Quality of routine health data at the onset of the COVID-19 pandemic in Ethiopia, Haiti, Laos, Nepal, and South Africa.

BACKGROUND: During the COVID-19 pandemic, governments and researchers have used routine health data to estimate potential declines in the delivery and uptake of essential health services. This research relies on the data being high quality and, crucially, on the data quality not changing because of the pandemic. In this paper, we investigated those assumptions and assessed data quality before and during COVID-19. METHODS: We obtained routine health data from the DHIS2 platforms in Ethiopia, Haiti, Lao People's Democratic Republic, Nepal, and South Africa (KwaZulu-Natal province) for a range of 40 indicators on essential health services and institutional deaths. We extracted data over 24 months (January 2019-December 2020) including pre-pandemic data and the first 9 months of the pandemic. We assessed four dimensions of data quality: reporting completeness, presence of outliers, internal consistency, and external consistency. RESULTS: We found high reporting completeness across countries and services and few declines in reporting at the onset of the pandemic. Positive outliers represented fewer than 1% of facility-month observations across services. Assessment of internal consistency across vaccine indicators found similar reporting of vaccines in all countries. Comparing cesarean section rates in the HMIS to those from population-representative surveys, we found high external consistency in all countries analyzed. CONCLUSIONS: While efforts remain to improve the quality of these data, our results show that several indicators in the HMIS can be reliably used to monitor service provision over time in these five countries.

Single-port Extraperitoneal and Transperitoneal Radical Prostatectomy: A Multi-Institutional Propensity-Score Matched Study.

OBJECTIVE: To compare the perioperative and early postoperative outcomes between single-port (SP) extraperitoneal radical prostatectomy (EPRP) and SP transperitoneal radical prostatectomy (TPRP), in a multi-institutional setting. METHODS: We identified all patients who underwent SP robot-assisted radical prostatectomy at 6 different institutes. Data of 650 patients were collected and divided into 2 groups based on the surgical approach: SP EPRP or SP TPRP. A Propensity-score matched-pair analysis for body mass index (BMI), prostate size, and National Comprehensive Cancer Network risk was performed with a 1:1 ratio. Analysis of perioperative and postoperative outcomes was performed using Wilcoxon signed-rank test and chi-square and Fisher's exact tests. RESULTS: After matching, 238 patients were included in each arm. The median follow-up period was 7 and 6 months for EPRP and TPRP groups, respectively. The total operative time was longer in the EPRP group (206 vs 155 minutes, P < .001). The EPRP group had a shorter length of hospitalization and same-day discharge rate compared to the TPRP approach (P < .001). There was no difference in the overall intraoperative or postoperative complications rate between the 2 groups, nor positive surgical margin rates. CONCLUSION: The SP extraperitoneal approach is associated with a shorter hospital stay and higher rate of same-day discharge, with no difference in the surgical margin, or complication rates.

Insight to urology patients' preferences regarding telemedicine.

INTRODUCTION: Due to COVID-19, telemedicine has become a common method of healthcare delivery. Our goal was to evaluate urology patients' satisfaction with telemedicine, examine patient preferences, and identify opportunities for improvement in readiness, access, and quality of care. MATERIALS AND METHODS: A total of 285 adult urology patients who completed at least one telemedicine visit from September to December 2020 were eligible. A paper survey was disseminated by postal mail with an option to complete electronically. Those who returned completed surveys received a $15 gift card. RESULTS: Seventy-six subjects completed the survey (response rate of 27%). The most common age bracket of the respondents was 70-79 years (37%). Readiness - To prepare, many subjects (49%) read the provided instructions. Most (91%) thought they were adequately prepared. A majority (82%) were satisfied with the ease of set up. Access - Types of visits included established patients (71%), new patient visits (17%), and postoperative visits (9%). Most respondents (84%) did not have difficulty accessing the visit. Quality of care - All respondents were satisfied with the length of visit, and 90% were satisfied with the overall experience. Patient preferences - Compared to office visits, most patients found telemedicine equal or superior in several areas. Preference to utilize telemedicine in the future was dependent on the nature of the complaint, length of their drive and their schedule. CONCLUSIONS: Patients reported high levels of satisfaction and a willingness to engage with telemedicine visits. To minimize future technical disruptions, we offer mock telehealth visits before their scheduled appointment and improved our clinicians' work flow.

