Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial.

BACKGROUND: Domestic violence and abuse (DVA), defined as threatening behavior or abuse by adults who are intimate partners or family members, is a key public health and clinical priority. The prevalence of DVA in the United Kingdom and worldwide is high, and its impact on physical and mental health is detrimental and persistent. There is currently little support within healthcare settings for women experiencing DVA. Psychological problems in particular may be difficult to manage outside specialist services, as conventional forms of therapy such as counseling that do not address the violence may be ineffective or even harmful. The aim of this study is to assess the overall effectiveness and cost-effectiveness of a novel psychological intervention tailored specifically for survivors of DVA and delivered by domestic violence advocates based in third-sector organizations. METHODS AND STUDY DESIGN: This study is an open, pragmatic, parallel group, individually randomized controlled trial. Women ages 16 years and older experiencing domestic violence are being enrolled and randomly allocated to receive usual DVA agency advocacy support (control) or usual DVA agency support plus psychological intervention (intervention). Those in the intervention group will receive eight specialist psychological advocacy (SPA) sessions weekly or fortnightly, with two follow-up sessions, 1 month and then 3 months later. This will be in addition to any advocacy support sessions each woman receives. Women in the control group will receive usual DVA agency support but no additional SPA sessions. The aim is to recruit 250 women to reach the target sample size. The primary outcomes are psychological well-being and depression severity at 1 yr from baseline, as measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) and the Patient Health Questionnaire (PHQ-9), respectively. Secondary outcome measures include anxiety, posttraumatic stress, severity and frequency of abuse, quality of life and cost-effectiveness of the intervention. Data from a subsample of women in both groups will contribute to a nested qualitative study with repeat interviews during the year of follow-up. DISCUSSION: This study will contribute to the evidence base for management of the psychological needs of women experiencing DVA. The findings will have important implications for healthcare commissioners and providers, as well as third sector specialist DVA agencies providing services to this client group. TRIAL REGISTRATION: ISRCTN58561170

Defining and evaluating novel procedures for involving patients in Core Outcome Set research: creating a meaningful long list of candidate outcome domains

Background Tinnitus is a complex audiological condition affecting many different domains of everyday life. Clinical trials of tinnitus interventions measure and report those outcome domains inconsistently and this hinders direct comparison between study findings. To address this problem, an ongoing project is developing a Core Outcome Set; an agreed list of outcome domains to be measured and reported in all future trials. Part of this project uses a consensus methodology (‘Delphi’ survey), whereby all relevant stakeholders identify important and critical outcome domains from a long list of candidates. This article addresses a gap in the patient involvement literature by describing and reflecting on our involvement of patients to create a meaningful long list of candidate outcome domains. Methods Two Public Research Partners with lived experience of tinnitus reviewed an initial list of 124 outcome domains over two face-to-face workshops. With the Study Management Team, they interpreted each candidate outcome domain and generated a plain language description. Following this, the domain names and descriptions underwent an additional lay review by 14 patients and 5 clinical experts, via an online survey platform. Results Insights gained from the workshops and survey feedback prompted substantial, unforeseen modifications to the long list. These included the reduction of the number of outcome domains (from 124 to 66) via the exclusion of broad concepts and consolidation of equivalent domains or domains outside the scope of the study. Reviewers also applied their lived experience of tinnitus to bring clarity and relevance to domain names and plain language descriptions. Four impacts on the Delphi survey were observed: recruitment exceeded the target by 171%, there were equivalent numbers of patient and professional participants (n=358 and n=312, respectively), feedback was mostly positive, and retention was high (87%). Conclusions Patient involvement was an integral and transformative step of the study design process. Patient involvement was impactful because the online Delphi survey was successful in recruiting and retaining participants, and there were many comments about a positive participatory experience. Seven general methodological features are highlighted which fit with general principles of good patient involvement. These can benefit other Core Outcome Set developers