Quality Appraisal in Systematic Literature Reviews of Studies Eliciting Health State Utility Values: Conceptual Considerations.

BACKGROUND: The increasing number of studies that generate health state utility values (HSUVs) and the impact of HSUVs on cost-utility analyses make a robust tailored quality appraisal (QA) tool for systematic reviews of these studies necessary. OBJECTIVE: This study aimed to address conceptual issues regarding QA in systematic reviews of studies eliciting HSUVs by establishing a consensus on the definitions, dimensions and scope of a QA tool specific to this context. METHODS: A modified Delphi method was used in this study. An international multidisciplinary panel of seven experts was purposively assembled. The experts engaged in two anonymous online survey rounds. After each round, the experts received structured and controlled feedback on the previous phase. Controlled feedback allowed the experts to re-evaluate and adjust their positions based on collective insights. Following these surveys, a virtual face-to-face meeting was held to resolve outstanding issues. Consensus was defined a priori at all stages of the modified Delphi process. RESULTS: The response rates to the first-round and second-round questionnaires and the virtual consensus meeting were 100%, 86% and 71%, respectively. The entire process culminated in a consensus on the definitions of scientific quality, QA, the three QA dimensions-reporting, relevance and  methodological quality-and the scope of a QA tool specific to studies that elicit HSUVs. CONCLUSIONS: Achieving this consensus marks a pivotal step towards developing a QA tool specific to systematic reviews of studies eliciting HSUVs. Future research will build on this foundation, identify QA items, signalling questions and response options, and develop a QA tool specific to studies eliciting HSUVs.

The socioeconomic impact of cancer on patients and their relatives: Organisation of European Cancer Institutes task force consensus recommendations on conceptual framework, taxonomy, and research directions.

Loss of income and out-of-pocket expenditures are important causes of financial hardship in many patients with cancer, even in high-income countries. The far-reaching consequences extend beyond the patients themselves to their relatives, including caregivers and dependents. European research to date has been limited and is hampered by the absence of a coherent theoretical framework and by heterogeneous methods and terminology. To address these shortages, a task force initiated by the Organisation of European Cancer Institutes (OECI) produced 25 recommendations, including a comprehensive definition of socioeconomic impact from the perspective of patients and their relatives, a conceptual framework, and a consistent taxonomy linked to the framework. The OECI task force consensus statement highlights directions for future research with a view towards policy relevance. Beyond descriptive studies into the dimension of the problem, individual severity and predictors of vulnerability should be explored. It is anticipated that the consensus recommendations will facilitate and enhance future research efforts into the socioeconomic impact of cancer and cancer care, providing a crucial reference point for the development and validation of patient-reported outcome instruments aimed at measuring its broader effects.

Developing a Conceptual Framework for Socioeconomic Impact Research in European Cancer Patients: A 'Best-Fit' Framework Synthesis.

BACKGROUND: Multiple studies have indicated a socioeconomic impact of cancer and cancer care on patients and their families. Existing instruments designed to measure this impact lack consensus in their conceptualization of the issue. Further, various terminologies have been used in the literature (e.g., financial burden, financial hardship, financial stress) without clear definitions and consistent conceptual background. Based on a targeted review of existing models addressing the socioeconomic impact of cancer, our goal was to develop a comprehensive framework from a European perspective. METHOD: A 'best-fit' framework synthesis was applied. First, we systematically identified existing models to generate a priori concepts. Second, we systematically identified relevant European qualitative studies and coded their results against these a priori concepts. Inclusion and exclusion criteria were predefined and applied thoroughly in these processes. Thematic analysis and team discussions were applied to finalize the (sub)themes in our proposed conceptual framework. Third, we examined model structures and quotes from qualitative studies to explore relationships among (sub)themes. This process was repeated until no further change in (sub)themes and their relationships emerged. RESULT: Eighteen studies containing conceptual models and seven qualitative studies were identified. Eight concepts and 20 sub-concepts were derived from the included models. After coding the included qualitative studies against the a priori concepts and following discussions among team members, seven themes and 15 sub-themes were included in our proposed conceptual framework. Based on the identified relationships, we categorized themes into four groups: causes, intermediate consequences, outcomes and risk factors. CONCLUSION: We propose a Socioeconomic Impact Framework based on a targeted review and synthesis of existing models in the field and adapted to the European perspective. Our work contributes as an input to a European consensus project on socioeconomic impact research by an Organization European Cancer Institute (OECI) Task Force.

The COVID-19 Pandemic and Cancer Patients in Germany: Impact on Treatment, Follow-Up Care and Psychological Burden.

