Cronbach's alpha values range from 0 (no stability) to 1 (complete stability). A minimum level of 0.7 was considered for Cronbach's alpha.[25]

Values between 0.10 and 0.50 were considered for the mean correlation of variables,[26] and a significance level of P < 0.001 was considered. To calculate the validity ratio, Lawshe's table (2014) with a minimum acceptance of 0.62 was used.[27] The minimum acceptable value for KMO was 0.6.[28] In exploratory factor analysis, a factor load of 0.4 and higher was considered.[29]


  Results Top


In this study, eight dimensions of patient safety management including planning (12 items), guidance and leadership (13 items), decision-making (11 items), organizing (15 items), information (14 items), communication (9 items), coordination (8 items), and control (12 items) were counted in the form of a questionnaire with a total of 94 items. Qualitative findings from the perspective of professors and experts in the field of formal and content narration showed items are simple, appropriate, and free from any ambiguity and complexity. Moreover, grammatically, the use of correct words and sentences and the placement of items in the relevant dimensions were appropriate. Quantitative results of face validity and CVR and CVI were also determined by evaluating the importance and scoring of items [Table 2].
Table 2: Content validity ratio, content validity index, and face validity

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The results of determining the Cronbach's alpha coefficient for each domain showed that the structure of the questionnaire has acceptable internal consistency, and the Cronbach's alpha coefficient for different domains is between 0.85 and 0.95 [Table 3].
Table 3: The Cronbach's alpha coefficients of variables

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In exploratory factor analysis, and in the demographic characteristics section, the result showed that, in the highest percentage, 86% of the study population were women, 87% were experts, 39.9% had 1–7 years of work experience, and 82.7% were shift responsible [Table 4].
Table 4: Demographic characteristics of participants in the study (n=450)

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The results of exploratory factor analysis in the items section to determine the factor load indicated that the minimum factor load obtained is 0.50, while the minimum factor load in this study was considered 0.4. The results for the percentage of variance and the practical load of each item are shown in [Table 5].
Table 5: Factors of the patient safety questionnaire after varimax rotation

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  Discussion Top


The purpose of this study was to design and evaluation of patient safety management questionnaire in Shahrekord Teaching Hospitals, which led to the identification of dimensions and items of patient safety. These dimensions included planning, guidance and leadership, decision-making, organizing, information, communication, coordination, and control, which were outlined as components of patient safety. The results in the field of planning showed that the key items are planning to replace human resources in emergency situations, developing patient safety culture, patient-centeredness, cooperation and teamwork, formulating strategy and policy, correcting, and designing patient safety program and use. Practical models were prioritized for any risk. Titzer et al. have defined programming variables as prioritizing action variables in the form of a documented program as a framework and guide for hospitals' participation in patient safety.[30],[31] Weaver et al. and Lenburg CB et al. also stated that patient safety planning can improve patient safety through staff empowerment, scientific care, and promoting patient safety culture in hospitals,[32],[33] which is consistent with the items identified in this study.

In the field of guidance and leadership, staff training, qualified staff, commitment of senior hospital management to improve patient safety, clinical risk management before an accident, comprehensive understanding of patient safety, development of professional skills. Patient attention, management discipline, human resource review, ensuring access to human resources, equipment and information, and focus on management values were counted, which is consistent with the statements obtained by Khana et al. and Boama et al. They consider the variables, determining the role and training of each member of the health team, goal sharing, good and appropriate communication, mutual support, measurable results, transformation in patient safety management, and supporting the professional behavior of employees.[34],[35],[36] Therefore, leaders make health-care decisions by carefully calculating clinical variables and interpreting their results correctly.[37]

In the field of decision-making, the points of using quality management, creating opportunities for discussion and decision-making, developing critical thinking skills, integrating knowledge and skills for effective decision-making, deciding whether to respect patients' treatment instructions, community participation in the implementation of patient safety and the use of collective wisdom in decision-making were determined.

Hughes et al. concluded that, in the decision-making process, patients' rights are also respected and enable them to participate in their care decisions. Joint decision-making has an intrinsic value for patient satisfaction and increasing the quality of health care. In addition to improving health care, this approach will increase patient satisfaction and reduce health-care costs.[38] The results of Hughes study are consistent with this study in terms of treatment and care decisions, respect for patients' rights, and opportunity for decision-making.

