Designing paper‐based records to improve the quality of nursing documentation in hospitals: A scoping review

Abstract Background Inpatient nursing documentation facilitates multi‐disciplinary team care and tracking of patient progress. In both high‐ and low‐ and middle‐income settings, it is largely paper‐based and may be used as a template for electronic medical records. However, there is limited evidence on how they have been developed. Objective To synthesise evidence on how paper‐based nursing records have been developed and implemented in inpatient settings to support documentation of nursing care. Design A scoping review guided by the Arksey and O'Malley framework and reported using PRISMA‐ScR guidelines. Eligibility criteria We included studies that described the process of designing paper‐based inpatient records and excluded those focussing on electronic records. Included studies were published in English up to October 2019. Sources of evidence PubMed, CINAHL, Web of Science and Cochrane supplemented by free‐text searches on Google Scholar and snowballing the reference sections of included papers. Results 12 studies met the eligibility criteria. We extracted data on study characteristics, the development process and outcomes related to documentation of inpatient care. Studies reviewed followed a process of problem identification, literature review, chart (re)design, piloting, implementation and evaluation but varied in their execution of each step. All studies except one reported a positive change in inpatient documentation or the adoption of charts amid various challenges. Conclusions The approaches used seemed to work for each of the studies but could be strengthened by following a systematic process. Human‐centred Design provides a clear process that prioritises the healthcare professional's needs and their context to deliver a usable product. Problems with the chart could be addressed during the design phase rather than during implementation, thereby promoting chart ownership and uptake since users are involved throughout the design. This will translate to better documentation of inpatient care thus facilitating better patient tracking, improved team communication and better patient outcomes. Relevance to clinical practice Paper‐based charts should be designed in a systematic and clear process that considers patient's and healthcare professional's needs contributing to improved uptake of charts and therefore better documentation.


| INTRODUC TI ON
Documentation of clinical care facilitates information flow between interdisciplinary healthcare providers, supports continuity of care for patients (Keenan et al., 2008) and supports the clinician's memory of care provided (Dalianis, 2018). Further, nursing care documentation serves objectives such as facilitating administrative processes that nurses perform, providing a formal legal document of nursing care provided, creating a record of care that can be used for education and providing data for quality improvement and research (Dalianis, 2018;Ioanna et al., 2007;Mann & Williams, 2003). Therefore, it is important to study the existing nursing documentation charts as their correct design and use could have significant implications for overall clinical management of patients (Urquhart et al., 2009).
While adoption of electronic patient records is progressing, paper continues to be an important medium for recording inpatient care in many settings and particularly in low-and middle-income countries (LMIC). Even in high-income settings such as the US, Australia and Europe, observation charts used to record daily patient physiological data such as vital signs are largely paper-based (Cornish et al., 2019;Odell et al., 2009;. Despite the dominance of paper as a medium for nursing records, research on their design is only beginning to emerge in high-income settings (Christofidis et al., 2013;Isaacs et al., 2019;. Structured and well-designed paper records facilitate efficient data collection for quality monitoring purposes (Mwakyusa et al., 2006) and prepare the ground for future electronic medical records. Therefore, without careful design and implementation of paper-based records in the first instance, the full benefits of computerisation are unlikely to be realised (Mann & Williams, 2003;Miller et al., 2010).
An evidence synthesis focussing on documenting nursing care found that aspects such as time spent documenting, documentation errors, legal accountability and interdisciplinary communication have been studied (Keenan et al., 2008). Cowden and Johnson (2004) found that many nursing admission forms in use were contributing to data duplication potentially hindering efforts for future computerisation. When data are collected multiple times, its integrity is compromised, contributing to inefficient use of limited resources.
However, there is a paucity of literature on how paper-based nursing records have been developed as part of efforts to improve the quality of documentation of inpatient care.
To fill this gap, this study aimed to synthesise evidence on how paper-based nursing records have been developed within inpatient settings to support documentation of nursing care. Building an understanding of how these paper-based records have been developed is important as it allows us to learn, compare and adopt methods that have been shown to work within our project in Kenya where documentation of inpatient paediatric care was found to be inadequate (Ogero et al., 2018) indicating the need for better charts. A scoping review was considered appropriate as we anticipated limited or poorly developed literature on the process of developing charts. We wanted to synthesise evidence from previous studies on the topic of interest, and we did not intend to do a meta-analysis.
2 | ME THODS The Arksey and O'Malley Framework (Arksey & O'Malley, 2005) for scoping reviews updated by Levac (Levac et al., 2010) was used to guide the review process. The PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines for reporting scoping reviews (Tricco et al., 2018) was adopted for reporting our results (Appendix S1). The protocol for this study was not registered in advance. from a Wellcome Trust Senior Clinical Research Fellowship (#207522) awarded to Professor Mike English supported this work. The funders had no role in drafting this manuscript. and uptake since users are involved throughout the design. This will translate to better documentation of inpatient care thus facilitating better patient tracking, improved team communication and better patient outcomes.
Relevance to clinical practice: Paper-based charts should be designed in a systematic and clear process that considers patient's and healthcare professional's needs contributing to improved uptake of charts and therefore better documentation.

