|Methods||Randomised controlled trial (September 1995 to September 1996 "on weekday mornings")|
|Participants||581 patients enrolled. 522 allocated to radiograph or to the control group (59 excluded)|
"Children aged 2 to 59 months who presented to the Red Cross Children's Hospital [Cape Town] as their first contact were eligible for this study if they met the WHO case definition for pneumonia (i.e. cough and tachypnoea but drinking well and without chest indrawing, cyanosis, abnormal level of consciousness or stridor)."
"Tachypnoea was defined as a respiratory rate of 50 breaths or more/min in children aged 2 to 11 months, and 40 breaths or more/min in children aged 12 months or more."
Exclusion criteria: "cough of more than 14 days duration, history of current household contact with active tuberculosis, a localised wheeze, clinical signs of cardiac failure or the clinician's assessment that a chest radiograph was mandatory"
"The study was done in the primary general outpatients section. Patients were enrolled from September, 1995, to September, 1996, on weekday mornings. An experienced registered nurse screened all waiting patients, and identified eligible individuals. Baseline information collected at this stage included age, weight, duration of symptoms before presentation, and respiratory rate."
N = 522
|Interventions||"Eligible patients identified by the nurse were seen by a clinician. After the medical history of each patient was taken and an examination done, eligible patients were allocated to the radiograph or to the control group."|
"The intervention was the use of a chest radiograph (anteroposterior and lateral views). The chest radiograph was viewed by the clinician and a routine report supplied by the duty paediatric radiologist or radiology registrar was available with the films. The control was standard of care without a chest radiograph. All other management was entirely at the discretion of the clinician."
- N = 286 allocated to have chest radiograph
- 13 did not have it done - 273 children X-rayed
|Outcomes||"The primary outcome measure was time to recovery, measured by twice weekly structured telephone interviews of the subset of 295 participants contactable by telephone."|
"Respondents were asked 'Is (child's name) completely well yet?' If the answer was 'Yes', the next questions was 'On what day was he/she last sick?'. Answers to three of the questions in the questionnaire (subsequent visits and admissions to the Children's Hospital and subsequent chest radiographs done there) were verified by examination of the clinical records"
"Subsidiary outcomes were management options used (additional tests ordered, number of drugs per prescription, antibiotic use, follow-up appointment, and immediate admission to hospital) and other clinical outcomes (return visits and later hospital admission). All subsidiary outcomes were ascertained by examination of clinical records of all patients by the principal investigator (whether contactable by telephone or not), except for visits to facilities other than the Children's Hospital, which were measured by the above telephone interview."
|Notes||"The aim of this study was to quantify the effect of the use of chest radiographs on the management and clinical outcome in children with ambulatory acute lower respiratory tract infection, and to determine whether any such effect was dependent on the experience of the clinician"|
|Risk of bias|
|Bias||Authors' judgement||Support for judgement|
|Random sequence generation (selection bias)||High risk||"..the random allocation [was] generated in advance by the principal investigator (by tossing a coin)."|
|Allocation concealment (selection bias)||High risk||"Allocation was done by the clinician opening a sealed sequentially numbered manila envelope attached to the consultation sheet and containing the random allocation..."|
"If a patient was excluded by the clinician before randomisation the sealed envelope was returned to the principal investigator. The return of envelopes was audited."
"There were no differences in baseline characteristics between groups or between randomised and excluded patients."
|Blinding of outcome assessment (detection bias) |
|Low risk||"The telephone interviewer was not informed of the study hypothesis, was blind to the randomisation status of the patients, and had no contact with the hospital other than through the principal investigator. On casual enquiry at the end of the study, the interviewer had guessed only that the study dealt with chest infections."|
"Coding and cleaning of telephone questionnaire data was done without knowledge of treatment group by the principal investigator on a separate data capture sheet and in a separate database."
|Incomplete outcome data (attrition bias) |
|High risk||"Patients were analyzed by intention-to-treat"|
"Of the 581 eligible patients identified by the registered nurse, 59 (26 contactable by telephone) were excluded by the clinicians before randomisation. The remaining 522 patients were randomly allocated, 259 to the radiograph group and 263 to the control group. Four (1.5%) patients in the radiograph group did not receive the intervention whereas 7 (2.7%) of the control group had a radiograph on the day of randomisation"
"295 (77.5%) of the patients providing a telephone number were followed till recovery or censored at 28 days. Of the 522 participants 518 (99.2%) record sheets of the first consultation were retrieved, and all 522 folders for assessment of subsequent visits."
"Although 22% of participants who had a telephone number were lost to follow-up: loss was similar between treatment groups. In addition, the lack of effect of a chest radiograph measured by telephone interview is consistent with the lack of effect on outcomes measured by examination of clinical records, where follow-up was virtually complete."
|Selective reporting (reporting bias)||Low risk||No trial protocol was available. However, all outcomes were reported|
|Other bias||Unclear risk||"Reliability of record review was assessed by repeat examination of a 10% random sample of clinical records by a second observer not involved in the study. 12 items were assessed: exclusion before randomisation, treatment allocation, clinician's perceived need for chest radiograph, diagnosis, and the outcome variable listed..."|
No conflicts of interest and financial disclosures reported. However, "this study was supported by the Medical Research Council of South Africa and the University of Cape Town."
Note: potential recruitment bias as "Patients were enrolled from September 1995 to September 1996 on weekday mornings."