The value of a second reviewer for study selection in systematic reviews.

BACKGROUND: Although dual independent review of search results by two reviewers is generally recommended for systematic reviews, there are not consistent recommendations regarding the timing of the use of the second reviewer. This study compared the use of a complete dual review approach, with two reviewers in both the title/abstract screening stage and the full-text screening stage, as compared with a limited dual review approach, with two reviewers only in the full-text stage. METHODS: This study was performed within the context of a large systematic review. Two reviewers performed a complete dual review of 15 000 search results and a limited dual review of 15 000 search results. The number of relevant studies mistakenly excluded by highly experienced reviewers in the complete dual review was compared with the number mistakenly excluded during the full-text stage of the limited dual review. RESULTS: In the complete dual review approach, an additional 6.6% to 9.1% of eligible studies were identified during the title/abstract stage by using two reviewers, and an additional 6.6% to 11.9% of eligible studies were identified during the full-text stage by using two reviewers. In the limited dual review approach, an additional 4.4% to 5.3% of eligible studies were identified with the use of two reviewers. CONCLUSIONS: Using a second reviewer throughout the entire study screening process can increase the number of relevant studies identified for use in a systematic review. Systematic review performers should consider using a complete dual review process to ensure all relevant studies are included in their review.

Multimorbidity in randomized controlled trials of behavioral interventions: A systematic review.

OBJECTIVE: As the population with multiple chronic conditions (MCC) increases, it is essential that randomized controlled trials (RCTs) consider MCC. Behavioral interventions have the potential to positively impact MCC patient outcomes; however, a comprehensive review of consideration of MCC in these trials has not been conducted. The purpose of this systematic review is to determine the frequency with which participants with MCC are represented in behavioral intervention RCTs targeting chronic illness published 2000-2014. METHOD: MEDLINE and EMBASE were searched from 2000 to 2014 to identify RCTs testing behavioral interventions among adults with chronic illness. A random sampling selection process was performed to identify 600 eligible studies representative of the literature. Two reviewers independently extracted information on consideration of MCC in eligibility criteria and evaluated the reporting and consideration of MCC in trial analyses. Risk of bias was assessed using the Cochrane Collaboration Risk of Bias Tool. RESULTS: In 600 behavioral intervention RCTs, targeting MCC was rare (4.3%). Exclusion of MCC was common (68.3%) and was done through general, specific, or vague exclusion criteria. 218 (36.3%) trials reported presence of MCCs through general or condition-specific measures. Comorbidities were only considered in 4.8% of all trial analyses. CONCLUSIONS: In this comprehensive systematic review of 600 studies published from 2000-2014, RCTs testing behavioral interventions rarely consider individuals with MCC, limiting generalizability. Given the public health relevance and limited evidence base, this work highlights the urgent need to improve the consideration of MCC in clinical trial research. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Levels and patterns of self-reported and objectively-measured free-living physical activity among prostate cancer survivors: A prospective cohort study.

BACKGROUND: No prior study has measured or compared self-reported and objectively measured physical activity trajectories in prostate cancer survivors before and after treatment. METHODS: Clinically localized prostate cancer patients treated with radical prostatectomy were recruited between 2011 and 2014. Of the 350 participants enrolled at the main site, 310 provided self-reported physical activity at baseline before radical prostatectomy, and 5 weeks, 6 months, and 12 months after radical prostatectomy. A subset of participants (n = 81) provided objectively measured physical activity at all study time points by wearing an accelerometer for 7 days each. Changes in activity over time were compared using Friedman's test. Agreement between self-reported and objective measures was evaluated using Spearman's rank correlation coefficient. RESULTS: Self-reported moderate-to-vigorous physical activity was high at baseline (median, 32.1 min/day), followed by a decline at 5 weeks (median, 15.0 min/day) and a recovery at 6 and 12 months (median, 32.1-47.1 min/day). In contrast, objectively measured moderate-to-vigorous physical activity was low at all 4 time points (median, 0.0-5.2 min/day), with no overall change across study assessments (global P = .29). Self-reported moderate-to-vigorous physical activity tended to be more closely related to objectively measured light-intensity physical activity (ρ = 0.29-0.42) than to objectively measured moderate-to-vigorous physical activity (ρ = 0.07-0.27, P = .009-.32). CONCLUSIONS: In our population of prostate cancer survivors with critically low moderate-to-vigorous physical activity levels, self-reported measures greatly overestimated moderate-to-vigorous physical activity and may have been more reflective of light-intensity physical activity. Because cancer survivor guidelines are derived from self-reported data, our findings may imply that intensities of physical activity below moderate, such as light intensity, still have health benefits.