Tracking health system performance in times of crisis using routine health data: lessons learned from a multicountry consortium.

COVID-19 has prompted the use of readily available administrative data to track health system performance in times of crisis and to monitor disruptions in essential healthcare services. In this commentary we describe our experience working with these data and lessons learned across countries. Since April 2020, the Quality Evidence for Health System Transformation (QuEST) network has used administrative data and routine health information systems (RHIS) to assess health system performance during COVID-19 in Chile, Ethiopia, Ghana, Haiti, Lao People's Democratic Republic, Mexico, Nepal, South Africa, Republic of Korea and Thailand. We compiled a large set of indicators related to common health conditions for the purpose of multicountry comparisons. The study compiled 73 indicators. A total of 43% of the indicators compiled pertained to reproductive, maternal, newborn and child health (RMNCH). Only 12% of the indicators were related to hypertension, diabetes or cancer care. We also found few indicators related to mental health services and outcomes within these data systems. Moreover, 72% of the indicators compiled were related to volume of services delivered, 18% to health outcomes and only 10% to the quality of processes of care. While several datasets were complete or near-complete censuses of all health facilities in the country, others excluded some facility types or population groups. In some countries, RHIS did not capture services delivered through non-visit or nonconventional care during COVID-19, such as telemedicine. We propose the following recommendations to improve the analysis of administrative and RHIS data to track health system performance in times of crisis: ensure the scope of health conditions covered is aligned with the burden of disease, increase the number of indicators related to quality of care and health outcomes; incorporate data on nonconventional care such as telehealth; continue improving data quality and expand reporting from private sector facilities; move towards collecting patient-level data through electronic health records to facilitate quality-of-care assessment and equity analyses; implement more resilient and standardized health information technologies; reduce delays and loosen restrictions for researchers to access the data; complement routine data with patient-reported data; and employ mixed methods to better understand the underlying causes of service disruptions.

Implementing an outpatient clinical trial on COVID-19 treatment in an emergency epidemic context: a mixed methods study among operational and research stakeholders within the Coverage trial, Bordeaux (France).

BACKGROUND: The emergency set-up and implementation of outpatient clinical trials on epidemic emerging infectious diseases such as COVID-19 raise many issues in terms of research structuration, regulations, and health systems organization. We aimed to describe the experience and points of view of different stakeholders involved in a French home-based outpatient trial on COVID-19 and to identify the early barriers and facilitators to the trial implementation. METHODS: We conducted a mixed-methods study in July 2020. A self-administered questionnaire was emailed to 213 clinical, operational and research stakeholders involved in the Coverage trial; individual semi-directed interviews were conducted among 14 stakeholders. Questionnaire data and written interview notes are presented together by key theme. RESULTS: One hundred fifty six stakeholders responded to the questionnaire. 53.4% did not have prior experience in clinical research. The motivation of most stakeholders to participate in the Coverage trial was to feel useful during the pandemic. 87.9% agreed that the trial had an unusual set-up timeframe, and many regretted a certain lack of regulatory flexibility. Mobile medical teams and specific professional skills were perceived as instrumental for outpatient research. CONCLUSIONS: The implementation of a home-based outpatient clinical trial on COVID-19 was perceived as relevant and innovative although requiring important adaptations of usual professional responsibilities and standard research procedures. Lessons learned from the Coverage trial underline the need for improved networks between hospital and community medicine, and call for a dedicated and reactive outpatient research platform on emerging or threatening infectious diseases.

COVID-19 and resilience of healthcare systems in ten countries.

