A comparison of cardiovascular disease, cancer, mortality, and Graves' ophthalmopathy following treatment for hyperthyroidism: A Bayesian network meta-analysis.

OBJECTIVES: This network meta-analysis aimed to evaluate the association of anti-thyroid drugs (ATD), radioactive iodine (RAI), and thyroidectomy with subsequent outcomes in patients with newly-diagnosed hyperthyroidism. METHODS: The Ovid Medline, Ovid Embase, and Cochrane Library databases were searched for observational studies and randomized controlled trials. Included studies were published on or before 1st May 2022 involving at least two of the treatments among ATD, RAI, and thyroidectomy for hyperthyroidism. Pairwise comparisons and Bayesian network meta-analysis were used to estimate hazard ratios (HRs) and their credible interval (CrI) of outcomes, including cardiovascular disease (CVD), cancer, overall mortality, and Graves' ophthalmopathy (GO). RESULTS: A total of 22 cohort studies with 131,297 hyperthyroidism patients were included. Thyroidectomy was associated with lower risks of mortality and GO than ATD (HR = 0.54, 95% CrI: 0.31, 0.96; HR = 0.31, 95% CrI: 0.12, 0.64) and RAI (HR = 0.62, 95% CrI: 0.41, 0.95; HR = 0.18, 95% CrI: 0.07, 0.35). RAI had a higher risk of GO (HR = 1.70, 95% CrI: 1.02, 2.99) than ATD treatment. CONCLUSIONS: This Bayesian network meta-analysis indicated that thyroidectomy was associated with lower risks of mortality and GO in newly-diagnosed hyperthyroid patients compared to ATD and RAI. Relative to ATD, RAI therapy increased the risk of GO.

Bariatric surgery, novel glucose-lowering agents, and insulin for type 2 diabetes and obesity: Bayesian network meta-analysis of randomized controlled trials.

BACKGROUND: This network meta-analysis aimed to compare the effects of bariatric surgery, novel glucose-lowering agents (SGLT2i, GLP1RA, DPP4i), and insulin for patients with type 2 diabetes mellitus (T2DM) and obesity. METHODS: Four databases were searched from inception to April 2023 to identify randomized controlled trials (RCTs) comparing bariatric surgery, SGLT2i, GLP1RA, DPP4i, insulin, and/or placebo/usual care among patients with T2DM and obesity in the achievement of HbA1c < 7.0 per cent within one year, and 12-month changes in HbA1c and body weight. RESULTS: A total of 376 eligible RCTs (149 824 patients) were analysed. Bariatric surgery had significantly higher rates of achieving HbA1c < 7.0 per cent than SGLT2i (RR = 2.46, 95 per cent c.i. = 1.28, 4.92), DPP4i (RR = 2.59, 95 per cent c.i. = 1.36, 5.13), insulin (RR = 2.27, 95 per cent c.i. = 1.18, 4.58) and placebo/usual care (RR = 4.02, 95 per cent c.i. = 2.13, 7.93), but had no statistically significant difference from GLP1RA (RR = 1.73, 95 per cent c.i. = 0.91, 3.44), regardless of oral (RR = 1.33, 95 per cent c.i. = 0.66, 2.79) or injectable (RR = 1.75, 95 per cent c.i. = 0.92, 3.45) administration. Significantly more GLP1RA patients achieved HbA1c < 7.0 per cent than other non-surgical treatments. Bariatric surgery had the greatest reductions in HbA1c (∼1 per cent more) and body weight (∼15 kg more) at 12 months. Among novel glucose-lowering medications, GLP1RA was associated with greater reductions in HbA1c than SGLT2i (-0.39 per cent, 95 per cent c.i. = -0.55, -0.22) and DPP4i (-0.51 per cent, 95 per cent c.i. = -0.64, -0.39) at 12 months, while GLP1RA (-1.74 kg, 95 per cent c.i. = -2.48, -1.01) and SGLT2i (-2.23 kg, 95 per cent c.i. = -3.07, -1.39) showed greater reductions in body weight than DPP4i at 12 months. CONCLUSION: Bariatric surgery showed superiority in glycaemic control and weight management compared to non-surgical approaches. GLP1RA administered by oral or injectable form demonstrated reduced HbA1c and body weight at 12 months, and was preferable over other non-surgical treatments among patients with T2DM and obesity. PROSPERO REGISTRATION NO: CRD42020201507.

