1980 to 2004/06 • ISTP (Index to Scientific and Technical Proceedings): to May 2000 • INSIDE (BL database of Conference Proceedings and Journals): to June 2000 • Aslib Index to Theses (UK and Ireland theses): 1970 to March 2003 • Dissertation Abstracts (USA): 1861 to March 2003 • http://clinicalstudies.info.nih.gov/ • National Research Register: issue 2/2005 • ClinicalTrials.gov (last searched June 2005) • LILACS (Latin American and Caribbean Health Science Literature): last searched April 2003 • http://www.forestclinicaltrials.com/CTR/CTRController/ CTRHome (last searched 2 July 2005) • ClinicalStudyResults.org (last searched 1 July 2005) • http://www.lillytrials.com/index.shtml (last searched 30 June 2005) • ISRCTN Register: last searched 2 July 2005 Massage and touch for dementia (Review) 4 Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. The search strategies we used to identify relevant records in MEDLINE, EMBASE, PsycINFO and CINAHL can be found in the Group’s module on the Cochrane Library. We made additional direct searches on MEDLINE, EMBASE, MANTIS, PsycINFO and CINAHL, for combinations of terms for the relevant conditions (Alzheimer’s or dementia), interventions (massage, touch, therapeutic touch, shiatsu or acupressure) and study types (randomized controlled trials or controlled trials). Finally, a number of patients’ and therapists’ organizations were asked if they knew of unpublished data from relevant trials, and reference lists from retrieved publications were checked for further relevant reports. Almost all published trials on complementary/alternative medicine are less than 20 years old, so we considered the search strategy likely to be comprehensive without the need for handsearching. Data collection and analysis The searches described yielded a total of 34 references. We obtained hard copies whenever possible. In the case of two articles, it was not possible to obtain abstracts or hard copies, but in both cases correspondence with the authors established that the article contained no original data that were otherwise unobtainable. Two reviewers performed independently an initial screening for relevance. This first screening resulted in a list of 18 potentially relevant studies, eight of these being definite or possible randomized controlled trials. In a second and final round of screening, two reviewers (NVH, TJ) independently evaluated the 8 articles that were potentially relevant RCTs for eligibility for inclusion in the review. We developed an electronic form through consultation and testing with all reviewers, with a quality (validity and bias) checklist constructed and agreed beforehand. Following the example of the Cochrane review on music therapy for dementia (Vink 2005), we used an adapted form of the ’Delphi’ checklist developed in Verhagen 1998. We consulted chapter 8 of the Cochrane Reviewers’ Handbook (Alderson 2004) to ensure that all relevant aspects were covered in the checklist. On testing the checklist we found it was not helpful to define a score with or without a threshold score to determine exclusion or inclusion. We also observed that two of the checklist’s standard criteria - blinding of patient, and blinding of provider - were not possible or relevant in any of the protocols studied in the eight reports, and probably will not be so in any reasonable trial of a massage or touch intervention. Hence, as anticipated in our protocol, we did not consider failure to meet these two criteria to be a relevant criterion of study quality (while of course criteria such as blinded assessment would still be relevant). Finally, the test run of the ’Delphi’ checklist made us aware of the desirability of an eighth criterion, which was added to the seven remaining in our adapted version of Verhagen’s ’Delphi’ list. This added criterion is the requirement that there be one well-defined primary outcome which clearly corresponds to a primary hypothesis that the study is designed to test. For five of the eight articles considered at this stage, additional information about study quality or the availability of raw data was sought from the authors. Several authors kindly made additional information and data available to us (see ’Acknowledgements’). R E S U L T S Description of studies See:Characteristics of included studies;Characteristics of excluded studies. Only two small trials (Eaton 1986; Remington 2002) with a total of 110 participants met the quality criteria for inclusion in the review. In this section we give brief descriptions of the two included and six excluded trials. Included Studies Eaton 1986: RCT assessing the effect on nutritional intake of “verbal encouragement with touch” during meals, compared with verbal encouragement alone. Forty-two institutionalized patients with a diagnosis of chronic organic brain syndrome (the article does not specify any procedure or criterion for this diagnosis) were randomly assigned to the two intervention groups. The experimental intervention was given at two meals per day for one week, with a pretreatment and post-treatment period of one week each, in which all patients received “verbal encouragement” only. Nutritional intake was estimated in each case by blinded evaluators on the basis of food remaining on the patients’ plates. This study met most of the quality requirements but the randomization