A Standard Perinatal Care Record in Canada: Justification, Acceptability and Feasibility

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OBSTETRI CS

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A STANDARD PERINATAL CARE RECORD IN CANADA: JUSTIFICATION, ACCEPTABILITY AND FEASIBILITY Janet B. Lacy, MSc,l Linda Bartlett, MD, MHSc, 2 Arne Ohlsson, MD, MSc, FRCPC,3 1Lecturer,

Departments of Physical Therapy and Paediatrics, 2Medical Consultant, Epidemiologist, First Nations and Inuit Programs, Medical Services Branch, Health Canada, Ottawa, 3Associate Professor, Departments of Paediatrics, Obstetrics and Gynaecology and Public Health Sciences, 1.3University of Toronto ABSTRACT

Use of a standard perinatal record will serve tile needs of health care consumers and providers wlw require expedient communication of aU aspects of care. The universal use of a standard record will provide accurate information on which to base health care policy and management strategies for health care planners and researchers. Acceptance of a standard record is dependent on involvement of all users of tile record in its development, collection of high quaUty data and designation of a minimum data set for a national perinatal database. Experience in tile Nordic countries has slwwn that a national standard record is feasible and serves well as a data collection instrument. The Canadian Perinatal Surveillance System is in tile process of developing a standard perinatal record for Canada. RESUME

Le recours aun dossier perinatal normaUse repondra aux besoins des cUentes et des prestateurs de soins de sante quand il faut communiquer taus les aspects des soins en temps opportun. Le recours universe! aun dossier normalise favorisera l' exactitude des renseignements sur lesquels seront fandees Ia poUtique en matiere de sante, ainsi que les strategies de gestian al' intention des planificateurs et des chercheurs dans

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' ' ' le domaine des soins de same. L' acceptation d' un dossier normalise repose sur la participation de tous les utilisateurs ason elaboration, sur la coUecte de donnees de haute qualiti et sur la designation d' un ensemble de donnees minimal pour creer une base de donnees nationale en matiere de perinataliti. L' experience des pays scandinaves a confirm€ la faisabiliti d' un dossier national normalise, qui constitue un tres bon outil de coUecte des donnees. Le Systeme canadien de surveillance perinatale est en train d' elaborer un dossier perinatal normalise a!'intention des Canadiennes. J SOC OBSTET GYNAECOL CAN 1998;20(6):557-65 KEY WORDS

Perinatal period, records, antenatal care, perinatal care, infant-newborn. Received on April 8th, 1997. RevisedandacceptedonMay 12th, 1997.

INTRODUCTION

PURPOSES/GOALS AND OBJECTIVES OF INFORMATION SYSTEMS

The purpose of this paper is to outline the rationale of a standard perinatal record with emphasis on justification, acceptability artd feasibility-both generally, artd specifically in Canada. Sources of information for this paper included published literature, personal contacts with users of startdard records in other countries artd minutes of the Cartadiart Perinatal Surveillartce System (CPSS) steering committee meetings. The process of designing a recordkeeping system that is useful for clinical practice, health care plarming, surveillartce artd research is complex.

In Sweden and Norway, where national perinatal information systems have been in place since the 1970s, the purposes of the patient record are legislated. These include: communication between health care providers, provision of information for health care consumers, quality assurance and health care research. 2•3 When Merkatz et al. developed a regional perinatal system, they included these goals: to startdardize record keeping, to identify the normal artd high risk pregnartcy artd to develop a plan of management for pregnancy problems. 4 Grover et al. delineated the goals of a perinatal reporting system as the evaluation of quality of care and the reduction of maternal and infant mortality and morbidity.5 They listed objectives in four areas: 1) direct patient care (risk assessment, referral models, treatment evaluation, practice surveillance); 2) clinical research (outcomes by diagnostic categories, registries of conditions, maternal and infant health summaries, development of new therapeutic approaches); 3) epidemiological research (demographic, geographic, systems effectiveness) artd 4) continuing education. In an overview of perinatal computing, Sokol and Chik discussed the development of computer systems for martagement in support of perinatal regionalization. They stated that although the assumption was that computer systems would lead to better diagnosis artd improved outcome, there was no proof that this had occurred. 6 The Nordic countries have been pioneers in the use of registries for research purposes. Some of these research studies have had ar1 effect on clinical care (e.g. recommendations for infartt sleep position artd vitamin-K administration). In Sweden, Norway and Finland, the standard national perinatal

