A quasi-experimental study was conducted in February 2017, after Approval from the Institutional Review Board of Guru Teg Bahadur Hospital, Delhi (IEC-HR/2017/29/11) which is a government referral hospital and medical college with 18000 labour room deliveries per annum. This study was conducted to evaluate the frequency of patient related parameters recorded in the control and intervention arms. The control arm filled the hospital case sheets already in use. These have unstructured entries, except, for the front sheet which contains details of patient identification. Two labour rooms in the Department of Obstetrics and Gynaecology, GTB Hospital were chosen for the study. Each labour room has a team of four resident doctors on eight hours shift. Due to the heavy workload in the labour rooms, it was planned to have PrasavRecord filled for the first two new cases admitted in the labour room in each shift i.e., a total of six PrasavRecords were filled per day upto a total of 65 sheets in each arm.

Pre-testing of the tool (PrasavRecord) for 20 cases was done in November 2016. It was also found that only 23% of total 130 parameters were complete in the currently used hospital records. Expecting an improvement of atleast 60% with the use of PrasavRecord; p=0.60, Z=1.65 i.e., 90% confidence interval and margin of error as 10%. Thus, the required sample size of case records for the study was determined by using the formula given below:

where, n is the sample size, Z is the Z-score, p is the estimate of population proportion, ε is the margin of error to be tolerated.

Hence, sample size obtained was 65 case records in each arm (control and intervention arm).

The PrasavRecord was used per mother baby pair from admission in labour room to the postnatal ward till discharge (intervention) while the existing hospital case sheets were used for the other arm (control). The intervention tool was self-explanatory and no formal training was imparted to the resident doctors for using it. Both types of sheets i.e., the completed PrasavRecord and equal number of completed hospital case sheets were assessed after patient discharge for completeness and uniformity. At the end of study, the resident doctors were requested to complete a questionnaire based on a five-point Likert scale, for assessing the acceptability of the intervention tool [Annexure].

Data extracted from the study tools was analysed in SPSS version 21.0 (IBM SPSS Statistics 21.0). Data was reported as simple statistics, including number (percentage). The average percentage of completeness along with its 95% confidence interval was reported for both the groups. The average proportion of completeness was compared using two samples z-test for proportion considering average completeness as proportion. The p-value less than 0.05 were considered as significant.

Completeness of parameters recorded in the currently used hospital case sheets (Control) and PrasavRecord (Intervention) are shown in the [Table/Fig-1,2 and 3]. While the very first examination findings at admission were found complete, subsequent noting recorded the parameters specifically being monitored for progress of labour. Recording of investigations (haemoglobin, blood group, Rhesus (Rh) factor, Veneral Disease Research Laboratory (VDRL), Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg) and ultrasound findings) were similar in the two arms [Table/Fig-4]. An important observation regarding the hospital case sheet was the haphazard entries of notes. The chronological sequence was frequently missing making it difficult to follow the sequence of events or treatment. Addition of new sheets of paper, inter-departmental referrals, hand drawn tables for recording patient progress resulted in interruption of the sequence while understanding the events through PrasavRecord was effortless and fast.

[Table/Fig-4,5] describe the Likert scale rating of thirteen resident doctors regarding their perception on the different attributes of the PrasavRecord and the existing hospital case sheet was rated as “good and very good” by 69.2% and 23.%, respectively and usefulness of PrasavRecord for recording labour processes was rated also as “good and very good” by 69.2% and 23.%, respectively versus 38.4% as good, none as very good for appearance of hospital case sheets. Ease of recording without missing details in PrasavRecord was recorded as ‘good’ and ‘very good’ by 61.5% and 23%, respectively, while that for hospital records 23% (good) and none (very good). Majority agreed that PrasvRecord would facilitate electronic medical record keeping during childbirth (38.4% ‘good’ and ‘very good’ each). Most of the participants agreed that the PrasavRecord is useful for recording labour processes, post-partum condition of mother and newborn. Overall rating for hospital records was average by 76.9% and good by 15.5%, none rated it as “very good” compared to 92.3% (good) and 7.6% (very good) for PrasavRecord. Two of the residents expressed that complete sentences in hospital records did contribute to better understanding. The only reservation expressed with PrasavRecord was the constraint of space for recording comments or other observations.

