Human resource challenges in health systems: evidence from ten African countries.

Sub-Saharan Africa has fewer medical workers per capita than any region of the world, and that shortage has been highlighted consistently as a critical constraint to improving health outcomes in the region. This paper draws on newly available, systematic, comparable data from ten countries in the region to explore the dimensions of this shortage. We find wide variation in human resources performance metrics, both within and across countries. Many facilities are barely staffed, and effective staffing levels fall further when adjusted for health worker absences. However, caseloads-while also varying widely within and across countries-are also low in many settings, suggesting that even within countries, deployment rather than shortages, together with barriers to demand, may be the principal challenges. Beyond raw numbers, we observe significant proportions of health workers with very low levels of clinical knowledge on standard maternal and child health conditions. This work demonstrates that countries may need to invest broadly in health workforce deployment, improvements in capacity and performance of the health workforce, and on addressing demand constraints, rather than focusing narrowly on increases in staffing numbers.

Assessment of the Interval to Diagnosis in Pediatric Bone Sarcoma.

OBJECTIVES: The timely diagnosis of primary bone malignancies in pediatric patients is critical to clinical outcomes. The purpose of this study is to investigate the initial presentation of pediatric bone sarcoma patients to an academic health care system and assess the current interval to diagnosis. METHODS: We conducted a retrospective review of pediatric patients (aged 1-18) with biopsy-proven diagnosis of osteosarcoma or Ewing sarcoma presenting between 2004 and 2020. All living patients had 1 year or more of follow-up. Primary outcomes were interval to diagnosis, clinical features on initial presentation, percent of patients with negative radiographic workup at initial presentation, and number of health care encounters before diagnosis. RESULTS: Seventy-one patients (osteosarcoma, 51; Ewing sarcoma, 20) were included. Average age at presentation was 13.1 ± 3.3 years (range, 4.4-18.3). Average symptom duration was 5.4 ± 13.9 months (range, 0.1-84). Clinical features at initial presentation included limb/back pain (91.5% of patients), activity modification/pain medication use (78.9%), palpable mass (40.8%), night pain (35.2%), limp (25.4%), limb disuse (18.3%), and recent fever history (2.8%). Fourteen of 71 patients (19.7%) had negative radiographs at initial presentation. Average number of health care encounters before diagnosis was 1.9 ± 0.6 (range, 1.0-4.0), with most in the outpatient pediatrician clinics (81.2%) and emergency department (18.3%). Average time to diagnosis from initial presentation was 19.5 ± 65 days (range, 0-493); the 14 patients with initial negative radiographs had a statistically significant prolonged interval to diagnosis of 54 ± 134 days (range, 0-493; P = 0.018). CONCLUSIONS: We found pediatric patients with primary bone sarcoma present with an average interval to diagnosis of 20 days. Twenty percent of patients had a significantly prolonged interval to diagnosis of 54 days. Clinical features suggest night pain is not a sensitive indicator. In patients of appropriate age with persistent unilateral pain in suspicious locations, early advanced imaging with magnetic resonance imaging should be considered.

ICD-10 codes do not accurately reflect ankle fracture injury patterns.

OBJECTIVE: To determine the accuracy of International Classification of Disease Version 10 (ICD-10) coding for ankle fracture injury patterns. DESIGN: Retrospective cohort study PATIENTS: 97 adult patients with fractures about the ankle (rotational ankle fracture or distal tibia fracture) from 2016 to 2020, selected by stratified random sampling. INTERVENTION: Assignment of an ICD-10 code representative of a rotational ankle fracture, pilon fracture, or unspecified fracture of the lower leg. OUTCOME MEASUREMENTS: Injury radiographs were reviewed by three authors to determine the correct code. Agreement between the correct code and the electronic medical record (EMR) assigned code was determined using kappa's statistic in the aggregate as well as percent agreement, sensitivity, specificity, and positive predictive value (PPV) between individual codes. RESULTS: 59 of 97 cases (60.8%) demonstrated discordance between the existing EMR and surgeon-assigned codes. Aggregate agreement between all codes was fair (K = 0.26). Lateral malleolus fracture codes demonstrated the highest PPV (0.91, 95% CI 0.72-0.99), while the lowest PPV was found for "other fractures of the lower leg" (0.05, 95% CI 0.0-0.24) and "other fracture of the fibula" (0.0, 95% CI 0.0-0.15). Generalized "other fracture" codes comprised 45% of EMR codes compared to only 6% of assigned codes (p < 0.001). EMR codes were specific but not sensitive. CONCLUSION: There is substantial discordance between existing EMR and surgeon-assigned ICD-10 codes for ankle fractures. Database research that relies on ICD-10 coding as a surrogate for primary clinical data should be interpreted with caution and institutions should make efforts to increase the accuracy of their coding.

