A Model for Empowering Rural Solutions for Cervical Cancer Prevention (He Tapu Te Whare Tangata): Protocol for a Cluster Randomized Crossover Trial.

BACKGROUND: Maori are the Indigenous people of Aotearoa (New Zealand). Despite global acceptance that cervical cancer is almost entirely preventable through vaccination and screening, wahine Maori (Maori women) are more likely to have cervical cancer and 2.5 times more likely to die from it than non-Maori women. Rural Maori residents diagnosed with cervical cancer have worse outcomes than urban residents. Living in rural Aotearoa means experiencing barriers to appropriate and timely health care, resulting from distance, the lack of community resourcing, and low prioritization of rural needs by the health system and government. These barriers are compounded by the current screening processes and referral pathways that create delays at each step. Screening for high-risk human papillomavirus (hrHPV) and point-of-care (POC) testing are scientific advances used globally to prevent cervical cancer. OBJECTIVE: This study aims to compare acceptability, feasibility, timeliness, referral to, and attendance for colposcopy following hrHPV detection between a community-controlled pathway and standard care. METHODS: This is a cluster randomized crossover trial, with 2 primary care practices (study sites) as clusters. Each site was randomized to implement either pathway 1 or 2, with crossover occurring at 15 months. Pathway 1 (community-controlled pathway) comprises HPV self-testing, 1-hour POC results, face-to-face information, support, and immediate referral to colposcopy for women with a positive test result. Pathway 2 (standard care) comprises HPV self-testing, laboratory analysis, usual results giving, information, support, and standard referral pathways for women with a positive test result. The primary outcome is the proportion of women with hrHPV-positive results having a colposcopy within 20 working days of the HPV test (national performance indicator). Qualitative research will analyze successes and challenges of both pathways from the perspectives of governance groups, clinical staff, women, and their family. This information will directly inform the new National Cervical Screening Program. RESULTS: In the first 15-month period, 743 eligible HPV self-tests were performed: 370 in pathway 1 with POC testing and 373 in pathway 2 with laboratory testing. The positivity rate for hrHPV was 7.3% (54/743). Data collection for the second period, qualitative interviews, and analyses are ongoing. CONCLUSIONS: This Maori-centered study combines quantitative and qualitative research to compare 2 clinical pathways from detection of hrHPV to colposcopy. This protocol draws on rural community practices strengths, successfully engaging Maori from a whanau ora (family wellness) approach including kanohi ki te kanohi (face-to-face), kaiawhina (nonclinical community health workers), and multiple venues for interventions. It will inform the theory and practice of rural models of the use of innovative technology, addressing Maori cervical cancer inequities and facilitating Maori wellness. The findings are anticipated to be applicable to other Indigenous and rural people in high-income countries. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621000553875; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621000553875. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51643.

Examining the potential preventability of adverse fetal/neonatal outcomes associated with severe maternal morbidity.

BACKGROUND: Severe maternal morbidity (SMM) occurs in 1-2% of pregnancies. Despite the knowledge that a SMM event can contribute to poor fetal/neonatal outcomes, little is known about the preventability of these adverse outcomes. AIMS: To examine adverse fetal/neonatal outcomes associated with SMM to determine if these outcomes were potentially preventable. MATERIALS AND METHODS: A New Zealand national retrospective cohort study examining cases of SMM with an adverse fetal/neonatal outcome. Maternity and initial neonatal care were explored by multidisciplinary panels utilising a preventability tool to assess whether the fetal/neonatal harm was potentially preventable. Adverse fetal/neonatal outcomes were defined as fetal or early neonatal death, Apgar score <7 at five minutes, admission to neonatal intensive care unit or special care baby unit and neonatal encephalopathy. RESULTS: Of 85 cases reviewed, adverse fetal/neonatal outcome was deemed potentially preventable in 55.3% of cases (n = 47/85). Preventability was related to maternal antenatal/peripartum care (in utero) in 39% (n = 33/85), to initial neonatal care (ex utero) in 36% (n = 29/80), and to both maternal and neonatal care in 20% (16/80) of cases. Main contributors to potential preventability were factors related to healthcare providers, particularly lack of recognition of high risk, delayed or failure to diagnose, and delayed or inappropriate treatment. CONCLUSIONS: Multidisciplinary panels found that over half of adverse fetal/neonatal harm associated with SMM was potentially preventable. The novel approach of examining both maternal and neonatal care identifies opportunities to improve fetal/neonatal outcomes associated with SMM at multiple points on the perinatal continuum of care.

He Tapu Te Whare Tangata (sacred house of humanity): Under-screened Maori women talk about HPV self-testing cervical screening clinical pathways.

