Characteristics of included studies [ordered by study ID]
Ansah 2003
|
| Methods | Quasi-randomized controlled trial
Generation of allocation sequence: alternate allocation
Allocation concealment: no information provided
Blinding of outcome assessor: none
Completeness of outcome data: 99% |
|
| | Participants | Participants: 299 analysed (155 intervention; 144 control); 301 initially recruited
Inclusion criteria: aged 0 to 5 years; brought to 1 of 2 clinics with malaria
Exclusion criteria: none given, but 2 participants excluded on developing severe malaria
Mean age: not stated
Age range: not stated
Male to female ratio: not stated
Education: not stated |
|
| | Interventions | See Appendix 2 for details |
|
| | Outcomes | Treatment adherence: number of participants following the prescribers' exact instructions in terms of dosage (spoon size for syrup not taken into account), frequency of daily administration, and duration of treatment; measured by participant interview
Caregivers' assessment of wellness at day 4
Vomiting of tablets
Not included in review:
Packaging acceptability and preference
Financial and economic costs
|
|
| | Notes | Location: Cape Coast, Ghana
Health facilities: 2 public health centres
Endemicity: highly endemic malaria
Antimalarial drug resistance: not stated
Malaria diagnosis: clinical (Plasmodium falciparum causes most morbidity and mortality in this area) |
|
|
Lauwo 2006
|
| Methods | Randomized controlled trial
Generation of allocation sequence: unclear
Allocation concealment: no information provided
Blinding of outcome assessor: none
Completeness of outcome data: 73% |
|
| | Participants | Participants: 103 analysed (91 intervention; 112 control); 180 initially recruited
Inclusion criteria: adult; clinical and microscopic diagnosis of malaria; prescribed standard antimalarial drugs; spoken and understood English, Tok Pisin or Motu
Exclusion criteria: inability to return for follow-up interview on day 4
Mean age: not stated
Age range: not stated
Male to female ratio: 242:194
Education: not stated |
|
| | Interventions | see Appendix 2 for details |
|
| | Outcomes | 1. Treatment failure at day 4
2. Treatment adherence at day 4: interview - good adherence if remember instructions and complete medication as prescribed or directed
Not included in review:
3. Health professionals' reactions to the packaging |
|
| | Notes | Location: Port Moresby, Papua New Guinea
Health facilities: outpatient department of Port Moresby General Hospital
Endemicity: not stated
Antimalarial drug resistance: chloroquine and amodiaquine
Malaria diagnosis: clinical and microscopic |
|
|
Li 1998a
|
| Methods | Quasi-randomized controlled trial
Generation of allocation sequence: alternate allocation
Allocation concealment: no information provided
Blinding of outcome assessor: none
Completeness of outcome data: number analysed provided but number recruited not provided |
|
| | Participants | Participants: 324 analysed (161 intervention; 163 control); no data provided on how many participants were initially recruited
Inclusion criteria: slide positive for Plasmodium vivax malaria; aged > 15 years; ambulatory
Exclusion criteria: major clinical symptoms requiring hospitalization; malaria treatment in the previous 6 months
Mean age: 31 years
Age range: 16 to 63 years
Male to female ratio: 300:24
Education: not stated |
|
| | Interventions | See Appendix 2 for details |
|
| | Outcomes | Treatment adherence: number of participants completing full treatment; measured by participant interview
Participants tested for parasitaemia at day 9
|
|
| | Notes | Location: Hunan province, China
Health facilities: staff highly qualified, each station had good working relationship with provincial authorities
Endemicity: epidemic (imported) malaria
Antimalarial drug resistance: not stated
Malaria diagnosis: microscopically confirmed Plasmodium vivax malaria |
|
|
Li 1998b
|
| Methods | Quasi-randomized controlled trial
Generation of allocation sequence: alternate allocation
Allocation concealment: no information provided
Blinding of outcome assessor: none
Completeness of outcome data: number analysed provided but number recruited not provided |
|
