[version 1; peer review: 1 approved, 3 not approved]
No competing interests were disclosed.
The objectives of this protocol are to understand the perception and impact of healthcare workers towards implementation of NABH standards and to study the impact of pre and post assessment of NABH with the help of 10 important key performance indicators in hospitals.
In light of the enormous social, financial, and technological changes of the 21st century, the Indian medical system is operating in a dynamic environment. Health care is now transforming widely with new technology. The healthcare system includes a variety of medical gadgets, clinical trials, health insurance, medical tourism, and outsourcing programs that have advanced to laudable levels which are more focused on the certification of accredited bodies to improve the services and productivity of the organization.
The NABH provide the standards and objective elements to improve the structure, process, and outcome of the organization which help to improve the healthcare quality and patient safety. Since the current healthcare system does not impose cost and quality standardization, certification is the only likely method of establishing the dependability and authenticity of a healthcare provider.
Healthcare accreditation and certification programs have progressed international efforts to raise the standard of healthcare since the 1970s. The accreditation process, which is carried out by qualified external peer reviewers, allows a healthcare organization to be officially recognized for achieving performance standards.
This cross sectional study will be conducted for assessing & evaluating the awareness among healthcare workers for NABH guidelines. Records for the assessment will be collected from medical record department (MRD) secondary source of information will be generated from ABVRH hospital Wardha. Ethical permission with hospital regularities will be taken from medical superintendent & medical record department in charge. Confidentiality of the data will be proofed for patient identification.
Questionnaire will be provided for assessment based on adopted questionnaire in use itself in ABVRH.
Post assessment survey will be conducted after 6 months of providing assistant over NABH guidelines among healthcare workers. Data will be gathered by data management team will be analyzed for objectives results considering per protocol basis on minimum sample size required for full analysis data set.
The synopsis for this study has been approved by Datta Meghe Institute of Higher Education and Research ethical committee, ethical reference no. is DMIHER (DU)/IEC/2023/563 on 4
th February 2023. Written informed consent will be obtained from the healthcare workers for this study. For collecting the data from medical records permission from the higher authority of the medical record department and chief medical superintendent has been granted for the collection of data. This article is reported in line with STROBE guidelines.
This study will adopt a descriptive cross-sectional design consisting of two phases. The first phase is a collection of data from the previous patients health records of the medical record department to assess how well staff adhere to the quality check list of NABH guidelines where we have taken 10 quality indicators from the check list
The second phase conducts a post-assessment survey with nursing staff, doctors, technicians and paramedical staff. The post assessment survey will be given by the 1 st week of October to see the knowledge of the healthcare workers regarding the quality indicators. The same questionnaires will be used.
This study will be conducted in a tertiary care hospital in central India. The study duration will be three years (Aug 2023- Aug 2025).
P = 0.500
D = estimated error (5 %) = 0.05
The minimum sample size required is 280
Estimate value of awareness of NABH guidelines among healthcare workers.
Demographic variables: age, gender, experience, department, qualification/designation, training on NABH (Yes/No).
Outcome variables:
Research questions based on organization (Yes/no) total 7 questions Quality Indicator Quality Indicator-1 No. of reporting errors per 1000 investigations Quality Indicator-2 Incidence of medication errors Quality Indicator-3 Percentage of unplanned return to OT Quality Indicator 4- Return to ICU within 48 hours Quality Indicator-5 Compliance of Hand Hygiene Quality Indicator 6- Time taken for discharge Quality Indicator 7-Incidence of patient fall Quality Indicator 8- Rate of needle stick Injuries Quality Indicator 9 – Percentage of near misses Quality Indicator 10 – Compliance rate to medication prescription in capitals
Research questions based on organization (Yes/no) total 7 questions will be evaluated for frequency & (%) basis. This indicators will be collection of 57 questionnaire each for 1 mark of correct answer total 57 marks, distributed amongst poor (0-19), Average (20-38), Good (39-57). Association with demographic variables will be tested at 5% l.o.s. (P<=0.05) using chi square analysis.
