The search for published data will include the following electronic databases: MEDLINE-PubMed (1966-present), EMBASE (1980-present), Cochrane Central Register of Controlled Trials (CENTRAL), AMED, Cochrane Library, Database of Abstracts or Reviews of Effectiveness (DARE), CINAHL, ISI Web of Science, Science Direct, and Scopus.
Preliminary MEDLINE (PubMed) Search Strategy: A preliminary search was conducted with search terms run sequentially and then line numbers combined in PubMed’s Advanced Search>Search Builder. The preliminary search strategy included three main concepts: the naturopathic element, the treatment/whole systems element, and the patients/outcomes element. On 2-14-12, it retrieved 192 hits.
Following planned peer-review of the prelimary search, adaptations were made to produce the finalized MEDLINE Search Strategy. This strategy will be revised according for each of the above databases. See notes below for discussion of decision points in formulating the search strategy.
Finalized MEDLINE Search Strategy (3-30-12)
#1 Naturopathy [mh] OR naturopath* [tw]
# 2 Therapeutics [mh] OR Therapy [sh] OR Therapeutic Use [sh] OR treatment* [tw] OR therapy [tw] OR therapies [tw] OR intervention* [tw] OR multimodal* [tw] OR multi-modal* [tw] OR modalit* [tw] OR “whole practice” [tw] OR “whole system” [tw] OR “whole systems” [tw]
#3 Patients [mh] OR patient [tw] OR patients [tw] OR client [tw] OR clients [tw] OR consumer [tw] OR consumers [tw]
#4 Patient Care [mh] OR Consumer Satisfaction [mh] OR Professional-Patient Relations [mh] OR Perception [mh] OR perception* [tw] OR perceiv* [tw] OR satisf* [tw]
#5 Self Care [mh] OR “self care” [tw] OR self regulat* [tw] OR self monitor* [tw] OR “self management” [tw] OR self efficac* [tw] OR “personal care” [tw] OR personal regulation* [tw] OR personal monitor* [tw] OR “personal management” [tw] OR personal efficac* [tw] OR “individual care” [tw] OR individual regulation* [tw] OR individual monitor* [tw] OR “individual management” [tw] OR individual efficac* [tw]
#6 Patient Acceptance of Health Care [mh] OR Utilization [sh] OR “service utilization” [tw] OR accept* [tw] OR attitude* [tw] OR behavio* [tw] OR complian* [tw] OR adhere* [tw] OR improve* [tw] OR improving [tw] OR chang* [tw] OR cope [tw] OR coped [tw] OR coping [tw] OR skill* [tw] OR knowledge* [tw] OR learn* [tw] OR productiv* [tw]
# 7 “Outcome Assessment (Health Care)” [mh] OR Treatment Outcome [mh] OR Program Evaluation [mh] OR outcome* [tw] OR evaluat* [tw] OR impact* [tw] OR effective* [tw] OR efficac* [tw] OR qualit* [tw]
#8 Quality of Life [mh] OR Quality-Adjusted Life Years [mh] OR life qualities [tw] OR life quality [tw] OR quality adjusted [tw] OR adjusted life [tw] OR qol [tw] OR qoly [tw] OR qolys [tw] OR hrqol [tw] OR qaly [tw] OR qalys [tw]
#9 Cost-Benefit Analysis [mh:noexp] OR Costs and Cost Analysis [mh:noexp] OR Cost Savings [mh] OR Economics [majr] OR EC [sh] OR cost-effective* [tw] OR cost-analys* [tw] OR cost [ti] OR costs [ti] OR costing [ti] OR economic* [ti] OR “sensitivity analysis” [tw]
#10 #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9
#11 #1 AND #2 AND #10
#12 Editorial [pt] OR Comment [pt] OR Letter [pt] OR Newspaper Article [pt]
#13 #11 NOT #12
#14 #11 NOT #12 Limits: Human
#15 Publisher [sb] OR In Process [sb] OR Pubmednotmedline [sb]
#16 #13 AND #15
#17 #14 OR #16
#18 #14 OR #16 Limits: English, French, Spanish
Notes regarding decisions and rationale for search strategy:
#1: Naturopathic aspect
Using quotes and [tiab] with “naturopathic”, “naturopathy”, and “naturopath” turns off PubMed mapping and searches for these terms only in the title and abstract fields.
