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In this thesis, we find that CQI including FBOS HBB simulation training was associated with improved perinatal survival over the period of six years. When evaluating potential effects of the FBOS HBB training, we documented that basic clinical practice, in particular resuscitating asphyxiated newborns improved. Birth asphyxia is the leading cause of perinatal mortality in this study setting [35]. During the CQI period, in 2013, the Safer Births research and innovation project was initiated. This project included some clinical RCTs to test novel equipment, focusing on improving FHR monitoring and BMV resuscitation [177,184]. These RCTs research projects could have influenced perinatal outcomes during parts of the six-year CQI study period, since fetuses with abnormal FHR are at high risk for negative birth outcomes due to asphyxia. Having a device that could easily detect abnormal FHR increased the chances for timely intervention [184]. Likewise, introducing a better tool to ventilate non-breathing newborns had the potential to reduce mortality due to birth asphyxia [177]. However, the findings from these RCTs did not demonstrate significant differences or improvement in perinatal outcomes. FBOS HBB simulation training, as part of CQI was the only potential intervention to improve clinical skills through the six years follow up period and we associate with improvement in perinatal survival that we observed.

5.1.1 Study I

FBOS HBB simulation training was evaluated for a one-year period following implementation. There was a substantial reduction in 24 hours newborn mortality by 39% compared to baseline [185], almost similar to what was found by Msemo et al. [159]. This powerful

General discussion

observation is the first time that FBOS (LDHF) was shown to reduce neonatal mortality. LDHF training has also been useful in other settings [201-203]. After implementation of FBOS HBB training, there was a substantial increase in the number of newborns being stimulated and suctioned, with a concomitant decrease in newborns who received BMV. We speculate that the described changes in implementation decrease use of BMV was due to increased competence among the midwives and timely management of newborns requiring some breathing support i.e. stimulation which helped to initiate spontaneous breathing. These finding are akin to those reported by Msemo et al [159]. More frequent practice of early appropriate stimulation and/or suction likely resulted in fewer cases requiring BMV. For the asphyxiated newborn who received BMV, the mortality decreased from 12.6% during baseline to 8.8% during FBOS HBB training. An improvement in BMV technique may have caused this reduction in mortality. Kc et al [190] reported a reduction in perinatal mortality following improvement in BMV practice. During the period with FBOS HBB training we observed an increased number of midwives involved in resuscitation from 72.8% during baseline to 77.5%, while involvement of operating room nurses decreased from 8.5% to 5.3%

and involvement of doctors from 7.4% to 4.0%. We associate the increased involvement of midwives in resuscitation to reflect an improved ability and confidence resulting from FBOS HBB training.

We speculate that increased competence, knowledge, skills and confidence, gained through FBOS training, are the reasons for the documented changes in clinical practice. Subsequent studies by Gomez et al [191] and Drake et al [192] also found that frequent HBB training reduced perinatal mortality. These findings further support our assumption that FBOS HBB training was the driving force for improved clinical skills and improved 24 hours newborn survival.

General discussion

5.1.2 Study II

Perinatal survival on monthly intervals through the study period was plotted using statistical process control (SPC) methods. Mukhtar-Vola et al [193] also used SPC in a low-resource setting. SPC has been useful in assessing processes where a trend (outcome) can be matched with different events taking place during the time-period to predict potential relationships [53]. In Study II, our evaluation included introduction and continuation of the CQI FBOS HBB training program, and other relevant interventions and events were noted in the CUSUM chart. Additionally, administrative actions with potential to influence perinatal outcomes were included. For example, midwives who were already experienced in FBOS HBB training were regularly replaced with midwives who had not been part of FBOS HBB training, and the promotion of HLH to become a referral level hospital. The CUSUM and VLAD charts illustrated continuous improvement of perinatal survival through the period with minimal variation at some time-period.

Transient reduction in newborn survival matched the dropout periods of midwives skilled through FBOS training. However, the SPC charts revealed improvement in survival again after a few months. We associate this improvement in newborn survival with the new midwives becoming skilled in HBB following their participation in ongoing FBOS HBB training. The concordances between the documented SPC trends and different events with potential to influence perinatal outcome, shows the relevance of SPC in evaluating healthcare services.

Additionally, the matching between FBOS HBB training related events (positive and negative) and changes in perinatal survival (in the CUSUM chart, Figure 9) reveals the critical potential of FBOS HBB training in improving perinatal survival. Study II lasted for a long period (5 years), and a continuous improvement in perinatal survival, compared to baseline was observed. We speculate that the CQI FBOS HBB training program was also responsible for sustaining improved

General discussion

clinical practice, which has been reported to be among the main challenges in HBB training [194,195].

5.1.3. Study III

We observed that after patient-risk adjustment, the SPC models revealed a further improvement in perinatal survival compared to before risk adjustment, in spite of an increased number of high-risk patients overtime. Using methods that account for the level of risks in a cohort, when evaluating an impact over time, has been applied in other settings and found to be valuable [196-198]. Risk factors that were not associated with clinical management were included in the model; i.e.

perinatal and maternal characteristics and risk factors like birth weight, pregnancy complication, and abnormal FHR. The increase in patients with higher risk was observed particularly during the last three years of the study. Abnormal FHR and not measured FHR were the most significant risks found, which is similar to what has been previously reported by Ersdal et al from the same clinical setting [199]. We observed that the increase in cases with abnormal and not measured FHR were associated with the introduction of ambulance (2013) and hospital delivery (2014) fees, and thus late hospital arrivals. Our catchment population is of low socio-economic status and introducing the fees could have resulted in more women giving birth at home and only attending HLH late when in complicated labor. Sialubanje et al [200] reported in a study done in Zambia that high cost for hospitalization was a reason for home deliveries. During the study period, we observed a reduction in number of women delivery at HLH from > 4300 during the years 2010-2013 to < 3750 between 2014-2017.

There was also an increase in complicated labor cases and the CS rate increased from 15% prior to 2012 to 21% after 2013. The VLAD plot revealed a total of 150 extra-averted perinatal deaths over the period of six years before adjusting for risk factors. After adjusting for the patient

General discussion

addition of 100 lives saved compared to before risk adjustment. The finding was surprising and interesting, illustrating that in spite of increased cases with high risks, improved survival was maintained. If the patient risks had been constant over the study period, perinatal survival might have been even greater than what was actually observed.

We speculate that the reduction in perinatal mortality observed in all three studies was due to improved birth attendant resuscitation practice (behavior) resulting from the CQI FBOS HBB simulation-training program. The observed change in behavior, i.e. improved clinical management, is most likely predominant cause of the beneficial perinatal outcome (increased survival).

5.2 Implementation of CQI efforts including