Solà et al. Systematic Reviews (2019) 8:299 https://doi.org/10.1186/s13643-019-1237-8 PROTOCOL Open Access 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 Solà1,2*† , Joan Trujols3,4,5† , Elisa Ribalta3, Saul Alcaraz3 , Gemma Robleda1,6,7, Clara Selva Olid8,9 and José Pérez de los Cobos3,4,5,10 Abstract Background: 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. 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. Methods: We 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. Conclusion: The 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. Keywords: Opioid maintenance treatment, Quality of life, Well-being, First-person perspective, Qualitative research, Personomics, Patient-centered research * Correspondence: isola@santpau.cat † Ivan Solà and Joan Trujols contributed equally to this work. 1 Iberoamerican Cochrane Center, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain 2 CIBER Epidemiología y Salud Pública (CIBERESP), Madrid, Spain Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Solà et al. Systematic Reviews (2019) 8:299 Page 2 of 7 Background synthetizing the existing knowledge allowing its applica- Nowadays opioid agonist maintenance treatment (OAMT) tion to practice and the process of decision-making and is a first-line psychopharmacological treatment for heroin avoiding the production of research of little value [22–24]. dependence [1]. Numerous studies have consistently However, to date—and despite a certain shift in how shown that OAMT is an effective treatment for opioid de- OAMT results are evaluated, with a greater emphasis on pendence [2–6]. However, the effectiveness of OAMT has including patient perspectives—we still lack accurate re- been assessed primarily—indeed, almost exclusively— views to evaluate the extent to which patient perspectives through clinical outcomes or “hard” indicators [7], such as have been incorporated into the development of instru- treatment retention, reduction of heroin or other non- ments evaluating QoL and well-being in patients on prescribed opioids use, a reduction of morbidity and mor- OAMT and to obtain an integrated and interpretative rep- tality, and decreases in criminality, among others. While resentation of how these meanings are constructed from these outcomes and indicators are valid and should be the OAMT patient’s perspective. The application of know- assessed—especially in efficacy studies—they are often ledge to action framework should allow to implement used to justify health care policies or to seek community such syntheses of the existing knowledge in the elabor- approval. Moreover, such indicators are based on a nega- ation of QoL and well-being assessment tools genuinely tive and disorder-centered conception of health [7] (see generated by patients [24, 25]. Additional file 1 Table S1). Given this context, here, we propose two interrelated The selection and assessment of the outcomes used to studies whose main aims are to, at least partially, address evaluate the effect of interventions (such as OAMT) in the knowledge gap in this area and to remedy the pau- the field of addictive disorders remains challenging, not city of patient-centered insight to assess QoL and well- only in the setting of clinical trials but particularly in being in patients on OAMT. Our aim is to conduct a routine clinical practice [8–10]. Nevertheless, the role of systematic review of qualitative research on how OAMT the patient perspective in such selection process has re- users perceive, experience and construct their quality of ceived little attention. At present, assessment of OAMT life and well-being and a scoping review of instruments efficacy and effectiveness primarily focuses on outcomes that measure this domain. defined by the scientific and clinical community, and these variables may not adequately reflect the patient’s Methods perspective, or they may not assess the outcomes in a We selected two specific methods for conducting know- way that is relevant to them. ledge synthesis adapted to the scope and nature of the The most developed line of research in exploring the topic of interest (how quality of life (QoL) and well-being OAMT patient’s perspective is focused on quality of life have been defined from OAMT users’ views), which are or, in a broader approach, on the well-being construct, described below. The systematic review of qualitative re- since both terms are often used interchangeably [11, 12]. search will allow us to increase understanding of the A growing number of authors, both in the field of ad- phenomenon of interest and its complexity [26], and the dictive disorders [13, 14] and in other areas of health scoping review will explore the extent, range, and charac- care [15, 16], have questioned whether the scales most teristics of existing measures for the aforementioned do- commonly used to assess QoL or well-being actually mains [27]. We adhered the PRISMA-P guideline to provide a truly patient-centered evaluation of this con- report this protocol (provided in the Additional file 2). struct. In this respect, De Maeyer and collaborators ex- plored the nature and dimensions of this construct from Study 1: Systematic review of qualitative research the perspective of patients receiving treatment for opioid We will conduct a systematic review of qualitative re- dependence [17]. The study showed that patients do not search exploring OAMT users’ views and perspectives primarily associate QOL with health, and moreover, they on QoL to synthesize them into an integrated and inter- spontaneously reported many more issues than those pretative representation [28]. We have prepared a proto- usually included in the instruments commonly used to col following methodological standards [29] and assess QoL in these patients. Similarly, a recent QOL in- according to specific guidance to synthesize qualitative strument developed with significant