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Caesarean section audit by peer review.

OBJECTIVE: To provide activity audit data on 50 consecutive caesarean sections and assess the justification for the decision to perform each caesarean section. DESIGN: A retrospective audit with peer review. SETTING: Aberdeen Maternity Hospital. SUBJECTS: Fifty consecutive women undergoing caesarean section. The peer review was undertaken by four consultants and four registrars. MAIN OUTCOME MEASURES: The proportions of caesarean sections by indication stratified according to primiparae or multiparae and emergency or elective procedures. The auditors were asked 'do you think caesarean section was reasonable?' RESULTS: There were 18 (36%) elective caesarean sections and 32 (64%) emergency procedures. Of the 25 (50%) parous women, 14 (56%) had a previous caesarean section and of these 12 (86%) had an elective repeat caesarean section. Foetal distress was the principal indication for emergency caesarean section in 20 (63%) women, with foetal blood sampling performed in only four cases. For emergency caesarean sections the decision to delivery interval ranged from 13 to 160 min (mean 50 min). At least one auditor disagreed with the decision to perform caesarean section in 24 (48%) cases. Between observers the range of disagreement was from 2 to 18 of the decisions. In only 6 (33%) of the 18 elective procedures was there complete agreement. Four (67%) of these women had two previous caesarean sections. There was complete agreement with 20 (63%) of the 32 emergency caesarean sections. Conclusions--Interventions considered as a result of this audit include the introduction of structured diagnostic criteria for caesarean section indications and peer review by the on-call team of the caesarean sections performed in the preceding 24 h.

Adolescent↗

A 12-month review of autopsies performed at a university-affiliated teaching hospital in Hong Kong.

OBJECTIVE: To review the autopsies performed at a university-affiliated teaching hospital over a 12-month period. DATA SOURCES: Records of autopsies performed at a university-affiliated teaching hospital during 1997, and Medline literature search (1966-1998). STUDY SELECTION: The key words used in the literature search were 'autopsy' and 'audit'. DATA EXTRACTION: Data were extracted and analysed by the authors. Any discrepant cases (in which the final diagnoses were either unexpected or not made before death) were identified from the hospital records. DATA SYNTHESIS: Interest in autopsy results has increased, owing to the greater emphasis on medical audit and quality assurance procedures. Of the yearly total of 403 autopsies, 332 cases were reviewed; the discrepancies found were classified as either major or minor, according to their effect on the clinical outcome. The major and minor discrepancy rates were 23% and 9%, respectively. In 2% of cases, the cause of death was due to complications resulting from surgical intervention. These discrepancy rates were comparable to the figures quoted in the literature. CONCLUSION: Autopsy is a valid medical quality-assurance mechanism in Hong Kong.

Autopsy↗

Reflections on the process of auditing myocardial infarction.

The publication of the National Service Framework for Coronary Heart Disease has meant that audit is becoming an increasingly important part of cardiac healthcare provision in England. Comparisons between hospitals will be made so it is essential that the audit data is as robust as possible. Nurses often play a key role in the collection of such data. This article reflects on this process, with particular reference to thrombolysis in acute myocardial infarction. Topics discussed include eligibility, the role of a clinician, electrocardiogram interpretation, justified delays, inappropriate and "missed" administration. As some of the information is, arguably, open to interpretation, the authors believe that clinical auditors will inevitably have to grapple with such clinical definitions and their implications.

Data Collection↗

Identification of neonatal hearing impairment: experimental protocol and database management.