Biomechanically superior treatments do not translate into improved outcomes in randomized controlled trials.

PURPOSE: Significant time and resources are devoted to conducting orthopaedic biomechanics research; however, it is not known how these studies relate to their subsequent clinical studies. The purpose of the present study was to determine whether biomechanically superior treatments were associated with improved clinical outcomes as determined by analogous randomized controlled trials (RCTs). METHODS: A systematic review was conducted to find RCTs that tested a research question based on a prior biomechanical study. PubMed and SCOPUS databases were queried for orthopaedic randomized controlled trials, and full text articles were reviewed to find RCTs which cited biomechanical studies with analogous comparison groups. A random-effects multi-level logistic regression model was conducted examining the association between RCT outcome and biomechanics outcome, adjusting for multiple outcomes nested within study. RESULTS: In total, 20,261 articles were reviewed yielding 21 RCTs citing a total of 43 analogous biomechanical studies. In 7 instances (16.2%), the RCT and a cited biomechanical study showed concordant results (i.e. the superior treatment in the RCT was also the superior construct in the biomechanical study). RCT outcome was not associated with biomechanical outcome (ß = -1.50, standard error = 0.78, p = .05). CONCLUSION: This study assessed 21 orthopaedic RCTs with 43 corresponding biomechanical studies and found no association between superior biomechanical properties of a given orthopaedic treatment and improved clinical outcomes. Favourable biomechanical properties alone should not be the primary reason for selecting one treatment over another. Furthermore, RCTs based on biomechanical studies should be carefully designed to maximize the chance of providing clinically relevant insights.

Outcome Measures of Medicare Patients With Diabetes Mellitus Undergoing Thoracolumbar Deformity Surgery.

STUDY DESIGN: This was a retrospective study. OBJECTIVE: The objective of this study was to identify the impact of diabetes on postoperative outcomes in Medicare patients undergoing adult spinal deformity (ASD) surgery. METHODS: We queried the MarketScan Medicare database to identify patients who underwent ASD surgery from 2007 to 2016. Patients were then stratified based on diabetes status at the time of the index operation. Patients not enrolled in the Medicare dataset and those with any prior history of trauma or tumor were excluded from this study. RESULTS: A total of 2564 patients met the inclusion criteria of this study, of which n=746 (29.1.%) were diabetic. Patients with diabetes had a higher rate of postoperative infection than nondiabetic patients (3.1% vs. 1.7%, P<0.05) within 90 days. Renal complications were also more elevated in the diabetic cohort (3.2% vs. 1.3%, P<0.05). Readmission rates were significantly higher in the diabetes cohort through of 60 days (15.2% vs. 11.8%, P<0.05) and 90 days (17.0% vs. 13.4%, P<0.05). When looking specifically at the outpatient payments, patients with diabetes did have a higher financial burden at 60 days ($8147 vs. $6956, P<0.05) and 90 days ($10,126 vs. $8376, P<0.05). CONCLUSIONS: In this study, diabetic patients who underwent ASD surgery had elevated rates of postoperative infection, outpatient costs, and rates of readmissions within 90 days. Further research should investigate the role of poor glycemic control on spine surgery outcomes.

Operationalizing respectful maternity care at the healthcare provider level: a systematic scoping review.

