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Statistical Methods For The Analysis Of Biomedical Data

Background: There are well-documented disparities in lung cancer outcomes across populations. Lung cancer screening (LCS) has the potential to reduce lung cancer mortality, but for this benefit to be realized by all high-risk groups, there must be careful attention to ensuring equitable access to this lifesaving preventive health measure.Objectives: To outline current knowledge on disparities in eligibility criteria for, access to, and implementation of LCS, and to develop an official American Thoracic Society statement to propose strategies to optimize current screening guidelines and resource allocation for equitable LCS implementation and dissemination.Methods: A multidisciplinary panel with expertise in LCS, implementation science, primary care, pulmonology, health behavior, smoking cessation, epidemiology, and disparities research was convened. Participants reviewed available literature on historical disparities in cancer screening and emerging evidence of disparities in LCS.Results: Existing LCS guidelines do not consider racial, ethnic, socioeconomic, and sex-based differences in smoking behaviors or lung cancer risk. Multiple barriers, including access to screening and cost, further contribute to the inequities in implementation and dissemination of LCS.Conclusions: This statement identifies the impact of LCS eligibility criteria on vulnerable populations who are at increased risk of lung cancer but do not meet eligibility criteria for screening, as well as multiple barriers that contribute to disparities in LCS implementation. Strategies to improve the selection and dissemination of LCS in vulnerable groups are described.

Addressing Disparities in Lung Cancer Screening Eligibility and Healthcare Access. An Official American Thoracic Society Statement.

The transition to electronic health records offers the potential for big data to drive the next frontier in healthcare improvement. Yet there are multiple barriers to harnessing the power of data. The Learning Health System (LHS) has emerged as a model to overcome these barriers, yet there remains limited evidence of impact on delivery or outcomes of healthcare. To gather evidence on the effects of LHS data hubs or aligned models that use data to deliver healthcare improvement and impact. Any reported impact on the process, delivery or outcomes of healthcare was captured. Systematic review from CINAHL, EMBASE, MEDLINE, Medline in-process and Web of Science PubMed databases, using learning health system, data hub, data-driven, ehealth, informatics, collaborations, partnerships, and translation terms. English-language, peer-reviewed literature published between January 2014 and Sept 2019 was captured, supplemented by a grey literature search. Eligibility criteria included studies of LHS data hubs that reported research translation leading to health impact. Overall, 1076 titles were identified, with 43 eligible studies, across 23 LHS environments. Most LHS environments were in the United States (n = 18) with others in Canada, UK, Sweden and Australia/NZ. Five (21.7%) produced medium-high level of evidence, which were peer-reviewed publications. LHS environments are producing impact across multiple continents and settings.

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Learning health systems using data to drive healthcare improvement and impact: a systematic review

Importance Lung cancer screening with low-dose computed tomography lowers lung cancer mortality but has potential harms. Current guidelines support patients receiving information about the benefits and harms of lung cancer screening during decision-making. Objective To examine the effect of a patient decision aid (PDA) about lung cancer screening compared with a standard educational material (EDU) on decision-making outcomes among smokers. Design, Setting, and Participants This randomized clinical trial was conducted using 13 state tobacco quitlines. Current and recent tobacco quitline clients who met age and smoking history eligibility for lung cancer screening were enrolled from March 30, 2015, to September 12, 2016, and followed up for 6 months until May 5, 2017. Data analysis was conducted between May 5, 2017, and September 30, 2018. Interventions Participants were randomized to the PDA videoLung Cancer Screening: Is It Right for Me?(n = 259) or to EDU (n = 257). Main Outcomes and Measures The primary outcomes were preparation for decision-making and decisional conflict measured at 1 week. Secondary outcomes included knowledge, intentions, and completion of screening within 6 months of receiving the intervention measured by patient report. Results Of 516 quit line clients enrolled, 370 (71.7%) were younger than 65 years, 320 (62.0%) were female, 138 (26.7%) identified as black, 47 (9.1%) did not have health insurance, and 226 (43.8%) had a high school or lower educational level. Of participants using the PDA, 153 of 227 (67.4%) were well prepared to make a screening decision compared with 108 of 224 participants (48.2%) using EDU (odds ratio [OR], 2.31; 95% CI, 1.56-3.44;P  Conclusions and Relevance In this study, a PDA delivered to clients of tobacco quit lines improved informed decision-making about lung cancer screening. Many smokers eligible for lung cancer screening can be reached through tobacco quit lines. Trial Registration ClinicalTrials.gov identifier:NCT02286713

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Effect of a Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A Randomized Clinical Trial

