WP02 – Definition of Optimal Evidence-Based Non-drug Therapies in Older People (ONTOP)

Objectives

  • to undertake a thorough literature search of systematic reviews concerning evidence-based non pharmacological treatments of the 15 most prevalent medical conditions affecting older people.
  • to define in bullet-point format indications and contraindications of non-pharmacological therapies for which there is the strongest evidence base in each of the 15 chronic conditions.

Workpackage Description

It is widely acknowledged that non pharmacological therapies can be as or more effective than drug therapy in the treatment of several common chronic conditions. Drug therapy and non-drug therapies are complementary in the management of older people with multimorbidity. To date, there is no widely used compendium of non-pharmacological therapies for the common chronic medical conditions of late life, therefore they are underappreciated and underused in clinical practice. To fill this knowledge gap, a systematic literature search for non-drug therapies will be undertaken in 15 of the most prevalent and difficult-to-manage medical conditions affecting older people.

Task 1: Formulation and prioritization of the clinical questions for evidence-based non-drug interventions.

In the first phase, the initial 5 conditions, starting with delirium, will be evaluated. Each condition will be discussed by the panel that will formulate and prioritize answerable clinical questions using the PICO methodology specifying the patient population, the intervention of interest, the comparator, and the outcomes of interest 1. The outcome component will be the driver in the formulation of clinical question, thus a preliminary classification of outcomes as critical, important but not critical, or low importance, will be considered. Evidence will be searched only for clinically relevant outcomes, e.g. disability, morbidity and mortality.

Task 2: Compiling evidence from Systematic Reviews.

For each condition of interest we will develop appropriate keywords and using Montori’s high sensitive search strategy (MEDLINE[Title/Abstract]) OR (systematic[Title/Abstract] AND review[Title/Abstract] OR meta-analysis[Publication Type]) we will launch a search of systematic reviews. In addition to Medline, the search strategy will be launched into Cochrane Database of Systematic Review, Pubmed, Psychinfo and CINAHL. Two pairs of reviewers will separately screen the titles and abstracts to identify the relevant papers. Full text of systematic reviews will be retrieved and assessed. When similar meta-analyses exist, the most recent or updated results will be selected. The research team participating in the WP02 will receive specific training in the methodology of searching and assessing the quality of systematic reviews.

Task 3: Quality assessment & synthesis.

From each included systematic review, the effect estimate will be taken into account. In order to gain confidence that the estimate of the effect is correct, the GRADE approach for rating the quality of evidence will be used. Evidence based on randomized trials will begin as high quality evidence, but the confidence in the estimate of the treatment effect may be downgraded after evaluating the following elements: study methodological quality, consistency, directness, precision, and reporting bias. A specific form for gathering quality items will be prepared and reviewers will be appropriately trained and separately will extract the following indicators of research quality: allocation concealment, blinding, intention-to-treat.

Task 4: Preparation of user friendly summary of indications and contraindications for use in SENATOR RCT.

At least one condition summary from supporting scientific evidence will be completed by month 12 in order to be available for the inclusion in the software.

Task 5: Extension to additional conditions and continuous update to complement RCT-derived inferences.

The literature search will be extended to the remaining 10 conditions for which a summary will be produced (month 18 to 48). Literature search will also be repeated to identify newly published systematic reviews to update the recommendations at least every 6 months up to 6 months before the end of the project.

WP Leader

Prof. Dr. Antonio Cherubini (INRCA)

Participating Partners

Servicio Madrileño de Salud (SERMAS)
Instituto Nazionale di Riposo e Cura per Anziani, Ancona (INRCA)
Grampian Health Board (NHSG)