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      Lay perspectives of the open-label placebo rationale: a qualitative study of participants in an experimental trial

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          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Objectives

          To analyse participants’ concepts about the open-label placebo (OLP) effect; to explore their views about the discussion points that are applied in conventional OLP trials and to examine their experiences of taking part in an OLP trial.

          Design

          A qualitative study using thematic analysis of semistructured interviews that were nested within a randomised controlled trial investigating experimental OLP analgesia (registered at ClinicalTrials.gov: NCT02578420).

          Participants

          30 healthy adults who took part in the randomised controlled trial.

          Results

          Participants mostly conceptualised placebo as something that is inert and requires deception in order to be effective. Interviewees used a broad definition of placebos, going beyond a conventional notion of sugar pills. In contrast to the conventional OLP rationale, participants seldom emphasised classical conditioning as a mechanism of placebo effects, stressing a variety of other well-established components through which placebos might be therapeutic, whereas the conventional OLP disclosures state that ‘a positive attitude helps but is not necessary’, participants in our study applied other attitudes, such as ‘it’s worth a try’. When asked about their experiences during the trial, the majority emphasised that the concept of OLP was completely novel to them. Participants were rather sceptical about the efficacy of the intervention.

          Conclusion

          Integrating lay perspectives into the scientific rationale of OLP treatments might enhance the plausibility and credibility of the rationale in ethical treatments.

          Trial registration number

          NCT02578420.

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          Most cited references73

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          Using thematic analysis in psychology

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            Three approaches to qualitative content analysis.

            Content analysis is a widely used qualitative research technique. Rather than being a single method, current applications of content analysis show three distinct approaches: conventional, directed, or summative. All three approaches are used to interpret meaning from the content of text data and, hence, adhere to the naturalistic paradigm. The major differences among the approaches are coding schemes, origins of codes, and threats to trustworthiness. In conventional content analysis, coding categories are derived directly from the text data. With a directed approach, analysis starts with a theory or relevant research findings as guidance for initial codes. A summative content analysis involves counting and comparisons, usually of keywords or content, followed by the interpretation of the underlying context. The authors delineate analytic procedures specific to each approach and techniques addressing trustworthiness with hypothetical examples drawn from the area of end-of-life care.
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              The qualitative content analysis process.

              This paper is a description of inductive and deductive content analysis. Content analysis is a method that may be used with either qualitative or quantitative data and in an inductive or deductive way. Qualitative content analysis is commonly used in nursing studies but little has been published on the analysis process and many research books generally only provide a short description of this method. When using content analysis, the aim was to build a model to describe the phenomenon in a conceptual form. Both inductive and deductive analysis processes are represented as three main phases: preparation, organizing and reporting. The preparation phase is similar in both approaches. The concepts are derived from the data in inductive content analysis. Deductive content analysis is used when the structure of analysis is operationalized on the basis of previous knowledge. Inductive content analysis is used in cases where there are no previous studies dealing with the phenomenon or when it is fragmented. A deductive approach is useful if the general aim was to test a previous theory in a different situation or to compare categories at different time periods.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2021
                18 August 2021
                : 11
                : 8
                : e053346
                Affiliations
                [1 ]departmentDepartment of Consultation-Liaison Psychiatry and Psychosomatics , University Hospital Zurich , Zurich, Switzerland
                [2 ]departmentDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology , University of Basel , Basel, Switzerland
                [3 ]departmentFaculty of Health , University of Plymouth , Plymouth, UK
                [4 ]departmentGeneral Medicine and Primary Care , Harvard Medical School , Boston, Massachusetts, USA
                Author notes
                [Correspondence to ] Dr Cosima Locher; cosimaantoinette.locher@ 123456uzh.ch
                Author information
                http://orcid.org/0000-0002-9660-0590
                http://orcid.org/0000-0001-7907-0439
                Article
                bmjopen-2021-053346
                10.1136/bmjopen-2021-053346
                8375733
                34408060
                382f2ef6-c74d-4848-8ad4-57cc0c31474f
                © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/.

                History
                : 10 May 2021
                : 30 July 2021
                Funding
                Funded by: Swiss National Science Foundation (SNSF);
                Award ID: P4P4PS_194536
                Categories
                Qualitative Research
                1506
                1725
                Original research
                Custom metadata
                unlocked

                Medicine
                qualitative research,quality in health care,mental health,pain management,primary care
                Medicine
                qualitative research, quality in health care, mental health, pain management, primary care

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