JUSTIFICATION

Justification of a standard perinatal record is based on the purposes of the record and the goals of the recordkeeping system. PURPOSES OF PATIENT CARE RECORDS

Patient care records provide immediate artd long-term information for patients artd health care providers. Information aggregated (collected into a whole) from many patient records may be used by health care providers artd consumers, policy plarmers artd researchers. Pisartelli artd Ricci discussed the clinical, hospital ward artd aggregation perspectives of patient record data. 1 Individual patient records are generally used to support patient care. A patient record is a collection of data aimed at clinical ffiarlagement in real time during the process of care. From the perspective of the ward, data are part of a dynamic process; "actions are needed to produce data and events occur based on the data." When data are aggregated, "similar events are classified under the same category and retrieved for epidemiological, quality assurance or costassessment purposes."

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' ' ' record keeping system, known as the medical birth registry, has been used for numerous studies. These have included evaluations of the association of sleeping position and sudden infant death syndrome, trends in infant survival, the effect of delayed childbearing on pregnancy outcome, the possible association between vitamin-K injections and childhood cancer and the combined interactive effects of maternal age, parity and smoking on pregnancy outcome. 7•12 In Sweden, in addition to birth registries, there are other registries, including those for death, cancer, fertility and malformations. These registries, "alone or in combination, permit simple descriptive studies of the incidence and prevalence of diseases, investigations of aetiology ... studies of short and long term consequences ... of medical or surgical procedures and survival analysis .... Moreover, complete registries allow investigations that are strictly population-based."13 Information in other registries, for example, cancer, abortion and twin regi;tries or from census data has been combined to study a variety of such topics as maternal, perinatal and neonatal risk factors for childhood cancer, the effects of medical abortions on perinatal statistics, twin births to mothers who are twins and secular trends in the effect of socio-economic factors on birth weight and survival. 14-20 In Canada, the planned CPSS will be an ongoing system of data collection, processing, analysis and interpretation for the perinatal period, and will include both maternal and infant health outcomes. 21 The results of the analyses will be communicated in a timely fashion and used to determine where and when interventions are required to respond to health disparities and, where possible, to monitor and provide feedback on the effectiveness of these interventions. 21

PROCESS FOR DESIGN OF A RECORDKEEPING SYSTEM

During the design of other national perinatal record systems, a wide variety of professionals and committees has been consulted. In Sweden, the working group that developed their information system consisted of obstetricians, midwives, paediatricians, nurses and administrators.2 Kahn, in an article on the computer-based patient record, suggested including experts in clinical and administrative systems, networking, the humancomputer interface, documentation and training, social anthropology and change management.ZZ During the development of perinatal record-keeping systems, simultaneous consideration of the needs of health care consumers, providers, policy planners and researchers is useful. In the Arizona Perinatal Program, the record system was developed with the infant as the primary patient. 23 The record was designed to provide information for day-to-day care during pregnancy, labour and the neonatal period, as well as a summary at the time of nursery discharge for use by those responsible for continuing health care. Before record design, major uses of data for patient care, planning and research and specific formats required should be determined. 24 Aggregation of all patient care information is not expedient. Designation of a minimum data set may ensure that all information collected on a regional basis is useful and that its collection is efficient. In Britain, the Royal College of Obstetricians and Gynaecologists and the British Paediatric Association have a large 'minimum data set.' This is designed to provide enough information for clinical audit and effective service planning.25 A core data set should be developed that is not large, but carefully designed, and local units should be able to add items for their use. 26 Sokol and Chik challenged the concept of a minimum perinatal database. They felt that perinatalogy/neonatology are rapidly changing fields and it would be difficult to predict all questions that would be asked in the future. 6 To meet changing needs, some flexibility in the determination of the data set and subsequent collection of information is necessary. British investigators discussed the need for flexibility in terms of analysis of the aggregate data.27,2 8 Items incorporated in their minimum data set had to be defined unequivocally, be readily available for all cases and provide useful information.

JUSTIFICATION FOR CANADA

A standard perinatal care record in Canada is justified because it will serve the needs of health care consumers and providers, and will supply useful aggregate information for health care planners and researchers. The resultant policies, guidelines and resource allocation can then be evaluated for their effectiveness in improving the health of pregnant women and their newborn infants. ACCEPTABILITY

Acceptability of a record-keeping system is related to the implementation process, user benefits, data quality and who holds the records.

