PPIE in a technical research study: Using public involvement to refine the concept and understanding and move towards a multidimensional concept of disability.

BACKGROUND: Disability is often an essentialised and oversimplified concept. We propose refining this while incorporating the multidimensional nature of disability by increasing the use of existing survey questions and their corresponding data to enrich, broaden and inform understandings of disability. METHODS: We combined patient and public involvement and engagement (PPIE) with focus groups and concept mapping to collaboratively map disability survey questions into conceptual models of disability with six members of the public with lived experiences of disability. RESULTS: Using reflexive thematic analysis, we identified three qualitative themes and eight subthemes through a series of four PPIE activities: (1) understanding concepts of disability based on individual experience, subthemes: 1.1-preference for the biopsychosocial model, 1.2-'Reviewing' instead of mapping survey questions and 1.3-comparing questions to real life; (2) consistency between understanding needs and implementing adjustments, subthemes: 2.1-connecting preparation and operation, 2.2-inclusivity and adjustments in activities and 2.3-feedback for improving activities and (3) real-world applications-targeted awareness raising, subthemes: 3.1-who, where, what and how to share activity findings and results, 3.2-sharing with human resource and equality, diversity and inclusion professionals. CONCLUSION: Members of the public who collaborated in these activities felt empowered, engaged and supported throughout this study. This approach offers a model for other researchers to cede power to the public over the research aspects typically reserved for researchers. PATIENT OR PUBLIC CONTRIBUTION: We involved members of the public with lived experience throughout this study-co-design, co-facilitation, collaboratively mapping the disability or disability-related survey questions into conceptual models of disability, evaluation of the activities, co-analysis and co-authorship.

A blueprint for patient and public involvement in the development of a reporting guideline for systematic reviews of outcome measurement instruments: PRISMA-COSMIN for OMIs 2024.

BACKGROUND: In recent years, projects to develop reporting guidelines have attempted to integrate the perspectives of patients and public members. Best practices for patient and public involvement (PPI) in such projects have not yet been established. We recently developed an extension of PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), to be used for systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) for OMIs 2024. Patients and public members formed a small but impactful stakeholder group. We critically evaluated the PPI component in this project and developed recommendations for conducting PPI when developing reporting guidelines. MAIN TEXT: A patient partner was an integral research team member at the project development and grant application stage. Once the project started, five patient and public contributors (PPCs) were recruited to participate in the Delphi study; three PPCs contributed to subsequent steps. We collected quantitative feedback through surveys; qualitative feedback was garnered through a focus group discussion after the Delphi study and through debrief meetings after subsequent project activities. Feedback was thematically combined with reflections from the research team, and was predominantly positive. The following themes emerged: importance of PPI partnership, number of PPCs involved, onboarding, design of Delphi surveys, flexibility in the process, complexity of PPI in methodological research, and power imbalances. Impacts of PPI on the content and presentation of the reporting guideline were evident, and reciprocal learning between PPCs and the research team occurred throughout the project. Lessons learned were translated into 17 recommendations for future projects. CONCLUSION: Integrating PPI in the development of PRISMA-COSMIN for OMIs 2024 was feasible and considered valuable by PPCs and the research team. Our approach can be applied by others wishing to integrate PPI in developing reporting guidelines.

Evaluating the acceptability of remote cognitive remediation from the perspective of psychosis service users.

OBJECTIVES: Cognitive remediation (CR) can reduce the cognitive difficulties experienced by people with psychosis. Adapting CR to be delivered remotely provides new opportunities for extending its use. However, doing so requires further evaluation of its acceptability from service users' views. We evaluate the acceptability of therapist-supported remote CR from the perspectives of service users using participatory service user-centred methods. METHOD: After receiving 12 weeks of therapist-supported remote CR, service users were interviewed by a service user researcher following a semi-structured 18-question interview guide. Transcripts were analysed using reflexive thematic analysis with themes and codes further validated by a Lived Experience Advisory Panel and member checking. RESULTS: The study recruited 26 participants, almost all of whom reported high acceptability of remote CR, and some suggested improvements. Four themes emerged: (1) perceived treatment benefits, (2) remote versus in-person therapy, (3) the therapist's role, and (4) how it could be better. CONCLUSIONS: This study used comprehensive service user involvement methods. For some participants, technology use remained a challenge and addressing these difficulties detracted from the therapy experience. These outcomes align with existing research on remote therapy, suggesting that remote CR can expand choice and improve access to treatment for psychosis service users once barriers are addressed. Future use of remote CR should consider technology training and equipment provision to facilitate therapy for service users and therapists.

