This protocol of overview of systematic reviews is being reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) [
48] (see checklist in Additional file
1). This protocol has been registered within the International Prospective Register of Systematic Reviews (PROSPERO) database (registration ID: CRD42020186003).
Overviews refer to systematic reviews of systematic reviews in this research [
49]. We will search for and identify multiple systematic reviews on paediatric massage-related study questions explicitly and systematically to extract and analyse the results across significant outcomes. The methods have been chosen in consultation with the methodological work of Cochrane Handbook (Cochrane Handbook, Chapter V.4). We will consider published articles of completed systematic reviews of randomised controlled trials. We will include reviews that explicitly stated methods to identify studies (e.g. a search strategy), explicitly stated methods of study selection (e.g. criteria for inclusion) and explicitly described methods of qualitative and/or quantitative data synthesis. We will also perform a supplementary systematic review to summarise the evidence of the adverse effects of massage on infants and children aged < 5 years. The methods of this review are based on the criteria of conducting systematic reviews of adverse events in the
Cochrane Handbook of Systematic Reviews of Interventions [
50], and the
CRD’
s guidance for undertaking reviews in health care [
51].
Types of interventions
We will include systematic reviews that examine the effects and/or safety of massage therapy for infants and children aged < 5 years. Massage is defined as manipulations conducted on the soft tissue of a child’s body, which might include kneading, grasping, pressing, pushing, nipping, rotating, stretching, rubbing and so forth [
52]. This intervention can be used for treating or preventing diseases, improving the situation of medical conditions, promoting growth, health preservation, improving immunity, among others. We will include all types of massage therapies.
Types of comparisons
We will include systematic reviews of RCTs that compare the effects between massage therapy and other interventions, control interventions, or no intervention. The comparisons include waitlist control, placebo or sham controls, positive controls, pharmacological treatments, combinations of treatments and usual or standard care. Studies comparing the effects of different kinds of massage therapies, or between massage and other complementary and alternative therapies, will be excluded.
Setting
We will include systematic reviews of RCTs that have been conducted in any setting. The intervention could be implemented anywhere, such as hospitals and at home. The therapists could be parents, caregivers, paediatricians, experts, practitioners or other qualified personnel. The clinical trials could be pilot studies, feasibility studies, fully powered studies or other phases. There are no limitations in other aspects of the setting.
We will search the following databases, from inception onwards: Ovid MEDLINE, Embase, Health Technology Assessment Database (HTA), the Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (DARE), Allied and Complementary Medicine (AMED), China National Knowledge Infrastructure (CNKI) and Wanfang Data. The following keywords will be used: (massag* OR touch OR tactile stimulation OR anmo OR acupressure OR
tuina OR manipulat*) AND (newborn* OR child* OR baby OR babies OR infant* OR youth OR paediatric* OR paediatric* OR toddler* OR pre-school* OR pre-school*). The literature searches will be designed and conducted by the review team in consultation with a health information specialist. The search will include a broad range of terms and keywords related to massage, children and systematic reviews. A draft search strategy for EMBASE is provided in Additional file
2. To search the Chinese databases, the corresponding Chinese keywords will be used. We will contact the authors of the studies if necessary information is missing from the publications. References for the included studies will be searched for useful information. To address the on-going systematic reviews, we will also search the PROSPERO database to identify the registered relevant systematic reviews. We will not impose any time or language restrictions. Information on adverse effects from the included systematic reviews may not be comprehensive. To supplement this, the index term, free-text searching approach and ‘Grey’ literature hand-searching will be used for identifying articles with information on adverse effects.
Data synthesis
We will report the results according to the Cochrane Handbook of Systematic Reviews of Interventions. A PRISMA flowchart will be used to present the process of study selection for both the overview and the systematic review. We will summarise the evidence for each universe of diseases, disorders, or other conditions. The universes will be classified according to the International Classification of Diseases, 11th version (ICD-11), which is the international standard for reporting diseases and health conditions [
57].
Characteristics of the included systematic reviews such as key features, effect estimates, 95% confidence intervals and measures of heterogeneity (if studies are pooled), as well as findings and variations of the studies will be extracted, transformed and presented in tables, and graphics (e.g. funnel plots) will be used as appropriate.
If multiple reviews/meta-analyses include information from overlapping individual studies, a meta-analysis will not be performed. Instead, a qualitative synthesis or summary for each outcome and intervention reporting the pooled treatment effects from the most comprehensive and highest-quality meta-analyses (as assessed by the AMSTAR-2 approach). We will provide a narrative summary of the quality assessment of the included meta-analyses, which will be supported by a table showing the results of the critical appraisal.
If there is discrepancy in the results of these reviews, then we will further explore the factors that lead to the variations or discrepancies, such as eligibility criteria settings, literature search details, outcome definitions used and statistical analysis approaches.
The problem of double-counting data will be considered prudently. To minimise the reduplicative information extracted from overlapping trials, the following strategies will be applied:
-
If the qualities of these reviews are similar, we will select the one that contributes the most outcome data.
-
If the outcomes of these reviews are completely overlapping, we will retain the one with the highest quality.
-
If the outcomes of these reviews are partly overlapping, we will completely retain the highest-quality review and partly retain those with lower-quality.
-
If the outcomes of these reviews do not overlap, we will retain all.
-
If the outcomes of these reviews are completely overlapping and their qualities are similar, we will select the most recent.
We will present the effects of massage therapy based on the most comprehensive reviews with the highest quality. For the overlapping reviews that are not included in the intervention effects analysis, we will report their general information in a table to enable readers to obtain useful data. The AMSTAR 2 instrument, Cochrane RoB tool and GRADE approach will be used to assess the quality of the reviews.
When possible, we will extract and report pooled effect estimates for meta-analysed outcomes for each review that meets the inclusion criteria. For dichotomous outcomes, relative risks (RRs) with 95% confidence intervals (CIs) will be pooled, while for continuous outcomes, mean differences (MDs) with 95% CIs for the same outcome measure or standardised mean differences (SMDs) with 95% CIs for different outcome measures will be expressed. For time-to-event data, hazard ratios (HRs) with 95% CIs will be expressed [
49]. However, we will not compute an overview meta-estimate due to the heterogeneity in ages and outcomes between trials, the absence of essential data and the lack of well-established quantification methods.
Adverse effects of massage therapy reported in the systematic reviews will be listed and summarised narratively. The mechanism of adverse effects of therapies for several conditions might be similar in different populations and settings [
50]. Therefore, we will collect adverse effects regardless of the condition or how massage therapy was conducted. We will also collect information on adverse effects from the overlapping included systematic reviews. We will consider a high drop-out rate (≥ 20%) as an outcome measure in study reports for adverse effects, since withdrawal might be related to upsetting side effects, stress on subjects, or others [
49,
58].
According to the results synthesised from the data on effects and safety issues, we will generate a figure to present the recommendation level of massage therapy for each included condition, considering the gender, age, and other factors. Since the mechanism of treatment effects might be similar on the same outcomes across different conditions, we will also generate a figure to summarise evidence for each outcome, if possible. Sufficient systematic review evidence will be the most important criterion for the generation of the final recommendation level figure, and all adverse effects for each condition will be emphasised and marked.