Utility and Generalizability of Multistate, Population-Based Cancer Registry Data for Rural Cancer Surveillance Research in the United States.

More than 46 million Americans live in rural areas, but rural populations remain relatively understudied in cancer disparities research. However, several analyses of multistate cancer registry data that describe the rural cancer incidence burden have been recently published. In light of this, our article aims to characterize the utility and generalizability of multistate, population-based cancer registry datasets for rural cancer surveillance research. First, we describe the accessibility, geographic coverage, available variables, and strengths and weaknesses of five data sources. Second, we evaluate two of these data sources-the North American Association of Central Cancer Registries (NAACCR) public use dataset (93% population coverage) and the Surveillance Epidemiology and End Results (SEER) 18 dataset (28% population coverage)-on their characterization of rural-urban cancer incidence rates and sociodemographic representation. The five data sources varied in geographic coverage and extent of available variables. SEER 18's cancer rates sociodemographic representation differed from the more geographically representative NAACCR data. We suggest that SEER increase its geographic coverage to improve their generalizability and to take advantage of their utility to assess disparities along the cancer control continuum. We also suggest that non-SEER data sources be utilized more frequently to capitalize on their extensive geographic coverage. Cancer Epidemiol Biomarkers Prev; 27(11); 1252-60. ©2018 AACR.

Rural-Urban Differences in Cancer Incidence and Trends in the United States.

Background: Cancer incidence and mortality rates in the United States are declining, but this decrease may not be observed in rural areas where residents are more likely to live in poverty, smoke, and forego cancer screening. However, there is limited research exploring national rural-urban differences in cancer incidence and trends.Methods: We analyzed data from the North American Association of Central Cancer Registries' public use dataset, which includes population-based cancer incidence data from 46 states. We calculated age-adjusted incidence rates, rate ratios, and annual percentage change (APC) for: all cancers combined, selected individual cancers, and cancers associated with tobacco use and human papillomavirus (HPV). Rural-urban comparisons were made by demographic, geographic, and socioeconomic characteristics for 2009 to 2013. Trends were analyzed for 1995 to 2013.Results: Combined cancers incidence rates were generally higher in urban populations, except for the South, although the urban decline in incidence rate was greater than in rural populations (10.2% vs. 4.8%, respectively). Rural cancer disparities included higher rates of tobacco-associated, HPV-associated, lung and bronchus, cervical, and colorectal cancers across most population groups. Furthermore, HPV-associated cancer incidence rates increased in rural areas (APC = 0.724, P < 0.05), while temporal trends remained stable in urban areas.Conclusions: Cancer rates associated with modifiable risks-tobacco, HPV, and some preventive screening modalities (e.g., colorectal and cervical cancers)-were higher in rural compared with urban populations.Impact: Population-based, clinical, and/or policy strategies and interventions that address these modifiable risk factors could help reduce cancer disparities experienced in rural populations. Cancer Epidemiol Biomarkers Prev; 27(11); 1265-74. ©2017 AACR.

Rural-urban differences in surgical treatment, regional lymph node examination, and survival in endometrial cancer patients.