Attaining biochemical euthyroidism early after total thyroidectomy in Graves' disease may lower long-term morbidity risk.

BACKGROUND: The relationship between good early control of thyroid hormone levels after thyroidectomy for Graves' disease (GD) and subsequent risks of mortality and morbidities is not well known. The aim of this study was to examine the association between thyroid hormone levels within a short interval after surgery and long-term mortality and morbidity risks from a population-based database. METHODS: Patients with GD who underwent complete/total thyroidectomy between 2006 and 2018 were selected from the Hong Kong Hospital Authority clinical management system. All patients were classified into three groups (euthyroidism, hypothyroidism, and hyperthyroidism) according to their thyroid hormone levels at 6, 12, and 24 months after surgery. Cox proportional hazards models were performed to compare the risks of all-cause mortality, cardiovascular disease (CVD), Graves' ophthalmopathy, and cancer. RESULTS: Over a median follow-up of 68 months with 5709 person-years, 949 patients were included for analysis (euthyroidism, n = 540; hypothyroidism, n = 282; and hyperthyroidism, n = 127). The hypothyroidism group had an increased risk of CVD (HR = 4.20, 95 per cent c.i. 2.37 to 7.44, P < 0.001) and the hyperthyroidism group had an increased risk of cancer (HR = 2.14, 95 per cent c.i. 1.55 to 2.97, P < 0.001) compared with the euthyroidism group. Compared with patients obtaining euthyroidism both at 6 months and 12 months, the risk of cancer increased in patients who achieved euthyroidism at 6 months but had an abnormal thyroid status at 12 months (HR = 2.33, 95 per cent c.i. 1.51 to 3.61, P < 0.001) and in those who had abnormal thyroid status at 6 months but achieved euthyroidism at 12 months (HR = 2.52, 95 per cent c.i. 1.60 to 3.97, P < 0.001). CONCLUSIONS: This study showed a higher risk of CVD in postsurgical hypothyroidism and a higher risk of cancer in hyperthyroidism compared with achieving euthyroidism early after thyroidectomy. Patients who were euthyroid at 6 months and 12 months had better outcomes than those achieving euthyroidism only at 6 months or 12 months. Attaining biochemical euthyroidism early after thyroidectomy should become a priority.

Long-term outcome of patients treated with antithyroid drugs, radioactive iodine or surgery for persistent or relapsed Graves' disease.

BACKGROUND: The aim of this study was to compare long-term mortality, morbidity, and cumulative healthcare costs between antithyroid drugs, radioactive iodine, and surgical treatment for patients with persistent or relapsed Graves' disease. METHODS: Data on patients with persistent or relapsed Graves' disease between 2006 and 2018 were retrieved from the Hong Kong Hospital Authority. Hazard ratios (HRs) estimated by Cox proportional hazards regression models were used to compare the risks of all-cause mortality, cardiovascular disease, atrial fibrillation, psychological disease, Graves' ophthalmopathy, and cancer across treatment groups. The 10-year healthcare cost and change in co-morbidity status were also estimated. RESULTS: Over a median follow-up of 79 months (22 636 person-years), a total of 3443 patients (antithyroid drug 2294, radioactive iodine 755, surgery 394) were analysed. Compared with antithyroid drug treatment, surgery was associated with significantly lower risks of all-cause mortality (HR 0.40, 95 per cent c.i. 0.36 to 0.45), cardiovascular disease (HR 0.54, 0.48 to 0.60), atrial fibrillation (HR 0.11, 0.09 to 0.14), psychological disease (HR 0.85, 0.79 to 0.92), Graves' ophthalmopathy (HR 0.09, 0.08 to 0.10), and cancer (HR 0.56, 0.50 to 0.63). Patients who underwent surgery also had a lower risk of all outcome events than those in the radioactive iodine group. The 10-year direct cumulative healthcare cost was €14 754 for surgery compared with €17 390 for antithyroid drugs, and €17 918 for the radioactive iodine group. CONCLUSION: Patients who underwent surgery for persistent or relapsed Graves' disease had lower risks of all-cause mortality and analysed morbidities. The 10-year cumulative healthcare cost in the surgery group was lowest among the three treatment alternatives.

Outcomes of Graves' Disease Patients Following Antithyroid Drugs, Radioactive Iodine, or Thyroidectomy as the First-line Treatment.

