Protocol for a systematic review of preference-based instruments for measuring care-related outcomes and their suitability for the palliative care setting.

Despite informal caregivers' integral role in supporting people affected by disease or disability, economic evaluations often ignore the costs and benefits experienced by this group, especially in the palliative setting. The purpose of this systematic review is to identify preference-based instruments for measuring care-related outcomes and provide guidance on the selection of instrument in palliative care economic evaluations. A comprehensive search of the literature will be conducted from database inception (ASSIA; CINAHL; Cochrane library including DARE, NHS EED, HTA; Econlit; Embase; PsychINFO; PubMed). Published peer-reviewed, English-language articles reporting preference-based instruments for measuring care-related outcomes in any clinical area will be included. One researcher will complete the searches and screen the results for potentially eligible studies. A randomly selected subset of 10% citations will be independently screened by two researchers. Any disagreement will be resolved by consensus among the research team. Subsequently, a supplementary search will identify studies detailing the development, valuation, validation and application of the identified instruments. The degree of suitability of the instruments for palliative economic evaluations will be assessed using criteria in the International Society for Quality of Life Research minimum standards for patient-reported outcome measures, the checklist for reporting valuation studies of multiattribute utility-based instruments and information on the development of the instrument in the palliative setting. A narrative summary of the included studies and instruments will be provided; similarities and differences will be described and possible reasons for variations explored. Recommendations for practice on selection of instruments in palliative care economic analyses will be provided. This is a planned systematic review of published literature. Therefore, ethics approval to conduct this research is not required. Findings will be presented at leading palliative care and health economic conferences and published in a peer-reviewed journal. CRD42016034188.

McCaffrey N ，Al-Janabi H ，Currow D ，Hoefman R ，Ratcliffe J ... -  《BMJ Open》

Protocol for a systematic review of instruments for the assessment of quality of life and well-being in children and adolescents with cerebral palsy.

Cerebral palsy is the most common cause of physical disability in children and adolescents and is associated with impairments that may reduce the quality of life (QOL) of this population. Patient-reported outcome measures (PROMs) can facilitate the assessment of the effect of disease and treatment on QOL, from a patient viewpoint. The purpose of this systematic review is to identify PROMs that are used to measure QOL and subjective well-being (SWB) outcomes in young people with cerebral palsy and to evaluate the suitability of these PROMs for application in economic evaluations within this population. MEDLINE, Scopus, the Cochrane Library, Web of Science Core Collection, EconLit, PsycINFO, CINAHL, EMBASE and Informit will be systematically searched from inception to date of search. Published peer-reviewed, English-language articles reporting PROMs measuring QOL or SWB outcomes in children and adolescents with cerebral palsy will be included. One reviewer will conduct the initial search and screen titles and abstracts for potentially eligible studies. The search will be performed in November 2017. To reduce the likelihood of reviewer selection bias, two other reviewers will independently screen a randomly selected subsample (10%) of the citations. Two reviewers will then retrieve full texts of potentially eligible studies and assess them against predefined inclusion criteria. The suitability of selected PROMs for use in economic evaluations of young people with cerebral palsy will be assessed using the International Society of Quality of Life Research recommended Minimum Standards and the Patient-Centered Outcomes and Comparative Effectiveness Research checklist. A narrative synthesis of extracted data will be presented including study descriptive data, PROMs measurement properties, settings in which they were applied and the valuation methods. Recommendations for practice on the selection of PROMs for use in economic evaluations of children and adolescents with cerebral palsy will be presented. Ethical approval is not required as the proposed systematic review will not use primary data. The results of this study will be widely disseminated through publication in a peer-reviewed journal and conference presentation(s). International Prospective Register of Systematic Reviews number: CRD42016049746.

Mpundu-Kaambwa C ，Chen G ，Huynh E ，Russo R ，Ratcliffe J ... -  《BMJ Open》

Protocol for a systematic review of the financial burden experienced by people affected by head and neck cancer.