The average percentage of completeness in PrasavRecord was 75.8 (95% CI: 74.2-77.4) and for hospital cases sheet was 42.2 (95%CI: 40.9-43.6). Using these average percentages as proportion in z-test, the result revealed a highly significant difference between these two records (z=5.38; p<0.001) [Table/Fig-6].

This project was planned to explore if user friendly structured case record from the time of admission to discharge would result in better documentation. This study demonstrated that documentation of patient details and labour room events were much better with PrasavRecord than that seen in the case sheets presently in use. Clinical records of 1239 births in public healthcare facilities in Madhya Pradesh were reviewed to study the quality of documentation. Only 1.9% records documented advice at discharge, 13.8% had postnatal blood pressure and 35.3% documented fetal heart rate [6]. An observational study of 1479 women in labour indicated partograph plotting in only 15.8% of deliveries [7]. A cross-sectional survey conducted in healthcare facilities of Punjab and North West Frontier province in Pakistan, to assess Emergency Obstetric Care (EmOC) services indicated that problems such as incompleteness, inaccuracy and duplication of data made it difficult for researchers to identify and define problems accurately and reliably. They also reported that, there is lack of motivation among health service personnel, since they rarely receive feedback on the data reported to higher levels and, little incentive to ensure the quality of data collected [8,9].

Proper documentation of clinical records is important in assigning cause for maternal and perinatal morbidity and mortality. Lack of basic health data makes it difficult to formulate policy for appropriate and rational resource allocation for patient care and disease prevention [10]. Collating of data from hospitals on standard indicators of quality of patient care that report maternal deaths is presently not followed in India therefore, little information can be gathered about the exact causes of maternal deaths [11]. Presently, the Health Ministry in India is working to setup an Integrated Health Information Platform (IHIP) [12].

To enable creation of inter-operable health records with the objective to replace existing paper records, as storing unstructured medical records on computer, is a difficult and impractical exercise. The electronic records, besides eliminating difficulties of deciphering poor handwriting or lost medical records, would allow accessibility by a wider group of care givers such as clinicians, pharmacists in different clinics and the patients’ themselves [13].

Structured ward round proforma improves documentation, communication, and overall quality of care. This was demonstrated in the studies focussing on ward rounds and surgical admissions [14,15]. Filling the forms was found to be very comfortable by all the participants though initially it took time to fill the same and 77% doctors expressed that PrasavRecord will facilitate electronic medical record keeping.

This study demonstrates that a well-made structured proforma can significantly enhance the quality of documentation. As an indirect benefit, the new proforma also improved the way in which patients in labour and postpartum were clinically assessed as it also served as a checklist. The long-term vision is to incorporate this proforma into an electronic medical record, which is believed to provide superior results to handwritten records [16].

In this study, all doctors agreed that the existing unstructured hospital case sheets are not suitable for electronic medical record keeping. The marked improvement of recording of various patient parameters in PrasavRecord shows changes in “process” of documentation. Introduction of PrasavRecord will act as a preliminary step in structuralising the paper-records of labour and peurperium and help in effective auditing. In addition, PrasavRecord can be converted easily into electronic format which will substantially improve the documentation and assist in addressing lacunae in healthcare delivery in India.

The design of this study focussed only on quality of documentation, clinical outcomes were not compared. In addition, while the authors relied heavily on the documentation for proof of clinical assessments and treatment, the authors were able to observe that a large amount of clinical activity took place in an undocumented fashion also e.g., more frequent patient monitoring, counselling etc. This came to light during conversation with few residents who had participated in the study. This is the first step towards further improvement of the hospital case records. The study was not blinded for duration of professional experience i.e., more experienced care givers might have better unstructured notes. An important drawback of using a proforma is the increased time initially required for its proper completion because of the learning curve involved in such a change of practice.

PrasavRecord is a particularly useful simplified form of recording of the longitudinal progress from admission till discharge of the mother and newborn. The acceptance of this simple to use proforma among the resident doctors was high thereby confirming its utility.