BACKGROUND: The long-term outcomes of first-line choice among ATD, RAI, and thyroidectomy for GD patients remain unclear. OBJECTIVE: To compare the long-term morbidity, mortality, relapse, and costs of GD patients receiving first-line treatment. METHODS: A population-based retrospective cohort of GD patients initiating first-line treatment with ATD, RAI, or thyroidectomy as a first-line primary treatment between 2006 and 2018 from Hong Kong Hospital Authority was analyzed. Risks of all-cause mortality, CVD, AF, psychological disease, diabetes, and hypertension were estimated using Cox proportional hazards regression models. The 10-year healthcare costs, change of comorbidities, and risk of relapse were compared across treatments. RESULTS: Over a median follow-up of 90 months with 47,470 person-years, 6385 patients (ATD, 74.93%; RAI, 19.95%; thyroidectomy, 5.12%) who received first-line treatment for GD were analyzed. Compared with ATD group, patients who had undergone surgery had significantly lower risks of all-cause mortality [hazard ratio (HR) = 0.363, 95% confidence interval (CI) = 0.332-0.396], CVD (HR = 0.216, 95% CI = 0.195-0.239), AF (HR = 0.103, 95% CI = 0.085-0.124), psychological disease (HR = 0.279, 95% CI = 0.258-0.301), diabetes (HR = 0.341, 95% CI = 0.305-0.381), and hypertension (HR = 0.673, 95% CI = 0.632-0.718). Meanwhile, RAI group was also associated with decreased risks of all-cause mortality (HR = 0.931, 95% CI = 0.882-0.982), CVD (HR = 0.784, 95% CI = 0.742-0.828), AF (HR = 0.622, 95% CI = 0.578-0.67), and psychological disease (HR = 0.895, 95% CI = 0.855-0.937). The relapse rate was 2.41% in surgery, 75.60% in ATD, and 19.53% in RAI group. The surgery group was observed with a significant lower Charlson Comorbidity Index score than the other 2 groups at the tenth-year follow-up. The mean 10-year cumulative healthcare costs in ATD, RAI, and surgery group was US$23915, US$24260, and US$20202, respectively. CONCLUSIONS: GD patients who received surgery as an initial treatment appeared to have lower chances of all-cause mortality, CVD, AF, psychological disease, diabetes, and hypertension in the long-term when compared to those treated with ATD or RAI. The surgery group had the lowest relapse and direct healthcare costs among the 3 treatment modalities. This long-term cohort study suggested surgery may have a larger role to play as an initial treatment for GD patients.

Association between bariatric surgery and risks of cancer among Chinese patients with type 2 diabetes mellitus: A retrospective cohort study.

BACKGROUND: To examine risks of cancers, obesity-related cancers (eg, cancers in digestive organs, breast, ovary, kidney, thyroid, and myeloma), cancer-related mortality, and all-cause mortality in patients with type 2 diabetes mellitus (T2DM) and obesity who underwent bariatric surgery. METHODS: A retrospective cohort of 1944 T2DM patients with obesity (345 bariatric surgery patients and 1599 matched controls) who were free of cancer from 2006 to 2017 was assembled. One-to-five propensity score matching followed by propensity score trimming was used to balance baseline covariates. RESULTS: During a mean follow-up period of 37 months, there are risks that in 3.2%, 1.4%, 0.9%, and 3.2% of bariatric patients cancer, obesity-related cancer, cancer-related mortality, and all-cause mortality, respectively, would occur. Surgical patients were found to have reduced incidence rates (IRs) of obesity-related cancer (0.531/100 person-years, 95% confidence interval [CI]: 0.172-1.238/100 person-years) and cancer of breast and genital organs (0.394/100 person-years, 95% CI: 0.048-1.424/100 person-years) than matched control patients whose IRs for obesity-related cancer and cancer of breast and genital organs were 0.627/100 person-years (95% CI: 0.426-0.889/100 person-years) and 0.521/100 person-years (95% CI: 0.277-0.891/100 person-years), respectively. Patients in the surgical group had a significant reduction in risk of all-cause mortality (hazard ratio [HR] = 0.508, P = .041). Effects of bariatric surgery on any cancers (HR = 1.254, P = .510), obesity-related cancers (HR = 0.843, P = .724), and cancer mortality (HR = 1.304, P = .694) were not significant. CONCLUSIONS: Bariatric surgery was not associated with risks of overall cancer, obesity-related cancer, and cancer mortality among T2DM patients with obesity at 3 years.

