Does Culture Confirmation of High-sensitivity Rapid Streptococcal Tests Make Sense? A Medical Decision Analysis

Webb, Kenneth H.

doi:10.1542/peds.101.2.e2

Cited by 61 publications

(54 citation statements)

References 32 publications

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“…There have been modelling studies in children 60 and adults, 61 but these studies did not collect resource use or quality of life data, and the studies came to opposite conclusions.…”

Section: Introductionmentioning

confidence: 99%

PRImary care Streptococcal Management (PRISM) study: in vitro study, diagnostic cohorts and a pragmatic adaptive randomised controlled trial with nested qualitative study and cost-effectiveness study

Little

Hobbs

Moore

et al. 2014

Health Technol Assess

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Background Antibiotics are still prescribed to most patients attending primary care with acute sore throat, despite evidence that there is modest benefit overall from antibiotics. Targeting antibiotics using either clinical scoring methods or rapid antigen detection tests (RADTs) could help. However, there is debate about which groups of streptococci are important (particularly Lancefield groups C and G), and uncertainty about the variables that most clearly predict the presence of streptococci. Objective This study aimed to compare clinical scores or RADTs with delayed antibiotic prescribing. Design The study comprised a RADT in vitro study; two diagnostic cohorts to develop streptococcal scores (score 1; score 2); and, finally, an open pragmatic randomised controlled trial with nested qualitative and cost-effectiveness studies. Setting The setting was UK primary care general practices. Participants Participants were patients aged ≥ 3 years with acute sore throat. Interventions An internet program randomised patients to targeted antibiotic use according to (1) delayed antibiotics (control group), (2) clinical score or (3) RADT used according to clinical score. Main outcome measures The main outcome measures were self-reported antibiotic use and symptom duration and severity on seven-point Likert scales (primary outcome: mean sore throat/difficulty swallowing score in the first 2–4 days). Results The IMI TestPack Plus Strep A (Inverness Medical, Bedford, UK) was sensitive, specific and easy to use. Lancefield group A/C/G streptococci were found in 40% of cohort 2 and 34% of cohort 1. A five-point score predicting the presence of A/C/G streptococci [FeverPAIN: Fever; Purulence; Attend rapidly (≤ 3 days); severe Inflammation; and No cough or coryza] had moderate predictive value (bootstrapped estimates of area under receiver operating characteristic curve: 0.73 cohort 1, 0.71 cohort 2) and identified a substantial number of participants at low risk of streptococcal infection. In total, 38% of cohort 1 and 36% of cohort 2 scored ≤ 1 for FeverPAIN, associated with streptococcal percentages of 13% and 18%, respectively. In an adaptive trial design, the preliminary score (score 1; n = 1129) was replaced by FeverPAIN (n = 631). For score 1, there were no significant differences between groups. For FeverPAIN, symptom severity was documented in 80% of patients, and was lower in the clinical score group than in the delayed prescribing group (–0.33; 95% confidence interval –0.64 to –0.02; p = 0.039; equivalent to one in three rating sore throat a slight rather than moderately bad problem), and a similar reduction was observed for the RADT group (–0.30; –0.61 to 0.00; p = 0.053). Moderately bad or worse symptoms resolved significantly faster (30%) in the clinical score group (hazard ratio 1.30; 1.03 to 1.63) but not the RADT group (1.11; 0.88 to 1.40). In the delayed group, 75/164 (46%) used antibiotics, and 29% fewer used antibiotics in the clinical score group (risk ratio 0.71; 0.50 to 0.95; p = 0.018) and 27% fewer in the RADT group (0.73; 0.52 to 0.98; p = 0.033). No significant differences in complications or reconsultations were found. The clinical score group dominated both other groups for both the cost/quality-adjusted life-years and cost/change in symptom severity analyses, being both less costly and more effective, and cost-effectiveness acceptability curves indicated the clinical score to be the most likely to be cost-effective from an NHS perspective. Patients were positive about RADTs. Health professionals’ concerns about test validity, the time the test took and medicalising self-limiting illness lessened after using the tests. For both RADTs and clinical scores, there were tensions with established clinical experience. Conclusions Targeting antibiotics using a clinical score (FeverPAIN) efficiently improves symptoms and reduces antibiotic use. RADTs used in combination with FeverPAIN provide no clear advantages over FeverPAIN alone, and RADTs are unlikely to be incorporated into practice until health professionals’ concerns are met and they have experience of using them. Clinical scores also face barriers related to clinicians’ perceptions of their utility in the face of experience. This study has demonstrated the limitation of using one data set to develop a clinical score. FeverPAIN, derived from two data sets, appears to be valid and its use improves outcomes, but diagnostic studies to confirm the validity of FeverPAIN in other data sets and settings are needed. Experienced clinicians need to identify barriers to the use of clinical scoring methods. Implementation studies that address perceived barriers in the use of FeverPAIN are needed. Trial registration Current Controlled Trials ISRCTN32027234. Source of funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 6. See the NIHR Journals Library website for further project information.