BACKGROUND: Ensuring the right to respectful care for maternal and newborn health, a critical dimension of quality and acceptability, requires meeting standards for Respectful Maternity Care (RMC). Absence of mistreatment does not constitute RMC. Evidence generation to inform definitional standards for RMC is in an early stage. The aim of this systematic review is clear provider-level operationalization of key RMC principles, to facilitate their consistent implementation. METHODS: Two rights-based frameworks define the underlying principles of RMC. A qualitative synthesis of both frameworks resulted in seven fundamental rights during childbirth that form the foundation of RMC. To codify operational definitions for these key elements of RMC at the healthcare provider level, we systematically reviewed peer-reviewed literature, grey literature, white papers, and seminal documents on RMC. We focused on literature describing RMC in the affirmative rather than mistreatment experienced by women during childbirth, and operationalized RMC by describing objective provider-level behaviors. RESULTS: Through a systematic review, 514 records (peer-reviewed articles, reports, and guidelines) were assessed to identify operational definitions of RMC grounded in those rights. After screening and review, 54 records were included in the qualitative synthesis and mapped to the seven RMC rights. The majority of articles provided guidance on operationalization of rights to freedom from harm and ill treatment; dignity and respect; information and informed consent; privacy and confidentiality; and timely healthcare. Only a quarter of articles mentioned concrete or affirmative actions to operationalize the right to non-discrimination, equality and equitable care; less than 15%, the right to liberty and freedom from coercion. Provider behaviors mentioned in the literature aligned overall with seven RMC principles; yet the smaller number of available research studies that included operationalized definitions for some key elements of RMC illustrates the nascent stage of evidence-generation in this area. CONCLUSIONS: Lack of systematic codification, grounded in empirical evidence, of operational definitions for RMC at the provider level has limited the study, design, implementation, and comparative assessment of respectful care. This qualitative systematic review provides a foundation for maternity healthcare professional policy, training, programming, research, and program evaluation aimed at studying and improving RMC at the provider level.

Respectful care for mothers and newborns is a right and important part of ensuring that their care is high quality and acceptable to them. Just because there is no mistreatment does not mean that Respectful Maternity Care (RMC) was given. Without a clear framework for provider behaviors that reflect RMC principles, it is hard to ensure every woman and newborn gets respectful care in practice. We compared and combined two frameworks summarizing maternal and newborn rights and came out with seven categories. Then we searched for articles that mentioned provider behaviors reflecting RMC. We found 514 articles and ended up with 54 after careful review, from which we pulled the observable behaviors for providers in each category. Almost all papers mentioned actions to protect women and newborns from harm and mistreatment, to treat them with dignity and respect, and to give information and respect choices. About half of papers mentioned actions to protect privacy and to make sure every mother and newborn gets care when needed. Only 25% of papers mentioned actions to make sure all women and newborns receive equal care, and only 15% included actions to make sure women and newborns are physically free to leave facilities at will, and get care whether or not they can pay. This framework defining RMC behaviors for providers is based on data from many studies and can be useful to look at whether maternal newborn care in facilities meets these standards and to inform training and more research to improve RMC.

Women's report of mistreatment during facility-based childbirth: validity and reliability of community survey measures.

BACKGROUND: Accountability for mistreatment during facility-based childbirth requires valid tools to measure and compare birth experiences. We analyse the WHO 'How women are treated during facility-based childbirth' community survey to test whether items mapping the typology of mistreatment function as scales and to create brief item sets to capture mistreatment by domain. METHODS: The cross-sectional community survey was conducted at up to 8 weeks post partum among women giving birth at hospitals in Ghana, Guinea, Myanmar and Nigeria. The survey contained items assessing physical abuse, verbal abuse, stigma, failure to meet professional standards, poor rapport with healthcare workers, and health system conditions and constraints. For all domains except stigma, we applied item-response theory to assess item fit and correlation within domain. We tested shortened sets of survey items for sensitivity in detecting mistreatment by domain. Where items show concordance and scale reliability ≥0.60, we assessed convergent validity with dissatisfaction with care and agreement of scale scores between brief and full versions. RESULTS: 2672 women answered over 70 items on mistreatment during childbirth. Reliability exceeded 0.60 in all countries for items on poor rapport with healthcare workers and in three countries for items on failure to meet professional standards; brief scales generally showed high agreement with longer versions and correlation with dissatisfaction. Brief item sets were ≥85% sensitive in detecting mistreatment in each country, over 90% for domains of physical abuse and health system conditions and constraints. CONCLUSION: Brief scales to measure two domains of mistreatment are largely comparable with longer versions and can be informative for these four distinct settings. Brief item sets efficiently captured prevalence of mistreatment in the five domains analysed; stigma items can be used and adapted in full. Item sets are suitable for confirmation by context and implementation to increase accountability and inform efforts to eliminate mistreatment during childbirth.