Effects of bariatric surgery on kidney diseases, cardiovascular diseases, mortality and severe hypoglycaemia among patients with Type 2 diabetes mellitus.

BACKGROUND: Bariatric surgery has been widely indicated for the management of obesity and related comorbidities. However, there are uncertainties pertaining to the risks of post-bariatric severe hypoglycaemia (SH), cardiovascular diseases (CVDs), end-stage kidney diseases (ESKDs) and all-cause mortality in obese patients with Type 2 diabetes mellitus (T2DM), especially among Asian populations. METHODS: A retrospective population-based cohort of 1702 obese T2DM patients who were free of CVD and ESKD were assembled based on the 2006-17 Hospital Authority database. One-to-five propensity-score matching was used to balance baseline covariates between patients in bariatric surgery and control groups. Incidence rates (IRs) of SH, CVD, Stage 4/5 chronic kidney diseases (CKD), ESKD and all-cause mortality events for two groups were calculated. Hazard ratios (HR) for SH, CVD and Stage 4/5 CKD events were assessed using Cox-proportional hazard models. Changes in estimated glomerular filtration rate (eGFR) and urine albumin-creatinine ratio (UACR) were measured up to 60 months. RESULTS: Over a mean follow-up period of 32 months with 5725 person-years, cumulative incidences of mortality, CVD, Stage 4/5 CKD, ESKD and SH were 0, 0.036, 0.050, 0.017 and 0.020, respectively. The surgery group had a significant reduction in risk of CVD events (HR = 0.464, P = 0.015) and no occurrence of mortality events. However, there were no significant differences in risks of SH [HR = 0.469, 95% confidence interval (CI): 0.204-1.081], Stage 4/5 CKD (HR =0.896, 95% CI: 0.519-1.545) and ESKD (HR = 0.666, 95% CI: 0.264-1.683) between two groups, although IRs were lower in the surgery group. Surgical patients had significantly higher eGFR within 12 months and had significantly lower UACR until 48 months. CONCLUSIONS: Among obese T2DM patients, bariatric surgery lowered the risk of CVD and mortality, and was beneficial towards the kidney outcomes.

Improvement in patient-reported outcomes in Chinese adults after bariatric surgery: 1-year follow-up of a prospective cohort.

BACKGROUND: Impaired health-related quality of life is commonly observed in patients with obesity who are scheduled for bariatric surgery. However, bariatric surgery tends to improve quality of life physically, with no final conclusion regarding mental domains. OBJECTIVE: To assess changes of patient-reported outcomes in terms of health-related quality of life, depression, anxiety status, and physical activity (PA) after bariatric surgery among patients with obesity. SETTINGS: Queen Mary Hospital, Tung Wah Hospital, and United Christian Hospital, Hong Kong SAR; a longitudinal study. METHODS: A multicenter, prospective, observational cohort study was conducted in Hong Kong between 2017 and 2018. Follow-up interviews at 1, 3, 6, and 12 months postoperatively were administrated via telephone. Short Form-12 Health Survey Version 2, Euroqol 5-dimension-5-level, and Impact of Weight on Quality of Life-Lite were used to assess health-related quality of life. Scores of anxiety and depression were evaluated by Hospital Anxiety and Depression Scale. Walking, moderate, and vigorous metabolic equivalent tasks and PA levels were measured by International Physical Activity Questionnaire-Short Form. Demographic and clinical characteristics, including age, sex, body mass index, and preexisting co-morbidities at baseline were collected. Comparisons of scores were made between baseline and 12 months using paired t test or McNemar test. RESULTS: A total of 25 patients who have received bariatric surgery (laparoscopic sleeve gastrectomy: 96%; laparoscopic gastric bypass: 4%) and 25 control patients matched using propensity scores derived by baseline covariates were involved. Significant improvements were observed in health-related quality of life regarding physical functioning (P < .001), role physical (P = .013), bodily pain (P = .011), general health (P < .011), vitality (P = .029), social functioning (P = .017), and physical composite summary (P < .001) of Short Form-12 Health Survey Version 2 from baseline to follow-up 12 months after surgery. Scores of physical composite summary, mental composite summary, and Short Form-6 D of surgical patients all had an overall upward trend during observation compared with those in the control group. All domains in Impact of Weight on Quality of Life-Lite were significantly higher at 12 months compared with baseline (P = .001 in sexual life domain, P < .001 in other domains). Patients experienced a decrease in depression score of Hospital Anxiety and Depression Scale 12 months after bariatric surgery (P = .026), while anxiety score was not found to differ from baseline (P = .164). No significant differences in total metabolic equivalent tasks (P = .224) and PA levels (P = .180) between baseline and 12-month follow-up were found. CONCLUSION: After 12 months of follow-up, increase in physical quality of life, reduction in depression status and less impairment caused by weight were observed, without significant changes in anxiety score and postoperative PA.

