Is implementing screening for distress an efficient means to recruit patients to a psychological intervention trial?

OBJECTIVES: Psychological interventions show greater efficacy when evaluated with distressed patients. We report on the feasibility of implementing screening for recruiting distressed cancer patients to a randomized controlled trial of problem-solving therapy (PST), characteristics associated with enrolment, and time investment and challenges of implementing screening. METHODS: Three medical settings implemented screening of patients, directly after cancer treatment (T1) and 2 months later (T2), using Hopkins Symptom Checklist-25 and one question about need for services. Distressed patients indicating need for services were interviewed. Eligible patients were offered the possibility to participate in the trial. Consenting patients were randomized to PST or waitlist. RESULTS: At T1, 366 of 970 screened patients (37%) scored above the cutoff and at T2, 208 of 689 screened patients (30%). At either or both T1 and T2, 423 patients reported distress, of whom 215 indicated need for services. Only 36 (4% of 970) patients consented to trial participation. Twenty-seven patients needed to be screened to recruit a single patient, with 17 h required for each patient recruited. Barriers to screening were time constraints and negative attitudes of oncology staff towards screening. CONCLUSIONS: Implementing screening proved inefficient for recruiting distressed cancer patients post-treatment to a randomized controlled trial on PST, with need for services being much less than anticipated. Consecutively screening patients did not result in a sample representative of the larger pool of distressed patients, which may lower generalizability. An adequately powered intervention trial using screening requires a feasibility study establishing recruitment rates and dedicated, funded staff assistance.

Depression screening and patient outcomes in pregnancy or postpartum: a systematic review.

OBJECTIVE: Clinical practice guidelines disagree on whether health care professionals should screen women for depression during pregnancy or postpartum. The objective of this systematic review was to determine whether depression screening improves depression outcomes among women during pregnancy or the postpartum period. METHODS: Searches included the CINAHL, EMBASE, ISI, MEDLINE, and PsycINFO databases through April 1, 2013; manual journal searches; reference list reviews; citation tracking of included articles; and trial registry reviews. RCTs in any language that compared depression outcomes between women during pregnancy or postpartum randomized to undergo depression screening versus women not screened were eligible. RESULTS: There were 9,242 unique titles/abstracts and 15 full-text articles reviewed. Only 1 RCT of screening postpartum was included, but none during pregnancy. The eligible postpartum study evaluated screening in mothers in Hong Kong with 2-month-old babies (N=462) and reported a standardized mean difference for symptoms of depression at 6 months postpartum of 0.34 (95% confidence interval=0.15 to 0.52, P<0.001). Standardized mean difference per 44 additional women treated in the intervention trial arm compared to the non-screening arm was approximately 1.8. Risk of bias was high, however, because the status of outcome measures was changed post-hoc and because the reported effect size per woman treated was 6-7 times the effect sizes reported in comparable depression care interventions. CONCLUSION: There is currently no evidence from any well-designed and conducted RCT that screening for depression would benefit women in pregnancy or postpartum. Existing guidelines that recommend depression screening during pregnancy or postpartum should be re-considered.

Effects of screening for psychological distress on patient outcomes in cancer: a systematic review.

OBJECTIVE: Several practice guidelines recommend routine screening for psychological distress in cancer care. The objective was to evaluate the effect of screening cancer patients for psychological distress by assessing the (1) effectiveness of interventions to reduce distress among patients identified as distressed; and (2) effects of screening for distress on distress outcomes. METHODS: CINAHL, Cochrane, EMBASE, ISI, MEDLINE, PsycINFO, and SCOPUS databases were searched through April 6, 2011 with manual searches of 45 relevant journals, reference list review, citation tracking of included articles, and trial registry reviews through June 30, 2012. Articles in any language on cancer patients were included if they (1) compared treatment for patients with psychological distress to placebo or usual care in a randomized controlled trial (RCT); or (2) assessed the effect of screening on psychological distress in a RCT. RESULTS: There were 14 eligible RCTs for treatment of distress, and 1 RCT on the effects of screening on patient distress. Pharmacological, psychotherapy and collaborative care interventions generally reduced distress with small to moderate effects. One study investigated effects of screening for distress on psychological outcomes, and it found no improvement. CONCLUSION: Treatment studies reported modest improvement in distress symptoms, but only a single eligible study was found on the effects of screening cancer patients for distress, and distress did not improve in screened patients versus those receiving usual care. Because of the lack of evidence of beneficial effects of screening cancer patients for distress, it is premature to recommend or mandate implementation of routine screening.

Is screening effective in detecting untreated psychiatric disorders among newly diagnosed breast cancer patients?

