Warf 2005.

Study characteristics
Methods	Study design: parallel‐group randomised trial Study dates: start date: 2001 ‐ end date: 2002 Setting: outpatient, single‐centre, national Country: Uganda
Participants	Inclusion criteria: infants with hydrocephalus Exclusion criteria: not reported Sample size: 90 Group 1 (n = 47): Chhabra shunt Age, median (IQR): 8.8 (0.75‐84) months Sex: not reported Group 2 (n = 43) Codman shunt Age, median (IQR): 7.4 (0.25‐32) months Sex: not reported Relevant participant details (diagnosis): Group 1 (n = 47) Chhabra shunt: 49% of patients had postinfectious hydrocephalus, 14% of patients had hydrocephalus related to myelomeningocele, 37% of patients had non‐postinfectious hydrocephalus from other causes (such as congenital). Group 2 (n = 43) Codman shunt: 64% of patients had postinfectious hydrocephalus, 7% of patients had hydrocephalus related to myelomeningocele, 29% of patients had non‐postinfectious hydrocephalus from other causes (such as congenital).
Interventions	Group 1 (n = 47): Patients received a Chhabra shunt. The Chhabra shunt (G. Surgiwear Ltd., India) is an unified shunt system that incorporates a proximal slit‐in‐spring valve. The Chhabra system is available in three pressure type models. A medium pressure system allows a flow of 20 mL/hr at a pressure gradient of 10 cm of water. Group 2 (n = 43): Patients received a Codman VP shunt. Codman‐Hakim Micro Precision Valve (Medos S. A. [Johnson & Johnson Co.], Switzerland) is a unified shunt using the Hakim Precision Valve. Codman‐Hakim Micro Precision Valves are fixed pressure valves and are available in 5 different opening pressure ranges. The operating pressures of the valve unit have been determined with a flow rate of 10–25 mL H2O per hour. The valve is classified by its operating pressure with a specified flow rate and not by its opening and closing pressures. Co‐interventions: "Patients were positioned for right frontal or right occipital shunt placement. An occipital approach was used with placement of the catheter in the occipital horn, with the exception of four Chhabra and one Codman shunts, which were placed frontally in the frontal horn. The shunt valve was flushed and tested to confirm an appropriate closing pressure. The shunt was tunnelled subcutaneously between the incisions. A pinpoint of dura was cauterised and punctured after removing bone, when necessary, and the ventricular catheter was passed. Flow was confirmed, a cerebrospinal fluid sample was obtained, and the catheter was secured to the valve connector (for the Chhabra) or the integral reservoir connector (for the Codman) with a 2‐0 silk tie. The valve construct was then secured to the dura or pericranial tissue with a 3‐0 silk stitch."
Outcomes	Treatment failure How measured: valve malfunction and infection Time points measured: 1 week and 3, 6, and 12 months postoperatively Time points reported: 12 months Subgroups: none Adverse events How measured: infections, obstruction and migration Time points measured: 1 week and at 3, 6, and 12 months postoperatively Time points reported: 12 months Subgroups: none Mortality for all causes How measured: not reported Time points measured: 1 week and at 3, 6, and 12 months postoperatively Time points reported: 1 and 12 months Subgroups: none Quality of life: not reported Ventricular size reduction: not reported Head circumference: not reported (only as a baseline characteristic)
Funding sources	International Federation for Spina Bifida and Hydrocephalus CURE International (which funds CURE Children’s Hospital of Uganda)
Declarations of interest	The author has no financial interest that relates in any way to this report.
Notes	The report of the study included a "Group 2" which consisted of 105 consecutive patients in whom only Chhabra shunts were placed over the course of 9 months. This was prior to March 2002, in which no Codman shunts were available during this period.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	"Therefore, the type of VP shunt selected for use was random, based on either coin toss at the time of operation or availability and was in no way influenced by clinical criteria." While there was a component of random sequence, the distribution of participants was also dependent on valve availability.
Allocation concealment (selection bias)	Unclear risk	No information available about allocation concealment
Blinding of participants and personnel (performance bias) Subjective outcomes: treatment failure, adverse events, quality of life	High risk	No information about blinding available, however personnel was aware of the type of shunt being placed during the procedure.
Blinding of participants and personnel (performance bias) Objective outcomes: mortality, head circumference, ventricular size	Low risk	No information about blinding available, however personnel was aware of the type of shunt being placed during the procedure. Outcomes were likely to be unaffected by blinding.
Blinding of outcome assessment (detection bias) Subjective outcomes: treatment failure, adverse events, quality of life	High risk	No information about blinding available, however personnel was aware of the type of shunt being placed during the procedure.
Blinding of outcome assessment (detection bias) Objective outcomes: mortality, head circumference, ventricular size	Low risk	No information about blinding available, however personnel was aware of the type of shunt being placed during the procedure. Outcomes were likely to be unaffected by blinding.
Incomplete outcome data (attrition bias) All outcomes	High risk	"Patients with no known problem but who were lost to follow up prior to 1 year postoperatively were eliminated from analysis." 4/47 participants were lost in the Chhabra group and 7/43 participants were lost in the Codman group. Unbalanced attrition (9% vs 16%)
Selective reporting (reporting bias)	Unclear risk	No protocol available. Head circumference and ventricular size were assessed at follow‐up but they were not reported as outcomes (no information as to whether they were prespecified).
Other bias	Low risk	No other sources of bias were detected.

CSF: cerebrospinal fluid
CT: computed tomography
ICP: intracranial pressure
IQR: interquartile range
IVP: intraventricular pressure
MEI: modified Evan's index
M/F: male/female
MRI: magnetic resonance imaging
NTD: neural tube defect
OFC: occipito frontal circumference
SV: slit ventricle
vs: versus