DPP4i, thiazolidinediones, or insulin and risks of cancer in patients with type 2 diabetes mellitus on metformin-sulfonylurea dual therapy with inadequate control.

INTRODUCTION: This study aims to compare the risks of cancer among patients with type 2 diabetes mellitus (T2DM) on metformin-sulfonylurea dual therapy intensified with dipeptidyl peptidase 4 inhibitors (DPP4i), thiazolidinediones, or insulin. RESEARCH DESIGN AND METHODS: We assembled a retrospective cohort data of 20 577 patients who were free of cancer and on metformin-sulfonylurea dual therapy, and whose drug treatments were intensified with DPP4i (n=9957), insulin (n=7760), or thiazolidinediones (n=2860) from January 2006 to December 2017. Propensity-score weighting was used to balance out baseline covariates across the three groups. HRs for any types of cancer, cancer mortality, and all-cause mortality were assessed using Cox proportional-hazards models. RESULTS: Over a mean follow-up period of 34 months with 58 539 person-years, cumulative incidences of cancer, cancer mortality, and all-cause mortality were 0.028, 0.009, and 0.072, respectively. Patients intensified with insulin had the highest incidence of all-cause mortality (incidence rate=3.22/100 person-years) and the insulin itself posed the greatest risk (HR 2.46, 95% CI 2.25 to 2.70, p<0.001; 2.44, 95% CI 2.23 to 2.67) compared with thiazolidinediones and DPP4i, respectively. Comparing between thiazolidinediones and DPP4i, thiazolidinediones was associated with higher risk of cancer (HR 1.43, 95% CI 1.25 to 1.63) but not cancer mortality (HR 1.21, 95% CI 0.92 to 1.58) and all-cause mortality (HR 0.99, 95% CI 0.88 to 1.11). Insulin was associated with the greatest risk of cancer mortality (HR 1.36, 95% CI 1.09 to 1.71; 1.65, 95% CI 1.31 to 2.07) compared with thiazolidinediones and DPP4i, respectively. CONCLUSIONS: For patients with T2DM on metformin-sulfonylurea dual therapy, the addition of DPP4i was the third-line medication least likely to be associated with cancer mortality and cancer effect among three options, and posed no increased risk for all-cause mortality when compared with thiazolidinediones.

Effects of health-related quality of life on health service utilisation in patients with colorectal neoplasms.

This study was to assess the impact of HRQOL on health service utilisation using four different count data models. The HRQOL was measured using the Short-Form Six-Dimension instrument and the functional assessment of cancer therapy-colorectal whereas health service utilisation was measured by the number of monthly clinical consultations and the number of monthly hospitalisation. Different count data models (Poisson's regression, negative binomial regression, zero-inflated Poisson's regression and zero-inflated negative binomial regression) were used to assess the association between HRQOL and health service utilisation. A performance comparison was made between the models. Goodness-of-fit statistics (the Pearson's chi-squared test statistic, the Akaike and Bayesian information criteria) were used to determine the best-fitting model. The negative binomial model performed the best in assessing the association between HRQOL measures and health service utilisation in patients with colorectal neoplasm and thus recommended. Physical well-being of patients was negatively and significantly associated with the monthly rate of health service utilisation after controlling for patient demographics. Both physical and function well-beings of patients were negatively and significantly associated with the number of monthly hospitalisations. If the data for the condition-specific FACT-C are not available, SF-6D showed a very strong negative relationship with health service utilisation. Such models can be used to guide the allocation of clinical resources and funding for the care of colorectal cancer patients.

Cost-effectiveness analysis of vaccinations and decision makings on vaccination programmes in Hong Kong: A systematic review.