In response to the ongoing coronavirus disease 2019 (COVID-19) pandemic, governments imposed various measures to decrease the rate of disease spread, and health care policy makers prioritized resource allocation to accommodate COVID-19 patients. We conducted a cross-sectional online survey in Germany (July 2020-June 2021) to assess the frequency of changes to cancer care among cancer patients and to explore the psychological impact of the pandemic writ large. Cancer patients who contacted the Cancer Information Service (Krebsinformationsdienst, KID) of the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) via email were invited to complete an online questionnaire, capturing demographics, cancer specifics (e.g., type, disease phase, primary place of treatment, etc.), and any changes to their medical, follow-up, psycho-oncological or nursing care. General level of psychological distress was measured using the Hospital Anxiety and Depression Scale (HADS) along with face-validated items regarding worries and social isolation specific to the pandemic. In total, 13% of 621 patients reported a change to their treatment or care plan. Of those patients with changes, the majority of changes were made to follow-up care after treatment (56%), to monitoring during treatment (29%) and to psychological counseling (20%). Of the overall sample, more than half of patients (55%) reported symptoms of anxiety and 39% reported symptoms of depression. Patients with a change in cancer care were more likely to report symptoms of depression than those with no change (AOR: 2.18; 95% CI: 1.26-3.76). Concern about the pandemic affecting the quality of health care was a predictor of both anxiety (AOR: 2.76; 95% CI: 1.75-4.35) and depression (AOR: 2.15; 95% CI: 1.43-3.23). Results showed that the majority of cancer patients in our study did not experience a change in their cancer care. However, the level of anxiety and psycho-social burden of cancer patients during the pandemic was high throughout the study period. Our findings underscore the need for health care services and policy makers to assess and to attend cancer patients' medical needs, with added emphasis on patients' psychological and social well-being. This applies particularly in situations where the healthcare system is strained and prioritization is necessary.

Alcohol problems, aggression, and other externalizing behaviors after return from deployment: understanding the role of combat exposure, internalizing symptoms, and social environment.

OBJECTIVES: The study examined whether elevated rates of externalizing behaviors following deployment could be explained by internalizing symptoms (depression, anxiety, and PTSD symptoms), and health of the social environment (unit leadership, organizational support, and stigma/barriers to care). DESIGN: A model of combat exposure, social environment, internalizing symptoms, and externalizing behaviors was tested in a military unit following a fifteen-month deployment to Iraq. The sample included 1,397 soldiers assessed four month post-deployment; 589 of these soldiers were assessed again nine months post-deployment. RESULTS: Externalizing behaviors were highly stable over the five-month post-deployment period. Both social environment and internalizing symptoms were significantly associated with level of externalizing behaviors at four months and nine months post-deployment, but combat exposure alone significantly predicted change in externalizing behaviors over the follow-up period. CONCLUSIONS: Results suggest the need to broaden the scope of interventions targeted to combat veterans and have implications for care providers and military leaders.

A2 diagnostic criterion for combat-related posttraumatic stress disorder.

Individuals trained to respond to a potentially traumatic event may not experience the posttraumatic stress disorder (PTSD) A2 diagnostic criterion of fear, helplessness, or horror and yet may still report significant PTSD symptoms. The present study included interviews with 202 soldiers returning from a year in Iraq. Although reporting an A2 response was associated with higher PTSD Checklist scores, there were no significant differences in the percentage of subjects who met cutoff criteria for PTSD. The most common alternative A2 responses were related to military training and anger. The A2 criterion for PTSD should be expanded so as not to underestimate the number of individuals trained for high-risk occupations who might benefit from treatment.

Structured clinical interview guide for postdeployment psychological screening programs.

Brief structured clinical interviews are a key component of the Department of Defense postdeployment health reassessment program. Such interviews are critical for recommending individuals for follow-up assessment and care. To standardize the interview process, U.S. Army Medical Research Unit-Europe developed a structured interview guide, designed in response to both clinical requirements and research findings. The guide includes sections on depression, suicidality, post-traumatic stress disorder, anger, relationship problems, alcohol problems, and sleep problems. In addition, there is an open-ended section on other problems and a section for case dispositions. Data from a 2005 blinded validation study with soldiers returning from a 1-year-long combat deployment are included to demonstrate the utility of the structured interview. Guidelines and implementation considerations for the use of the structured interview are discussed.

Contrasting approaches to psychological screening with U.S. combat soldiers.

Psychological screening can be conducted using global screens, single items, symptom-based scales, or composite measures. These four different approaches were evaluated against structured clinical interviews in studies with U.S. soldiers preparing to deploy and returning from combat operations in Iraq. Three samples (N = 337, N = 574, and N = 348) were screened to assess the effectiveness of a short global measure of distress, a single self-referral item, symptom-specific scales selected for the target population, and a composite instrument that included a combination of clinical domains. A composite screen with measures of posttraumatic stress, depression, and alcohol problems, along with a single self-referral item, performed most effectively.