The perception and impact of healthcare workers towards implementation of NABH standards.
The impact of pre and post assessment of NABH with the help of 10 important key performance indicators in hospitals.
Confounders: The knowledge of the study participants and their previous exposure for NABH training can be a confounding factor.
For the post-assessment survey of 10 quality indicators, participants will be given a self-administered questionnaire that will be created with the assistance of the NABH checklist.
Pre-assessment information will be gathered from MRD records, and we will compare the progress and productivity of employees. The following indicators for pre and post assessing are:
No. of reporting errors per 1000 investigations Incidence of medical errors Percentage of unplanned return to OT Return to ICU within 48 hours Compliance to hand hygiene Time taken for discharge Incidence of patient fall Rate of needle stick injuries Percentages of near misses Compliance rate to medication prescription in capital
Quantitative variables:
Level of awareness and knowledge among the healthcare workers. Number of healthcare workers who attended the NABH training (provided by the Chief Medical superintendent).
The mean and standard deviation of the data for the outcome variables will be checked for normality, and the median statistics will be used to locate skewed distributions and the interquartile range (IQR). Descriptive statistics will be used to tabulate and describe the results for the outcome variables. Frequency and percentages for binary and categorical variables will be totaled for descriptive statistics.
Primary outcome
The two groups' measurement scores (before versus post-assessment) and the major variable's mean change will be compared using inferential statistics. Participants will take a test to determine how the major variable changed from the baseline to the period measured during the study.
Fixed effects will be examined by taking into account the two-year follow-up period and will be assessed with the matching 95% confidence interval (CI) reported. The impacts of chance will be generalized to research participants.
The aforementioned linear mixed model effect on secondary outcomes (pre-analysis) will be used to predict how much the active and control groups' effects will differ from each other. The T-test (unpaired) will be used to evaluate whether there is a normal distribution-conforming difference in the means between the two groups if there is one. Chi square, Mann Whitney, and Wilcoxon test are additional non-parametric tests that we will use if the data for the principal variable are still distributed non-normally.
In this study we will identify the different impacts of implementation of NABH standards after pre- and post-assessment of 280 staff working in a tertiary care hospital.
A cross-sectional study on the effectiveness of implementation of NABH standards among healthcare workers in a tertiary care center in India concluded that more than 80% of participants believe that NABH accreditation has a positive impact on the hospital's services and operational procedures, which have since improved. 85% of participants reported that after post NABH accreditation, their level of job satisfaction had changed. Also, an average of 83.66% think that after NABH accreditation, hospital procedures have improved. It was found that 91.09% of participants believe that hospital processes have improved since NABH accreditation; 85.78% of participants believe that patient satisfaction has improved continuously since NABH accreditation; 82.61% of participants think the training they received on NABH accreditation was valuable; 83.66% believe that systems and processes have become more standardized since NABH accreditation; NABH accreditation; 84.28% of participants believed that following NABH accreditation, the organization provided them with enough support for their contributions to hospital procedures; 79.14% of participants thought that staff complaints were resolved more quickly; and overall, 87.27% of participants said they would refer their family members to this hospital for treatment. 85.55% of participants said it had a favorable effect on employees' morale and job satisfaction.
A systematic review on Impact of Accreditation on the Quality of Healthcare Services conducted by Abdullah Alkhenizan
An observational study was carried out on every single patient admitted to the ICU for a period of five months (from April to August 2015) in a Hospital at Hubli, in order to know whether the effective application of NABH guidelines was able to control the number of new cases of hospital-acquired infections in their ICU. At first, they conducted an initial evaluation of infection control, and then consistently carried out an evaluation every month about infection control. This study concluded that there was a significantly lower number of new cases that occurred in their ICU which could be, accredited to the application of NABH guidelines.
A cross-sectional, descriptive study conducted by Lallu Joseph
Generalizability
The outcome of the study will help in improving the quality of care and update the policies at institution level.