OBJECTIVES: To describe and systematically review the modelling and reporting of cost-effectiveness analysis of vaccination in Hong Kong, and to identify areas for quality enhancement in future cost-effectiveness analyses. METHODS: We conducted a comprehensive and systematic review of cost-effectiveness studies related to vaccination and government immunisation programmes in Hong Kong published from 1990 to 2015, through database search of Pubmed, Web of Science, Embase, and OVID Medline. Methodological quality of selected studies was assessed using Consolidated Health Economic Evaluation Reporting Standards checklist (CHEERS). Decision making of vaccination was obtained from Scientific Committee on Vaccine Preventable Diseases (SCVPD) and Department of Health in Hong Kong. RESULTS: Nine eligible studies reporting twelve comparative cost-effectiveness comparisons of vaccination programme for influenza (n=2), pneumococcal disease (n=3), influenza plus pneumococcal disease (n=1), chickenpox (n=2), Haemophilus influenzae b (n=1), hepatitis A (n=1), cervical cancer (n=1) and rotavirus (n=1) were identified. Ten comparisons (83.3%) calculated the incremental cost-effectiveness ratio (ICER) of a vaccination strategy versus status quo as outcomes in terms of cost in USD per life-years, cost per quality-adjusted life-years, or cost per disability-adjusted life-years. Among those 10 comparisons in base-case scenario, 4 evaluated interventions were cost-saving relative to status quo while the ICER estimates in 3 of the 6 remaining comparisons were far below commonly accepted threshold and WHO willingness-to-pay threshold, suggestive of very cost-effective. Seven studies were of good quality based on the CHEERS checklist; one was of moderate quality; and one was of excellent quality. The common methodological problems were characterisation of heterogeneity and reporting of study parameters. CONCLUSIONS: There was a paucity of cost-effectiveness models evaluating vaccination targeted to the Hong Kong population. All evaluated vaccinations and immunisation interventions in Hong Kong, except for Haemophilus influenzae b, hepatitis A and HPV vaccinations, were considered either cost-saving or very cost-effective when compared to status quo.

EQ-5D-5L and SF-6D Utility Measures in Symptomatic benign Thyroid Nodules: Acceptability and Psychometric Evaluation.

PURPOSE: The aim of this study was to examine the acceptability, validity, and reliability of the EuroQoL Five-Dimension Five-Level (EQ-5D-5L) and Short-Form Six-Dimension (SF-6D) health utility measures in patients with symptomatic benign thyroid nodules. METHODS: Data from a randomized controlled trial (ClinicalTrials.gov identifier: NCT02398721) of 294 patients with symptomatic benign thyroid nodules were utilized for this psychometric evaluation of health-related quality of life (HR-QOL) measurement. Three HR-QOL questionnaires-the generic 12-item Short Form Health Survey (SF-12v2), EQ-5D-5L, and SF-6D-were interviewer-administered at baseline and 2 weeks afterwards. Responses to SF-6D were transformed to SF-6D utility scores using a Hong Kong population scoring algorithm derived by standard gamble, whereas responses to EQ-5D-5L were mapped onto EQ-5D-3L response via interim mapping algorithms and then converted to EQ-5D-5L utility scores using a Chinese-specific value set. Construct validity was determined by evaluating Spearman correlation between SF-12v2 scores and utility scores. Two-week test-retest reliability was assessed using intra-class correlation coefficient. RESULTS: No significant (>15%) floor and ceiling effects were observed for SF-6D utility scores. The SF-6D utility scores had a moderate Spearman rank correlation with the SF-12v2 domain score providing evidence for adequate construct validity. The SF-6D utility scores showed good test-retest reliability (0.794; range 0.696-0.860). Better reliability was observed in SF-6D utility scores than in EQ-5D-5L utility scores. CONCLUSIONS: While the EQ-5D-5L instrument was less reproducible, the SF-6D instrument appeared to be an applicable, valid, and reliable measure in assessing the HR-QOL of Chinese patients with symptomatic benign thyroid nodules. The impact of utility score selection on the effectiveness and cost effectiveness of clinical interventions targeted to these patients needs further exploration. CLINICAL TRIAL NUMBER AND REGISTRY: NCT02398721, ClinicalTrials.gov.

Methodological and Reporting Quality of Comparative Studies Evaluating Health-Related Quality of Life of Colorectal Cancer Patients and Controls: A Systematic Review.