Estimating the smallest worthwhile difference of antidepressants: a cross-sectional survey.

BACKGROUND: Approximately 30% of patients experience substantial improvement in depression after 2 months without treatment, and 45% with antidepressants. The smallest worthwhile difference (SWD) refers to an intervention's smallest beneficial effect over a comparison patients deem worthwhile given treatment burdens (harms, expenses and inconveniences), but is undetermined for antidepressants. OBJECTIVE: Estimating the SWD of commonly prescribed antidepressants for depression compared to no treatment. METHODS: The SWD was estimated as a patient-required difference in response rates between antidepressants and no treatment after 2 months. An online cross-sectional survey using Prolific, MQ Mental Health and Amazon Mechanical Turk crowdsourcing services in the UK and USA between October 2022 and January 2023 garnered participants (N=935) that were a mean age of 44.1 (SD=13.9) and 66% women (n=617). FINDINGS: Of 935 participants, 124 reported moderate-to-severe depressive symptoms but were not in treatment, 390 were in treatment and 495 reported absent-to-mild symptoms with or without treatment experiences. The median SWD was a 20% (IQR=10-30%) difference in response rates for people with moderate-to-severe depressive symptoms, not in treatment, and willing to consider antidepressants, and 25% (IQR=10-35%) for the full sample. CONCLUSIONS: Our observed SWDs mean that the current 15% antidepressant benefit over no treatment was sufficient for one in three people to accept antidepressants given the burdens, but two in three expected greater treatment benefits. IMPLICATIONS: While a minority may be satisfied with the best currently available antidepressants, more effective and/or less burdensome medications are needed, with more attention given to patient perspectives.

A qualitative interview study exploring the psychological health impacts of the SPIN-CHAT program among people with systemic sclerosis at the onset of COVID-19: perceptions of trial participants and research team members.

PURPOSE: Explore trial participants' and research team members' perceptions of the impact of the videoconference-based, supportive care program (SPIN-CHAT Program) during early COVID-19 for individuals with systemic sclerosis (SSc). METHODS: Data were collected cross-sectionally. A social constructivist paradigm was adopted, and one-on-one videoconference-based, semi-structured interviews were conducted with SPIN-CHAT Trial participants and research team members. A hybrid inductive-deductive approach and reflexive thematic analysis were used. RESULTS: Of the 40 SPIN-CHAT Trial participants and 28 research team members approached, 30 trial participants (Mean age = 54.9; SD = 13.0 years) and 22 research team members agreed to participate. Those who took part in interviews had similar characteristics to those who declined. Five themes were identified: (1) The SPIN-CHAT Program conferred a range of positive psychological health outcomes, (2) People who don't have SSc don't get it: The importance of SSc-specific programming, (3) The group-based format of the SPIN-CHAT Program created a safe space to connect and meet similar others, (4) The structure and schedule of the SPIN-CHAT Program reduced feelings of boredom and contributed to enhanced psychological health, (5) The necessity of knowledge, skills, and tools to self-manage SSc and navigate COVID-19. CONCLUSION: Participants' and research team members' perspectives elucidated SPIN-CHAT Program benefits and how these benefits may have been realized. Results underscore the importance of social support from similar others, structure, and self-management to enhance psychological health during COVID-19. TRIAL REGISTRATION: clinicaltrials.gov (NCT04335279)IMPLICATIONS FOR REHABILITATIONThe videoconference-based, supportive care SPIN-CHAT Program enhanced psychological health amongst individuals affected by systemic sclerosis.SPIN-CHAT Program participants and research team members shared that being around similar others, program structure, and self-management support were important and may have contributed to enhanced psychological health.Further efforts are required to explore experiences within supportive care programs to better understand if and how psychological health is impacted.

Procedural justice and forensic mental health: An introduction and future directions.

This article advocates for integrating procedural justice principles into forensic mental health services to enhance patient engagement and autonomy. Procedural justice, broadly defined as fair decision-making processes, is introduced and key principles including voice, neutrality, respect and trustworthiness are described. Evidence suggestive of positive outcomes following procedural justice experiences, such as improved satisfaction, collaboration and reduced perceptions of coercion is outlined. Practical applications are suggested, including staff training and reflective practices using procedural justice principles. The article then calls for further research to explore patients' and staff members' experiences of procedural justice in forensic settings, develop measurement tools, undertake intervention studies and establish causal links between procedural justice and outcomes important for forensic patients.

A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials.