Declines in health service use during the Coronavirus Disease 2019 (COVID-19) pandemic could have important effects on population health. In this study, we used an interrupted time series design to assess the immediate effect of the pandemic on 31 health services in two low-income (Ethiopia and Haiti), six middle-income (Ghana, Lao People's Democratic Republic, Mexico, Nepal, South Africa and Thailand) and high-income (Chile and South Korea) countries. Despite efforts to maintain health services, disruptions of varying magnitude and duration were found in every country, with no clear patterns by country income group or pandemic intensity. Disruptions in health services often preceded COVID-19 waves. Cancer screenings, TB screening and detection and HIV testing were most affected (26-96% declines). Total outpatient visits declined by 9-40% at national levels and remained lower than predicted by the end of 2020. Maternal health services were disrupted in approximately half of the countries, with declines ranging from 5% to 33%. Child vaccinations were disrupted for shorter periods, but we estimate that catch-up campaigns might not have reached all children missed. By contrast, provision of antiretrovirals for HIV was not affected. By the end of 2020, substantial disruptions remained in half of the countries. Preliminary data for 2021 indicate that disruptions likely persisted. Although a portion of the declines observed might result from decreased needs during lockdowns (from fewer infectious illnesses or injuries), a larger share likely reflects a shortfall of health system resilience. Countries must plan to compensate for missed healthcare during the current pandemic and invest in strategies for better health system resilience for future emergencies.

Inhaled ciclesonide for outpatient treatment of COVID-19 in adults at risk of adverse outcomes: a randomised controlled trial (COVERAGE).

OBJECTIVES: To assess the efficacy of inhaled ciclesonide in reducing the risk of adverse outcomes in COVID-19 outpatients at risk of developing severe illness. METHODS: COVERAGE is an open-label, randomized controlled trial. Outpatients with documented COVID-19, risk factors for aggravation, symptoms for ≤7 days, and absence of criteria for hospitalization are randomly allocated to either a control arm or one of several experimental arms, including inhaled ciclesonide. The primary efficacy endpoint is COVID-19 worsening (hospitalization, oxygen therapy at home, or death) by Day 14. Other endpoints are adverse events, maximal follow-up score on the WHO Ordinal Scale for Clinical Improvement, sustained alleviation of symptoms, cure, and RT-PCR and blood parameter evolution at Day 7. The trial's Safety Monitoring Board reviewed the first interim analysis of the ciclesonide arm and recommended halting it for futility. The results of this analysis are reported here. RESULTS: The analysis involved 217 participants (control 107, ciclesonide 110), including 111 women and 106 men. Their median age was 63 years (interquartile range 59-68), and 157 of 217 (72.4%) had at least one comorbidity. The median time since first symptom was 4 days (interquartile range 3-5). During the 28-day follow-up, 2 participants died (control 2/107 [1.9%], ciclesonide 0), 4 received oxygen therapy at home and were not hospitalized (control 2/107 [1.9%], ciclesonide 2/110 [1.8%]), and 24 were hospitalized (control 10/107 [9.3%], ciclesonide 14/110 [12.7%]). In intent-to-treat analysis of observed data, 26 participants reached the composite primary endpoint by Day 14, including 12 of 106 (11.3%, 95% CI: 6.0%-18.9%) in the control arm and 14 of 106 (13.2%; 95% CI: 7.4-21.2%) in the ciclesonide arm. Secondary outcomes were similar for both arms. DISCUSSION: Our findings are consistent with the European Medicines Agency's COVID-19 task force statement that there is currently insufficient evidence that inhaled corticosteroids are beneficial for patients with COVID-19.

Performance de la télé-expertise dans le diagnostic des cancers cutanés : étude rétrospective dans trois départements de Nouvelle-Aquitaine