OBJECTIVE: The purposes of this article are to describe the overall protocol for the Identification of Neonatal Hearing Impairment (INHI) project and to describe the management of the data collected as part of this project. A well-defined protocol and database management techniques were needed to ensure that data were 1) collected accurately and in the same way across sites; 2) maintained in a database that could be used to provide feedback to individual sites regarding enrollment and the extent to which the protocol was complete on individual subjects; and 3) available to answer project questions. This article describes techniques that were used to meet these needs. DESIGN: This study was a prospective, randomized study that was designed to evaluate auditory brain stem responses, transient evoked otoacoustic emissions, and distortion product otoacoustic emissions as hearing-screening tools, and to relate neonatal test findings to hearing status, defined by visual reinforcement audiometry at 8 to 12 mo of age. Measures of middle-ear function also were obtained at some sites as part of the neonatal test battery. In addition, other clinical and demographic data were gathered to determine the extent to which factors, other than auditory status, influenced test behavior. Three groups were evaluated: neonatal intensive care unit (NICU) infants (those who spent 3 or more days in a NICU), well babies with risk factors for hearing loss, and well babies without risk factors. Six centers participated in the trial. The testers for the project included audiologists, technicians, audiology graduate students, and medical research staff. The same computerized neonatal test program was applied at each center. This program generated the neonatal test database automatically. Clinical and demographic data were collected by means of concise data collection forms and were entered into a database at each site. After the neonatal test, subjects from the NICU and at-risk well babies were evaluated with visual reinforcement audiometry starting at 8 to 12 mo of age. All data were electronically transmitted to the core site where they were merged into one overall database. This database was exercised to provide feedback and to identify discrepancies throughout the course of the study. In its final form, it served as the database on which all analyses were performed. RESULTS AND CONCLUSION: The protocol was a departure from typical hearing screening procedures in terms of 1) its regimented application of three screening measures; 2) the detailed information that was obtained regarding subject clinical and demographic factors; and 3) its application of the same procedures across six centers having diverse geographic location and subject demographics. A learning curve for successfully executing the study protocols was observed. Throughout the study, monthly reports were generated to monitor subject enrollment, check for data completeness, and to perform data integrity checks. In combination with monthly data reports and checks that occurred throughout the progression of the study, miscellaneous data audits were performed to check accuracy of neonatal testing programs and to cross-check information entered in the clinical and demographic database. The data management techniques used in this project helped to ensure the quality of the data collection process and also allowed for detailed analyses once data were collected. This was particularly important because it enabled us to evaluate not only the performance of individual measures as screening tools, but also permitted an evaluation of the influence of other variables on screening test results.

Acoustic Stimulation↗

Complications of endoscopic retrograde cholangiopancreatography.

AIM: The aim of this prospective study was to audit all endoscopic retrograde cholangiopancreatographic (ERCP) procedures performed between July 1999 and November 1999, in particular to determine the spectrum and rate of complications. METHODS: An audit data sheet was designed with 100 variables on which the endoscopist recorded all the relevant details of the procedure, from patient demographics to overall success of the procedure. Data were collected at the time of ERCP and before discharge. Any complications within 30 days of ERCP were also recorded. RESULTS: Of 210 consecutive patients audited, successful diagnostic and therapeutic ERCP was performed in 93% with an overall complication rate of 9.5%. The incidence of pancreatitis was 4.76% and haemorrhage 2.38%. No severe complication or procedure-related mortality occurred. CONCLUSION: The most common complications of ERCP were pancreatitis and haemorrhage.

Cholangiopancreatography, Endoscopic Retrograde↗

Public access defibrillation--designing a universal report form and database for a national programme.

We describe the design of a universal report form for use by lay-responders using an automated external defibrillator (AED) as part of a national programme for public access defibrillation (PAD). The form was designed initially because the Department of Health in England required detailed audit data about the national programme for public access defibrillation they initiated. At that time (1999) there was very little reported experience of public access defibrillation and none from the UK. The form evolved pragmatically as experience showed the wide range of situations under which lay-persons might use an AED, and also the information likely to be available that could be collected reliably. This report may help others who wish to audit schemes for PAD and facilitate the evolution of an internationally acceptable template for data collection.

Databases, Factual↗

An empirical investigation of the factor structure of the AUDIT.

This study investigated the Alcohol Use Disorders Identification Test's (AUDIT) factor structure and psychometric properties. The factor structure was derived from a sample of 7,035 men and women primary care patients. A principal components analysis identified 2 factors in the AUDIT data and was supported in a confirmatory factor analysis (CFA). The 2 factors were Dependence/Consequences and Alcohol Consumption. The CFA also provided support for a 3-factor model whose factors (Alcohol Consumption, Alcohol Dependence, and Related Consequences) matched those proposed by the AUDIT's developers. Psychometric indexes were determined by use of the baseline and 12-month follow-up data of 301 men and women who entered a clinical trial. The results showed that the 2 factors had good reliability. Validity tests supported the interpretation of what the 2 factors measure, its implications for relationships to other variables, and the comparability of the 2- and 3-factor models.

Adult↗

Medical costs of osteoporosis.