In the field of organizing, items of appropriate, transparent and accountable organizational structure, accurate job descriptions, performance in accordance with patient safety goals, knowledge-based and standardized organization, staff empowerment, development of staff abilities and skills, Understanding the responsibility and role of employees and optimal use of resources and ensuring high productivity were obtained. Hosseini Iran et al. In a study entitled: A Study of Patient Safety Management Patterns in the Field of Organization,

Setting goals, participating in teamwork, sharing information for patient care, understanding the role and responsibility, optimal use of resources, high productivity, hiring skilled personnel, organizing care based on knowledge and standards, organizing medicine and blood transfusion, organizing medical equipment, organizational learning, organizing human resources, and improving the structure of patient safety management have been declared important, which is consistent with the results of this study.[39]

In the field of information, information exchange during shift delivery, patient referral to the care team, recording and reporting of actions, consultation on emergency care, review of patient history, sharing of medical procedures, information analysis, transparency in information, and the use of modern information methods have been identified that are consistent with some of the items recorded in the Minimum Patient Safety Information Framework that provide a set of patient safety information sets.[40] Feldman also showed that automated information recall and alerting are essential and supports safe and effective clinical decision-making, with the use of this process, leading to a 22% increase in child safety management and a 22% reduction in medication errors.[41]

In the field of communication, discussion about patient safety, communicating with colleagues and patients, encouraging patients to criticize and express their views, patient access and use of information, communicating with patients to evaluate their concerns and problems, communicating with patients as partners in the care process. Weaver et al. analyzed 258 surgical errors that resulted in injury to the patient and showed that, in 24% of cases, a communication disorder occurred.[32] In his study, Bagian and Paul considered inadequate or misleading information, lack of patient safety culture, unsuccessful communication methods, inappropriate communication, and inadequate feedback between sender and receiver, interruption, or distraction. Moreover, the lack of standard procedures in communication stated that it is consistent with the results of this study.[42]

In the field of coordination, constructive and positive interaction between staff and patients and their families, coordination in patient transfer and dispatch, coordination in dangerous situations, anticipation of needs, use of experiences for more coordination, and coordination between members. The health-care team was obtained with the results of the study of Michel et al., which included team communication, team interventions, team effectiveness, and role-playing in team building and collaboration, is consistent.[40] Therefore, the quality and safety of the patient depends on technical management, diagnosis, prevention, rehabilitation, coordination, continuity of care, and patient-centeredness.[43]

In the field of control, items of inspection and control by the clinical supervisor in all shifts, instantaneous performance monitoring, control of clinical processes, use of noncompliant feedback and audits in control, determination of performance control indicators, continuous control of care measures, and daily round. The patient safety management team was counted.

Francis's report presents 29 variables for patient safety, the most important of which is control. In other words, control is an absolute priority for health-care providers.[12] In a way, this can lead to professional development and improvement of patient safety indicators.[44] Today, patient safety is considered as one of the main dimensions of quality. Therefore, monitoring, controlling, evaluating, and improving patient safety, especially in intensive care units, is a major problem for health care that requires hospital officials to pay attention to these variables.[45] Therefore, the findings of these studies are consistent with the results of this study.


  Conclusions Top


The findings of this study emphasize the importance of planning, leadership, decision-making, organizing, information, communication, coordination, and control in patient safety. Therefore, its results can help to continue applied research and increase patient safety knowledge. On the other hand, patient safety is one of the most important components of the health system today. Moreover, the need to pay attention to it by managers and staff of hospitals to improve patient safety is inevitable.

Conflicts of interest

There are no conflicts of interest.

Authors' contribution

L R, M R, SJ HI, and A K involved in the study conception/design. L R, M R, SJ HI, and A K contributed to the data collection/analysis. L R, M R, and SJ HI drafted the manuscript. L R, R M, SJ HI, and A K involved in critical revisions for important intellectual content and administrative/technical/material support. L R, R M, and SJ HI supervised the work.

Financial support and sponsorship

Nil.

Acknowledgment

We would like to thank the faculty members, supervisors, patient safety officials, and nursing staff working in the educational and medical centers of Ayatollah Kashani and Hajar (PBUH) of Shahrekord University of Medical Sciences who helped us in this research.



 
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  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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