K E Y W O R D S
charting, documentation, inpatient, nursing records, observation charts, paper, review What does this paper contribute to the wider global clinical community?
• Paper-based charts for inpatient care have been developed following a general non-systematic process of problem identification, literature review, chart (re)design, piloting, implementation and evaluation.
• The studies however executed each step differently leading to various documentation outcomes.
• This review proposes that a systematic process to chart design such as the human-centred design approach might yield optimally designed charts that meet users' needs and lead to better documentation outcomes.

| Conceptualisation of key terms
Four key terms, related synonyms and combinations were applied in developing the search syntax: 'nursing care', 'documentation', 'inpatient', and 'quality improvement'. We focussed on care provided by nurses during the inpatient stay and the paper-based nursing records used to document this care. We expected that relevant articles would be published as a quality improvement project and therefore included this term. A detailed description of the terms is provided in Table 1.

| Search strategy
The terms used to build the search syntax were based on the following: Documentation AND Nursing care AND Inpatient AND Quality improvement. Related terms are presented in Table 1 and the detailed search strategy is provided in Appendix A.

| Running the search
Between August and October 2019, and with the help of an information specialist, the search was constructed in PubMed and adapted to other databases including CINAHL, Web of Science and Cochrane. We included publications up to October 2019. Free-text searches on Google Scholar and snowballing from the reference sections of included papers were conducted to supplement the search.

| Study selection
All titles retrieved from the search were managed using Endnote X7.8 (Clarivate Analytics). Duplicate records were removed using Endnote duplicate function and by manual de-duplication using Microsoft Excel. We adopted a two-stage process for study selection. In the first stage, two researchers independently screened the titles and abstracts to identify studies for inclusion guided by two criteria: (1) Was the study about improving the quality of documentation? and (2) Was the study about nursing documentation for inpatient care (including emergency departments). We included emergency departments are these are likely to use similar observation charts to inpatient wards. We excluded studies that focused only on electronic documentation, those that designed charts specifically for nursing handover, and those whose purpose was to improve communication between staff rather than improve nursing documentation. In the second stage and before complete extraction commenced, one researcher scanned through the shortlisted articles to verify that they were appropriate for full data extraction. At this second stage, some papers were excluded for full data extraction for similar reasons as in stage one through consensus with two researchers as their

Documentation #1
Process of recording the details of patient care using either computerised information systems or paper-based charts. Focus is on paper-based charts only The following words were used with the Boolean operator OR: checklists, charts, flow charts, job aids, decision aids, decision support tools, tools, instruments, protocol, guideline Nursing care #2 The nursing process has been described as a 5-sequential step process that guides nursing care. It involves assessment, diagnosis, planning, implementation, and evaluation (Toney-Butler & Thayer, 2019). In the first step, subjective or objective data are required. Subjective data are verbal statements from patients or caregivers while objective data are measurable; data such as vital signs, intake and output, and height and weight (Toney-Butler & Thayer, 2019). These objective measures are often repeated (depending on the severity of illness) at regular intervals throughout the admission until the patient is discharged. The process of improving paper-based charts will likely be published as part of a quality improvement project which may be described in a variety of ways. These studies might refer to the process of developing a chart as well as the outcomes Combinations of the following words were used with the Boolean operator OR: Quality improvement, practice improvement, before and after, develop, standardise

Filters
English and humans only suitability could not be established in the title and abstract screening phase. Figure 1 shows the flow of study selection.

| Data extraction and analysis
A data extraction tool was developed by adapting and revising the Joana Briggs data extraction tool for scoping reviews (Joanna Briggs Institute, 2019) in discussion with the reviewers. Information extracted included general study information such as authors, year of study, country where the study was performed, hospital department and name of the chart. Other data extracted are described in Box 1.
For quality assurance, full data extraction was performed independently by one researcher (all papers) and two researchers (6 papers each), ensuring that each paper was read and extracted by at least two authors.