o Truncating to naturop* retrieved far too many irrelevant hits. (For a line-by-line analysis of how PubMed runs naturop* and the number of relevant hits based on scanning abstracts, see the end of this document.)
o Without [tiab], PubMed searches these terms in all fields, including Affiliation (i.e. Canadian College of Naturopathic Medicine; Southwest College of Naturopathic Medicine; Council of Naturopathic Medical Education; etc.), again resulting in irrelevant hits.
o Naturopathy[mh] searches the MeSH Subject field, including all subheadings only found relevant results with economics, methods and standards subheadings, but chose to increase sensitivity by searching them all.
#2: Outcomes/therapeutic aspect
Virtually all citations that meet the criteria of this review will include at least one of the outcome/therapeutic terms; this search string hardly reduces the number of hits retrieved without it (by 8 citations on 2-14) but seems a crucial element of the search.
o Outcome runs as: outcome[All Fields]
o Treatment Outcome runs as: "treatment outcome"[MeSH Terms] OR ("treatment"[All Fields] AND "outcome"[All Fields]) OR "treatment outcome"[All Fields]
o Outcome Assessment (Health Care) runs as: ("outcome assessment (health care)"[MeSH Terms] OR ("outcome"[All Fields] AND "assessment"[All Fields] AND "(health"[All Fields] AND "care)"[All Fields]) OR "outcome assessment (health care)"[All Fields] OR ("outcome"[All Fields] AND "assessment"[All Fields]) OR "outcome assessment"[All Fields]) AND ("delivery of health care"[MeSH Terms] OR ("delivery"[All Fields] AND "health"[All Fields] AND "care"[All Fields]) OR "delivery of health care"[All Fields] OR ("health"[All Fields] AND "care"[All Fields]) OR "health care"[All Fields])
o Outcomes research runs as: "outcome assessment (health care)"[MeSH Terms] OR ("outcome"[All Fields] AND "assessment"[All Fields] AND "(health"[All Fields] AND "care)"[All Fields]) OR "outcome assessment (health care)"[All Fields] OR ("outcomes"[All Fields] AND "research"[All Fields]) OR "outcomes research"[All Fields]
o Comparative Effectiveness Research runs as: "comparative effectiveness research"[MeSH Terms] OR ("comparative"[All Fields] AND "effectiveness"[All Fields] AND "research"[All Fields]) OR "comparative effectiveness research"[All Fields]
o therapeutic modality runs as: ("therapeutics"[MeSH Terms] OR "therapeutics"[All Fields] OR "therapeutic"[All Fields]) AND modality[All Fields]
o treatment runs as: "therapy"[Subheading] OR "therapy"[All Fields] OR "treatment"[All Fields] OR "therapeutics"[MeSH Terms] OR "therapeutics"[All Fields]
o Combined Modality Therapy runs as: "combined modality therapy"[MeSH Terms] OR ("combined"[All Fields] AND "modality"[All Fields] AND "therapy"[All Fields]) OR "combined modality therapy"[All Fields]
#3: Study types other than RCTs
o Some of these study types were specifically mentioned in the inclusion criteria of the protocol. Additionally, MEDLINE indexers were assigned to key studies that were likely candidates for inclusion in the review, some seemed like logical additions.
o Using the singular “study” for methodologies that are also MeSH terms searches both text word and MeSH. (PubMed’s publication types use the singular, “study”, but few other than clinical trials are so designated; MeSH study types use the plural, “studies”.)
#4: RCT filter
o The Cochrane Highly Sensitive Search Strategy was used: Sensitivity- and precision-maximizing (2008 revision); PubMed format. (From: Cochrane Handbook for Systematic Reviews of Interventions, p. 137.)
o NOT-ing out animals[mh] NOT humans[mh] creates a double negative to retain humans[mh].
Misc.:
o NOT australia (Naturopathic medicine is an undergraduate degree and is not licensed in Australia; it is therefore outside the scope of this review. Scoping probe suggests that NOT eliminates few citations)
o NOT “classical naturopathy” (refers primarily to German naturopathy, outside review scope)
MeSH terms:
• Many study types not listed here are MeSH (plural form, e.g. Retrospective Studies); using the singular form in line #3 searches them as text words and also maps to the MeSH.
