Dataset Information

Researcher allegiance in research on psychosocial interventions: meta-research study protocol and pilot study.

ABSTRACT:

Introduction

One potential source of bias in randomised clinical trials of psychological interventions is researcher allegiance (RA). The operationalisation of RA differs strongly across studies, and there is not a generally accepted method of operationalising or measuring it. Furthermore, it remains unclear as to how RA affects the outcomes of trials and if it results in better outcomes for a preferred intervention. The aim of this project is to develop and validate a scale that accurately identifies RA, contribute to the understanding of the impact that RA has in a research setting and to make recommendations for addressing RA in practice.

Methods and analysis

A scale will first be developed and validated to measure RA in psychotherapy trials. The scale will be validated by surveying authors of psychotherapy trials to assess their opinions, beliefs and preferences of psychotherapy interventions. Furthermore, the scale will be validated for use outside the field of psychotherapy. The validated checklist will then be used to examine two potential mechanisms of how RA may affect outcomes of interventions: publication bias (by assessing grants) and risk of bias (RoB). Finally, recommendations will be developed, and a feasibility study will be conducted at a national mental health agency in The Netherlands. Main analyses comprise inter-rater reliability of checklist items, correlations to examine the relationship between checklist items and author survey (convergent validity) as well as checklist items and trial outcomes and multivariate meta-regression techniques to assess potential mechanisms of how allegiance affects trial outcomes (publication bias and RoB).

Ethics and dissemination

This study has been reviewed and approved by the Scientific and Ethical Review Board (VCWE) at the Vrije Universiteit Amsterdam. Study result and advancements will also be published on the Open Science Framework. Furthermore, main findings will be disseminated through articles in international peer-reviewed open access journals. Results and recommendations will be communicated to the Cochrane Collaboration, the Campbell Collaboration and other funding agencies.

SUBMITTER: Yoder WR

PROVIDER: S-EPMC6377509 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Publications

Researcher allegiance in research on psychosocial interventions: meta-research study protocol and pilot study.

Yoder Whitney Rose WR Karyotaki Eirini E Cristea Ioana-Alina IA van Duin Daniëlle D Cuijpers Pim P

BMJ open 20190219 2

<h4>Introduction</h4>One potential source of bias in randomised clinical trials of psychological interventions is researcher allegiance (RA). The operationalisation of RA differs strongly across studies, and there is not a generally accepted method of operationalising or measuring it. Furthermore, it remains unclear as to how RA affects the outcomes of trials and if it results in better outcomes for a preferred intervention. The aim of this project is to develop and validate a scale that accurat ...[more]

PMID: 30782912

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Project description:ObjectivesTo investigate whether an authorship effect is found that leads to better performance in studies conducted by the original developers of the Patient Health Questionnaire (PHQ-9) (allegiant studies).DesignSystematic review with random effects bivariate diagnostic meta-analysis. Search strategies included electronic databases, examination of reference lists and forward citation searches.Inclusion criteriaIncluded studies provided sufficient data to calculate the diagnostic accuracy of the PHQ-9 against a gold standard diagnosis of major depression using the algorithm or the summed item scoring method at cut-off point 10.Data extractionDescriptive information, methodological quality criteria and 2×2?contingency tables.ResultsSeven allegiant and 20 independent studies reported the diagnostic performance of the PHQ-9 using the algorithm scoring method. Pooled diagnostic OR (DOR) for the allegiant group was 64.40, and 15.05 for non-allegiant studies group. The allegiance status was a significant predictor of DOR variation (p<0.0001).Five allegiant studies and 26 non-allegiant studies reported the performance of the PHQ-9 at recommended cut-off point of 10. Pooled DOR for the allegiant group was 49.31, and 24.96 for the non-allegiant studies. The allegiance status was a significant predictor of DOR variation (p=0.015).Some potential alternative explanations for the observed authorship effect including differences in study characteristics and quality were found, although it is not clear how some of them account for the observed differences.ConclusionsAllegiant studies reported better performance of the PHQ-9. Allegiance status was predictive of variation in the DOR. Based on the observed differences between independent and non-independent studies, we were unable to conclude or exclude that allegiance effects are present in studies examining the diagnostic performance of the PHQ-9. This study highlights the need for future meta-analyses of diagnostic validation studies of psychological measures to evaluate the impact of researcher allegiance in the primary studies.