Anterior Cervical Discectomy and Fusion Versus Laminoplasty for Multilevel Cervical Spondylotic Myelopathy: A National Administrative Database Analysis.

BACKGROUND: Anterior cervical discectomy and fusion (ACDF) is effective for the treatment of single-level cervical spondylotic myelopathy (CSM). However, the data surrounding multilevel CSM have remained controversial. One alternative is laminoplasty, although evidence comparing these strategies has remained sparse. In the present report, we retrospectively reviewed the readmission and reoperation rates for patients who had undergone ACDF or laminoplasty for multilevel CSM from a national longitudinal administrative claims database. METHODS: We queried the MarketScan Commercial Claims and Encounters database to identify patients who had undergone ACDF or laminoplasty for multilevel CSM from 2007 to 2016. The patients were stratified by operation type. Patients aged <18 years, patients with a history of tumor or trauma, and patients who had undergone anteroposterior approach were excluded from the present study. RESULTS: A total of 5445 patients were included, of whom 1521 had undergone laminoplasty. A matched cohort who had undergone ACDF was identified. The overall 90-day postoperative complication rate was greater in the laminoplasty cohort (odds ratio, 1.48; 95% confidence interval, 1.18-1.86; P < 0.0001). The mean length of stay and 90-day readmission rates were greater in the laminoplasty cohort. The hospital and total payments of the index hospitalization were greater in the ACDF cohort, as were the total payments for ≤2 years after the index hospitalization. CONCLUSIONS: In the present administrative claims database study, no difference was found in the reoperation rate between ACDF and laminoplasty. ACDF resulted in fewer complications and readmissions compared with laminoplasty but was associated with greater costs. Additional prospective research is required to investigate the factors driving the higher costs of ACDF in this population and the long-term clinical outcomes.

Changes in Pediatric Sports Injury Presentation During the COVID-19 Pandemic: A Multicenter Analysis.

BACKGROUND: The current coronavirus 2019 (COVID-19) pandemic has prompted a multitude of public health response measures including social distancing, school cancellations, and cessation of organized sports. PURPOSE: To examine the impact of COVID-19 and corresponding public health measures on the characteristics of common pediatric musculoskeletal injuries associated with sports. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: This was a multicenter retrospective cohort study comparing patients with sports injuries presenting to 3 geographically diverse level I pediatric trauma hospitals and outpatient orthopaedic surgery clinics in the United States during the COVID-19 pandemic and a prepandemic period at the same institutions. Patients were included if they presented for care between February 15 and July 15 in 2020 (pandemic cohort) or between March 15 and April 15 in 2018 and 2019 (prepandemic cohort). RESULTS: Included were 1455 patients with an average age of 12.1 ± 4.5 years. When comparing patients presenting in 2018 and 2019 with those presenting in 2020, we observed a decrease in mean age during the pandemic (12.6 ± 4.0 vs 11.0 ± 5.2 years; P = .048). Additionally, a decrease in the proportion of injuries attributed to sports (48.8% vs 33.3%; P < .001) and those occurring at school (11.9% vs 4.0%; P = .001) was observed. The proportion of injuries attributable to clavicle fractures increased during the early stages of the pandemic (13.2% vs 34.7%; P < .001). There was no statistically significant delay to care in injuries presenting during the pandemic (41.5 ± 141.2 vs 19.23 ± 79.1 days; P = .175). CONCLUSION: Across 3 tertiary care institutions, patients were seen without significant delay during the pandemic. We observed a significant decline in pediatric musculoskeletal injuries associated with sports during the COVID-19 pandemic. This decrease has been accompanied by a shift in both injury type and mechanism.

Tumor metabolism and neurocognition in CNS lymphoma.