| RE SULTS
12 studies were included in the analysis with all, except one conducted in high-income countries. Majority of the studies were conducted in the USA (n = 5) followed by Australia (n = 3) and the United Kingdom (n = 2). New Zealand and Uganda had one study each.
F I G U R E 1 Flow of study selection [Colour figure can be viewed at wileyonlinelibrary.com] All studies were published between the year 1992 and 2017. The charts identified were either admission and/or discharge charts (Hill et al., 2014;North & Serkes, 1996;Okaisu et al., 2014;Street et al., 2017;Torakis & Smigielski, 2000;Vander Meer & Gabert, 1993) that capture one-time events in the inpatient period, or were observation charts (also called flowsheets) (Cahill et al., 2011;Chatterjee et al., 2005;Gordon et al., 2008;Kuc, 2009;Robb & Seddon, 2010) that are used multiple times during the inpatient stay. The studies were descriptive case studies that employed a before and after study design. Where explicitly mentioned, the studies reported a non-randomised prospective before and after intervention design (Cahill et al., 2011;Street et al., 2017) and an action research or cyclic methodology to design (Gordon et al., 2008;Hill et al., 2014;Okaisu et al., 2014).
The charts covered a range of clinical areas: adult surgical/medical or emergency care (Cahill et al., 2011;Gordon et al., 2008;Hill et al., 2014;Street et al., 2017), paediatric care (Okaisu et al., 2014;Torakis & Smigielski, 2000;Vander Meer & Gabert, 1993), and specialised seizure care (Kuc, 2009). In three studies, the charts covered all nursing units in the hospital (Chatterjee et al., 2005;North & Serkes, 1996;Robb & Seddon, 2010). We inferred the population to be adult, based on the cut-off values of vital signs on the observation charts in two studies (Chatterjee et al., 2005;Robb & Seddon, 2010) and we found no nursing observation charts for newborn inpatient care. Uniquely, DiBlasi and Savage (1992) developed a complete documentation system comprising of: nursing admission assessment, a nursing care flowsheet and a re-organised nursing care plan.
An overview of the studies is provided in Table 2. The findings are presented in a narrative form as per the review questions (Box 1) in the next section.

| Nature of problems leading to (re-) design of charts
Where mentioned, the decision to improve paper charts in the inpatient setting originated from within the hospital or an external organisation. Within the hospitals, nursing departments or doctors identified challenges that needed to be addressed as ( (Kuc, 2009); e) outdated charts (Cahill et al., 2011); and (f) in response to multiple factors identified in the literature (such as failure to recognise clinical deterioration) (Robb & Seddon, 2010). In two studies, external organisations identified inefficiencies in the documentation that needed to be addressed to meet accreditation standards (Gordon et al., 2008;North & Serkes, 1996). The need for such standards was further supported by data gathered internally from the nursing departments.  Street et al., 2017;Vander Meer & Gabert, 1993), and incorporating staff experience (Hill et al., 2014;Okaisu et al., 2014).

| Process of chart development
Various procedures were used to (re)design the charts. In two studies (Hill et al., 2014;Okaisu et al., 2014), researchers designed the chart with feedback from charge nurses, while in seven studies, a hospital committee or development group was constituted to design the chart in consultation with staff (Cahill et al., 2011;Gordon et al., 2008;North & Serkes, 1996;Robb & Seddon, 2010;Street et al., 2017;Torakis & Smigielski, 2000;Vander Meer & Gabert, 1993).
In contrast, one study did not constitute a formal documentation committee but engaged groups of individuals at each phase of the     (Chatterjee et al., 2005). While studies used participatory approached to design, we found none that mention co-design as an approach to designing the charts.

| Chart features
Six studies provided a full sample of the chart, three provided a partial chart while three only described the chart. Where full charts were available, the charts were commonly printed on both sides of A4 sheets in either portrait or landscape orientation. Two charts were three pages long; one printed as a booklet.
The observation charts plotted physiological data (temperature, heart rate, respiratory rate, blood pressure and oxygen saturation) and incorporated a colour-coded early warning system overlaid on the chart (or provided on the reverse) to help in identification of out