BACKGROUND: A key purpose of routine distress screening is to ensure that cancer patients receive appropriate mental health care. Most studies validating screening instruments overestimate the effectiveness of screening by not differentiating between patients with untreated disorders and patients who are already being treated. This study adopts the novel strategy of evaluating the effectiveness of screening after correcting for disorder for which treatment is already being provided. METHODS: A total of 437 recently diagnosed breast cancer patients received in-clinic distress screening and telephone-based psychiatric interviews. Analyses were conducted using receipt of psychotropic medication for mental health difficulties in the context of a psychiatric disorder as a proxy for identification and treatment. RESULTS: Rates of elevated distress (33%), major depressive disorder (8%), minor depression (6%), dysthymia (2%), or generalized anxiety disorder (3%) were similar to those in other samples. Thirty-six percent of patients received psychotropic medication around the time of cancer diagnosis, including 64% of those with a current psychiatric diagnosis. Although 39% of patients with elevated distress had a psychiatric disorder, the positive predictive value of screening fell to 15% for an untreated psychiatric disorder and 6% had untreated depression. CONCLUSION: Given the high rates of existing treatment, screening may not be efficient for identifying untreated disorder. Almost two-thirds of patients with treated disorders remain symptomatic. Use of symptom scales might reasonably be expanded to surveillance of treatment response or ruling out disorder. Substantial resources would likely be required to coordinate or manage psychiatric care among patients, as would a willingness to intervene in existing relationships with other providers.

Depression screening and patient outcomes in cancer: a systematic review.

BACKGROUND: Several practice guidelines recommend screening for depression in cancer care, but no systematic reviews have examined whether there is evidence that depression screening benefits cancer patients. The objective was to evaluate the potential benefits of depression screening in cancer patients by assessing the (1) accuracy of depression screening tools; (2) effectiveness of depression treatment; and (3) effect of depression screening, either alone or in the context of comprehensive depression care, on depression outcomes. METHODS: Data sources were CINAHL, Cochrane, EMBASE, ISI, MEDLINE, PsycINFO and SCOPUS databases through January 24, 2011; manual journal searches; reference lists; citation tracking; trial registry reviews. Articles on cancer patients were included if they (1) compared a depression screening instrument to a valid criterion for major depressive disorder (MDD); (2) compared depression treatment with placebo or usual care in a randomized controlled trial (RCT); (3) assessed the effect of screening on depression outcomes in a RCT. RESULTS: There were 19 studies of screening accuracy, 1 MDD treatment RCT, but no RCTs that investigated effects of screening on depression outcomes. Screening accuracy studies generally had small sample sizes (median = 17 depression cases) and used exploratory methods to set sample-specific cutoff scores that varied substantially across studies. A nurse-delivered intervention for MDD reduced depressive symptoms moderately (effect size = 0.37). CONCLUSIONS: The one treatment study reviewed reported modest improvement in depressive symptoms, but no evidence was found on whether or not depression screening in cancer patients, either alone or in the context of optimal depression care, improves depression outcomes compared to usual care. Depression screening in cancer should be evaluated in a RCT in which all patients identified as depressed, either through screening or via physician recognition and referral in a control group, have access to comprehensive depression care.

Confirmatory bias and the persistent influence of discredited data in interpreting the stress-cancer link: commentary on Michael et al. (2009).

Comments on the original article, "Influence of stressors on breast cancer incidence in the Women's Health Initiative" by Y. L. Michael et al (see record 2009-03297-001). The current authors assert that Michael et al (2009) missed an opportunity for a straightforward reporting of null findings concerning the association between stress and incidence of cancer. They urge greater skepticism toward the claims about a stress-cancer link more generally. Using data from the Women's Health Initiative, Michael and colleagues suggested an association between stress and the incidence of breast cancer. However, the current authors believe their results and those from other studies failed to confirm that stress is a risk factor of breast cancer. Starting with their abstract and continuing in their discussion, Michael et al selectively and inaccurately reported findings with a strong confirmatory bias, and with further selective and uncritical reference to the existing literature. Moreover, they inadvertently perpetuated the direct and indirect influence of discredited data in the literature purporting to show a stress-cancer link.

Reporting of conflicts of interest in meta-analyses of trials of pharmacological treatments.