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“…There have been modelling studies in children 60 and adults, 61 but these studies did not collect resource use or quality of life data, and the studies came to opposite conclusions.…”

Section: Introductionmentioning

confidence: 99%

PRImary care Streptococcal Management (PRISM) study: in vitro study, diagnostic cohorts and a pragmatic adaptive randomised controlled trial with nested qualitative study and cost-effectiveness study

Little

Hobbs

Moore

et al. 2014

Health Technol Assess

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“…16 On the other hand, culture confirmation of negative high-sensitivity rapid antigen tests is not cost-effective. 17 Other limiting factors for throat cultures are its logistics. Providing patient follow-up and prescribing or discontinuing treatment are cumbersome, particularly in the ED setting.…”

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confidence: 99%

Multivariate Predictive Models for Group A Beta‐hemolytic Streptococcal Pharyngitis in Children

Attia

Zaoutis

Eppes

et al. 1999

Academic Emergency Medicine

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Abstract. Objectives:To create predictive models for the clinical diagnosis of group A beta-hemolytic streptococcal (GABHS) pharyngitis in children. Methods: Patients aged 6 months to 18 years presenting to a pediatric ED with suspected GABHS pharyngitis were prospectively enrolled in the study. Clinicians recorded pertinent clinical information using a standardized form and obtained a throat swab to culture GABHS using a reference standard method. Twelve demographic and clinical features of patients with positive throat cultures were compared with the features of patients with negative throat cultures. Significantly different features were entered in a stepwise logistic regression analysis to create predictive models for the diagnosis. Results: Eighty-five patients (29%) were culture-positive and 212 (71%) were culture-negative for GABHS. Respective mean ages were 6.2 years and 6.1 years in the two groups. Univariate chi-square analysis of the 12 features identified six variables that were significantly associated with GABHS. All significant features were initially included in a stepwise logistic regression analysis. In model I, four independent variables were identified: moderate to severe presentation of tonsillar swelling, moderate to severe tenderness and enlargement of cervical lymph nodes, the presence of scarlatiniform rash, and the absence of moderate to severe coryza, yielding a 95% probability for GABHS. Excluding the rare scarlatiniform rash, the remaining variables were used in the second regression analysis. In model II, three independent variables were identified: moderate to severe tonsillar swelling, moderate to severe tenderness and enlargement of cervical lymph nodes, and absence of moderate to severe coryza, yielding a probability of 65% for the diagnosis. A probability of <15% was observed in the absence of scarlatiniform rash, the absence of moderate to severe tenderness and enlargement of cervical lymph nodes, and the presence of moderate to severe coryza. Conclusions: In children with moderate to severe presentation of tonsillar swelling, tenderness and enlargement of cervical lymph nodes, and the absence of coryza, the probability of a positive throat culture is >65%. Conversely, in the absence of a moderate to severe presentation of tonsillar swelling, enlargement of cervical nodes, and the presence of coryza, the probability of a positive throat culture is <15%. If prospectively validated, these models could be integrated into a consistent treat, test, and no treatment/no testing approach to the clinical management of childhood pharyngitis.

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“…Furthermore, despite the probable beneficial effect of tonsillectomy, it is still a surgical procedure with an associated morbidity that includes possible hospitalization, risks of anesthesia, prolonged throat pain, and financial costs. Several surgical related complications including; throat pain, postoperative nausea and vomiting, delayed feeding, voice changes, hemorrhage, and rarely death have been reported and must be considered [54,55] Although this strategy of prophylactic treatment of all patients with recurrent pharyngitis might be debated to expose patients to unnecessary side effects and increased antibiotics resistance [56,57], however several studies have found this to be the most cost-effective strategy with the greatest reduction for potential complications and death [58][59][60]. It has been reported that the health benefits gained from reducing complications and socioeconomic burden much outweighs the minimal risk of antibiotic treatment.…”

Section: Discussionmentioning

confidence: 99%

Comparative Study of Oral Daily Amoxicillin, Long Acting Intramuscular Penicillin, and Tonsillectomy in Prevention of Recurrent Pharyngitis

Ahmed¹,

Wahsh²,

Ahmed³

2015

Med-Science

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Does Culture Confirmation of High-sensitivity Rapid Streptococcal Tests Make Sense? A Medical Decision Analysis

Cited by 61 publications

References 32 publications

PRImary care Streptococcal Management (PRISM) study: in vitro study, diagnostic cohorts and a pragmatic adaptive randomised controlled trial with nested qualitative study and cost-effectiveness study

PRImary care Streptococcal Management (PRISM) study: in vitro study, diagnostic cohorts and a pragmatic adaptive randomised controlled trial with nested qualitative study and cost-effectiveness study

Multivariate Predictive Models for Group A Beta‐hemolytic Streptococcal Pharyngitis in Children

Comparative Study of Oral Daily Amoxicillin, Long Acting Intramuscular Penicillin, and Tonsillectomy in Prevention of Recurrent Pharyngitis

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