Head and neck cancer (HNC) is the seventh most common cancer worldwide. Treatment may be associated with the inability to work and substantial out-of-pocket expenses. However, to date, there is little research synthesising quantitative evidence on the financial burden experienced by people affected by HNCs, including family members and informal carers. The purpose of this systematic review is to estimate out-of-pocket costs, reduced or lost income and informal care costs associated with HNC, identify categories of financial burden and investigate which costs predominate when considering financial burden in this population. A comprehensive search of peer-reviewed literature will be conducted for articles published from 01/01/2010 to 19/03/2021 (CINAHL, Cochrane library, EconLit, Embase, Medline Complete). Published, English-language articles describing primary and secondary research directly related to the topic and quantitative cost data will be included. One researcher will complete the searches and screen results for potentially eligible studies. Three other researchers will independently screen the titles and abstracts of a subset of 30% citations, that is, 10% each. Full text articles will be independently screened by three reviewers. Any disagreement will be resolved by consensus among the team. Study and patient characteristics, cost categories and financial burden will be independently extracted by one reviewer and checked by a second. Methodological quality will be evaluated independently by two reviewers. Descriptive analyses will be undertaken and a narrative summary of the included studies will be provided. Ethics approval is not required to conduct this research because this is a planned systematic review of published literature. Findings will be presented at leading cancer and health economic conferences, published in a peer-reviewed journal and disseminated via website postings and social media channels. CRD42021252929.

McCaffrey N ，Engel L 《BMJ Open》

Methodological aspects of economic evaluations conducted in the palliative or end of life care settings: a systematic review protocol.

In light of this growing palliative care and end of life care patient population, as well as new (expensive) drugs and treatments, quality research providing evidence for decision-making is required. However, common research guidance is lacking in this field, especially in respect to the methods applied in economic evaluations. Therefore, the aim of the planned systematic review is to identify and summarise relevant information on methodological challenges, potential solutions and recommendations for conducting economic evaluations of interventions in adult patients, irrespective of their underlying disease and gender in the palliative or end of life care settings, with no restrictions in regards to countries/geographical regions. The results of this systematic review may help to clarify the current methodological questions and form the basis of new, setting specific methods guidelines and support ongoing applied economic evaluations in the field. A systematic review will be conducted using Medline, Embase, Health Technology Assessment Database and NHS Economic Evaluation Database to identify the studies published from 1999 onwards with relevant information on methodological challenges, potential solutions and recommendations for conducting economic evaluations in the palliative or end of life care settings. Articles in English, German, Spanish, French or Dutch language will be considered. Two independent reviewers will conduct the screening of articles; any discrepancies will be resolved by discussion and involvement of a third reviewer. Predesigned data extraction forms will be applied, consequently narratively synthesised and categorised. Studies' methodological quality will be critically appraised. Besides existing economic guidelines and checklists for specific information on the palliative and end of life care sector will be searched. Ethical approval is not required, as this is a planned systematic review of published literature. An article will be disseminated in a related peer-reviewed journal, as well as presented at leading palliative care and health economic conferences. CRD42020148160.

Fischer C ，Chwala E ，Simon J 《BMJ Open》

Protocol for a systematic review of economic evaluations of preoperative smoking cessation interventions for preventing surgical complications.

The short-term economic benefit of embedding best practice tobacco dependence treatment (TDT) into healthcare services prior to surgery across different populations and jurisdictions is largely unknown. The aim of this systematic review is to summarise the cost-effectiveness of preoperative smoking cessation interventions for preventing surgical complications compared with usual care. The results will provide hospital managers, clinicians, healthcare professionals and policymakers with a critical summary of the economic evidence on providing TDT routinely before surgery, aiding the development and dissemination of unified, best practice guidelines, that is, implementation of article 14 of the WHO Framework Convention on Tobacco Control. A comprehensive search of peer-reviewed literature will be conducted from database inception until 23 June 2021 (Cochrane, Econlit, Embase, Health Technology Assessment, Medline Complete, Scopus). Published, English-language articles describing economic evaluations of preoperative smoking cessation interventions for preventing surgical complications will be included. One researcher will complete the searches and two researchers will independently screen results for eligible studies. Any disagreement will be resolved by the third researcher. A narrative summary of included studies will be provided. Study characteristics, economic evaluation methods and cost-effectiveness results will be extracted by one reviewer and descriptive analyses will be undertaken. A second reviewer will review data extracted for accuracy from 10% of the included studies. Reporting and methodological quality of the included studies will be evaluated independently by two reviewers using the Consolidated Health Economic Evaluation Reporting Standards statement and the Quality of Health Economic Studies Instrument checklist, respectively. This research does not require ethics approval because the study is a planned systematic review of published literature. Findings will be presented at health economic, public health and tobacco control conferences, published in a peer-reviewed journal and disseminated via social media. CRD42021257740.

McCaffrey N ，Higgins J ，Lal A 《BMJ Open》