Background: Interventional trials that evaluate treatment effects using surrogate endpoints have become increasingly common. This paper describes four linked empirical studies and the development of a framework for defining, interpreting and reporting surrogate endpoints in trials. Methods: As part of developing the CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) extensions for randomised trials reporting surrogate endpoints, we undertook a scoping review, e-Delphi study, consensus meeting, and a web survey to examine current definitions and stakeholder (including clinicians, trial investigators, patients and public partners, journal editors, and health technology experts) interpretations of surrogate endpoints as primary outcome measures in trials. Findings: Current surrogate endpoint definitional frameworks are inconsistent and unclear. Surrogate endpoints are used in trials as a substitute of the treatment effects of an intervention on the target outcome(s) of ultimate interest, events measuring how patients feel, function, or survive. Traditionally the consideration of surrogate endpoints in trials has focused on biomarkers (e.g., HDL cholesterol, blood pressure, tumour response), especially in the medical product regulatory setting. Nevertheless, the concept of surrogacy in trials is potentially broader. Intermediate outcomes that include a measure of function or symptoms (e.g., angina frequency, exercise tolerance) can also be used as substitute for target outcomes (e.g., all-cause mortality)-thereby acting as surrogate endpoints. However, we found a lack of consensus among stakeholders on accepting and interpreting intermediate outcomes in trials as surrogate endpoints or target outcomes. In our assessment, patients and health technology assessment experts appeared more likely to consider intermediate outcomes to be surrogate endpoints than clinicians and regulators. Interpretation: There is an urgent need for better understanding and reporting on the use of surrogate endpoints, especially in the setting of interventional trials. We provide a framework for the definition of surrogate endpoints (biomarkers and intermediate outcomes) and target outcomes in trials to improve future reporting and aid stakeholders' interpretation and use of trial surrogate endpoint evidence. Funding: SPIRIT-SURROGATE/CONSORT-SURROGATE project is Medical Research Council Better Research Better Health (MR/V038400/1) funded.

Development of a framework and research impact capture tool for nursing, midwifery, allied health professions, healthcare science, pharmacy and psychology (NMAHPPs).

BACKGROUND: There is an ambitious target to create a UK clinical academic workforce representing 1% of clinicians from nursing, midwifery, the allied health professions, healthcare science, pharmacy and psychology (NMAHPPs). Understanding and recording the impact that clinical academics make across healthcare services is crucial if we are to grow, value and support this highly skilled workforce group. However, it is currently difficult to systematically record, collate and report the impacts associated with NMAHPP research activity. The aims of this project were to i) develop a framework outlining the impacts that were important for key stakeholder groups, and ii) create and pilot a research impact capture tool to record these impacts. METHODS: The framework was developed from the existing literature. It was refined, remodelled and approved by multidisciplinary stakeholder involvement, including patient and public representatives, healthcare managers and research-active clinicians. The framework was converted into a series of questions to create an electronic research impact capture tool, which was also refined through feedback from these stakeholder groups. The impact capture tool was piloted with research-active clinicians across a large NHS Trust and its associated organisations. RESULTS: The impact framework contained eight elements: clinical background, research and service improvement activities, research capacity building, research into practice, patients and service users, research dissemination, economics and research funding, and collaborations. Thirty individuals provided data for the research impact capture tool pilot (55% response rate). Respondents reported a range of positive impacts representing all elements of the framework. Importantly, research-activity appeared to be a key driver for recruitment and retention in the sample population. CONCLUSIONS: The impact capture tool is a feasible method of recording the breadth of impacts associated with NMAHPP research activity. We encourage other organisations to collaboratively use and refine our impact capture tool, with the aim of standardising reporting, and facilitating discussions about research activity within clinical appraisal. Pooling and comparing data will also allow comparison between organisations, and assessment of change over time or after implementation of interventions aimed at supporting and increasing research activity.

Comparison of mental health symptoms before and during the covid-19 pandemic: evidence from a systematic review and meta-analysis of 134 cohorts.