PURPOSE: Endometrial cancer (EC) is the most common gynecological malignancy and one of few cancers with an increasing US mortality rate. Rural patients may have less access to specialty care affecting their receipt of surgery and adequate lymphadenectomy (AL). We sought to assess rural-urban differences in EC surgery, lymphadenectomy, and survival. METHODS: We analyzed data from the Surveillance Epidemiology and End Results database on EC patients (2004-2013). We performed univariate analyses to compare rural and urban patients on demographic and clinical characteristics and receipt of nodal examination and AL. We assessed rural-urban differences in trends of receipt of AL, performed logistic regression to evaluate differences in receipt of surgery, nodal examination, and AL, and performed survival analysis. RESULTS: Rural patients were less likely to have any lymph nodes removed, had a smaller median number removed, and a smaller proportion had AL. Even after controlling for established risk factors, rural patients had lower odds of lymph node examination and adequate AL than urban patients and also had poorer survival. CONCLUSIONS: Future research should continue to assess the association between access to care and disparities in surgical care and the effect of these disparities on survival.

Caution with Use of the EPIC-50 Urinary Bother Scale: How Voiding Dysfunction Modifies its Performance.

PURPOSE: We evaluated agreement between patient reported urinary function and bother, and sexual function and bother in patients treated with radical prostatectomy to help inform possible nonfunctional, modifiable mechanisms for patient bother. MATERIALS AND METHODS: Patients were recruited from 2011 to 2014 at Washington University, and Brigham and Women's Hospital. Urinary and sexual outcomes were assessed by EPIC-50 (Expanded Prostate Cancer Index Composite-50) before, 5 weeks and 12 months after radical prostatectomy. Spearman rank correlation coefficients and agreement/disagreement categories were used to describe the relation between function and bother. RESULTS: Despite moderate to good agreement between function and bother (urinary r = 0.51-0.69 and sexual r = 0.65-0.80) discordant groups were observed. In the urinary domain these groups were men disproportionately bothered by function at baseline (16.9%) and 12 months after radical prostatectomy (6.1%) and men less bothered by function 5 weeks (26.8%) and 12 months (9.9%) after radical prostatectomy. Discordant groups in the sexual domain were men less bothered by function at baseline (20.8%), and 5 weeks (21.1%) and 12 months (15.7%) after radical prostatectomy. Splitting the urinary bother scale into 2 subscales, including one for incontinence related bother to complement the urinary function scale which measures only incontinence, and one for voiding dysfunction related bother yielded considerably better agreement (urinary function and incontinence related bother r = 0.78-0.83). Factors contributing to the group less bothered by sexual function were unclear. CONCLUSIONS: When using EPIC-50, investigators should consider splitting the urinary bother scale by the relation to incontinence to prevent distortions of function-bother and comparisons before vs after radical prostatectomy by coexisting voiding dysfunction.

Spontaneous mental associations with the words "side effect": Implications for informed and shared decision making.

OBJECTIVE: To gain insight into patients' medical decisions by exploring the content of laypeople's spontaneous mental associations with the term "side effect." METHODS: An online cross-sectional survey asked 144 women aged 40-74, "What are the first three things you think of when you hear the words 'side effect?"' Data were analyzed using content analysis, chi-square, and Fisher's exact tests. RESULTS: 17 codes emerged and were grouped into 4 themes and a Miscellaneous category: Health Problems (70.8% of participants), Decision-Relevant Evaluations (52.8%), Negative Affect (30.6%), Practical Considerations (18.1%) and Miscellaneous (9.7%). The 4 most frequently identified codes were: Risk (36.1%), Health Problems-Specific Symptoms (35.4%), Health Problems-General Terms (32.6%), and Negative Affect-Strong (19.4%). Code and theme frequencies were generally similar across demographic groups (ps>0.05). CONCLUSION: The term "side effect" spontaneously elicited comments related to identifying health problems and expressing negative emotions. This might explain why the mere possibility of side effects triggers negative affect for people making medical decisions. Some respondents also mentioned decision-relevant evaluations and practical considerations in response to side effects. PRACTICE IMPLICATIONS: Addressing commonly-held associations and acknowledging negative affects provoked by side effects are first steps healthcare providers can take towards improving informed and shared patient decision making.

