Utility of the Patient-Reported Outcomes Measurement Information System (PROMIS) to measure primary health outcomes in cancer patients: a systematic review.

OBJECTIVE: To systematically review the literature on how the Patient-Reported Outcomes Measurement Information System (PROMIS) measure system is used to assess patient-reported outcomes (PROs) in cancer patients. METHODS: We conducted a systematic review following the PRISMA guidelines. Articles were identified through searches of PubMed, EMBASE, and additional manual review of the publications listed on the PROMIS website. We included studies measuring outcomes, including physical function, fatigue, pain, anxiety, and depression in cancer patients. Eligible articles included interventional and observational studies published in English between 2009 and 2019. RESULTS: A total of 1789 records were identified and screened by three reviewers, 118 articles were reviewed in full text, and 42 articles met the inclusion criteria. The majority of studies used the PROMIS measure system to prospectively assess longitudinal changes in PROs; the number of measurements ranges from 2 to 4 with the time points of follow-up set at 3, 6, and 12 months after the baseline assessment. Depression and fatigue were the most frequently measured outcomes. Fixed-length short forms with four items were the most common measure types. A transition toward utilizing a web- or smartphone-based electronic tool was observed to limit the burden of the conventional paper-based survey to collect and store PROs. CONCLUSION: The PROMIS measure system is increasingly popular to measure PROs in cancer patients with acceptance of its various short forms and electronic-based systems to administer data electronically. Findings from this review highlight various aspects of PROMIS and may help health professionals in their choice of PRO tools for optimizing care and support for cancer patients.

Gallstones, Cholecystectomy and the Risk of Hepatobiliary and Pancreatic Cancer: A Nationwide Population-based Cohort Study in Korea.

Several epidemiological studies suggest a potential association between gallstones or cholecystectomy and hepatobiliary and pancreatic cancers (HBPCs). The aim of this study was to evaluate the risk of HBPCs in patients with gallstones or patients who underwent cholecystectomy in the Korean population. A retrospective cohort was constructed using the National Health Insurance Service-National Sample Cohort (NHIS-NSC). Gallstones and cholecystectomy were defined by diagnosis and procedure codes and treated as time-varying covariates. Hazard ratios (HRs) in relation to the risk of HBPCs were estimated by Cox proportional hazard models. Among the 704,437 individuals who were included in the final analysis, the gallstone prevalence was 2.4%, and 1.4% of individuals underwent cholecystectomy. Between 2002 and 2015, 487 and 189 individuals developed HBPCs in the gallstone and cholecystectomy groups, respectively. A significant association was observed between gallstones and all HBPCs (HR 2.16; 95% CI 1.92-2.42) and cholecystectomy and all HBPCs (HR 2.03; 95% CI 1.72-2.39). However, when 1-, 3-, and 5-year lag periods were applied, the HBPC and subsites risk approached zero. A significant association was observed between cholecystectomy and intrahepatic bile duct cancer (IBDC) (HR 2.68; 95% CI 1.63-4.40). When 1-, 3- and 5-year lag periods were applied, the IBDC risk after cholecystectomy was 2.86-fold (95% CI 1.68-4.85), 2.92-fold (95% CI 1.51-5.64), and 4.08-fold (95% CI 1.94-8.61) higher, respectively, than that in the comparison group. In conclusion, gallstone diagnosis and cholecystectomy seem to correlate with HBPCs, especially cholecystectomy and IBDC.

Prognosis of Patients with Colorectal Cancer with Diabetes According to Medication Adherence: A Population-Based Cohort Study.

BACKGROUND: Diabetes mellitus is known to have a negative effect on colorectal cancer survival due to hyperinsulinemia or hyperglycemia, and medications such as metformin, which targets insulin resistance and hyperinsulinemia, have a preventive effect on the risk of death. The aim of this study was to compare the risk of death among patients with colorectal cancer with diabetes with different levels of adherence to oral antidiabetics. METHODS: National Health Information Database was used, which has all claims data for those who are registered for national health insurance in Korea, from 2002 to 2016, for conducting a retrospective cohort study. Newly diagnosed patients with colorectal cancer among diabetics were followed up from the date of diagnosis until death or December 31, 2016. The medication adherence was calculated as the proportion of days covered (PDC). The HR and 95% confidence interval (CI) for death were estimated using the low-adherence patients as a reference. RESULTS: A total of 33,841 diabetic patients with newly diagnosed colorectal cancer were followed for an average of 4.7 years. Patients with colorectal cancer with good adherence (PDC ≥ 80%) showed a reduced risk of death [HR (95% CI), 0.82 (0.78-0.86)] compared with those with poor adherence (PDC < 80%). A reduced risk of death was observed for all cancer subsites. CONCLUSIONS: The maintenance of good medication adherence for diabetes mellitus was related to a favorable prognosis of colorectal cancer. IMPACT: This study provides evidence that patients with colorectal cancer who are adherent to their diabetes medication will have better survival than patients who are not adherent.

Efficacy of health coaching and a web-based program on physical activity, weight, and distress management among cancer survivors: A multi-centered randomised controlled trial.