OBJECTIVE: To synthesise results of mental health outcomes in cohorts before and during the covid-19 pandemic. DESIGN: Systematic review. DATA SOURCES: Medline, PsycINFO, CINAHL, Embase, Web of Science, China National Knowledge Infrastructure, Wanfang, medRxiv, and Open Science Framework Preprints. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Studies comparing general mental health, anxiety symptoms, or depression symptoms assessed from 1 January 2020 or later with outcomes collected from 1 January 2018 to 31 December 2019 in any population, and comprising ≥90% of the same participants before and during the covid-19 pandemic or using statistical methods to account for missing data. Restricted maximum likelihood random effects meta-analyses (worse covid-19 outcomes representing positive change) were performed. Risk of bias was assessed using an adapted Joanna Briggs Institute Checklist for Prevalence Studies. RESULTS: As of 11 April 2022, 94 411 unique titles and abstracts including 137 unique studies from 134 cohorts were reviewed. Most of the studies were from high income (n=105, 77%) or upper middle income (n=28, 20%) countries. Among general population studies, no changes were found for general mental health (standardised mean difference (SMD)change 0.11, 95% confidence interval -0.00 to 0.22) or anxiety symptoms (0.05, -0.04 to 0.13), but depression symptoms worsened minimally (0.12, 0.01 to 0.24). Among women or female participants, general mental health (0.22, 0.08 to 0.35), anxiety symptoms (0.20, 0.12 to 0.29), and depression symptoms (0.22, 0.05 to 0.40) worsened by minimal to small amounts. In 27 other analyses across outcome domains among subgroups other than women or female participants, five analyses suggested that symptoms worsened by minimal or small amounts, and two suggested minimal or small improvements. No other subgroup experienced changes across all outcome domains. In three studies with data from March to April 2020 and late 2020, symptoms were unchanged from pre-covid-19 levels at both assessments or increased initially then returned to pre-covid-19 levels. Substantial heterogeneity and risk of bias were present across analyses. CONCLUSIONS: High risk of bias in many studies and substantial heterogeneity suggest caution in interpreting results. Nonetheless, most symptom change estimates for general mental health, anxiety symptoms, and depression symptoms were close to zero and not statistically significant, and significant changes were of minimal to small magnitudes. Small negative changes occurred for women or female participants in all domains. The authors will update the results of this systematic review as more evidence accrues, with study results posted online (https://www.depressd.ca/covid-19-mental-health). REVIEW REGISTRATION: PROSPERO CRD42020179703.

Individual participant data meta-analysis to compare EPDS accuracy to detect major depression with and without the self-harm item.

Item 10 of the Edinburgh Postnatal Depression Scale (EPDS) is intended to assess thoughts of intentional self-harm but may also elicit concerns about accidental self-harm. It does not specifically address suicide ideation but, nonetheless, is sometimes used as an indicator of suicidality. The 9-item version of the EPDS (EPDS-9), which omits item 10, is sometimes used in research due to concern about positive endorsements of item 10 and necessary follow-up. We assessed the equivalence of total score correlations and screening accuracy to detect major depression using the EPDS-9 versus full EPDS among pregnant and postpartum women. We searched Medline, Medline In-Process and Other Non-Indexed Citations, PsycINFO, and Web of Science from database inception to October 3, 2018 for studies that administered the EPDS and conducted diagnostic classification for major depression based on a validated semi-structured or fully structured interview among women aged 18 or older during pregnancy or within 12 months of giving birth. We conducted an individual participant data meta-analysis. We calculated Pearson correlations with 95% prediction interval (PI) between EPDS-9 and full EPDS total scores using a random effects model. Bivariate random-effects models were fitted to assess screening accuracy. Equivalence tests were done by comparing the confidence intervals (CIs) around the pooled sensitivity and specificity differences to the equivalence margin of δ = 0.05. Individual participant data were obtained from 41 eligible studies (10,906 participants, 1407 major depression cases). The correlation between EPDS-9 and full EPDS scores was 0.998 (95% PI 0.991, 0.999). For sensitivity, the EPDS-9 and full EPDS were equivalent for cut-offs 7-12 (difference range - 0.02, 0.01) and the equivalence was indeterminate for cut-offs 13-15 (all differences - 0.04). For specificity, the EPDS-9 and full EPDS were equivalent for all cut-offs (difference range 0.00, 0.01). The EPDS-9 performs similarly to the full EPDS and can be used when there are concerns about the implications of administering EPDS item 10.Trial registration: The original IPDMA was registered in PROSPERO (CRD42015024785).

Exploring research team members' and trial participants' perceptions of acceptability and implementation within one videoconference-based supportive care program for individuals affected by systemic sclerosis during COVID-19: a qualitative interview study.