Project description:IntroductionDespite the recent global mental health movement of the transition from hospital-centred to integrated community-based services, comprehensive evidence of psychosocial interventions focusing on community-dwelling individuals with schizophrenia is still lacking. To overcome this gap in the current knowledge, we will conduct a systematic review and meta-analysis to assess the efficacy of all types of psychosocial interventions for community-dwelling (non-hospitalised) individuals with schizophrenia when compared with non-active control conditions (eg, treatment as usual).Methods and analysisThis study protocol has been developed according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. By March 2022, the following sources will have been searched, without restrictions for language or publication period: Embase, PubMed, PsycINFO, CINAHL, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform. We will also try to identify other potentially eligible studies by searching the reference lists of included studies, other relevant systematic reviews and grey literature. All relevant randomised controlled trials from both high-income and low-income to middle-income countries will be allowed. Two independent reviewers will conduct the selection/screening of studies, data extraction and methodological quality assessment of included studies. The primary outcomes are quality of life and psychiatric hospital admission. Standard pairwise meta-analyses with a random-effects model will be conducted. Subgroup and sensitivity analyses will be performed to assess the robustness of the findings. Risk of bias will be assessed with the Revised Cochrane Risk-of-Bias Tool for Randomised Trials. The Grades of Recommendation Assessment, Development and Evaluation approach will be used to assess the quality of evidence.Ethics and disseminationEthics approval is not required for this study. The study findings will be disseminated through conference presentations as well as peer-reviewed publications.Prospero registration numberCRD42021266187.

Project description:BACKGROUND:Integrated knowledge translation refers to researcher and research user partnerships to co-generate and implement knowledge. This type of partnership may be critical to success in increasing knowledge use and impact, but the conceptualisation of its initiation has not been fully developed. Initiating this type of partnership has proven to be challenging but crucial to its success. The purpose of this study was to conduct a meta-narrative review of partnership initiation concepts, processes, enablers, barriers and outcomes in the disciplines of healthcare and social sciences where examples of researcher and research user partnerships were found. METHODS:Seven research traditions were identified. Three were in the discipline of social sciences (including psychology, education and business) and five were in the discipline of healthcare (including medicine, nursing, public health, health services research). Searches were conducted in MEDLINE, EMBASE, CINAHL, ABI Inform, ERIC, PsychInfo and the Cochrane Library on June 9, 2017. Fifty titles and abstracts were screened in triplicate; data were extracted from three records in duplicate. Narratives comprised of study characteristics and conceptual and empirical findings across traditions were tabulated, summarised and compared. RESULTS:A total of 7779 unique results were identified and 17 reviews published from 1998 to 2017 were eligible. All reviews identified a partnership initiation phase referred to as 'early' or 'developmental', or more vaguely as 'fuzzy', across six traditions - integrated knowledge translation, action research, stakeholder engagement, knowledge transfer, team initiation and shared mental models. The partnership initiation processes, enablers, barriers and outcomes were common to multiple narratives and summarised in a Partnership Initiation Conceptual Framework. Our review revealed limited use or generation of theory in most included reviews, and little empirical evidence testing the links between partnership initiation processes, enablers or barriers, and outcomes for the purpose of describing successful researcher and research user partnership initiation. CONCLUSIONS:Narratives across multiple research traditions revealed similar integrated knowledge translation initiation processes, enablers, barriers and outcomes, which were captured in a conceptual framework that can be employed by researchers and research users to study and launch partnerships. While partnership initiation was recognised, it remains vaguely conceptualised despite lengthy research in several fields of study. Ongoing research of partnership initiation is needed to identify or generate relevant theory, and to empirically establish outcomes and the determinants of those outcomes.

Project description:Alcohol use is an important issue among problem drug users. Although screening and brief intervention (SBI) are effective in reducing problem alcohol use in primary care, no research has examined this issue among problem drug users.The objective of this study is to determine if a complex intervention including SBI for problem alcohol use among problem drug users is feasible and acceptable in practice. This study also aims to evaluate the effectiveness of the intervention in reducing the proportion of patients with problem alcohol use.Psychosocial intervention for alcohol use among problem drug users (PINTA) is a pilot feasibility study of a complex intervention comprising SBI for problem alcohol use among problem drug users with cluster randomization at the level of general practice, integrated qualitative process evaluation, and involving general practices in two socioeconomically deprived regions. Practices (N=16) will be eligible to participate if they are registered to prescribe methadone and/or at least 10 patients of the practice are currently receiving addiction treatment. Patient must meet the following inclusion criteria to participate in this study: 18 years of age or older, receiving addiction treatment/care (eg, methadone), or known to be a problem drug user. This study is based on a complex intervention supporting SBI for problem alcohol use among problem drug users (experimental group) compared to an "assessment-only" control group. Control practices will be provided with a delayed intervention after follow-up. Primary outcomes of the study are feasibility and acceptability of the intervention to patients and practitioners. Secondary outcome includes the effectiveness of the intervention on care process (documented rates of SBI) and outcome (proportion of patients with problem alcohol use at the follow-up). A stratified random sampling method will be used to select general practices based on the level of training for providing addiction-related care and geographical area. In this study, general practitioners and practice staff, researchers, and trainers will not be blinded to treatment, but patients and remote randomizers will be unaware of the treatment.This study is ongoing and a protocol system is being developed for the study. This study may inform future research among the high-risk population of problem drug users by providing initial indications as to whether psychosocial interventions for problem alcohol use are feasible, acceptable, and also effective among problem drug users attending primary care.This is the first study to examine the feasibility and acceptability of complex intervention in primary care to enhance alcohol SBI among problem drug users. Results of this study will inform future research among this high-risk population and guide policy and service development locally and internationally.