Introduction Dans la Creuse, les Deux-Sèvres et le Lot-et-Garonne, la densité de dermatologues est inférieure à 3,8/100 000 habitants. Cette pauvreté de l’offre de soins en dermatologie est susceptible d’entraîner des retards diagnostiques et de prise en charge, notamment pour les tumeurs cutanées. Le projet SmartDerm est un réseau de télé-expertise développé en 2018 en Nouvelle-Aquitaine pour aider les médecins généralistes à accéder à un avis dermatologique. Les avis pour lesquels le dermatologue évoquait un cancer cutané ont été étudiés. L’objectif principal était de déterminer la concordance entre le diagnostic évoqué par le dermatologue et le résultat anatomopathologique. Matériel et méthodes Il s’agit d’une cohorte rétrospective menée entre octobre 2018 et décembre 2020 sur les demandes de télé-expertise réalisées sur la plateforme de télémédecine PAACO/Globule dans les départements de la Creuse, du Lot-et-Garonne et des Deux-Sèvres. Ont été inclus les patients pour lesquels le dermatologue requis évoquait un diagnostic de cancer cutané, qui ont eu un prélèvement histologique au décours et dont le résultat était disponible. Résultats Sur les 1727 demandes d’avis pendant la période d’étude, 163 (9 %) étaient éligibles. Pour 61 avis, aucun résultat anatomopathologique n’était disponible : n=23 données manquantes, n=9 abstentions thérapeutiques, n=7 traitements locaux, n=6 lésions non suspectes en présentiel, n=6 perdus de vue, n=4 refus du patient, n=3 régressions spontanées, n=3 consultations en attente. Quatre vingt treize patients ont été inclus, pour 102 lésions cutanées. L’âge moyen était de 72 ans, avec 53 % de femmes. Les lésions cutanées évoluaient depuis 8 mois [0,5–36] en moyenne. Le délai médian de réponse du dermatologue sollicité pour la téléexpertise était de 1 jour [0–61] ;65jours [1–667] s’écoulaient en moyenne entre cet avis et le prélèvement histologique. Les prélèvements histologiques ont montré 83 lésions malignes (57 carcinomes basocellulaires (69 %), 18 carcinomes épidermoïdes (22 %), 6 mélanomes (7 %), 1 lymphome cutané (1 %), 1 localisation secondaire d’un cancer primitif (1 %)) et 19 lésions bénignes. La concordance entre l’avis du médecin requis et le résultat anatomopathologique de la lésion était de 83 % pour les lésions non mélanocytaires et 67 % pour les lésions mélanocytaires. Discussion Cette étude montre une fiabilité de la téléexpertise dans le diagnostic des cancers cutanés, comparable aux données de la littérature en l’absence de dermoscopie. Le délai de 2 mois entre l’avis et l’histologie est plus rapide que le délai des rdv habituels dans ces départements. Les résultats sont limités par l’absence de prélèvement histologique chez 61 patients. La télémédecine, dont l’activité a été catalysée par la crise sanitaire de la COVID-19, offre une réponse pertinente pour la prise en charge des patients résidant en zone de sous-densité médicale.

Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial).