Global healthcare expenditure has risen at an alarming rate over the past thirty years and the situation is most pronounced in the USA, which now spends 12% of its gross domestic product on healthcare. The greatest component of this expenditure is accounted for by the costs of hospitalisation, and is also particularly centred on the elderly sector of the population - a group that, relative to other sections of the population, will expand over the next thirty years. Osteoporosis, a chronic, disabling disorder, predominantly affects the elderly. Growth in the recognition and level of intervention in osteoporosis, when viewed alongside the increase in the elderly population, emphasises the need to examine the costs of osteoporosis against the already burgeoning healthcare bill. A detailed study in the USA in 1986 assessed the direct medical costs of osteoporosis in women over the age of 45; analysis included the costs of hospitalisation, nursing home care and outpatient services. The results of this survey revealed a figure for total direct costs of $5.15 billion, with hospital and nursing home care being the greatest contributors. A subsequent analysis of data for 1989 has shown expenditure to have risen to over $6 billion. This form of economic assessment of direct medical costs, based on discharge surveys and audit data, is likely to be reasonably accurate for osteoporosis-related hip and wrist fractures, which will generally present to hospitals, but less so for vertebral fractures, which have a varied clinical presentation.(ABSTRACT TRUNCATED AT 250 WORDS)

Age Factors↗

Recommendations for care related to follow-up of abnormal cancer screening tests: accuracy of patient report.

When using patient self-report of processes of care as part of measuring quality performance, validity and reliability are important considerations. In this study, the congruence of patient report of recommendations of screening follow-up care was compared with record audit data. Survey data were collected from a random sample of patients with abnormal breast (n = 230) or cervical (n = 219) cancer screening tests from four health centers. With patient consent, record audits were conducted to validate self-report. Measures of congruence for recommendations for follow-up were calculated along with sensitivity and specificity for procedure-specific recommendations. Overall congruence was higher in the mammography sample (81%) as compared to the Pap sample (61%). Predictors of overall congruence for the abnormal Pap test sample included health plan, self-reported health status, and test result. There were no significant predictors of congruence for the abnormal mammogram test sample from the potential variables collected. Raw agreement rates support using patient self-report in assessing abnormal test follow-up recommendations.

Breast Neoplasms↗

Preventing hospital-acquired pressure ulcers: a point prevalence study.

The deleterious effects of mechanical forces on the development of pressure ulcers have been recognized for many years. A cross-sectional study was conducted to ascertain the effect of implementing a new support surface on the development of pressure ulcers in one acute care facility. Two pressure ulcer prevalence studies were conducted using the Pressure Ulcer Prevalence Audit Data Collection Tool. To ascertain whether ulcers were facility-acquired, a retrospective chart review was completed for all patients with pressure ulcers. Following completion of the first audit, only the support surface used for at-risk patients was changed. The second audit was conducted 3 months after the new support surface was implemented. Pressure ulcer prevalence was 8.3% in June 1999 and 7.8% in October 2000; whereas, the prevalence of nosocomial pressure ulcers was 5.5% in 1999 and 3.1% in October 2000. Despite the inherent limitations of this study design, the results suggest that use of the new support surfaces for at-risk patients has lowered the prevalence of nosocomial pressure ulcers in this facility.

Adult↗

The violence management team. An approach to aggressive behaviour in a general hospital.

OBJECTIVES: To describe the establishment of a violence management team (VMT) to manage patients who exhibit violent behaviour in a general hospital (Flinders Medical Centre), and to review data collected in the first 44 months of operation. METHODS: The VMT consisted of a doctor, a senior nurse and four orderlies. Calls to the team were recorded and audited. Data were collected from patient case notes and supplemented, where necessary, with information from medical and nursing staff. RESULTS: There were 282 calls for the VMT during the study period, most often to patients with organic mental disorders (45%), substance abuse disorders (18%) and personality disorders (15%). In 30% of calls, verbal placation alone was sufficient to manage the patient; however, 62% of patients needed physical restraint (i.e., were physically held by team members) and 53% were administered a sedative medication. CONCLUSIONS: Violent behaviour in patients in a general hospital is an important problem, often caused by organic mental disorders. This, and the need to restrain aggressive patients so that they can receive essential medical care, suggest that such behaviour should be treated as a clinical problem rather than one for security guards or the police. The VMT provides a mechanism for dealing with aggressive patients which ensures good patient management, as well as protecting the health and safety of staff. It is also a monitor for quality assurance purposes, and provides data to determine the causes of patient violence and to implement prevention programs.

