Quality of life and well-being from the perspective of patients on opioid agonist maintenance treatment: study protocol for a systematic review of qualitative research and a scoping review of measures

Ivan Solà,Gemma Robleda,Saul Alcaraz,Elisa Ribalta,José Pérez De Los Cobos,Clara Selva Olid,Joan Trujols

doi:10.1186/s13643-019-1237-8

Abstract

BackgroundOpioid agonist maintenance treatment (OAMT) is a first-line treatment for heroin dependence, but its effectiveness has been assessed primarily through clinical outcomes with a limited attention to patient perspectives. Despite the increased use of patient reported outcome measures their patient-centeredness is highly questionable. This is the protocol of a systematic review of qualitative research on how OAMT users construct the meaning of their quality of life and well-being and a scoping review of instruments that measure these domains.MethodsWe will conduct a systematic review of qualitative research exploring the views of quality of life of patients on OAMT (registration number CRD42018086490). According pre-specified eligibility criteria, we will include studies from a comprehensive search of bibliographical databases from their inception. We will extract data from included studies and assess their risk of bias with the CASP appraisal criteria, and will implement a thematic analysis to generate a set of interpretative analytical themes ascertaining their confidence using the CERQual approach. We will implement similar methods to conduct a scoping review to assess to what extent the existing measures of these domains were focused on user’s views, assessing their validity using the COSMIN methodology, and summarizing their characteristics and level of patient centeredness.ConclusionThe findings from the reviews will contribute to obtain a genuine understanding of the perspective from users on OAMT regarding their perception of well-being and quality of life and will likely lead to greater patient centeredness when assessing such variables, which in turn may contribute to a more patient-centered care.

Highlights

Opioid agonist maintenance treatment (OAMT) is a first-line treatment for heroin dependence, but its effectiveness has been assessed primarily through clinical outcomes with a limited attention to patient perspectives
Numerous studies have consistently shown that OAMT is an effective treatment for opioid dependence [2,3,4,5,6]
Here, we propose two interrelated studies whose main aims are to, at least partially, address the knowledge gap in this area and to remedy the paucity of patient-centered insight to assess quality of life (QoL) and wellbeing in patients on OAMT

Summary

Introduction

Opioid agonist maintenance treatment (OAMT) is a first-line treatment for heroin dependence, but its effectiveness has been assessed primarily through clinical outcomes with a limited attention to patient perspectives. The effectiveness of OAMT has been assessed primarily—almost exclusively— through clinical outcomes or “hard” indicators [7], such as treatment retention, reduction of heroin or other nonprescribed opioids use, a reduction of morbidity and mortality, and decreases in criminality, among others. While these outcomes and indicators are valid and should be assessed—especially in efficacy studies—they are often used to justify health care policies or to seek community approval. Assessment of OAMT efficacy and effectiveness primarily focuses on outcomes defined by the scientific and clinical community, and these variables may not adequately reflect the patient’s perspective, or they may not assess the outcomes in a way that is relevant to them

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