input from OAMT research [26, 30, 31], that was publicly registered in patients did not include items on physical health [18]. PROSPERO [32] (registration number In fact, in certain areas of health outcomes research CRD42018086490). We will report the review findings [19–21], there seems to be a growing consensus that endorsing the ENTREQ reporting guidelines [33]. patients should be significantly involved—through truly participatory methods—in developing any new patient- Inclusion criteria reported outcome measure (PROM). The development of The review will include studies focusing on individuals new PROMs, however, should not be promoted without diagnosed with opioid dependence disorder (according Solà et al. Systematic Reviews (2019) 8:299 Page 3 of 7 to the current version of either the Diagnostic and Stat- studies included in the systematic review of qualitative istical Manual of Mental Disorders (DSM) or Inter- research [42]. national Classification of Diseases and Related Health We will extract data in two stages. First, we will ex- Problems (ICD) diagnostic systems) and who are receiv- tract study design and descriptive information and then, ing – or have recently received – OAMT. Eligible we will extract quotes and categories identified through studies will focus on their views, experiences and per- the included studies' findings. Data collection in this sec- spectives about the construct of interest, considering ond part will be iterative, and we will revisit the texts to those studies that have used the phenomenological per- compare ideas and original findings in light of any new spective of a qualitative research. data identified [43–45]. We will pilot a pre-defined data extraction form ap- Search methods to identify studies praising at least three studies to verify the structure of We will perform a search in MEDLINE (Ovid), EMBASE the form and the suitability of the process. (Ovid), CINAHL (EBSCOHost), PsycINFO (Ovid), and Cork database (Project Cork) from their inception. We Data analysis and synthesis of findings will design a search strategy combining terms related to We will use an integrative and interpretative approach the inclusion criteria as well as controlled vocabulary re- for the findings from the systematic review of qualitative lated to these terms [for the strategy designed to search research through a continuous comparison of results MEDLINE see Additional file 3]. The search algorithms from the original studies, implementing a thematic ana- will be adapted to the specific requirements of each spe- lysis standardized methodology [44, 45]. Based on the cific database. We will execute the searches in these da- data collected from the studies, we will code emerging tabases with no limitations other than language themes and iteratively compare them to recurring or (restricted to English, French, German, Dutch and Span- new themes identified in other studies. Through the ish) and the use of validated filters to obtain qualitative continuous comparison of data we will revisit previously research [34–37]. reviewed studies to delimit potential thematic overlap In addition to the search in databases we will identify and develop descriptive themes to finally generate con- studies from the reference lists from the studies initially textualized, reflective and trustworthy analytical themes included in our review, and will search unpublished [43–45]. studies in Open Access Theses and Dissertations, Pro- Quest Dissertations & Theses Database and through a Assessment of confidence in the findings of the review specific search in Google Scholar. Besides, we will track We will use the Confidence in the Evidence from Re- references of additional studies citing the eligible studies views of Qualitative research (CERQual) approach as a using the Web of Science. structured and explicit method to ascertain the confi- dence level that can be placed in the findings from the Study selection and data collection systematic review of qualitative research [46]. For each We will manage the search results using a reference of the findings obtained in the thematic analysis, we will manager software. Two researchers will independently assess the following determinants of their confidence: screen the references’ titles and abstracts against the in- methodological limitations; relevance (of the findings in clusion criteria, obtaining a copy of eligible studies to the context of the research question); coherence (of the determine their final inclusion. We will describe the en- data to substantiate the explanation of phenomenon) tire eligibility and selection process into a PRISMA flow- and adequacy (of the data in terms of their quantity and chart and report the reasons for exclusion of ineligible richness in supporting the finding). Depending on the studies in a specific table. evaluation of each of these domains, the confidence level Although the optimal approach to identifying sources for each finding will be classified as high, moderate, low, of bias in a qualitative study is a matter of discussion or very low. A summary table will provide the findings [38–40], there is guidance to use approaches focusing at of the review, the explanation or interpretation of those least on the clarity of the study aims and its research findings, the confidence classification, and an explan- question, the congruence between aims and research de- ation of the criteria used to determine this classification. sign and methodology, the rigour in sampling and case identification, and the appropriateness of the application Study 2: Scoping review of measuring instruments of of the method, conceptual depth of findings, exploration quality of life of deviant cases, and reflexivity of the researchers [41]. In addition to the systematic review of qualitative re- The Critical Appraisal Skills Programme (CASP) ap- search we will also conduct a