Background Patient-reported outcomes measures (PROMs) assess a patient's subjective appraisal of health outcomes from their own perspective. Despite hypothesised benefits that feedback on PROMs can support decision-making in clinical practice and improve outcomes, there is uncertainty surrounding the effectiveness of PROMs feedback. Objectives To assess the effects of PROMs feedback to patients, or healthcare workers, or both on patient-reported health outcomes and processes of care. Search methods We searched MEDLINE, Embase, CENTRAL, two other databases and two clinical trial registries on 5 October 2020. We searched grey literature and consulted experts in the field. Selection criteria Two review authors independently screened and selected studies for inclusion. We included randomised trials directly comparing the effects on outcomes and processes of care of PROMs feedback to healthcare professionals and patients, or both with the impact of not providing such information. Data collection and analysis Two groups of two authors independently extracted data from the included studies and evaluated study quality. We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. We conducted meta-analyses of the results where possible. Main results We identified 116 randomised trials which assessed the effectiveness of PROMs feedback in improving processes or outcomes of care, or both in a broad range of disciplines including psychiatry, primary care, and oncology. Studies were conducted across diverse ambulatory primary and secondary care settings in North America, Europe and Australasia. A total of 49,785 patients were included across all the studies. The certainty of the evidence varied between very low and moderate. Many of the studies included in the review were at risk of performance and detection bias. The evidence suggests moderate certainty that PROMs feedback probably improves quality of life (standardised mean difference (SMD) 0.15, 95% confidence interval (CI) 0.05 to 0.26; 11 studies; 2687 participants), and leads to an increase in patient-physician communication (SMD 0.36, 95% CI 0.21 to 0.52; 5 studies; 658 participants), diagnosis and notation (risk ratio (RR) 1.73, 95% CI 1.44 to 2.08; 21 studies; 7223 participants), and disease control (RR 1.25, 95% CI 1.10 to 1.41; 14 studies; 2806 participants). The intervention probably makes little or no difference for general health perceptions (SMD 0.04, 95% CI -0.17 to 0.24; 2 studies, 552 participants; low-certainty evidence), social functioning (SMD 0.02, 95% CI -0.06 to 0.09; 15 studies; 2632 participants; moderate-certainty evidence), and pain (SMD 0.00, 95% CI -0.09 to 0.08; 9 studies; 2386 participants; moderate-certainty evidence). We are uncertain about the effect of PROMs feedback on physical functioning (14 studies; 2788 participants) and mental functioning (34 studies; 7782 participants), as well as fatigue (4 studies; 741 participants), as the certainty of the evidence was very low. We did not find studies reporting on adverse effects defined as distress following or related to PROM completion. Authors' conclusions PROM feedback probably produces moderate improvements in communication between healthcare professionals and patients as well as in diagnosis and notation, and disease control, and small improvements to quality of life. Our confidence in the effects is limited by the risk of bias, heterogeneity and small number of trials conducted to assess outcomes of interest. It is unclear whether many of these improvements are clinically meaningful or sustainable in the long term. There is a need for more high-quality studies in this area, particularly studies which employ cluster designs and utilise techniques to maintain allocation concealment.

Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice

Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned.

........................................................................................................................................................ 3 Background ................................................................................................................................................... 5 Participation of Patients and Other Stakeholders in the Study Planning and Design, Conduct of Research, and Dissemination of Findings ...................................................................................................................... 7 Types of Stakeholders and Their Involvement ....................................................................................... 7 Impact of Stakeholder Involvement on the Research Project ............................................................... 9 Methods ...................................................................................................................................................... 11 Study Overview .................................................................................................................................... 11 Study Design ......................................................................................................................................... 12 Participants ........................................................................................................................................... 14 Interventions and Comparators or Controls ........................................................................................ 15 Study Outcomes ................................................................................................................................... 17 Study Setting ........................................................................................................................................ 19 Timeframe for the Study ...................................................................................................................... 20 Data Collection and Sources ................................................................................................................. 20 Analytical and Statistical Approaches .................................................................................................. 21 Results ......................................................................................................................................................... 24 Sources of Participants ......................................................................................................................... 24 Participant Flow .................................................................................................................................... 26 Characteristics of the Study Patients ................................................................................................... 29 Comparisons of Patients Who Did and Did Not Complete the Follow-up Assessments ...................... 30 Primary Outcomes ................................................................................................................................ 33 Secondary Outcome: Knowledge of Lung Cancer Screening ............................................................... 35 Additional Outcomes Related to Screening Intentions and Behaviors ................................................ 37 Acceptability of the Patient Decision Aid ............................................................................................. 39 Discussion.................................................................................................................................................... 40 Decisional Context ................................................................................................................................ 40 Study Results in Context ....................................................................................................................... 41 Implementation of Study Findings ....................................................................................................... 43 Generalizability of the Findings ............................................................................................................ 43 Subpopulation Considerations ............................................................................................................. 44 Study Limitations .................................................................................................................................. 44 Future Research.................................................................................................................................... 44 Conclusions ................................................................................................................................................. 45 References .................................................................................................................................................. 46 Acknowledgments ....................................................................................................................................... 50 Related Publications ................................................................................................................................... 50

Linda Bailey

Papers

Effect of a Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A Randomized Clinical Trial

Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned.

A Patient Decision Aid to Help Heavy Smokers Make Decisions about Lung Cancer Screening