Diagnosis-Related Groups↗

Audit and feedback and clinical practice guideline adherence: making feedback actionable.

BACKGROUND: As a strategy for improving clinical practice guideline (CPG) adherence, audit and feedback (A&F) has been found to be variably effective, yet A&F research has not investigated the impact of feedback characteristics on its effectiveness. This paper explores how high performing facilities (HPF) and low performing facilities (LPF) differ in the way they use clinical audit data for feedback purposes. METHOD: Descriptive, qualitative, cross-sectional study of a purposeful sample of six Veterans Affairs Medical Centers (VAMCs) with high and low adherence to six CPGs, as measured by external chart review audits. One-hundred and two employees involved with outpatient CPG implementation across the six facilities participated in one-hour semi-structured interviews where they discussed strategies, facilitators and barriers to implementing CPGs. Interviews were analyzed using techniques from the grounded theory method. RESULTS: High performers provided timely, individualized, non-punitive feedback to providers, whereas low performers were more variable in their timeliness and non-punitiveness and relied on more standardized, facility-level reports. The concept of actionable feedback emerged as the core category from the data, around which timeliness, individualization, non-punitiveness, and customizability can be hierarchically ordered. CONCLUSION: Facilities with a successful record of guideline adherence tend to deliver more timely, individualized and non-punitive feedback to providers about their adherence than facilities with a poor record of guideline adherence. Consistent with findings from organizational research, feedback intervention characteristics may influence the feedback's effectiveness at changing desired behaviors.

Journal Article↗

Quantitative whole-body autoradiography in the pharmaceutical industry. Survey results on study design, methods, and regulatory compliance.

INTRODUCTION: Quantitative whole-body autoradiography (QWBA) is a technique used to determine the tissue distribution of radiolabeled compounds in laboratory animals. This relatively new technique is quickly replacing wet-tissue dissection techniques, which, up to now, have been used by the pharmaceutical industry when performing tissue distribution studies to develop new drugs and to address regulatory compliance needs. In an effort to harmonize QWBA procedures across the pharmaceutical industry, the Society for Whole Body Autoradiography (SWBA) surveyed its membership to gain insight into the procedures and practices being used to perform tissue distribution studies conducted in support of drug development. METHODS: The survey polled 29 respondents, who represent pharmaceutical companies in the United States, Europe, and Asia. Participants answered approximately 50 questions related to study design, applications, autoradiography methods, tissue quantitation, and regulatory compliance. RESULTS: The survey revealed general consistencies and inconsistencies among the labs that responded. Consistencies were related to: isotope use and doses of radioactivity, number of animals per time point, exsanguination of animals, freezing methods, section thickness, tissue collection lists, section lyophilization, imaging technology, blood and calibration standards, tissues and sections sampled for quantitation, use of QWBA data for human dosimetry, and QWBA method validation. Inconsistencies were related to: number of time points used, euthanasia methods, carcass freezing time, microtome calibration, section thickness verification, sample collection, validation of commercial standards, use of background measurements during calibration, definition of limits of quantitation, reporting of extrapolated values, reexposure of section to determine low levels, computer system validation, definitions of raw data, audit trail documentation, studies performed under Good Laboratory Practices (GLP) vs. non-GLP conditions. DISCUSSION: The survey indicated that most labs are now using QWBA to perform their tissue distribution studies and that these data have been submitted and accepted by regulatory authorities around the world. Procedures and practices involved in the design of these studies appear to vary somewhat. An important inconsistency found related to the number of time points used to determine the pharmacokinetic (PK) parameters for tissues, which may effect the reliability of these parameters for use in predicting human exposure to radioactivity during human radiolabeled studies. Survey results regarding QWBA methods indicated that there is a lot of consistency across surveyed labs; however, there are some inconsistent areas that raise regulatory compliance issues and these are related to the verification of section thickness, validation of commercial standards and their use in quantitation, definitions of limits of quantitation, and consideration of background measurements during quantitation. This survey provides autoradiographers, managers, and regulators with an important reference on the state-of-the art of QWBA and shows that the technique has gained wide acceptance across the pharmaceutical industry. However, it also shows that there are some key areas, such as inconsistencies in the procedures used for quantitation, that investigators may want to probe further to assure that the highest quality and most useful studies are performed.