The SPIN-CHAT Program was designed to support mental health among individuals with systemic sclerosis (SSc; commonly known as scleroderma) and at least mild anxiety symptoms at the onset of COVID-19. The program was formally evaluated in the SPIN-CHAT Trial. Little is known about program and trial acceptability, and factors impacting implementation from the perspectives of research team members and trial participants. Thus, the propose of this follow-up study was to explore research team members' and trial participants' experiences with the program and trial to identify factors impacting acceptability and successful implementation. Data were collected cross-sectionally through one-on-one, videoconference-based, semi-structured interviews with 22 research team members and 30 purposefully recruited trial participants (Mage = 54.9, SD = 13.0 years). A social constructivist paradigm was adopted, and data were analyzed thematically. Data were organized into seven themes: (i) getting started: the importance of prolonged engagement and exceeding expectations; (ii) designing the program and trial: including multiple features; (iii) training: research team members are critical to positive program and trial experiences; (iv) offering the program and trial: it needs to be flexible and patient-oriented; (v) maximizing engagement: navigating and managing group dynamics; (vi) delivering a videoconference-based supportive care intervention: necessary, appreciated, and associated with some barriers; and (vii) refining the program and trial: considering modification when offered beyond the period of COVID-19 restrictions. Trial participants were satisfied with and found the SPIN-CHAT Program and Trial to be acceptable. Results offer implementation data that can guide the design, development, and refinement of other supportive care programs seeking to promote psychological health during and beyond COVID-19.

The Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Program, a videoconference-based supportive care program, was designed to protect and enhance mental health in individuals affected by systemic sclerosis (commonly known as scleroderma) with at least mild anxiety symptoms during the COVID-19 pandemic. A trial was conducted to evaluate the SPIN-CHAT Program, and results were generally positive. However, important gaps in knowledge remained. Specifically, research team members' and participants' perceptions of SPIN-CHAT Trial acceptability (including satisfaction) and factors impacting implementation of the SPIN-CHAT Program had not yet been explored. To fill this gap, we conducted one-on-one, videoconference-based, semi-structured interviewed with 22 research team members and 30 purposefully recruited trial participants. Interviews sought to gain insights into research team members' and trial participants' experiences within the SPIN-CHAT Program, delivery preferences, and aspects that were/were not beneficial. Findings suggest research team members and participants valued the SPIN-CHAT Program and found the trial to be acceptable. Results also highlight important factors to consider when designing, developing, and/or refining videoconference-based supportive care programs.

Comparison of the accuracy of the 7-item HADS Depression subscale and 14-item total HADS for screening for major depression: A systematic review and individual participant data meta-analysis.

The seven-item Hospital Anxiety and Depression Scale Depression subscale (HADS-D) and the total score of the 14-item HADS (HADS-T) are both used for major depression screening. Compared to the HADS-D, the HADS-T includes anxiety items and requires more time to complete. We compared the screening accuracy of the HADS-D and HADS-T for major depression detection. We conducted an individual participant data meta-analysis and fit bivariate random effects models to assess diagnostic accuracy among participants with both HADS-D and HADS-T scores. We identified optimal cutoffs, estimated sensitivity and specificity with 95% confidence intervals, and compared screening accuracy across paired cutoffs via two-stage and individual-level models. We used a 0.05 equivalence margin to assess equivalency in sensitivity and specificity. 20,700 participants (2,285 major depression cases) from 98 studies were included. Cutoffs of ≥7 for the HADS-D (sensitivity 0.79 [0.75, 0.83], specificity 0.78 [0.75, 0.80]) and ≥15 for the HADS-T (sensitivity 0.79 [0.76, 0.82], specificity 0.81 [0.78, 0.83]) minimized the distance to the top-left corner of the receiver operating characteristic curve. Across all sets of paired cutoffs evaluated, differences of sensitivity between HADS-T and HADS-D ranged from -0.05 to 0.01 (0.00 at paired optimal cutoffs), and differences of specificity were within 0.03 for all cutoffs (0.02-0.03). The pattern was similar among outpatients, although the HADS-T was slightly (not nonequivalently) more specific among inpatients. The accuracy of HADS-T was equivalent to the HADS-D for detecting major depression. In most settings, the shorter HADS-D would be preferred. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

'Optimal' cutoff selection in studies of depression screening tool accuracy using the PHQ-9, EPDS, or HADS-D: A meta-research study.