| Chart piloting, re-design and implementation
The of the charts by Okaisu et al. (2014) andVander Meer andGabert (1993) were found to be unnecessarily long, required large amounts of writing and the fold-out format was not desirable. Following piloting, charts were re-designed and implemented to additional wards or within the same ward on a larger scale. Lastly, an evaluation or chart audit was conducted.
Two studies, Vander Meer and Gabert (1993) and Hill et al. (2014), adopted a trainer of trainers (TOT) model to pilot and implement the chart while in the Cahill et al. (2011) study, a coordinator who was in contact with staff was identified. This review found that charts were often one part of a quality improvement project. Seven studies (Cahill et al., 2011;Gordon et al., 2008;Hill et al., 2014;Okaisu et al., 2014;Robb & Seddon, 2010;Torakis & Smigielski, 2000;Vander Meer & Gabert, 1993) developed and implemented the chart together with other strategies such as introducing a new assessment policy or a medical emergency response team while five (Chatterjee et al., 2005;DiBlasi & Savage, 1992;Kuc, 2009;North & Serkes, 1996;Street et al., 2017) focused on chart development and implementation.
To facilitate implementation, most studies trained staff on chart use (Cahill et al., 2011;Gordon et al., 2008;Hill et al., 2014;North & Serkes, 1996;Okaisu et al., 2014;Robb & Seddon, 2010;Torakis & Smigielski, 2000;Vander Meer & Gabert, 1993) while one study trained only ward sisters but no other staff (Kuc, 2009). Training programmes covered a range of issues including how to use the chart and education programmes specific to quality improvement projects. For example, where a process model was being introduced, staff also received training on the model (Torakis & Smigielski, 2000). Training was delivered via posters, presentations, meetings and written guidelines. To support implementation of charts, some studies instituted a policy or practise change (Gordon et al., 2008;Okaisu et al., 2014) while others improved how emergencies were identified (triggering mechanisms) by strengthening the emergency teams (Cahill et al., 2011;Robb & Seddon, 2010). Additional support during implementation was provided in some studies by conducting documentation compliance audits and giving feedback to nurses to stimulate documentation improvements (Gordon et al., 2008;Hill et al., 2014;Robb & Seddon, 2010).

| Documentation outcomes
For this review, we considered the primary outcomes as those related to documentation to allow for comparison. Documentation evaluation was carried out after 2-12 months of implementation with two studies repeating the evaluation; 5 months (Hill et al., 2014) and 3 years (North & Serkes, 1996). Seven studies reported better documentation measured by the number of new charts filled (Hill et al., 2014;North & Serkes, 1996), complete documentation of all vital signs (Cahill et al., 2011;Robb & Seddon, 2010), clinical assessment scores (Cahill et al., 2011;Robb & Seddon, 2010), pain management and adverse events (Gordon et al., 2008;Street et al., 2017). One study reported on improved accuracy of plotting vital signs (Chatterjee et al., 2005).
Of the remaining five studies, various measures of documentation outcomes were reported. One study reported decreased documentation time of more than 50% (DiBlasi & Savage, 1992)

| Barriers and facilitators to implementation
The studies reported barriers and facilitators to chart development and implementation. Gordon et al. (2008) identified challenges related to process, people, policy and forms using an Ishikawa/fishbone diagram. The Fishbone diagram is a quality improvement tool for identifying problems and their causes (Ishikawa, 1976). Following this, they conducted an intensive 2-week review which was not well received by the staff as it was perceived as being unnecessary.
Knowledge deficit was a challenge when implementing the new programmes within which the new charts were being implemented (Robb & Seddon, 2010;Vander Meer & Gabert, 1993). Both stud- Introducing a major design change to a section of the admission chart caused staff resistance during the initial implementation of admission chart reported by North and Serkes (1996). Nevertheless, following discussions, staff agreed to pilot the new form and found it easier to use it. Lastly, two studies suggested that successful implementation of charts requires staff involvement at all levels including the top level (DiBlasi & Savage, 1992;Vander Meer & Gabert, 1993).

