METHODS: Literature search was performed to identify all level I and II studies reporting the clinical and structural outcome of any ACI generation in human knees using the following medical electronic databases: PubMed, EMBASE, Cochrane Library, CINAHL, SPORTDiscus and NICE healthcare database. The level of evidence, sample size calculation and risk of bias were determined for all included studies to enable quality assessment.
RESULTS: Twenty studies were included in the analysis, reporting on a total of 1094 patients. Of the 20 studies, 13 compared ACI with other treatment modalities, seven compared different ACI cell delivery methods, and one compared different cell source for implantation. Studies included were heterogeneous in baseline design, preventing meta-analysis. Data showed a trend towards similar outcomes when comparing ACI generations with other repair techniques and when comparing different cell delivery methods and cell source selection. Majority of the studies (80 %) were level II evidence, and overall the quality of studies can be rated as average to low, with the absence of power analysis in 65 % studies.
CONCLUSION: At present, there are insufficient data to conclude any superiority of ACI techniques. Considering its two-stage operation and cost, it may be appropriate to reserve ACI for patients with larger defects or those who have had inadequate response to other repair procedures until hard evidence enables specific clinical recommendations be made.
LEVEL OF EVIDENCE: II.
METHODS: Full and partial economic evaluations, published in English, associated with the management of neonatal systemic infections in South Asia will be included. Any intervention related to management of neonatal systemic infections will be eligible for inclusion. Comparison can include a placebo or alternative standard of care. Interventions without any comparators will also be eligible for inclusion. Outcomes of this review will include measures related to resource use, costs and cost-effectiveness. Electronic searches will be conducted on PubMed, CINAHL, MEDLINE (Ovid), EMBASE, Web of Science, EconLit, the Centre for Reviews and Dissemination Library (CRD) Database, Popline, IndMed, MedKnow, IMSEAR, the Cost Effectiveness Analysis (CEA) Registry and Pediatric Economic Database Evaluation (PEDE). Conference proceedings and grey literature will be searched in addition to performing back referencing of bibliographies of included studies. Two authors will independently screen studies (in title, abstract and full-text stages), extract data and assess risk of bias. A narrative summary and tables will be used to summarize the characteristics and results of included studies.
DISCUSSION: Neonatal systemic infections can have significant economic repercussions on the families, health care providers and, cumulatively, the nation. Pediatric economic evaluations have focused on the under-five age group, and published consolidated economic evidence for neonates is missing in the developing world context. To the best of our knowledge, this is the first review of economic evidence on neonatal systemic infections in the South Asian context. Further, this protocol provides an underst anding of the methods used to design and evaluate economic evidence for methodological quality, transparency and focus on health equity. This review will also highlight existing gaps in research and identify scope for further research.
SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017047275.
OBJECTIVE: This review aimed to summarize the current evidence base of reported utility values for chemotherapy-related ADEs.
METHODS: A structured electronic search combining terms for utility, utility valuation methods and generic terms for cancer treatment was conducted in MEDLINE and EMBASE in June 2011. Inclusion criteria were: (1) elicitation of utility values for chemotherapy-related ADEs and (2) primary data. Two reviewers identified studies and extracted data independently. Any disagreements were resolved by a third reviewer.
RESULTS: Eighteen studies met the inclusion criteria from the 853 abstracts initially identified, collectively reporting 218 utility values for chemotherapy-related ADEs. All 18 studies used short descriptions (vignettes) to obtain the utility values, with nine studies presenting the vignettes used in the valuation exercises. Of the 218 utility values, 178 were elicited using standard gamble (SG) or time trade-off (TTO) approaches, while 40 were elicited using visual analogue scales (VAS). There were 169 utility values of specific chemotherapy-related ADEs (with the top ten being anaemia [34 values], nausea and/or vomiting [32 values], neuropathy [21 values], neutropenia [12 values], diarrhoea [12 values], stomatitis [10 values], fatigue [8 values], alopecia [7 values], hand-foot syndrome [5 values] and skin reaction [5 values]) and 49 of non-specific chemotherapy-related adverse events. In most cases, it was difficult to directly compare the utility values as various definitions and study-specific vignettes were used for the ADEs of interest.
LIMITATIONS: This review was designed to provide an overall description of existing literature reporting utility values for chemotherapy-related ADEs. The findings were not exhaustive and were limited to publications that could be identified using the search strategy employed and those reported in the English language.
CONCLUSIONS: This review identified wide ranges in the utility values reported for broad categories of specific chemotherapy-related ADEs. There were difficulties in comparing the values directly as various study-specific definitions were used for these ADEs and most studies did not make the vignettes used in the valuation exercises available. It is recommended that a basic minimum requirement be developed for the transparent reporting of study designs eliciting utility values, incorporating key criteria such as reporting how the vignettes were developed and presenting the vignettes used in the valuation tasks as well as valuing and reporting the utility values of the ADE-free base states. It is also recommended, in the future, for studies valuing the utilities of chemotherapy-related ADEs to define the ADEs according to the National Cancer Institute (NCI) definitions for chemotherapy-related ADEs as the use of the same definition across studies would ease the comparison and selection of utility values and make the overall inclusion of adverse events within economic models of chemotherapy agents much more straightforward.