Animals↗

Breast and cervical cancer screening in obese minority women.

PURPOSE: Studies using survey data from mostly white women showed that obese women are less likely than nonobese women to undergo breast and cervical cancer screening. It is unclear if these findings are true in nonwhite women. Using chart audit data, we examined the relationship between obesity and mammography and Pap smear screening among minority women. METHODS: Data from retrospective chart review of women in three urban New Jersey academic family medicine practices were analyzed (n = 1809) using hierarchical logistic regression models. Outcome measures were being up-to-date in mammography and Pap smears among obese and nonobese women. RESULTS: There was no difference in mammography rates among obese and nonobese women. Independent risk factors for not being up-to-date in mammography included age 40-49, smoking, and comorbidity. Obese women were less likely than nonobese women to be upto- date in Pap smears (69% vs. 77%, p = 0.001). In multivariate analysis, obesity was associated with 25% decreased odds of being up-to-date on Pap smears (OR, 0.75, 95% CI, 0.58-0.99, p = 0.041). Age >or=65 years was also associated with decreased odds of being up-to-date in Pap smears. Hispanic women had increased odds of being up-to-date in mammography (OR 2.43, 95% CI 1.63-3.63) and Pap smears (OR 1.94, 95% CI 1.24-3.03) compared with white women. CONCLUSIONS: Obesity was associated with decreased Pap smear screening but not with decreased mammography. Further studies are needed to determine barriers and effective interventions to improve screening in obese minority women.

Adult↗

Outcome measures in palliative care for advanced cancer patients: a review.

Information generated using outcome measures to measure the effectiveness of palliative care interventions is potentially invaluable. Depending on the measurement tool employed the results can be used to monitor clinical care, carry out comparative research, provide audit data or inform purchasing decisions. However, the data collected can only ever be as good as the method used to obtain them. This review aimed to systematically identify and examine outcome measures that have been used, or proposed for use in the clinical audit of palliative care of patients with advanced cancer. Database searches were performed using MEDLINE (1991-1995), CANCERLIT (1991-1995), Healthplan (1985-1995), and 'Oncolink' on the internet. Further measures were located with the assistance of other professionals working in palliative care. The criteria for the inclusion and assessment of measures were a measure assessing more than one domain and a target population of advanced disease or palliative care Forty-one measures were identified, 12 of which satisfied the inclusion criteria. These contained between five and 56 items and covered aspects of physical, psychological and spiritual domains. Each measure meets some but not all of the objectives of measurement in palliative care, and fulfils some but not all of our criteria for validity, reliability, responsiveness and appropriateness.

Activities of Daily Living↗

Clinical effectiveness and cost-effectiveness of immediate angioplasty for acute myocardial infarction: systematic review and economic evaluation.