OBJECTIVE: To develop an in-depth understanding of HPV self-testing cervical screening clinical pathways for never-/under-screened Maori women. METHODS: Based on a community-based cluster randomized controlled trial in Aotearoa (New Zealand), a Kaupapa Maori (by Maori, for Maori) qualitative study enrolled Maori women who met the eligibility criteria of the HPV trial intervention (aged 25-69 years, no screen in >4 years). In total, 28 were recruited (22 had a negative test, six had a positive test and colposcopy). They were asked about their clinical pathway. RESULTS: The HPV self-test was seen as empowering and promoting bodily autonomy, although some women expressed fears or misconceptions about this new technology. While those with a negative test were relieved, for the six women who had a positive test, there were many fears, compounded by seeking out information on the Internet. When attending colposcopy, the importance of support and responsive care was emphasized. CONCLUSION: HPV self-testing has the potential to improve access to cervical screening and reduce inequities for Maori. Care must be taken in the delivery of screening and colposcopy results. Primary care and colposcopy services need to take special care with never-/under-screened Maori women to provide sensitive, responsive care, and mitigate trauma.

Reaching under-screened/never-screened indigenous peoples with human papilloma virus self-testing: A community-based cluster randomised controlled trial.

BACKGROUND: Indigenous women in the high-income countries of Canada, Australia, New Zealand and USA, have a higher incidence and mortality from cervical cancer than non-Indigenous women. Increasing cervical screening coverage could ultimately decrease cervical cancer disparities. AIMS: To increase cervical screening for under-screened/never-screened Maori women. MATERIALS AND METHODS: This study was a cluster randomised controlled trial. Inclusion criteria were women aged 25-69, last screened ≥4 years ago, in Northland, New Zealand. The intervention arm was the offer of a human papilloma virus (HPV) self-test and the control arm was the usual offer of standard care - a cervical smear. The primary outcome was rate of cervical screening in the intervention group compared to control in Maori, the Indigenous peoples of New Zealand. Six primary care clinics were randomly allocated to intervention or control. RESULTS: Of 500 eligible Maori women in the intervention arm, 295 (59.0%) were screened. Of 431 eligible Maori women in the control arm, 94 (21.8%) were screened. Adjusting for age, time since last screen, deprivation index, Maori women in the intervention arm were 2.8 times more likely to be screened than women in the control arm (95% CI: 2.4-3.1, P-value <0.0001). CONCLUSIONS: Offer of HPV self-testing could potentially halve the number of under-screened/never-screened Maori women and decrease cervical morbidity and mortality. These results may be generalisable to benefit Indigenous peoples facing similar barriers in other high-income countries.

Examining adverse fetal/neonatal outcomes associated with severe maternal morbidity.

BACKGROUND: While there is a global focus on severe maternal morbidity (SMM), less is known about the impact of SMM on fetal and neonatal outcomes. AIMS: To examine fetal/neonatal outcomes associated with SMM. MATERIALS AND METHODS: A national New Zealand (NZ) retrospective cohort study describing fetal/neonatal outcomes of all women with SMM admitted to a NZ Intensive Care Unit (ICU) or High Dependency Unit (HDU) in 2014. Adverse fetal/neonatal outcomes were defined as one or more of the following: fetal or early neonatal death, hypoxic ischaemic encephalopathy, Apgar score less than seven at five minutes, admission to Neonatal Intensive Care Unit or Special Care Baby Unit. RESULTS: There were 400 women with SMM admitted to NZ ICU/HDU units in 2014, and 395 (98.8%) had complete birth/pregnancy outcome information. Of these, 49.4% (195/395) were associated with an adverse fetal/neonatal outcome. Indigenous Maori women had a 30% higher rate of adverse fetal/neonatal outcome compared to NZ European women (63.7% and 48.9% respectively; relative risk = 1.30, 95% CI 1.04-1.64). Pre-eclampsia was associated with an adverse fetal/neonatal outcome in 67% (81/120). Perinatal-related mortality rate was 53.1 per 1000 total births compared to NZ perinatal mortality of 11.2 per 1000 total births for 2014. CONCLUSION: SMM events are associated with high rates of adverse fetal/neonatal outcomes with a higher burden of adverse events for Maori. Further research is needed to explore opportunities in maternal and neonatal care pathways to improve fetal/neonatal outcomes and address inequities.

Severe maternal morbidity due to obstetric haemorrhage: Potential preventability.