The study will be published in an institutional-indexed journal.
Data collection of the study will be started in the first week of July 2023.
No underlying data is associated with this article.
Zenodo: Questions and consent on To study the impact of implementation of NABH standards among healthcare workers in tertiary care hospital, Maharashtra.
Zenodo: STROBE Checklist for A protocol to study the impact of implementation of NABH standards among health care workers in tertiary care hospital.
Data are available under the terms of the
I appreciate the support of my supervisor and my family for helping me to complete the research.
This protocol, as presented, lacks clarity and is incomplete, making it challenging to understand or replicate. The following are detailed comments and recommendations for improvement:
Study objectives are unclear. Pre and post-assessments must be clearly defined. Explain what is being assessed and why it is important. The title of your manuscript mentions impact assessment, but sometimes, in the main body of the manuscript, it mentions awareness, perceptions towards NABH implementation, etc. The rationale for pre- and post-assessments is unclear. First, I would call it a protocol, not a method aligned with journal standards. There is not enough information in the methodology section. Describe both phases of the study's methodology in detail. It is necessary to reconsider the study design mentioned in your manuscript, "a descriptive cross-sectional design." Based on what you've mentioned, consider changing the study design to an intervention (quasi-experimental design) to justify pre- and post-assessments. Target Population: Neither the total number of your population nor how you came to your sample are clear. Although you have added your formula, that is not enough. Further categorization is needed for the 280 employees. Decide whether to study the same staff twice or use different groups. Is there a matching sample? If yes, is it one-to-one, one-to-two, or others? If the same staff is studied twice, clarify the method for consistency. To ensure reliability, divide the staff into relevant categories and clarify the methodology. It was mentioned that you would conduct purposive sampling. This technique isn't used in quantitative research. If you are using quantitative methods, you may use random or convenience sampling, and you should be able to explain why you are using this method. Please identify any limitations regarding the generalizability of the findings. Healthcare workers and medical records should have separate sample size calculations and inclusion/exclusion criteria. There is a misunderstanding of what inclusion and exclusion criteria mean. On page 3, you mentioned that "this will be a purposive selection of data records and trained doctors for NABH." It is even confusing that you sometimes describe your sample as trained doctors. In other places, you mentioned the study would include healthcare providers such as nurses, technicians, paramedics, and doctors. Make sure you are clear. There is no information about the source or validation of the adopted questionnaire. The collection of data from medical records is not sufficiently detailed. To collect data from medical records, it is important to make clear the steps that will be followed, including which quality indicators will be assessed and how they are aligned with the guidelines from NABH. The data you will use is a combination of primary and secondary. Isn't that right? Please elaborate on that. As you have added under outcome variables: A) research question and B) quality indicators. Please note that the research question is not an outcome. I think you are mixing up the research question and the questionnaire terms. Rewriting and restructuring the entire manuscript are also needed. The primary and secondary outcomes to be measured are not clearly described to readers. Statistical analysis needs review. Some of the suggested tests are inappropriate. The data analysis and statistical plan is not clear. Your discussion lacks cohesion between paragraphs and does not connect to the protocol. Ensure each paragraph logically follows the previous one and collectively builds a coherent argument. Discuss the limitations regarding generalizability and suggest ways future studies can address these issues. The statement under generalizability, "The results of the study will assist in improving quality of care and updating institutional policies." needs to be improved. Plans for dissemination of the study outcome (including the associated data): Could you suggest other plans in addition to what you suggested?
The provided protocol must be revised significantly to clarify objectives, methodology, and data analysis plans. Addressing the above points can improve replicability, scientific soundness, and coherence.
Is the study design appropriate for the research question?
Partly
Is the rationale for, and objectives of, the study clearly described?
No
Are sufficient details of the methods provided to allow replication by others?
No
Are the datasets clearly presented in a useable and accessible format?
No
Reviewer Expertise:
Quality and Patient Safety, Healthcare Services, Public Health, Health Informatics, Research Methods, and Quantitative and Qualitative Research.