scoping review to deter- praisal criteria are the most commonly used for this pur- mine how and to what extent the patients' perspective pose and so we will use these criteria to assess the has been incorporated into the development process of Solà et al. Systematic Reviews (2019) 8:299 Page 4 of 7 the measures used to evaluate QoL and well-being in pa- thematic analysis framework [44], mapping the find- tients on OAMT. We prepared a protocol according to ings in accordance with the study objectives [47]. standardized guidance [47], which is publicly available at Open Science Framework (https://osf.io/2cks9/). We will Utility and applicability of the findings conduct the scoping review in accordance to the meth- Once the findings of the scoping review have been ob- odological framework proposed by Arksey and O'Malley tained, a consultation process will be performed [48, 49] to conduct a scoping review [47–49]. We will report the in which patients receiving OAMT will be contacted and results of the scoping review according the correspond- asked to provide their views of these findings. ing PRISMA extension [27]. Discussion Inclusion criteria In this paper we describe the protocol of a systematic re- We will consider for inclusion psychometric and /or de- view of qualitative research to obtain a genuine under- velopment studies of instruments measuring QoL or standing of the perspective from users on opioid agonist well-being in patients which have been diagnosed with maintenance treatments (OAMT) regarding their per- opioid dependence disorder according accepted diagnos- ception of well-being and quality of life (QoL), as well as tic classification criteria and had been receiving OAMT. a scoping review to assess to what extent the existing measures of these domains were focused on user’s views. Search methods to identify studies Applying a knowledge transfer framework [24, 25], the We will conduct searches according to the methodology findings from these reviews will inform the drafting of described for the systematic review of qualitative re- the items of a patient-centered QoL scale that will be search [see Additional file 3 for the detailed MEDLINE constructed according to measures development stan- search strings] but using a validated filter to obtain dards [53, 54] PROMs [50]. The improvement and evaluation of processes and outcomes of care should be open to a broad approach Study selection and data collection that may reflect patient’s voice and perspectives. It After exporting search results to a reference manager has been hypothesized that patient reported outcomes software, two researchers will independently screen titles (PROMs) improve patient’s skills at identifying, bring- and abstracts and obtain copies of eligible studies to de- ing meaning and describing health states. Shifting dis- cide their inclusion in a process that will be detailed into cussion into patients’ perspectives improves their a PRISMA flowchart. functioning because it addresses some of their funda- We will design a data extraction form to collect study’s mental needs, enables them at constructing messages descriptive data and instruments’ characteristics according about their health state, and allows healthcare profes- to: (a) the instrument type [OAMT specific, focused on sionals to improve their understanding about these the treatment of addictive disorders, or generic]; (b) its health states [55]. content validity, relevance, comprehensiveness and The measurement of relevant outcomes entails the comprehensibility assessed using the COnsensus-based challenge to evaluate processes of care focusing beyond Standards for the selection of health Measurement INstru- the effectiveness of a determinate intervention, and ments (COSMIN) methodology [51]; (c) factor structure broadening the perspective to the patient perception of [global or unidimensional measures, or multidimensional its benefits or the response to treatment. PROMs have instruments]; and (d) the extent to which patient perspec- shown some positive impact in processes of care such as tives are incorporated into the instrument, based on the diagnosis, monitoring progression of disease or manage- level of patient involvement. We will assess patient in- ment of health conditions and response to treatment volvement (i.e., consultation, contribution, collaboration, [56, 57]. These findings are specifically consistent in the or control [52]) during all the stages of the tool's develop- field of mental health [58]. PROMs also constitute a pre- ment: (a) conceptualization of the construct to be mea- sumably effective method to enhance the communica- sured and determination of the domains to be assessed; tion at medical encounter [59]. (b) item generation; (c) evaluation of item relevance, com- On the other hand, PROMs face some practical prehensiveness and comprehensibility; and (d) psychomet- challenges hindering their ability to truly focus on pa- ric analysis. tient perspective: who decides what to include and what to emphasize in such measures or, in other Data analysis and synthesis of findings words, whether they reflect a true representation of We will integrate the characteristics included instru- patient experience [57]. Despite their potential con- ments, their content validity, the degree of patient tent validity and relevance for respondents many centeredness, and the domains assessed following a PROMs have been developed without direct patient Solà et al. Systematic Reviews (2019) 8:299 Page 5 of 7 participation thus threatening the instruments’ cap- Additional file 3. Strategy designed to search MEDLINE (OVID Medline acity to be sensible to patients’ needs, priorities and Epub ahead of print, in-process and other non-indexed citations, Ovid preferences [13, 58]. For these reasons the develop- MEDLINE(R) Daily and Ovid MEDLINE(R) 1946 to present). ment of measures that are