Project description:IntroductionSuicide is an important public health problem. Providing evidence-based psychosocial interventions to individuals presenting with self-harm is recognised as an important suicide prevention strategy. Therefore, it is crucial to understand which intervention is most effective in preventing self-harm repetition. We will evaluate the comparative efficacy of psychosocial interventions for the prevention of self-harm in adults.Methods and analysisWe will perform a systematic review and network meta-analysis (NMA) of randomised controlled trials (RCTs) testing psychosocial interventions for the prevention of self-harm repetition. We will include RCTs in adults (mean age: 18 years or more) who presented with self-harm in the 6 months preceding enrolment in the trial. Interventions will be categorised according to their similarities and underpinning theoretical approaches (eg, cognitive behavioural therapy, case management). A health sciences librarian will update and adapt the search strategy from the most recent Cochrane pairwise systematic review on this topic. The searches will be performed in MEDLINE (Ovid), Embase (Ovid), PsycInfo (Ovid), CINAHL (EBSCO), Cochrane Central (Wiley), Cochrane Protocols (Wiley), LILACS and PSYNDEX from 1 July 2020 (Cochrane review last search date) to 1 September 2023. The primary efficacy outcome will be self-harm repetition. Secondary outcomes will include suicide mortality, suicidal ideation and depressive symptoms. Retention in treatment (ie, drop-outs rates) will be analysed as the main acceptability outcome. Two reviewers will independently assess the study eligibility and risk of bias (using RoB-2). An NMA will be performed to synthesise all direct and indirect comparisons. Ranked forest plots and Vitruvian plots will be used to represent graphically the results of the NMA. Credibility of network estimates will be evaluated using Confidence in NMA (CINeMA).Ethics and disseminationAs this is the protocol for an aggregate-data level NMA, ethical approval will not be required. Results will be disseminated at national/international conferences and in peer-review journals.Trial registration numberCRD42021273057.

Project description:BACKGROUND:In many countries, humanistic psychotherapy (HPT) is viewed as a broad psychotherapeutic approach and is accepted in health care systems. To qualify for reimbursement by health insurance in Germany, psychotherapy approaches have to be evaluated positively by the German Scientific Board of Psychotherapy (GSBP). The GSBP examined HPT and its subapproaches based on an application by a number of professional organizations affiliated with HPT (Work Group Humanistic Psychotherapy, WGHPT). The GSBP came to the decision that none of the HPT subapproaches provided sufficient evidence to be evaluated as evidence based. Potential reasons for the discrepancy between international recognition of HPT and GSBP's decision will be explored: researchers' allegiance may have led to a risk of bias disadvantaging HPT. Furthermore, the evaluation criteria of the GSBP did not systematically consider whether HPT was conceptualized bona fide and implemented with sufficient treatment integrity in the studies. OBJECTIVE:This systematic review will re-examine the studies included in the review of the GSBP. Within 2 comparisons (HPT vs control and HPT vs other psychotherapeutic interventions), we will examine moderating effects of treatment quality (bona fide and treatment integrity) and allegiance on the effectiveness of HPT. METHODS:This review is based on the prior systematic review by the GSBP. The GSBP examined randomized controlled trials (RCTs) and studies with non-RCTs of HPT interventions for individuals with mental disorders. All studies suggested by the WGHPT were included; moreover, the GSBP conducted searches in standard electronic databases (Cochrane Central Register of Controlled Trials, MEDLINE, PsycINFO, and PSYNDEX) and handsearches in relevant systematic reviews and contacted experts. A total of 2 independent GSBP reviewers performed study screening using a structured form. On the basis of the prior work of the GSBP, all studies that were positively screened by the GSBP will be included in this review. Data will be extracted independently by 4 authors. Standardized mean difference will be calculated, and possible publication bias will be tested using funnel plots and Egger test. A priori defined subgroup or meta-regression analyses will be performed for treatment quality, allegiance, type of nonactive control, study quality, type of subapproach, and target population (children and adolescents or adults). RESULTS:The GSBP identified 115 eligible studies that will be reanalyzed in this systematic review. CONCLUSIONS:Results about moderator effects of treatment quality and allegiance will provide important information about their impact on the evaluation of HPT and other psychotherapy approaches and can be used for further evaluation methods. TRIAL REGISTRATION:PROSPERO CRD42019128983; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=128983. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/15140.

Dataset Information

Researcher allegiance in research on psychosocial interventions: meta-research study protocol and pilot study.

Introduction

Methods and analysis

Ethics and dissemination

Publications

Researcher allegiance in research on psychosocial interventions: meta-research study protocol and pilot study.

Similar Datasets

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