I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.
First, the study objectives are vague and unclear.
The data collection from medical records is not specified. neither the sample size of medical records to be studied is drawn
Secondly, the staff of 280 needs to be further divided into carders and author need to mention if she is going to study same staff twice or it will be different staff. if its same staff, how can she ensure that.
Third is objective on impact assessment - how does author want to assess "impact". What categorical variable is she going to use need ot be specified
Fourth, what is the mechanism of studying the perception of staff towards NABH implementation. Using a binomial scale (Yes/no) is not suitable for perception based studies.
Make crystal clear objectives and then draw the methodology around it in scientific manner.
Is the study design appropriate for the research question?
Yes
Is the rationale for, and objectives of, the study clearly described?
No
Are sufficient details of the methods provided to allow replication by others?
No
Are the datasets clearly presented in a useable and accessible format?
Yes
Reviewer Expertise:
Hospital Management (Research area-Quality and Disasters management)
I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.
Overall comment:
The protocol was incomplete; it is confusing to read and even more difficult to understand, let alone replicate.
Study objective:
The study objective is confusing. Why pre and post-assessment? What assessment are the authors referring to? There was no mention of the assessment. It also doesn't make any sense because the researchers are the ones doing the assessment, not the participants. So why the need to measure pre and post-assessment?
It is recommended to change the study design to an intervention study. Which increases the value of publishing the study protocol and makes more sense to measure pre and post-intervention.
Understanding perception should be investigated using a qualitative method, suggest to rewrite.
Method:
This is the most important section for a protocol publication, yet it is the most underwritten.
Stated as 'descriptive cross-sectional', but if association with demographic variables will be carried out, then it is no longer descriptive.
If the study has two phases, the methodology has to extensively cover everything in the two phases.
There should be a separate sample size calculation and different sets of inclusion/exclusion criteria for:
- medical records in the secondary data collection
- the healthcare workers in the pre and post intervention survey
Must state which formula was used to calculate the sample size for both medical records and healthcare workers
"Questionnaire will be provided for assessment based on adopted questionnaire"--what is the name of the adopted questionnaire to be used, was it validated? in what language? What is the alpha cronbach value?
Purposive sampling is commonly used for qualitative method. In quantitative, it is convenience sampling. Convenience sampling is a non-randomized sampling which means the study findings cannot be inferred/generalized to the population (because the sampling is no longer by chance).
The new questionnaire to be developed, will it be face- and content- validated? What about the reliability of the questionnaire?
"The first phase is a collection of data from the previous patients health records of the medical record department to assess how well staff adhere to the quality check list of NABH guidelines where we have taken 10 quality indicators from the check list"----not clear how this will be carried out since no further information was provided. What checklist? not clear.
Data collection method is missing.
Why a t-test (unpaired)? Pre and post-analysis should be paired-T test
Result:
The result section is not acceptable. Requires a rewrite.
Discussion:
The discussion has to be improved; there is no link with the protocol. There is also no connectivity between all paragraphs. It is simply 'placing' what others have done.
Studies that utilize non-randomized sampling cannot be generalized to the population
Is the study design appropriate for the research question?
No
Is the rationale for, and objectives of, the study clearly described?
No
Are sufficient details of the methods provided to allow replication by others?
No
Are the datasets clearly presented in a useable and accessible format?
No
Reviewer Expertise:
Research methods, quantitative and qualitative.
I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.
Abstract Can be improved. Background should be trimmed out and methodology needs to be explained.
Keywords can be arranged in alphabetical order.
Remaining sections looks fine as this is just a protocol rather than a research paper. The protocol looks scientific and the objectives can be met by using the mentioned methodology.
Is the study design appropriate for the research question?
Yes
Is the rationale for, and objectives of, the study clearly described?
Partly
Are sufficient details of the methods provided to allow replication by others?
Partly
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Reviewer Expertise:
Patient Safety, Pharmacy Practice
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.