| Principle findings
This review aimed to synthesise evidence on how paper-based nursing records have been developed and implemented in inpatient settings to support documentation of nursing care. From the evidence, studies reported developing paper-based nursing records that were used once during the admission episode (admission and/or discharge charts) and those that were used multiple times to record patient progress (flowsheets or observation charts).
The studies reported varied methodologies in developing the charts beginning with problem identification and specification of the Design problems identified during the piloting phase could have been averted or minimised by applying a systematic approach to chart design that considers the user's need and context. An example is the Human-centred Design approach. This is an approach to developing interactive systems that focuses on the user, their needs and requirements by applying human factors/ergonomics techniques to improve user satisfaction, usability and sustainability of a product (International Organization for Standardization, 2019). The process has four major activities that occur iteratively: observation, idea generation, prototyping and testing (Norman, 2013). It follows a diamond model where designers go back and forth between generating diverse ideas and converging to workable solutions throughout the design process. To illustrate this, these four steps have been further expanded into 6 steps by various authors (Bowen et al., 2013;Boyd et al., 2012;Kim et al., 2019) beginning with understanding the experiences, exploring inspirational ideas, converging to practical proposals, developing together, consensus building and prototyping ( Figure 3). The process is presented in a linear format, but one may go back and forth between stages as problems become clearer and new ideas emerge. A key emphasis of the Human-centred Design approach is engagement with end-users throughout the whole process.
In comparison, the studies in this review used literature reviews or an assessment of current practices to identify the problem and this would typically fall under step 1 of the Human-centred Design process where one seeks to understand the user and the problem.
However, the studies emphasised the problem rather than the user.
More emphasis on the user would have enabled underlying issues such as knowledge deficit or team communication to be identified and addressed at design rather than implementation phase. This coupled with a systems approach to problem-solving or other systematic quality improvement strategies such as the Fishbone approach provide opportunities to identify and solve problems. Steps 2-5 under the Human-centred Design approach allow idea (including aspirational ideas), converging to practical proposals and developing together with users. The approach specifies a range of methods or tools that can be adopted to ensure that the users' needs are captured and addressed in the product design. In contrast, the studies reviewed tended towards receiving user feedback during the piloting and implementation phases. Finally, the Human-centred Design approach includes a step to develop a prototype and change which can be compared to the piloting and re-design phase reported by the studies.
The Human-centred Design approach can be applied to both electronic and paper-based products. As an illustration, Rogers et al. Body in the UK develops and helps to implement standards for the structure and content of digital health and social care records ensuring a consistent and coherent approach to development and implementation of records that also facilitates information sharing (The PRSB, 2020). Developing a similar approach for paper-based records, which may serve as templates for future electronic records, would ensure a consistent and comprehensive approach to documenting care where paper continues to dominate as a medium for recording care.
To evaluate the charts, the studies sought feedback from health professionals as well as assessed the chart use using various measures. However, there is an opportunity to conduct a systematic evaluation of charts using processes such as heuristics evaluation-a usability inspection method used in software development (Nielsen, 1994b). Heuristics evaluation is a method for identifying usability problems in an interface so that they can be addressed during the design period Nielsen (1994a). The method borrows from principles in human-computer interaction and can be applied to any interface that requires human interaction including paper-based charts. Their evaluation identified 1189 usability problems to do with chart and content layout among other issues and these would inform usability principles related to paper-based charts.
The limited body of work around the systematic, evidence-based design of paper-based charts has so far originated from high-income countries but provides a starting point to developing charts. We suggest that more studies are required in low-income settings so contextual differences can be identified and addressed. To contribute to this growing body of work, we are developing an inpatient newborn observation chart using the Human-centred design approach to meet the need of better monitoring charts in LMIC. Additionally, we suggest that further work explores development of a systematic guide to designing and reporting on paper-based charts be conducted.

| Limitations
We Additionally, other issues such as lack of knowledge by health professionals and team dynamics as may have been identified early by adopting a systems thinking approach to chart development. We suggest that further work exploring the development of a systematic guide to developing and reporting on paper-based charts be conducted.

| RELE VAN CE TO CLINI C AL PR AC TI CE
Paper-based charts should be designed in a systematic and clear process that considers patient's and healthcare professional's needs.
This study has identified gaps in the process of designing observation charts for inpatient care and suggests the Human-centred Design approach as a systematic process to design for better documentation outcomes. Using the Human-centred Design approach provides an opportunity to address problems with the chart during the design phase as well as meeting the health professional's needs. This in turn promotes ownership and uptake because the users are involved at all stages of design. With improved uptake of charts, this will translate to better documentation of monitoring care thereby allowing health professionals to track patient progress, facilitate team communication, tailor care and achieve better patient outcomes.

ACK N OWLED G EM ENTS
We would like to thank Elli Harris, an information specialist, who was instrumental in developing the searches and retrieval of articles for review. This work is published with the permission of the Director of KEMRI.

CO N FLI C T O F I NTE R E S T
The authors declare that they have no conflict of interests.

AUTH O R CO NTR I B UTI O N S
Study design: all authors; data collection and analysis: NM, IOA, CP; and manuscript preparation and revisions: NM, IOA, CP, ME, MZ. All authors approved the final version of the manuscript.

E TH I C A L A PPROVA L
Ethical approval was not required for this paper.

R E FE R E N C E S A PPEN D I X A S E A RCH S TR ATEGY
Search run on PubMed on 28 08 19 and translated to other databases with the help of an information specialist. (MH 'Quality Improvement+') OR TI 'quality improvement*' OR AB 'quality improvement*' OR TI 'practice improvement*' OR AB 'practice improvement*' OR TI (before AND after) OR AB (before AND after) OR TI (improve* OR develop* OR standard*) OR AB (improve* OR develop* OR standard*) #1 AND #2 AND #3 AND #4 AND ENGLISH AND HUMANS