Antipyretic Therapy in Critically Ill Septic Patients: A Systematic Review and Meta-Analysis.

OBJECTIVE: This meta-analysis aimed to examine the impact of antipyretic therapy on mortality in critically ill septic adults. DATA SOURCES: Literature searches were implemented in Ovid Medline, Embase, Scopus, Cumulative Index of Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, NHS Economic Evaluation Database, and ClinicalTrials.gov through February 2016. STUDY SELECTION: Inclusion criteria were observational or randomized studies of septic patients, evaluation of antipyretic treatment, mortality reported, and English-language version available. Studies were excluded if they enrolled pediatric patients, patients with neurologic injury, or healthy volunteers. Criteria were applied by two independent reviewers. DATA EXTRACTION: Two reviewers independently extracted data and evaluated methodologic quality. Outcomes included mortality, frequency of shock reversal, acquisition of nosocomial infections, and changes in body temperature, heart rate, and minute ventilation. Randomized and observational studies were analyzed separately. DATA SYNTHESIS: Eight randomized studies (1,507 patients) and eight observational studies (17,432 patients) were analyzed. Antipyretic therapy did not reduce 28-day/hospital mortality in the randomized studies (relative risk, 0.93; 95% CI, 0.77-1.13; I = 0.0%) or observational studies (odds ratio, 0.90; 95% CI, 0.54-1.51; I = 76.1%). Shock reversal (relative risk, 1.13; 95% CI, 0.68-1.90; I = 51.6%) and acquisition of nosocomial infections (relative risk, 1.13; 95% CI, 0.61-2.09; I = 61.0%) were also unchanged. Antipyretic therapy decreased body temperature (mean difference, -0.38°C; 95% CI, -0.63 to -0.13; I = 84.0%), but not heart rate or minute ventilation. CONCLUSIONS: Antipyretic treatment does not significantly improve 28-day/hospital mortality in adult patients with sepsis.

Effect of weight loss on bone health in overweight/obese postmenopausal breast cancer survivors.

Current guidelines recommend weight loss in obese cancer survivors. Weight loss, however, has adverse effects on bone health in obese individuals without cancer but this has not been evaluated in breast cancer survivors. We investigated the associations of intentional weight loss with bone mineral density (BMD) and bone turn-over markers in overweight/obese postmenopausal breast cancer survivors. Participants were overweight/obese breast cancer survivors (N = 81) with stage I, II or IIIA disease enrolled in the St. Louis site of a multi-site Exercise and Nutrition to Enhance Recovery and Good health for You (ENERGY) study; a randomized-controlled clinical trial designed to achieve a sustained ≥7 % loss in body weight at 2 years. Weight loss was achieved through dietary modification with the addition of physical activity. Generalized estimating equations were used to assess differences in mean values between follow-up and baseline. Mean weight decreased by 3 and 2.3 % between baseline and 6-month follow-up, and 12-month follow-up, respectively. There were decreases in osteocalcin (10.6 %, p value < 0.001), PINP (14.5 %, p value < 0.001), NTx (19.2 % p value < 0.001), and RANK (48.5 %, p value < 0.001), but not BALP and CTX-1 levels between baseline and 12-month follow-up. No significant changes occurred in mean T-scores, pelvis and lumbar spine BMD between baseline and 12-month follow-up. A 2.3 % weight loss over 12 months among overweight/obese women with early-stage breast cancer does not appear to have deleterious effect on bone health, and might even have beneficial effect. These findings warrant confirmation, particularly among breast cancer survivors with a larger magnitude of weight loss.