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' ' ' (e.g. birth weight of 400 grams) are verified for accuracy. Logic checks ensure that impossible conditions from the combination of variables are identified and changes made in the appropriate variables (e.g. an infant with a birth weight of 1,000 grams who was not admitted to a neonatal intensive care unit).

USER BENEFITS OF A RECORD-KEEPING SYSTEM

Appropriate use of any record-keeping system is associated with its acceptability by those who enter the information.26 Clinicians will not accept a system that fails to capture the key elements and daily activities of the clinical environmentY The speed with which clinicians receive statistics from the database is important as these statistics are only of value if readily available in modifying the care of patients. 29 There must be a balance between simple forms which do not collect sufficient information and complex forms which are time-consuming to use. The need for and influence of feedback from the Finnish birth register to data providers were studied. 30 Most hospital personnel were found to have negative attitudes to the register. This was attributed to hasty introduction of the system, late contact with hospital staff, lack of use of information obtained in a pilot test of the form and initial negative feedback from the register to the data providers. The first feedback most hospitals received was a list of mistakes to be corrected. Some of these mistakes were due to deficient information from the National Board of Health. The authors concluded that feedback (i.e. statistics on diagnoses and interventions) to the original data providers is a basic requirement of a registry.

WHO HOLDS THE RECORDS?

Traditionally, in North America, patient records are held by health care providers or hospitals, and the patient has limited access to the information. In most of Europe, pregnant women keep their own medical recordsY In a clinical trial where women were randomly allocated to hold their full record or the usual "cooperation card," women holding their own records were more likely to feel in control of their antenatal care, to feel it was easier to talk to doctors and midwives and to prefer to hold the same kind of record again than were the women holding a cooperation card.46 The study authors found no evidence of negative effects or an increased rate of lost notes in the women who held their own recorqs. In a commentary on this study, Lovell related the women's feelings of being "more in control" to a sense of power, and suggested that this feeling of control might be a method to shift power from the physician to the patient. 47 In another randomized trial, similar to the previous study, women who held their own records expressed more satisfaction with most aspects of their care and delivery.4B These women were also less likely to miss antenatal appointments.

DATA QuALITY

Poor data quality has often been cited as a problem with statistics from hospital records, regional databases, birth and death certificates and registries, and this limits their usefulness for health care planning and research. 31 '39 Several methods to improve data quality have been reported, including: 1. use of computer-generated rather than handwritten admission record forms; 40 2. use of standard definitions; 40•42

AccEPTABILITY IN CANADA

Acceptability of a standard perinatal care record in Canada will be ensured if the form fulfils the requirements of the health care consumers and providers who will be suppliers of data in this system. Information from a minimum data set will help planners to ensure the efficient use of health care services and will assistresearchers in determining how to improve the quality of perinatal care. Use of a standard record with precise definitions of terms will ensure high quality data collected in real-time. A womenheld record system will improve the participation ofhealth care consumers in the management of their care.

3. use of check boxes rather than open-ended questions;36,37.43.44

4.

provision of feedback to data providers on the importance of their work and need for high quality data; 43 5. field testing of forms and training of staff who will use them. 2,6,23,42

The development of audit systems is necessary to ensure high quality data in any database of patient information. This requires the design of range and logic checks. Range checks ensure that outliers that are either impossible (e.g. birth weight of 6,000 grams) or outside the normal range

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FEASIBILITY

The feasibility of a standard perinatal record has been demonstrated in the Nordic countries where the medical birth registries provide efficient and reliable data

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' ' ' on ~rinatal events. Data collection fonns also serve as the standard charts for antenatal, obstetrical and neonatal care, thus avoiding duplication of efforts. 49 PRESENT CANADIAN PERINATAL DATA COLLECTION ACTIVITIES

In Alberta, British Columbia, Nova Scotia and Prince Edward Island, regional or provincial standard perinatal record-keeping systems have been developed and are currently in use. Data for these systems are collected by data abstraction from hospital charts and·manual entry of data into a computer database. Standard antenatal record fonns are available in all provinces, but are used inconsistently. THE CANADIAN PERINATAL SURVEILLANCE SYSTEM (CPSS)

A surveillance system requires a method of data collection, analysis and response. One objective of the CPSS is to collect risk factors and short and medium term outcome data on all recognized pregnancies in Canada on an ongoing basis. Once the data are collected, they will be analysed, and mechanisms for response to the information will be set in place.