BACKGROUND: Haemorrhage in pregnancy may be life-threatening to woman and infant. The impact of severe obstetric haemorrhage can be reduced by detecting high-risk women, implementing guidelines and treatment plans, early detection of hypovolaemia and timely appropriate treatment. AIMS: To describe cases of severe maternal morbidity caused by obstetric haemorrhage in New Zealand and investigate the potential preventability of these cases. MATERIALS AND METHODS: A multidisciplinary expert review panel was established to review cases of obstetric haemorrhage admitted to intensive care or high-dependency units over an 18-month span in New Zealand. Cases were critically analysed by a multidisciplinary team of clinicians to determine the potential preventability. RESULTS: One hundred and twenty cases were identified, most commonly due to postpartum haemorrhage with 36% (n = 43) deemed potentially preventable, mainly due to delay or failure of diagnosis (65%, 28/43) and/or failure or delay in treatment (91%, 39/43). Twenty-three per cent of cases (28/120) resulted in peripartum hysterectomy of which one-third were deemed potentially preventable. CONCLUSIONS: Prompt recognition and treatment in accordance with evidence-based guidelines is imperative to decrease the burden of morbidity from obstetric haemorrhage. An emphasis on training clinicians to identify haemorrhage in a timely way may avoid unnecessary obstetric emergencies and can improve maternity and neonatal outcomes.

Pre-eclampsia causing severe maternal morbidity - A national retrospective review of preventability and opportunities for improved care.

INTRODUCTION: Pre-eclampsia and related sequelae are a leading cause of severe maternal and neonatal morbidity and mortality. A significant proportion of these poor outcomes may be preventable with improvements along the continuum of maternal and neonatal care. AIMS: The aim of this study was to review cases of pre-eclampsia resulting in severe maternal morbidity, describing the maternal and neonatal outcomes and the potential preventability of severe maternal morbidity (SMM). MATERIALS AND METHODS: This was a retrospective cohort study of cases of SMM associated with severe pre-eclampsia - a subset of a national SMM review study. Inclusion criteria for this subset were women who were pregnant or within 42 days of delivery with severe pre-eclampsia as the main reason for admission to an intensive care unit or high dependency unit in New Zealand between 1 August 2013 and 31 January 2015 inclusive. A multidisciplinary expert panel reviewed cases for preventability using a validated preventability tool. RESULTS: Of the 89 severe morbidities that were reviewed, 10 had eclampsia (11%) and there were four neonatal mortalities (4.3%). Multidisciplinary committees assessed the severe morbidity as potentially preventable in 31% (28) of cases with the majority due to delays in diagnosis and suboptimal treatment. CONCLUSION: We found a high level of preventable morbidity in cases of severe pre-eclampsia with a concerning number of preventable eclampsia. Implementation of evidence-based guidelines reinforced with education would assist clinicians to improve risk recognition, timely diagnosis and treatment and decrease potentially preventable severe morbidity associated with pre-eclampsia.

Establishment of a national severe maternal morbidity preventability review in New Zealand.

Severe maternal morbidity (SMM) review is an accepted quality measure to evaluate maternity care standards. Assessment of the potential preventability of SMM enables identification of factors and themes to inform clinical training and policy to improve maternal outcomes. The present report outlines the introduction of a national/regional external case review system using multidisciplinary panels to assess potential preventability of SMM, to assist other health jurisdictions to establish similar processes. Implementation steps are outlined including ethics, engagement with health services, recruitment and training of panel clinicians, identifying and preparing cases, and structuring meetings. More than 100 clinicians from all District Health Boards in New Zealand were recruited to form six panels. From August 2013, each panel met quarterly to review. By August 2015, 374 anonymized cases had been reviewed for potential preventability and practice improvement themes. This process established a quality monitoring tool to quantitate potential preventability of SMM, and identify practice and policy themes that can be reported locally and nationally for quality improvement. To our knowledge, this is the first national SMM preventability review using an internationally validated tool enabling intercountry comparisons. On the basis of this research, the New Zealand Ministry of Health funded the translation of the process to ongoing SMM national preventability review.

Preventability of severe acute maternal morbidity.

OBJECTIVE: We sought to assess potential preventability of severe acute maternal morbidity (SAMM) cases admitted to intensive-care units (ICUs) or high-dependency units (HDUs). STUDY DESIGN: Inclusion criteria were admissions to ICUs or HDUs of women who were pregnant or within 42 days of delivery in 4 District Health Board areas (accounting for a third of annual births in New Zealand) during a 17-month period. Cases were reviewed by external multidisciplinary panels using a validated model for assessing preventability. RESULTS: In all, 98 SAMM cases were assessed; 38 (38.8%) cases were deemed potentially preventable, 36 (36.7%) not preventable but improvement in care was needed, and 24 (24.5%) not preventable. The most frequent preventable factors were clinician related: delay or failure in diagnosis or recognition of high-risk status (51%); and delay or inappropriate treatment (70%). The most common causes of preventable severe morbidity were blood loss and septicemia. CONCLUSION: The majority of SAMM cases were potentially preventable or required improvement in care. Themes around substandard care related to delay in diagnosis and treatment for postpartum hemorrhage and septicemia. These findings can inform clinical educational programs and policies to improve maternal outcomes. This study has now been expanded to a national New Zealand audit of all SAMM cases admitted to an ICU/HDU.