BACKGROUND: The mechanistic basis for neurocognitive deficits in central nervous system (CNS) lymphoma and other brain tumors is incompletely understood. We tested the hypothesis that tumor metabolism impairs neurotransmitter pathways and neurocognitive function. METHODS: We performed serial cerebrospinal fluid (CSF) metabolomic analyses using liquid chromatography-electrospray tandem mass spectrometry to evaluate changes in the tumor microenvironment in 14 patients with recurrent CNS lymphoma, focusing on 18 metabolites involved in neurotransmission and bioenergetics. These were paired with serial mini-mental state examination (MMSE) and MRI studies for tumor volumetric analyses. Patients were analyzed in the setting of the phase I trial of lenalidomide/rituximab. Associations were assessed by Pearson and Spearman correlation coefficient. Generalized estimating equation (GEE) models were also established, adjusting for within-subject repeated measures. RESULTS: Of 18 metabolites, elevated CSF lactate correlated most strongly with lower MMSE score (P < 8E-8, ρ = -0.67). High lactate was associated with lower gamma-aminobutyric acid (GABA), higher glutamate/GABA ratio, and dopamine. Conversely, high succinate correlated with higher MMSE scores. Serial analysis demonstrated a reproducible, time-dependent, reciprocal correlation between changes in lactate and GABA concentrations. While high lactate and low GABA correlated with tumor contrast-enhancing volume, they correlated more significantly with lower MMSE scores than tumor volumes. CONCLUSIONS: We provide evidence that lactate production and Warburg metabolism may impact neurotransmitter dysregulation and neurocognition in CNS lymphomas. We identify novel metabolomic biomarkers that may be applied in future studies of neurocognition in CNS lymphomas. Elucidation of mechanistic interactions between lymphoma metabolism, neurotransmitter imbalance, and neurocognition may promote interventions that preserve cognitive function.

Measuring experiences of facility-based care for pregnant women and newborns: a scoping review.

BACKGROUND: Access to high-quality, person-centred care during pregnancy and childbirth is a global priority. Positive experience of care is key in particular, because it is both a fundamental right and can influence health outcomes and future healthcare utilisation. Despite its importance for accountability and action, systematic guidance on measuring experience of care is limited. METHODS: We conducted a scoping review of published literature to identify measures/instruments for experience of facility-based pregnancy and childbirth (abortion, antenatal, intrapartum, postnatal and newborn) care. We systematically searched five bibliographic databases from 1 January 2007 through 1 February 2019. Using a predefined evidence template, we extracted data on study design, data collection method, study population and care type as reported in primary quantitative articles. We report results narratively. RESULTS: We retrieved 16 528 unique citations, including 171 eligible articles representing, 157 unique instruments and 144 unique parent instruments across 56 countries. Half of the articles (90/171) did not use a validated instrument. While 82% (n=141) of articles reported on labour and childbirth care, only one reported on early pregnancy/abortion care. The most commonly reported sub-domains of user experience were communication (84%, 132/157) and respect and dignity (71%, 111/157). The primary purpose of most papers was measurement (70%, 119/171), largely through cross-sectional surveys. CONCLUSION: There are alarming gaps in measurement of user experience for abortion, antenatal, postnatal and newborn care, including lack of validated instruments to measure the effects of interventions and policies on user experience. PROTOCOL REGISTRATION DETAILS: This review was registered and published on PROSPERO (CRD42017070867). PROSPERO is an international database of prospectively registered systematic reviews in health and social care.

When the patient is the expert: measuring patient experience and satisfaction with care.

In 2018, three independent reports were published, emphasizing the need for attention to, and improvements in, quality of care to achieve effective universal health coverage. A key aspect of high quality health care and health systems is that they are person-centred, a characteristic that is at the same time intrinsically important (all individuals have the right to be treated with dignity and respect) and instrumentally important (person-centred care is associated with improved health-care utilization and health outcomes). Following calls to make 2019 a year of action, we provide guidance to policy-makers, researchers and implementers on how they can take on the task of measuring person-centred care. Theoretically, measures of person-centred care allow quality improvement efforts to be evaluated and ensure that health systems are accountable to those they aim to serve. However, in practice, the utility of these measures is limited by lack of clarity and precision in designing and by using measures for different aspects of person-centeredness. We discuss the distinction between two broad categories of measures of patient-centred care: patient experience and patient satisfaction. We frame our discussion of these measures around three key questions: (i) how will the results of this measure be used?; (ii) how will patient subjectivity be accounted for?; and (iii) is this measure validated or tested? By addressing these issues during the design phase, researchers will increase the usability of their measures.

