Rotavirus and illness severity in children presenting with acute gastroenteritis at the primary care out-of-hours service

Figures & data

Figure 1. Flowchart of patient selection.

Table 1. Baseline characteristics of the total cohort, included children, excluded children and children included in the trial.

Characteristics	Total cohort	Included	Excluded	Trial
Number, N	201	75	126	191
Gender (male), N (%)	99 (49.3)	34 (45.3)	65 (51.6)	92 (48.3)
Age in years, median (IQR)	1.5 (0.9–2.1)	1.5 (0.9–2.0)	1.6 (0.9–2.3)	1.5 (0.9–2.2)
Age categories
6–12 months, N (%)	52 (25.9)	19 (25.3)	33 (26.2)	52 (27.2)
≥1–6 years, N (%)	149 (74.1)	56 (74.7)	93 (73.8)	139 (72.8)
Vomiting at presentation
Duration in hours, median (IQR)^a	48.0 (24.0–72.0)	24.0 (1.8–72.0)	48.0 (24.0–72.0)	48.0 (24.0–72.0)
Frequency in previous 24 h, median (IQR)^b	4.0 (2.0–8.0)	2.0 (1.0–4.0)	4.0 (2.0–8.0)	5.0 (4.0–10.0)
Diarrhoea at presentation
Duration in hours, median (IQR)^a	72.0 (48.0–96.0)	48.0 (17.0–96.0)	48.0 (0.0–96.0)	24.0 (0.0–72.0)
Frequency in previous 24 h, median (IQR)^b	4.0 (2.0–6.0)	3.0 (2.0–6.0)	3.0 (0.0–4.0)	2.0 (0.0–0.5)
Fever at presentation, N (%)^c	51 (25.4)	27 (36.0)	24 (19.0)	49 (25.7)
Referral to secondary care at presentation, n (%)^d	11 (5.5)	4 (5.3)	7 (5.6)	9 (4.7)

^aDuration of vomiting and diarrhoea is the duration of symptoms from start to presentation at the primary care OOH and included all children.

^bNumbers of vomiting and diarrhoeal episodes in the previous 24 h included all children.

^cFever was defined as a documented temperature of ≥ 38.0 °C.

^dReferral to secondary care at presentation was defined as direct referral from the primary care OOH service to secondary care.

IQR = interquartile range.

Table 2. Prevalence different pathogens and corresponding cycle threshold values (N = 75).

Subgroups	N	Rotavirus	Adenovirus	Astrovirus	Enterovirus	Norovirus	Sapovirus
All children, N (%) (95% CI)	75	49 (65.3) (53.5–76.0)	32 (42.7) (31.3–54.6)	8 (10.7) (4.7–19.9)	23 (30.7) (20.5–42.4)	17 (22.7) (13.8–33.8)	25 (33.3) (22.9–45.2)
Children aged 6–12 months, N (%) (95% CI)	19	10 (52.6) (28.9–75.6)	9 (47.4) (24.4–71.1)	2 (10.5) (1.3–33.1)	7 (36.8) (16.3–61.6)	6 (31.6) (12.6–56.6)	4 (21.1) (6.1–45.6)
Children aged ≥ 1–6 years, N (%) (95% CI)	56	39 (69.6) (55.9–81.2)	23 (41.1) (28.1––55.0)	6 (10.7) (4.0–21.9)	16 (28.6) (17.3–42.2)	11 (19.6) (10.2–32.4)	21 (37.5) (24.9–51.5)
Ct value median		16.0	30.5	21.5	29.0	21.0	25.0
Ct value range		10–37	4–38	8–33	13–38	10–37	10–35
Ct value categories
<20, N (%)^a		37 (75.5)	5 (15.6)	4 (50.0)	7 (30.4)	8 (47.1)	4 (16.0)
20–30, N (%)^a		11 (22.4)	11 (34.4)	3 (37.5)	8 (34.8)	3 (17.6)	17 (68.0)
>30, N (%)^a		1 (2.0)	16 (50.0)	1 (12.5)	8 (34.8)	6 (35.3)	4 (16.0)

The cycle threshold (Ct) was used to quantify the viral load, with lower values indicating a higher load. There were no significant differences between age groups.

^aPercentages are calculated with total amount of children with each specific virus infection as denominator.

Table 3. Differences between pathogens and factors related to the course of acute gastroenteritis.

Outcome	N	Total	Rotavirus	No rotavirus	p-value
Severe course of acute gastroenteritis, n/N(%)	71	31/71 (43.7)	20/47 (42.6)	11/24 (45.8)	0.81
Referral at baseline or during follow-up, n/N(%)	54	8/54 (14.8)	5/33 (15.2)	3/21 (14.3)	0.93

STROBE Statement—Checklist of items that should be included in reports of cohort studies.

Table

	Item No	Recommendation	Page No
Title and abstract	1	(a) Indicate the study’s design with a commonly used term in the title or the abstract	1 (Title page document)
		(b) Provide in the abstract an informative and balanced summary of what was done and what was found	1 (Manuscript document)
Introduction
Background/rationale	2	Explain the scientific background and rationale for the investigation being reported	2/3
Objectives	3	State-specific objectives, including any prespecified hypotheses	3
Methods
Study design	4	Present key elements of study design early in the paper	3
Setting	5	Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection	4
Participants	6	(a) Give the eligibility criteria and the sources and methods of selection of participants. Describe methods of follow-up	4
		(b) For matched studies, give matching criteria and number of exposed and unexposed	n/a
Variables	7	Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable	5/6
Data sources/ measurement	8*	For each variable of interest, give sources of data and details of assessment methods (measurement). Describe comparability of assessment methods if there is more than one group	4/5
Bias	9	Describe any efforts to address potential sources of bias	4
Study size	10	Explain how the study size was arrived at	6
Quantitative variables	11	Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why	6/7
Statistical methods	12	(a) Describe all statistical methods, including those used to control for confounding	6/7
		(b) Describe any methods used to examine subgroups and interactions	6/7
		(c) Explain how missing data were addressed	6/7
		(d) If applicable, explain how loss to follow-up was addressed	6/7
		(e) Describe any sensitivity analyses	n/a
Results
Participants	13*	(a) Report numbers of individuals at each stage of study—e.g. numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analysed	7
		(b) Give reasons for non-participation at each stage	7
		(c) Consider use of a flow diagram	See Flowchart
Descriptive data	14*	(a) Give characteristics of study participants (e.g. demographic, clinical, social) and information on exposures and potential confounders	7
		(b) Indicate number of participants with missing data for each variable of interest	7
		(c) Summarise follow-up time (e.g. average and total amount)	n/a
Outcome data	15*	Report numbers of outcome events or summary measures over time	8
Main results	16	(a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (e.g. 95% confidence interval). Make clear which confounders were adjusted for and why they were included	8
		(b) Report category boundaries when continuous variables were categorised	8
		(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period	n/a
Other analyses	17	Report other analyses done—e.g. analyses of subgroups and interactions, and sensitivity analyses	8
Discussion
Key results	18	Summarise key results with reference to study objectives	9
Limitations	19	Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias	9/10
Interpretation	20	Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence	9–12
Generalisability	21	Discuss the generalisability (external validity) of the study results	12
Other information
Funding	22	Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based	1 (Title page document)

*Give information separately for exposed and unexposed groups.

Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting. The STROBE checklist is best used in conjunction with this article (freely available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is available at http://www.strobe-statement.org.