truly representative of pa- tient’s views and experiences should entail an Abbreviations CASP: Critical Appraisal Skills Programme; CERQual: Confidence in the understanding and capacity to capture their nuances Evidence from Reviews of Qualitative research; COSMIN: COnsensus-based and complexity. Standards for the selection of health Measurement Instruments; Grounded in the knowledge to action framework DSM: Diagnostic and Statistical Manual of Mental Disorders; ICD: International Classification of Diseases; OAMT: Opioid agonist maintenance treatment; [25], we plan to conduct a study to adapt and tailor PRISMA: Preferred Reporting Items for Systematic Reviews and Meta- the existing research on the views of patients that are Analyses; QoL: Quality of life; PROMs: Patient reported outcome measures on OAMT about QoL and well-being and implement Acknowledgements this knowledge in the development of a patient- Not applicable. centered instrument. To ease the implementation of existing knowledge we are convinced of the role of Authors’ contribution IS and JT conceived of the study, developed the protocol and drafted the syntheses of qualitative research in achieving a better manuscript. The rest of authors contributed to the manuscript content understanding of complexity and subjectivity [28, 31]. according to their field of expertise. All authors read and approved the final The scoping review will also contribute to identify the manuscript. IS and JT contributed equally and should be considered co-first authors. key approaches already existing in the literature to the domain of interest and to define gaps in this area. Authors’ information For that reason we will conduct a review of qualita- Ivan Solà is a doctoral candidate in Public Health and Methodology of tive studies to obtain a contextualized and reflective Biomedical Research, at the Department of Pediatrics, Obstetrics, Gynaecology and Preventive Medicine at Universitat Autònoma de representation of OAMT patients’ views of QoL and Barcelona, Spain. well-being. Furthermore we will use the CERQual ap- proach to assess the confidence in the synthesis find- Funding This study is funded through a grant from Instituto de Salud Carlos III (PI16/ ings [46] and we will use the findings with the 00056), co-financed by funds from the European Regional Development highest confidence as a reliable representation of Fund. The funding sources have played no role in the study design or prep- patients’ views that could serve to draft items of the aration of this protocol and will have no role in the execution of the study, analyses and interpretation of data, or decision to submit results for initial version of the scale. Pursuing triangulation of publication. data, we will try to gain in comprehensiveness by col- lecting additional information from truly patient- Availability of data and materials Not applicable as no datasets were generated for the development of this centered measurement instruments identified from a protocol. Registration for the systematic review of qualitative research can be scoping review. checked at the following URL: https://www.crd.york.ac.uk/prospero/display_ At the end we will be able to compile a body of evi- record.php?RecordID = 86490. The protocol for the scoping review is publicly available at Open Science Framework (https://osf.io/2cks9/). dence to genuinely grasp the perspective from patients on OAMT regarding their perception of well-being and Ethics approval and consent to participate QoL. We firmly consider that such knowledge is likely This project (code IIBSP-PAC-2017-28) was approved by the Clinical Research Ethics Committee of the Hospital de la Santa Creu i Sant Pau on 27 Septem- to lead to greater patient centeredness in considering ber 2017. QoL and well-being in OAMT, which in turn may con- tribute to a more patient-centered care for opioid- Consent for publication dependent patients in agonist maintenance treatment Not applicable. [60–62]. Competing interests All authors declare no financial interests or potential conflicts of interest related directly or indirectly to this study. Author details 1 Iberoamerican Cochrane Center, Biomedical Research Institute Sant Pau (IIB Supplementary information Sant Pau), Barcelona, Spain. 2CIBER Epidemiología y Salud Pública (CIBERESP), Supplementary information accompanies this paper at https://doi.org/10. Madrid, Spain. 3Addictive Behaviours Unit, Department of Psychiatry, Hospital 1186/s13643-019-1237-8. de la Santa Creu i Sant Pau, Barcelona, Spain. 4Biomedical Research Networking Center on Mental Health (CIBERSAM), Barcelona, Spain. 5 Additional file 1: Table S1. Differences between indicators based on Addictive Behaviors Research Group, Biomedical Research Institute Sant Pau hard and soft criteria (adapted from [7]). (IIB Sant Pau), Barcelona, Spain. 6Escuela Superior de Enfermería Mar, Additional file 2. PRISMA-P (Preferred Reporting Items for Systematic Barcelona, Spain. 7Departament de Ciències Experimentals i de la Salut, UPF, Review and Meta-analysis Protocols) 2015 checklist for the manuscript: Barcelona, Spain. 8PETRO Research Group, Bellaterra, Spain. 9Department of quality of life and well-being from the perspective of patients on opioid Social Psychology, Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain. 10Department of Psychiatry and Forensic Medicine, School of agonist maintenance treatment: study protocol for a systematic review of qualitative research and a scoping review of measures. Medicine, Autonomous University of Barcelona (UAB), Bellaterra, Bellaterra, Spain. Solà et al. Systematic Reviews (2019) 8:299 Page 6 of 7 Received: 21 February 2019 Accepted: 17 November 2019 development and delivery of patient-reported outcomes. Qual Life Res. 2015;24:1077–85. 22. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. 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