CONTEXT: Disclosure of conflicts of interest (COIs) from pharmaceutical industry study funding and author-industry financial relationships is sometimes recommended for randomized controlled trials (RCTs) published in biomedical journals. Authors of meta-analyses, however, are not required to report COIs disclosed in original reports of included RCTs. OBJECTIVE: To investigate whether meta-analyses of pharmacological treatments published in high-impact biomedical journals report COIs disclosed in included RCTs. DATA SOURCES AND STUDY SELECTION: We selected the 3 most recent meta-analyses of patented pharmacological treatments published January 2009 through October 2009 in each general medicine journal with an impact factor of at least 10; in high-impact journals in each of the 5 specialty medicine areas with the greatest 2008 global therapeutic sales (oncology, cardiology, respiratory medicine, endocrinology, and gastroenterology); and in the Cochrane Database of Systematic Reviews. DATA EXTRACTION: Two investigators independently extracted data on disclosed study funding, author-industry financial ties, and author employment from each meta-analysis, from RCTs included in each meta-analysis, and on whether meta-analyses reported disclosed COIs of included RCTs. RESULTS: Of 29 meta-analyses reviewed, which included 509 RCTs, only 2 meta-analyses (7%) reported RCT funding sources; and 0 reported RCT author-industry ties or employment by the pharmaceutical industry. Of 318 meta-analyzed RCTs that reported funding sources, 219 (69%) were industry funded; and 91 of 132 (69%) that reported author financial disclosures had 1 or more authors with pharmaceutical industry financial ties. In 7 of the 29 meta-analyses reviewed, 100% of included RCTs had at least 1 form of disclosed COI (pharmaceutical industry funding, author-industry financial ties, or employment), yet only 1 of these 7 meta-analyses reported RCT funding sources, and 0 reported RCT author-industry ties or employment. CONCLUSION: Among a group of meta-analyses of pharmacological treatments published in high-impact biomedical journals, information concerning primary study funding and author COIs for the included RCTs were only rarely reported.

Does screening for distress efficiently uncover meetable unmet needs in cancer patients?

OBJECTIVES: We evaluated screening for distress in terms of its ability to uncover unmet need for psychosocial services in cancer patients. Correlates of distress, need for services and met and unmet need for services were investigated. METHODS: Immediately after cancer treatment (T1) and 2 months later (T2), 302 patients completed the Hopkins Symptom Checklist-25 (HSCL-25) and a single question assessing the need for services. All distressed patients (HSCL-25≥39) and non-distressed patients endorsing a need for services were then called (n = 99) to assess their need. RESULTS: Thirty-seven percent (T1) and 31% (T2) of patients were distressed and 31% (T1) and 18% (T2) expressed the need for services. Both time points showed higher distress in younger patients and females and lower distress in prostate cancer and patients treated by radiotherapy only. Less need for services was found in prostate cancer (T1), greater need was related to being single (T1) and younger (T2). Distress and need for services were positively related (p<0.001). The HSCL-25 showed modest sensitivity (T1: 0.59, T2: 0.65) and specificity (T1: 0.75, T2: 0.78) as an indicator of need for services. Interviews at T2 revealed that 51% of distressed patients needed no psychosocial services and 25% were already receiving services. At T2, regardless of distress level, 10% of all screened patients reported an unmet need for psychosocial services. CONCLUSIONS: Depending on the clinical context, screening might be more efficient if it assessed the unmet need for services rather than distress. More attention should be concentrated on directing patients with meetable unmet needs to available services.

Risky health behaviors among mothers-to-be: the impact of adverse childhood experiences.

OBJECTIVES: Adverse childhood experiences (ACEs) are risk factors for health problems later in life. This study aims to assess the influence of ACEs on risky health behaviors among mothers-to-be and determine whether a dose response occurs between ACEs and risky behaviors. METHODS: A prospective survey of women attending health centers was conducted at the first prenatal care visit, and at 3 and 11 months postpartum. Surveys obtained information on maternal sociodemographic and health characteristics, and 7 ACEs prior to age 16. Risky behaviors included smoking, alcohol use, marijuana use, and other illicit drug use during pregnancy. RESULTS: Our sample (N = 1476) consisted of low-income (mean annual personal income, $8272), young (mean age, 24 years), African American (71%), single (75%) women. Twenty-three percent of women reported smoking even after finding out they were pregnant, 7% reported alcohol use, and 7% reported illicit drug use during pregnancy. Nearly three fourths (72%) had one or more ACEs. There was a higher prevalence of each risky behavior among those exposed to each ACE than among those unexposed. The exception was alcohol use during pregnancy, where there was not an increased risk among those exposed when compared with those unexposed to witnessing a shooting or having a guardian in trouble with the law or in jail. The adjusted odds ratio for each risky behavior was >2.5 for those with >3 ACEs when compared with those without. CONCLUSIONS: ACEs were associated with risky health behaviors reported by mothers-to-be. Greater efforts should target the prevention of ACEs to lower the risk for adverse health behaviors that have serious consequences for adults and their children.

Invited commentary: personality as a causal factor in cancer risk and mortality--time to retire a hypothesis?

In this issue of the Journal, Nakaya et al. (Am J Epidemiol. 2010;172(4):377-385) report null findings from a large-scale prospective study of the prognostic value of 2 personality dimensions, neuroticism and extraversion, for cancer risk and mortality. The study stands out because of its exceptionally large sample size and its methodological strengths. The authors discuss the Nakaya et al. study in the context of persistent beliefs about the role of personality in cancer onset and survival despite a pattern of null findings in the literature, as well as the influence of extreme outlier findings from one investigator group that continue to be cited. They question whether it is time for the field to move on from considering a role for personality in cancer to more promising and modifiable factors.