CONTENT OF A CANADIAN STANDARD PERINATAL RECORD

Large numbers of indicators have been developed by the "Indicators Subcommittee" of the CPSS, and the necessary variables for those indicators have been identified by the "Data Collection Subcommittee." An indicator is a measurement that , when compared to either a standard or a desired level of achievement, provides information regarding health determinants, outcomes or management process evaluation. An indicator includes both a numerator and a denominator. It is usually composed of two or more variables. The members of the Steering Committee of the CPSS have ranked all indicators. Some indicators will be eliminated; this may reduce the number of variables. DESIGN OF A CANADIAN STANDARD PERINATAL RECORD

Review of record-keeping systems used nationally and internationally suggests that: 1. data be collected on forms that serve both as the perinatal clinical care record and the data collection instrument;

TWO DISTINCT S

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' ' ' 2. in addition to progress notes, at least three forms are necessary for care-antenatal, delivery and neonatal records; 3. each record have several copies with the last copy containing only the necessary fields to collect information for the variables to be aggregated; 4. these forms be processed centrally, either optically or manually, and the information be entered into a database; 5. one copy of the antenatal record be carried by the mother and updated at subsequent antenatal visits; 6. copies of antenatal and delivery records be added to the infant's chart and follow the infant to other levels of care; 7. in order to make information available at the first health care visit following birth, the mother be provided with a copy of the infant(s)' chart(s) at the time of discharge; 8. unique identifiers for both mother and infant(s) are needed for subsequent linkage. Several provinces have a system of health card numbers in place which could serve as the unique identifier. The possibilities of developing a national system of

unique identifiers should be explored. In the future, a system of"Smartcards" (plastic cards, similar to credit cards that are encoded with information) could replace the proposed "paper-based" record system. Perinatal record forms have been developed in draft mode, and will be finalized when consensus on the indicators has been reached and input from computer experts has been obtained. This form may be used as both the clinical care record and data collection instrument. These record forms are flexible so that specific information pertinent to a special population or region can be collected by the addition of new fields to the forms. Information for specific research projects could also be included. FEASIBILITY IN CANADA

There are some obstacles to the development of a standard perinatal record in Canada. The Nordic countries (where such standardization has been established) have populations smaller than that of Canada; however, the combined population of all Nordic countries (total population 24 million) is close to that ofCanada.49 Implementation by several provinces or territories at a time ffia:Y be more realistic than implementation in the whole country at the same time.

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' ' ' SUMMARY AND RECOMMENDATIONS

A standard perinatal record is an important part of a perinatal surveillance system of data collection, data analysis and response. As information will be collected in "real-time," deviations from the desired norm in a specific pregnancy can be highlighted and linked to practice guidelines which suggest the most appropriate mode of action. The record may, therefore, not only lead to ex post facto analyses and responses based on aggregated data, but may improve the outcome of pregnancies while they occur.

The experience of the Nordic countries with their national birth registries has demonstrated that the development and use of a national standard perinatal recordkeeping system is both feasible and useful. The process requires considerable planning and the expertise of many individuals. Clear delineation of the goals and objectives of the record-keeping system will foster the formation of an effective system. Such a system will benefit the patient, health care providers, health care planners and researchers. A standard record-keeping system will foster uniformity of care, but will allow flexibility in how this care is provided. Aggregation of information with specified standard definitions will provide more accurate statistics. This accuracy will be valuable in local and regional utilization of services planning and surveillance, policy development and epidemiological research. Designation of a minimum data set is essential for the expedient aggregation of data; " ... any national standardization should be concerned with simple information which can be validly and universally collected."28 Flexibility in the identification of variables in the minimum data set is necessary to allow for changes in practice. In order to meet the needs of data providers and local planners, the form needs to be adaptable to allow for the collection of more or different information than is in the minimum data set. As health care providers may be reluctant to accept a new record system (i.e. be resistant to change), marketing of the new system is required. Users of the new record system must accept it. This is more likely to happen if they are involved in its development and if there are clear benefits for them in its use. Support of the record system by the professional societies of the various health care providers (family practice physicians, midwives, nurses, obstetricians, paediatricians) may facilitate acceptance of the new system. Development of any new system is associated with costs. After development of the record-keeping system is completed, ongoing costs should not be greater and may be less than current costs. If a copy of the form used to record patient care is forwarded to a central source, rather than data providers transcribing information on to a standard form and then sending it to the central source, there will be a reduction in time spent by the data providers. Transcription errors and the time needed to make corrections will also be reduced.

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