OBJECTIVES: To assess the efficacy of several repurposed drugs to prevent hospitalisation or death in patients aged 65 or more with recent symptomatic SARS-CoV-2 infection (COVID-19) and no criteria for hospitalisation. TRIAL DESIGN: Phase III, multi-arm (5) and multi-stage (MAMS), randomized, open-label controlled superiority trial. Participants will be randomly allocated 1:1:1:1:1 to the following strategies: Arm 1: Control arm Arms 2 to 5: Experimental treatment arms Planned interim analyses will be conducted at regular intervals. Their results will be reviewed by an Independent Data and Safety Monitoring Board. Experimental arms may be terminated for futility, efficacy or toxicity before the end of the trial. New experimental arms may be added if new evidence suggests that other treatments should be tested. A feasibility and acceptability substudy as well as an immunological substudy will be conducted alongside the trial. PARTICIPANTS: Inclusion criteria are: 65-year-old or more; Positive test for SARS-CoV-2 on a nasopharyngeal swab; Symptoms onset within 3 days before diagnosis; No hospitalisation criteria; Signed informed consent; Health insurance. Exclusion criteria are: Inability to make an informed decision to participate (e.g.: dementia, guardianship); Rockwood Clinical Frailty Scale ≥7; Long QT syndrome; QTc interval > 500 ms; Heart rate <50/min; Kalaemia >5.5 mmol/L or <3.5 mmol/L; Ongoing treatment with piperaquine, halofantrine, dasatinib, nilotinib, hydroxyzine, domperidone, citalopram, escitalopram, potent inhibitors or inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin; Known hypersensitivity to any of the trial drugs or to chloroquine and other 4-aminoquinolines, amodiaquine, mefloquine, glafenine, floctafenine, antrafenine, ARB; Hepatic porphyria; Liver failure (Child-Pugh stage ≥B); Stage 4 or 5 chronic kidney disease (GFR <30 mL/min/1.73 m²); Dialysis; Hypersentivity to lactose; Lactase deficiency; Abnormalities in galactose metabolism; Malabsorption syndrome; Glucose-6-phosphate dehydrogenase deficiency; Symptomatic hyperuricemia; Ileus; Colitis; Enterocolitis; Chronic hepatitis B virus disease. The trial is being conducted in France in the Bordeaux, Corse, Dijon, Nancy, Paris and Toulouse areas as well as in the Grand Duchy of Luxembourg. Participants are recruited either at home, nursing homes, general practices, primary care centres or hospital outpatient consultations. INTERVENTION AND COMPARATOR: The four experimental treatments planned in protocol version 1.2 (April 8th, 2020) are: (1) Hydroxychloroquine 200 mg, 2 tablets BID on day 0, 2 tablets QD from day 1 to 9; (2) Imatinib 400 mg, 1 tablet QD from day 0 to 9; (3) Favipiravir 200 mg, 12 tablets BID on day 0, 6 tablets BID from day 1 to 9; (4) Telmisartan 20 mg, 1 tablet QD from day 0 to 9. The comparator is a complex of vitamins and trace elements (AZINC Forme et Vitalité®), 1 capsule BID for 10 days, for which there is no reason to believe that they are active on the virus. In protocol version 1.2 (April 8th, 2020): People in the control arm will receive a combination of vitamins and trace elements; people in the experimental arms will receive hydroxychloroquine, or favipiravir, or imatinib, or telmisartan. MAIN OUTCOME: The primary outcome is the proportion of participants with an incidence of hospitalisation and/or death between inclusion and day 14 in each arm. RANDOMISATION: Participants are randomized in a 1:1:1:1:1 ratio to each arm using a web-based randomisation tool. Participants not treated with an ARB or ACEI prior to enrolment are randomized to receive the comparator or one of the four experimental drugs. Participants already treated with an ARB or ACEI are randomized to receive the comparator or one of the experimental drugs except telmisartan (i.e.: hydroxychloroquine, imatinib, or favipiravir). Randomisation is stratified on ACEI or ARBs treatment at inclusion and on the type of residence (personal home vs. nursing home). BLINDING (MASKING): This is an open-label trial. Participants, caregivers, investigators and statisticians are not blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 1057 participants will be enrolled if all arms are maintained until the final analysis and no additional arm is added. Three successive futility interim analyses are planned, when the number of participants reaches 30, 60 and 102 in the control arm. Two efficacy analyses (interim n°3 and final) will be performed successively. TRIAL STATUS: This describes the Version 1.2 (April 8th, 2020) of the COVERAGE protocol that was approved by the French regulatory authority and ethics committee. The trial was opened for enrolment on April 15th, 2020 in the Nouvelle Aquitaine region (South-West France). Given the current decline of the COVID-19 pandemic in France and its unforeseeable dynamic in the coming months, new trial sites in 5 other French regions and in Luxembourg are currently being opened. A revised version of the protocol was submitted to the regulatory authority and ethics committee on June 15th, 2020. It contains the following amendments: (i) Inclusion criteria: age ≥65 replaced by age ≥60; time since first symptoms <3 days replaced by time since first symptoms <5 days; (ii) Withdrawal of the hydroxychloroquine arm (due to external data); (iii) increase in the number of trial sites. TRIAL REGISTRATION: The trial was registered on Clinical Trials.gov on April 22nd, 2020 (Identifier: NCT04356495): and on EudraCT on April 10th, 2020 (Identifier: 2020-001435-27). FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).