OBJECTIVES: To investigate the efficacy of health coaching and a web-based program on survivor physical activity (PA), weight, and distress management among stomach, colon, lung and breast cancer patients. METHODS: This randomised, controlled, 1-year trial conducted in five hospitals recruited cancer survivors within 2 months of completing primary cancer treatment who had not met ≥1 of these behavioural goals: (i) conducting moderate PA for at least 150 minutes/week or strenuous exercise for over 75 minutes per week or, in the case of lung cancer patients, low or moderate intensity exercise for over 12.5 MET per week, (ii) maintaining normal weight, and (iii) attaining a score >72 in the Post Traumatic Growth Inventory (PTGI). Participants were randomly assigned to one of three groups: the control group, a web-only group, or a health coaching + web group. The primary endpoint was based on a composite of PA, weight, and PTGI score at 12 months. RESULTS: Patients in the health coaching + web group (difference = 6.6%, P = .010) and the web-only group (difference = 5.9%, P = .031) had greater overall improvements across the three-outcome composite than the control group. The health coaching + web group had greater overall improvement in PTGI (difference = 12.6%; P < .001) than the control group, but not in PA and weight. CONCLUSION: The web-based program, with or without health coaching, may improve health behaviours including PA, weight, and distress management among cancer survivors within 2 months of completing primary cancer treatment. The web-based program with health coaching was mainly effective for reducing psychological distress.

National cancer screening program for gastric cancer in Korea: Nationwide treatment benefit and cost.

BACKGROUND: The purpose of this study was to evaluate the nationwide benefit and cost of the national cancer screening program (NCSP) for gastric cancer treatment. METHODS: For this nationwide, population-based study, the Korean National Health Insurance Big Data Base, which included gastric cancer-related treatment information and the costs for all patients with gastric cancer who were 40 years old or older between 2004 and 2013, was restructured. Patients with gastric cancer who participated in the NCSP at least once (the screening group) were compared with those who did not participate in the NCSP (the nonscreening group). RESULTS: The screening group (n = 116,775) spent significantly less on medical care expenses than the nonscreening group (n = 74,927) during the 5 years since the initial treatment (P < .0001). The screening group presented a significantly better prognosis for 5 and 9 years than the nonscreening group (P < .0001). The screening group revealed a 41% decreased hazard ratio (P < .0001) for death in comparison with the nonscreening group; the prognostic benefit became more obvious when treatment was started within the first 4 months after screening. The age-standardized mortality rate ratio of the screening group versus the nonscreening group was 0.62 (P < .0001). The NCSP for gastric cancer required an average of 22,169,769 Korean Republic won (US $20,309) for 1 life-year saved, which was less than the average gross domestic product (GDP) per capita in Korea. CONCLUSIONS: The screening group had significantly lower medical care expenses and showed a significantly better prognosis than the nonscreening group. On the basis of the GDP per capita, the NCSP for gastric cancer was cost-effective for treatment prognosis.

Association between sedative-hypnotic medication use and incidence of cancer in Korean Nation Health Insurance Service data.

OBJECTIVES: We aimed to investigate the association between the use of various sedative-hypnotics and the incidence of overall and individual cancers in a large, population-based, retrospective cohort study. METHODS: We selected a 5% random sample of individuals aged 50 years or older from data maintained by the Korean National Health Insurance Service for the years 2002-2015, excluding individuals with a prior diagnosis of cancer and with any sedative-hypnotic use in the initial two years of follow-up, leaving 236,759 participants for the final analysis. Exposure to sedative-hypnotics was defined by type of drug, standardized to a defined daily dose, and coded as a time-varying variable. Cox proportional hazard models were applied after adjusting for sex, socio-economic status, and comorbidities. RESULTS: We observed increased risk for overall cancer among men and women who used sedative-hypnotics (hazard ratio (HR) = 1.07, 95% confidence interval (CI) = 1.01-1.13 for men; HR = 1.21, 95% CI = 1.09-1.25 for women) compared with non-users after full adjustment. In the fully adjusted model, women with any sedative-hypnotic use had significantly increased risk for thyroid (HR = 1.53, 95% CI = 1.24-1.87), breast (HR = 1.29, 95% CI = 1.04-1.61), ovarian (HR = 1.65, 95% CI = 1.10-2.46), and lung cancer (HR = 1.40, 95% CI = 1.17-1.69) compared with non-users. Men with sedative-hypnotic use had increased risk for prostate (HR = 1.36, 95% CI = 1.16-1.58), brain (HR = 1.67, 95% CI = 1.04-2.69), and lung cancer (HR = 1.20, 95% CI = 1.07-1.35) compared with non-users. CONCLUSION: We found a significant increase in overall cancer incidence among participants who used sedative-hypnotics, and both male and female sedative-hypnotic users had significantly increased risk for certain types of cancer.

The Risk of Colorectal Cancer After Cholecystectomy or Appendectomy: A Population-based Cohort Study in Korea.

OBJECTIVES: We investigated the association between cholecystectomy or appendectomy and the subsequent risk of colorectal cancer (CRC) in the Korean population. METHODS: A retrospective cohort study was conducted with the National Health Insurance Service-National Sample Cohort of Korea; this sample was followed up from January 1, 2002, until the date of CRC incidence, loss to follow-up, or December 31, 2015. The exposure status of cholecystectomy and appendectomy was treated as a time-varying covariate. The calculated risk of CRC was stratified by follow-up period, and the association between these surgical procedures and CRC was investigated by a Cox regression model applying appropriate lag periods. RESULTS: A total of 707 663 individuals were identified for analysis. The study population was followed up for an average of 13.66 years, and 4324 CRC cases were identified. The hazard ratio (HR) of CRC was elevated in the first year after cholecystectomy (HR, 1.71; 95% confidence interval [CI], 1.01 to 2.89) and in the first year and 2-3 years after appendectomy (HR, 4.22; 95% CI, 2.87 to 6.20; HR, 2.34; 95% CI, 1.36 to 4.03, respectively). The HRs of CRC after applying 1 year of lag after cholecystectomy and 3 years of lag after appendectomy were 0.80 (95% CI, 0.57 to 1.13) and 0.77 (95% CI, 0.51 to 1.16), respectively. CONCLUSIONS: The risk of CRC increased in the first year after cholecystectomy and appendectomy, implying the possibility of bias. When appropriate lag periods after surgery were applied, no association was found between cholecystectomy or appendectomy and CRC.