| | Participants | Participants: 272 analysed (138 intervention; 134 control); no information provided on the number of participants initially recruited
Inclusion criteria: slide positive for Plasmodium vivax malaria; aged > 15 years; ambulatory
Exclusion criteria: major clinical symptoms requiring hospitalization; malaria treatment in the previous 6 months
Mean age: not stated
Age range: 11 to 67 years
Male to female ratio: mostly male
Education: not stated |
|
| | Interventions | See Appendix 2 for details |
|
| | Outcomes | Treatment adherence: adherence to chloroquine at day 4 and to primaquine at day 9; measured by participant interview and phenobarbital marker level-to-dose ratios (for each drug separately and for both drugs together)
Recrudescence at days 1 to 100
Not included in review:
Reasons for non-adherence
|
|
| | Notes | Location: Hunan province, China; conducted in same region as Li 1998a, but different participants (clarified following correspondence with trialists)
Health facilities: staff highly qualified, each station had good working relationship with provincial authorities
Endemicity: epidemic (imported) malaria
Antimalarial drug resistance: not stated
Malaria diagnosis: microscopically confirmed Plasmodium vivax malaria |
|
|
Yeboah-Antwi 2001
|
| Methods | Cluster-randomized controlled trial
Generation of allocation sequence: adequate
Allocation concealment: no information provided
Blinding of outcome assessor: none
Completeness of outcome data: number analysed provided but number recruited unclear
Trialists did not take clustering into account in the analysis of this cluster-randomized controlled trial |
|
| | Participants | Participants: facilities randomized rather than participants; 3 intervention facilities (262 participants) and 3 control facilities (247 participants); 190 participants excluded from this review as they did not receive unit-dose packaged drugs; unclear how many were recruited initially
Inclusion criteria: diagnosed with malaria; treated with chloroquine; living in the town of the facility
Exclusion criteria: diagnosed as having malaria but not treated with chloroquine; living outside the town where the facility is located
Mean age: not stated
Age range: adults and children (7+ years)
Male to female ratio: 197:312
Education: 309 none; 170 primary; 30 other
Note: these data are for the entire trial; we have excluded participants receiving syrup from the review |
|
| | Interventions | See Appendix 2 for details |
|
| | Outcomes | Treatment adherence: number completing full treatment in relation to given treatment guidelines. Measured by patient interview and drug inspection
Wellness at day 4: participants asked if they were feeling better, same, or worse compared to the day they went to the clinic/hospital
Adverse events (reasons for non-adherence/withdrawal)
Not included in review:
Packaging perceptions and acceptance
Some costs data
|
|
| | Notes | Location: Wenchi District, Brong Ahafo Region, Ghana
Health facilities: no data available
Endemicity: intense stable malaria transmission with slight seasonal variations (45.9% to 46.8%)
Antimalarial drug resistance: chloroquine resistance said to be low (only drug used at health centres, health posts and rural clinics)
Malaria diagnosis: confirmed clinically (Plasmodium falciparum is the main cause of morbidity and mortality in this region) |
|
|
Characteristics of excluded studies [ordered by study ID]
|
| Study | Reason for exclusion |
|---|
| | Agyepong 2002 | This trial was not controlled |
| | Browne 2001 | This trial was not controlled |
| | Cullinan 1997 | Participants included in this trial had severe malaria |
| | Krudsood 2002 | Both treatment groups received identical packaging intervention |
| | Okonkwo 2001 | The packaging used in this trial was not unit-dose packaging |
| | Pagnoni 1997 | This trial was not controlled |
| | Shwe 1998 | Both treatment groups received identical packaging interventions |
| | Sirima 2003 | This trial was not controlled |
|
|
Comparison 1. Blister-packed tablets and capsules versus tablets and capsules in paper envelopes
Comparison 2. Tablets in sectioned polythene bags versus bottled syrup
Comparison 3. Tablets in sectioned polythene bags versus polythene bags (unsectioned)