• Naturopathy (1966; preferred term)
• Treatment Outcome
• Outcome Assessment (Health Care)
• Comparative Effectiveness Research (2010)
• Costs and Cost Analysis (1966; used cost)
• Combined Modality Therapy (Usually for chemo, etc., but applied, e.g., to PMID 19644905)
• Holistic Health
• Systems Theory
• Health Promotion
Search was updated 6-14-12 including scoping of grey literature.
Grey literature search consisted of reviewing journals frequently publishing on naturopathic medicine (International Journal of Naturopathic Medicine, Townsend Letter for Doctors, Natural Medicine Journal and Journal of Orthomolecular Medicine) as well as conference abstracts from the annual American Association of Naturopathic Physicians (AANP) and Canadian Association of Naturopathic Doctors (CAND) and all meetings and symposium of the International Research Congress on Integrative Medicine and Health (IRCIMH).
Whole practice observational treatments or standardized protocols modeling whole practice care (based on naturopathic clinical practices, but standardized for research delivery); any treatments author-defined as “naturopathic” (with caveats specified above in Population/Problem). “Whole practice treatment” means the individualized combination of treatments provided by U.S. or Canadian licensed N.D. or N.M.D. with accredited naturopathic training.
Inclusion criteria
- Involvement of U.S. or Canadian licensed N.D. or N.M.D. practitioner with accredited naturopathic training.
-Intervention trials: RCTs, non-randomized or uncontrolled.
-Longitudinal observational studies: case control, cohort, prospective or retrospective
-Case series: n>4.
-“Any journal article, abstract, poster session, report, etc., published or not, peer reviewed or not, blinded or not.” (from review protocol).
Exclusion criteria
– Monotherapies, unless specifically evaluating use in naturopathic clinical practice.
– Animal and other preclinical studies.
– Pharmacokinetic or pharmacodynamic trials.
– Cross-sectional studies.
– Studies performed outside of the U.S.or Canada.
– Studies performed under the clinical supervision of non-licensed “ND” or graduates of non-accredited naturopathy programs.
Two review authors will independently assess the risk of bias in included studies by considering the following characteristics:
•Randomisation sequence generation: was the allocation sequence adequately generated?
•Treatment allocation concealment: was the allocated treatment adequately concealed from study participants and clinicians and other healthcare or research staff at the enrolment stage?
•Blinding: were the personnel assessing outcomes and analysing data sufficiently blinded to the intervention allocation throughout the trial?
•Completeness of outcome data: were participant exclusions, attrition and incomplete outcome data adequately addressed in the published report?
•Selective outcome reporting: is there evidence of selective outcome reporting and might this have affected the study results?
•Other sources of bias: was the trial apparently free of any other problems that could produce a high risk of bias?
Risk of bias scoring will be described and reported using the Cochrane Risk of Bias criteria and the Down's and Black assessment tools for risk of bias.
Disagreements between the review authors over the risk of bias in particular studies will be resolved by discussion, with involvement of a third review author where necessary.
We will provide a narrative synthesis of the findings from the included studies, structured around the type of intervention, target population characteristics, type of outcome and intervention content. We will provide summaries of intervention effects for each study by calculating risk ratios (for dichotomous outcomes) or standardised mean differences (for continuous outcomes).
We anticipate that there will be limited scope for meta-analysis because of the range of different outcomes measured across the small number of existing trials. However, where studies have used the same type of intervention and comparator, with the same outcome measure, we will pool the results using a random-effects meta-analysis, with standardised mean differences for continuous outcomes and risk ratios for binary outcomes, and calculate 95% confidence intervals and two sided P values for each outcome. In studies where the effects of clustering have not been taken into account, we will adjust the standard deviations for the design effect.
Heterogeneity between the studies in effect measures will be assessed using both the chi-squared test and the I-squared statistic. We will consider an I-squared value greater than 50% indicative of substantial heterogeneity. We will conduct sensitivity analyses based on study quality. We will use stratified meta-analyses to explore heterogeneity in effect estimates according to: study quality; study populations; the logistics of intervention provision; and intervention content. We will also assess evidence of publication bias.