En 2018, la publication de trois rapports indépendants soulignait la nécessité de prêter attention à la qualité des soins et de l'améliorer pour parvenir à une réelle couverture sanitaire universelle. L'un des aspects clés de la qualité des soins et des systèmes de santé est qu'ils soient centrés sur la personne, caractéristique qui revêt une importance à la fois intrinsèque (toutes les personnes ont le droit d'être traitées avec dignité et respect) et pratique (des soins centrés sur la personne sont associés à un plus grand recours aux soins et à de meilleurs résultats). Suite aux appels à l'action pour 2019, nous donnons des indications aux responsables politiques, aux chercheurs et aux personnes chargées de la mise en œuvre quant à la manière dont ils peuvent entreprendre de mesurer les soins centrés sur la personne. Théoriquement, les mesures des soins centrés sur la personne permettent d'évaluer les efforts visant à améliorer la qualité et garantissent la responsabilité des systèmes de santé vis-à-vis des patients. Or, dans la pratique, l'utilité de ces mesures est limitée par le manque de clarté et de précision de leur conception et par leur utilisation pour différents aspects de l'approche centrée sur la personne. Nous abordons ici la distinction entre deux grandes catégories de mesures des soins centrés sur le patient: l'expérience du patient et la satisfaction du patient. Notre discussion concernant ces mesures s'inscrit autour de trois questions clés: (i) comment les résultats de cette mesure seront-ils utilisés?; (ii) comment la subjectivité du patient sera-t-elle prise en compte?; (iii) cette mesure a-t-elle été validée ou testée? La prise en compte de ces points durant la phase de conception permettra aux chercheurs d'améliorer l'utilité de leurs mesures.

Se publicaron tres informes independientes en 2018, en los que se hacía hincapié en la necesidad de prestar atención a la calidad de la atención sanitaria y de mejorarla para lograr una cobertura sanitaria universal eficaz. Un aspecto fundamental de la atención sanitaria y los sistemas de salud de alta calidad es que están centrados en las personas, una característica que es al mismo tiempo intrínsecamente importante (todas las personas tienen derecho a ser tratadas con dignidad y respeto) e instrumentalmente importante (la atención centrada en las personas se asocia a una mejor utilización de la atención sanitaria y a mejores resultados en materia de salud). Tras los llamados para que el año 2019 sea un año de acción, proporcionamos orientación a los responsables de la formulación de políticas, investigadores y ejecutores sobre cómo pueden asumir la tarea de medir la atención centrada en las personas. Teóricamente, las medidas de atención centrada en la persona permiten evaluar los esfuerzos de mejora de la calidad y garantizar que los sistemas de salud rindan cuentas a aquellos a los que pretenden servir. Sin embargo, en la práctica, la utilidad de estas medidas se ve limitada por la falta de claridad y precisión en el diseño y el uso de medidas para diferentes aspectos de la atención centrada en la persona. Discutimos la distinción entre dos amplias categorías de medidas de atención centrada en el paciente: la experiencia del paciente y la satisfacción del paciente. Enmarcamos nuestro debate sobre estas medidas en torno a tres cuestiones clave: (i) ¿cómo se utilizarán los resultados de esta medida?; (ii) ¿cómo se contabilizará la subjetividad del paciente? y (iii) ¿se valida o se prueba esta medida? Al abordar estas cuestiones durante la fase de diseño, los investigadores aumentarán la utilidad de sus medidas.

Measuring quality of care for all women and newborns: how do we know if we are doing it right? A review of facility assessment tools.

BACKGROUND: Ensuring quality of care during pregnancy and childbirth is crucial to improving health outcomes and reducing preventable mortality and morbidity among women and their newborns. In this pursuit, WHO developed a framework and standards, defining 31 quality statements and 352 quality measures to assess and improve quality of maternal and newborn care in health-care facilities. We aimed to assess the capacity of globally used, large-scale facility assessment tools to measure quality of maternal and newborn care as per the WHO framework. METHODS: We identified assessment tools through a purposive sample that met the following inclusion criteria: multicountry, facility-level, major focus on maternal and newborn health, data on input and process indicators, used between 2007 and 2017, and currently in use. We matched questions in the tools with 274 quality measures associated with inputs and processes within the WHO standards. We excluded quality measures relating to outcomes because these are not routinely measured by many assessment tools. We used descriptive statistics to calculate how many quality measures could be assessed using each of the tools under review. Each tool was assigned a 1 for fulfilling a quality measure based on the presence of any or all components as indicated in the standards. FINDINGS: Five surveys met our inclusion criteria: the Service Provision Assessment (SPA), developed for the Demographic and Health Surveys programme; the Service Availability and Readiness Assessment, developed by WHO; the Needs Assessment of Emergency Obstetric and Newborn Care developed by the Averting Maternal Death and Disability programme at Columbia University; and the World Bank's Service Delivery Indicator (SDI) and Impact Evaluation Toolkit for Results Based Financing in Health. The proportion of quality measures covered ranged from 62% for the SPA to 12% for the SDI. Although the broadest tool addressed parts of each of the 31 quality statements, 68 (25%) of 274 input and process quality measures were not measured at all. Measures of health information systems and patient experience of care were least likely to be included. INTERPRETATION: Existing facility assessment tools provide a valuable way to assess quality of maternal and newborn care as one element within the national measurement toolkit. Guidance is clearly needed on priority measures and for better harmonisation across tools to reduce measurement burden and increase data use for quality improvement. Targeted development of measurement modules to address important gaps is a key priority for research. FUNDING: None.