OBJECTIVES: To review the clinical evidence comparing immediate angioplasty with thrombolysis, and to consider whether it would be cost-effective. DATA SOURCES: Electronic databases. Experts in the field. REVIEW METHODS: For clinical effectiveness, a comprehensive review of randomised control trials (RCTs) was used for efficacy, and a selection of observational studies such as case series or audit data used for effectiveness in routine practice. RCTs of thrombolysis were used to assess the relative value of prehospital and hospital thrombolysis. Observational studies were used to assess the representativeness of patients in the RCTs, and to determine whether different groups have different capacity to benefit. Clinical effectiveness was synthesised through a narrative review with full tabulation of results of all included studies and a meta-analysis to provide a precise estimate of absolute clinical benefit. Consideration was given to the effect of the growing use of stents. The economic modelling adopted an NHS perspective to develop a decision-analytical model of cost-effectiveness focusing on opportunity costs over the short term (6 months). RESULTS: The results were consistent in showing an advantage of immediate angioplasty over hospital thrombolysis. The updated meta-analysis showed that mortality is reduced by about one-third, from 7.6% to 4.9% in the first 6 months, and by about the same in studies of up to 24 months. Reinfarction is reduced by over half, from 7.6% to 3.1%. Stroke is reduced by about two-thirds, from 2.3% with thrombolysis to 0.7% with percutaneous coronary intervention (PCI), with the difference being due to haemorrhagic stroke. The need for coronary artery bypass graft is reduced by about one-third, from 13.2% to 8.4%. Caution is needed in interpreting some of the older trials, as changes such as an increase in stenting and the use of the glycoprotein IIb/IIa inhibitors may improve the results of PCI. There is little evidence comparing prehospital thrombolysis with immediate PCI. Research on thrombolysis followed by PCI, known as 'facilitated PCI', is underway, but results are not yet available. Trials may be done in select centres and results may not be as good in lower volume centres, or out of normal working hours. In addition, much of the marginal mortality benefit of PCI over hospital thrombolysis may be lost if door-to-balloon time were more than an hour longer than door-to-needle time. Conversely, within the initial 6 hours, the later patients present, the greater the relative advantage of PCI. Results suggest that PCI is more cost-effective than thrombolysis, providing additional benefits in health status at some extra cost. In the longer term, the cost difference is expected to be reduced because of higher recurrence and reintervention rates among those who had thrombolysis. CONCLUSIONS: If both interventions were routinely available, the economic analysis favours PCI, given the assumptions of the model. However, very few units in England could offer a routine immediate PCI service at present, and there would be considerable resource implications of setting up such services. Without a detailed survey of existing provision, it is not possible to quantify the implications, but they include both capital and revenue: an increase in catheter laboratory provision and running costs. The greatest problem would be staffing, and that would take some years to resolve. A gradual incrementalist approach based on clinical networks, with transfer to centres able to offer PCI, may be used. In rural areas, one option may be to promote an increase in prehospital thrombolysis, with PCI for thrombolysis failures. There is a need for data on the long-term consequences of treatment, the quality of life of patients after treatment, and the effects of PCI following thrombolysis failure.

Angioplasty↗

Maintaining prevention in practice: survival of PPIP in primary care settings. Put Prevention Into Practice.

INTRODUCTION: Put Prevention Into Practice (PPIP) consists of a kit of office-based tools intended to support the provision of preventive services by primary care providers. The purpose of this study was to examine the institutionalization of PPIP within five primary care clinics funded by the Texas Department of Health to implement PPIP, and to examine the organizational determinants of program institutionalization. METHODS: We utilized an adaptation of the Level of Institutionalizaton (LoIn) scales for qualitative data collection and for development of an institutionalization score for each site. The determinants of institutionalization were derived from the organizational behavior and health promotion literatures and used as categories for analysis. In addition, for purposes of triangulation, chart audit data for three documentation behaviors were also collected. RESULTS: PPIP has been maintained--at varying degrees of integration--in four of the five sites studied, for 6 years after adoption. Organizational factors that facilitated the institutionalization process were the site's institutional strength, the integration of PIPP within extant programs and services, visibility of the program within and outside the site, planning for the termination of grant funding, and presence of a program champion with mid- to upper-level managerial authority. Successful initiation of the program was not a predictor of institutionalization outcomes. CONCLUSIONS: We have highlighted the need to consider organizational determinants of institutionalization in relation to their specific sociopolitical contexts, and in relation to each other, not in isolation.

Health Plan Implementation↗

A survey of contact tracing practice for sexually transmitted diseases in GUM clinics in England and Wales.

We set out to determine current policy and practice in relation to contact tracing (partner notification) for sexually transmitted diseases (STDs) within genitourinary medicine (GUM) clinics in England and Wales. A confidential postal questionnaire survey of all GUM clinics in England and Wales was undertaken. Completed questionnaires were returned by 105 GUM clinics (a response rate of 65%). All respondents undertook routine contact tracing for gonorrhoea and chlamydia. The most popular method of contact tracing used was patient referral. The majority of contact tracing was undertaken by health advisers. Information on the time period over which contact tracing was undertaken showed wide variation. Audit data on the effectiveness of contact tracing in terms of the proportion of sexual contacts seen were available from only a minority of GUM clinics (33/79, 42%). Only chlamydia (24/79, 30%) and gonorrhoea (22/79, 28%) were the subject of any appreciable audit activity. There is wide variation in contact tracing policy and practice in GUM clinics in England and Wales. Audit of contact tracing effectiveness appears to be a minority activity. Further research is needed before an evidence-based approach to contact tracing can be implemented.

Contact Tracing↗