OBJECTIVES: Optimal cutoff thresholds are selected to separate 'positive' from 'negative' screening results. We evaluated how depression screening tool studies select optimal cutoffs. METHODS: We included studies from previously conducted meta-analyses of Patient Health Questionnaire-9, Edinburgh Postnatal Depression Scale, or Hospital Anxiety and Depression Scale-Depression accuracy. Outcomes included whether an optimal cutoff was selected, method used, recommendations made, and reporting guideline and protocol citation. RESULTS: Of 212 included studies, 172 (81%) attempted to identify an optimal cutoff, and 147 of these 172 (85%) reported one or more methods. Methods were heterogeneous with Youden's J (N = 35, 23%) most common. Only 23 of 147 (16%) studies described a rationale for their method. Rationales focused on balancing sensitivity and specificity without describing why desirable. 131 of 172 studies (76%) identified an optimal cutoff other than the standard; most did not make use recommendations (N = 56; 43%) or recommended using a non-standard cutoff (N = 53; 40%). Only 4 studies cited a reporting guideline, and 4 described a protocol with optimal cutoff selection methods, but none used the protocol method in the published study. CONCLUSIONS: Research is needed to guide how selection of cutoffs for depression screening tools can be standardized and reflect clinical considerations.

Development of the FORUM: a new patient and clinician reported outcome measure for forensic mental health services.

Forensic mental health services provide care to people in secure psychiatric hospitals and via specialised community teams. Such services are typically low volume and high cost, often highly restrictive and average duration of inpatient care prior to discharge is long. Measuring outcomes of care is important to safeguard patients and the public, monitor progress, inform treatment plans and assist in service evaluation and planning. We describe the development in England of a new outcome measure for forensic mental health services. Patient interviews and multistakeholder focus groups were held to elicit key concepts. Thematic analysis was used to develop an outcomes framework. Fifteen patients participated in the interviews and 48 stakeholders in the focus groups. Six domains were identified in thematic analysis: 'about me, my quality of life, my health, my safety and risk, my life skills and my progress'. Sixty-two stakeholders participated in the first round of the Delphi process, and 49 completed round two. Eight of the top fifteen outcomes were shared between patients/carers and professionals. Based on these results, a new outcome measure, the FORensic oUtcome Measure (FORUM), was developed including both a patient reported and clinician reported measure. Further assessment of the FORUM's use to track patients' progress over time, and facilitate shared decision-making and care planning, is required.

Time to re-evaluate the risks and benefits of valproate and a call for action.

Valproate is widely used in psychiatry and neurology, including off-label use. Here we consider its potential benefits and risks, particularly for women of childbearing potential, and the evidence that clinical guidelines are adhered to. Finally, we consider the implications for clinical practice and research into its efficacy in off-label indications.

Systematic review of mental health symptom changes by sex or gender in early-COVID-19 compared to pre-pandemic.

Women and gender-diverse individuals have faced disproportionate socioeconomic burden during COVID-19. There have been reports of greater negative mental health changes compared to men based on cross-sectional research that has not accounted for pre-COVID-19 differences. We compared mental health changes from pre-COVID-19 to during COVID-19 by sex or gender. MEDLINE (Ovid), PsycINFO (Ovid), CINAHL (EBSCO), EMBASE (Ovid), Web of Science Core Collection: Citation Indexes, China National Knowledge Infrastructure, Wanfang, medRxiv (preprints), and Open Science Framework Preprints (preprint server aggregator) were searched to August 30, 2021. Eligible studies included mental health symptom change data by sex or gender. 12 studies (10 unique cohorts) were included, all of which reported dichotomized sex or gender data. 9 cohorts reported results from March to June 2020, and 2 of these also reported on September or November to December 2020. One cohort included data pre-November 2020 data but did not provide dates. Continuous symptom change differences were not statistically significant for depression (standardized mean difference [SMD] = 0.12, 95% CI -0.09-0.33; 4 studies, 4,475 participants; I2 = 69.0%) and stress (SMD = - 0.10, 95% CI -0.21-0.01; 4 studies, 1,533 participants; I2 = 0.0%), but anxiety (SMD = 0.15, 95% CI 0.07-0.22; 4 studies, 4,344 participants; I2 = 3.0%) and general mental health (SMD = 0.15, 95% CI 0.12-0.18; 3 studies, 15,692 participants; I2 = 0.0%) worsened more among females/women than males/men. There were no significant differences in changes in proportions above cut-offs: anxiety (difference = - 0.05, 95% CI - 0.20-0.11; 1 study, 217 participants), depression (difference = 0.12, 95% CI -0.03-0.28; 1 study, 217 participants), general mental health (difference = - 0.03, 95% CI - 0.09-0.04; 3 studies, 18,985 participants; I2 = 94.0%), stress (difference = 0.04, 95% CI - 0.10-0.17; 1 study, 217 participants). Mental health outcomes did not differ or were worse by small amounts among women than men during early COVID-19.