Does the safe childbirth checklist (SCC) program save newborn lives? Evidence from a realistic quasi-experimental study, Rajasthan, India.

BACKGROUND: The WHO Safe Childbirth Checklist (SCC) is a facility-based reminder tool focusing on essential care to improve quality of intrapartum care. We aimed to assess the impact of an intervention package using the SCC tool on facility-based stillbirths (SBs) and very early neonatal deaths (vENDs), in Rajasthan, India. METHODS: Within a quasi-experimental framework, districts were selected as intervention or comparison, matched by annual delivery load. The SCC tool was introduced at all district and sub-district level health facilities in the seven intervention districts, followed by monthly supportive supervision visits. In addition, supply of drugs and equipment were facilitated in all facilities (2013-2015). Facilities in the comparison districts provided routine care. Analysis included only the facilities with a specialized newborn care unit and information on all births was collected from facility registers. The primary outcome was the combined facility-based stillbirths and very early neonatal deaths (within 3-days after birth). We used generalized estimating equation with a Poisson regression model, with time as a linear term and adjusted for facility type in our model to estimate the effect of the intervention. [ClinicalTrials.gov: NCT01994304]. RESULTS: 77,239 births were recorded from 19 intervention facilities and 59,800 births from 15 comparison facilities. The intervention facilities reported 1621 stillbirths and 505 vENDs compared to 1390 stillbirths and 420 vENDs from the comparison facilities (RR 0.89, CI 0.81, 0.97). This translated to 11.16% (p = 0.01) reduction in total mortality (11.39% in stillbirths alone) in the intervention facilities. CONCLUSION: Our results suggest that the SCC program is an effective intervention that could potentially avert 40,000 intrapartum deaths in India annually, most of reduction coming from prevention of stillbirths.

Phase 1 investigation of lenalidomide/rituximab plus outcomes of lenalidomide maintenance in relapsed CNS lymphoma.

There is an unmet need for effective biological therapies for relapsed central nervous system (CNS) lymphoma. Lenalidomide is active in activated B-cell type diffuse large B-cell lymphoma and rituximab is effective in CNS lymphoma. These observations are the basis for this first trial of an immunomodulatory drug as monotherapy in CNS lymphoma, and, in patients with inadequate responses to lenalidomide, with rituximab. In an independent cohort, we evaluated lenalidomide maintenance after salvage with high-dose methotrexate or focal irradiation in relapsed primary CNS lymphoma (PCNSL). We determined safety, efficacy, and cerebrospinal fluid (CSF) penetration of lenalidomide at 10-, 15-, and 20-mg dose levels in 14 patients with refractory CD20+ CNS lymphoma. Nine subjects with relapsed, refractory CNS lymphoma achieved better than partial response with lenalidomide monotherapy, 6 maintained response ≥9 months, and 4 maintained response ≥18 months. Median progression-free survival for lenalidomide/rituximab was 6 months. In the independent cohort, response duration with lenalidomide maintenance after complete responses 2 through 5 were significantly longer than response durations after standard therapy. The CSF/plasma partition coefficient of lenalidomide was ≥20% at 15- and 20-mg dose levels. Change in CSF interleukin-10 at 1 month correlated with clinical response and response duration to lenalidomide. Metabolomic profiling of CSF identified novel biomarkers, including lactate, and implicated indoleamine-2,3 dioxygenase activity with CNS lymphoma progression on lenalidomide. We conclude that lenalidomide penetrates ventricular CSF and is active as monotherapy in relapsed CNS lymphomas. We provide evidence that maintenance lenalidomide potentiates response duration after salvage in relapsed PCNSL and delays whole brain radiotherapy (WBRT). This trial was registered at www.clinicaltrials.gov as #NCT01542918.

Can India's primary care facilities deliver? A cross-sectional assessment of the Indian public health system's capacity for basic delivery and newborn services.

OBJECTIVES: To assess input and process capacity for basic delivery and newborn (intrapartum care hereafter) care in the Indian public health system and to describe differences in facility capacity between rural and urban areas and across states. DESIGN: Cross-sectional study. SETTING: Data from the nationally representative 2012-2014 District Level Household and Facility Survey, which includes a census of community health centres (CHC) and sample of primary health centres (PHC) across 30 states and union territories in India. PARTICIPANTS: 8536 PHCs and 4810 CHCs. OUTCOME MEASURES: We developed a summative index of 33 structural and process capacity items matching the Indian Public Health Standards for PHCs as a metric of minimum facility capacity for intrapartum care. We assessed differences in performance on this index across facility type and location. RESULTS: About 30% of PHCs and 5% of CHCs reported not offering any intrapartum care. Among those offering services, volumes were low: median monthly delivery volume was 8 (IQR=13) in PHCs and 41 (IQR=73) in CHCs. Both PHCs and CHCs failed to meet the national standards for basic intrapartum care capacity. Mean facility capacity was low in PHCs in both urban (0.64) and rural (0.63) areas, while in CHCs, capacity was slightly higher in urban areas (0.77vs0.74). Gaps were most striking in availability of skilled human resources and emergency obstetric services. Poor capacity facilities were more concentrated in the more impoverished states, with 37% of districts from these states receiving scores in the lowest third of the facility capacity index (<0.70), compared with 21% of districts otherwise. CONCLUSIONS: Basic intrapartum care capacity in Indian public primary care facilities is weak in both rural and urban areas, especially lacking in the poorest states with worst health outcomes. Improving maternal and newborn health outcomes will require focused attention to quality measurement, accountability mechanisms and quality improvement. Policies to address deficits in skilled providers and emergency service availability are urgently required.

Effectiveness of a WHO Safe Childbirth Checklist Coaching-based intervention on the availability of Essential Birth Supplies in Uttar Pradesh, India.

OBJECTIVE: Evaluate the impact of a World Health Organization Safe Childbirth Checklist coaching-based intervention (BetterBirth Program) on availability and procurement of essential childbirth-related supplies. DESIGN: Matched pair, cluster-randomized controlled trial. SETTING: Uttar Pradesh, India. PARTICIPANTS: 120 government-sector health facilities (60 interventions, 60 controls). Supply-availability surveys were conducted quarterly in all sites. Coaches collected supply procurement sources from intervention sites. INTERVENTIONS: Coaching targeting implementation of Checklist with data feedback and action planning. MAIN OUTCOME MEASURES: Mean supply availability by study arm; change in procurement sources for intervention sites. RESULTS: At baseline, 6 and 12 months, the intervention sites had a mean of 20.9 (95% confidence interval (CI): 20.2-21.5); 22.4 (95% CI: 21.8-22.9) and 22.1 (95% CI:21.4-22.8) items, respectively. Control sites had 20.8 (95% CI: 20.3-21.3); 20.9 (95% CI: 20.3-21.5) and 21.7 (95% CI: 20.8-22.6) items at the same time-points. There was a small but statistically significant higher availability in intervention sites at 6 months (difference-in-difference (DID) = 1.43, P < 0.001), which was not seen by 12 months (DID = 0.37, P = 0.53). Greater difference between intervention and control sites starting in the bottom quartile of supply availability was seen at 6 months (DID = 4.0, P = 0.0002), with no significant difference by 12 months (DID = 1.5, P = 0.154). No change was seen in procurement sources with ~5% procured by patients with some rates as high as 29% (oxytocin). CONCLUSIONS: Implementation of the BetterBirth Program, incorporating supply availability, resulted in modest improvements with catch-up by control facilities by 12 months. Supply-chain coaching may be most beneficial in sites starting with lower supply availability. Efforts are needed to reduce reliance on patient-funding for some critical medications. TRIAL REGISTRATION: ClinicalTrials.gov #NCT02148952; Universal Trial Number: U1111-1131-5647.