BACKGROUND: Health-related quality of life is an important outcome measure in patients with colorectal cancer. Comparison with normative data has been increasingly undertaken to assess the additional impact of colorectal cancer on health-related quality of life. OBJECTIVE: This review aimed to critically appraise the methodological details and reporting characteristics of comparative studies evaluating differences in health-related quality of life between patients and controls. DATA SOURCES: A systematic search of English-language literature published between January 1985 and May 2014 was conducted through a database search of PubMed, Web of Science, Embase, and Medline. STUDY SELECTION: Comparative studies reporting health-related quality-of-life outcomes among patients who have colorectal cancer and controls were selected. MAIN OUTCOME MEASURES: Methodological and reporting quality per comparison study was evaluated based on a 11-item methodological checklist proposed by Efficace in 2003 and a set of criteria predetermined by reviewers. RESULTS: Thirty-one comparative studies involving >10,000 patients and >10,000 controls were included. Twenty-three studies (74.2%) originated from European countries, with the largest number from the Netherlands (n = 6). Twenty-eight studies (90.3%) compared the health-related quality of life of patients with normative data published elsewhere, whereas the remaining studies recruited a group of patients who had colorectal cancer and a group of control patients within the same studies. The European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 was the most extensively used instrument (n = 16; 51.6%). Eight studies (25.8%) were classified as "probably robust" for clinical decision making according to the Efficace standard methodological checklist. Our further quality assessment revealed the lack of score differences reported (61.3%), contemporary comparisons (36.7%), statistical significance tested (38.7%), and matching of control group (58.1%), possibly leading to inappropriate control groups for fair comparisons. LIMITATIONS: Meta-analysis of differences between the 2 groups was not available. CONCLUSIONS: In general, one-fourth of comparative studies that evaluated health-related quality of life of patients who had colorectal cancer achieved high quality in reporting characteristics and methodological details. Future studies are encouraged to undertake health-related quality-of-life measurement and adhere to a methodological checklist in comparison with controls.

Possible Impact of Incremental Cost-Effectiveness Ratio (ICER) on Decision Making for Cancer Screening in Hong Kong: A Systematic Review.

OBJECTIVES: The aim of this paper was to critically review the literature on the cost effectiveness of cancer screening interventions, and examine the incremental cost-effectiveness ratios (ICERs) that may influence government recommendations on cancer screening strategies and funding for mass implementation in the Hong Kong healthcare system. METHODS: We conducted a literature review of cost-effectiveness studies in the Hong Kong population related to cancer screening published up to 2015, through a hand search and database search of PubMed, Web of Science, Embase, and OVID Medline. Binary data on the government's decisions were obtained from the Cancer Expert Working Group, Department of Health. Mixed-effect logistic regression analysis was used to examine the impact of ICERs on decision making. Using Youden's index, an optimal ICER threshold value for positive decisions was examined by area under receiver operating characteristic curve (AUC). RESULTS: Eight studies reporting 30 cost-effectiveness pairwise comparisons of population-based cancer screening were identified. Most studies reported an ICER for a cancer screening strategy versus a comparator with outcomes in terms of cost per life-years (55.6 %), or cost per quality-adjusted life-years (55.6 %). Among comparisons with a mean ICER of US$102,931 (range 800-715,137), the increase in ICER value by 1000 was associated with decreased odds (odds ratio 0.990, 0.981-0.999; p = 0.033) of a positive recommendation. An optimal ICER value of US$61,600 per effectiveness unit yielded a high sensitivity of 90 % and specificity of 85 % for a positive recommendation. A lower ICER threshold value of below US$8044 per effectiveness unit was detected for a positive funding decision. CONCLUSIONS: Linking published evidence to Government recommendations and practice on cancer screening, ICERs influence decisions on the adoption of health technologies in Hong Kong. The potential ICER threshold for recommendation in Hong Kong may be higher than those of developed countries.

Main predictors in health-related quality of life in Chinese patients with type 2 diabetes mellitus.

PURPOSE: This study aimed to identify the predictors of decline in health-related quality of life (HRQOL) in Chinese patients with type 2 diabetes mellitus (T2DM). METHODS: A prospective longitudinal observational study was conducted on 1826 Chinese T2DM patients managed in public primary care setting. HRQOL was measured at baseline, 1 and 2 years by the Short Form-12 Health Survey version 2 (SF-12v2) and Chinese (HK) Short Form-6 Dimensions (SF-6D). Linear mixed effect models with forward stepwise method were performed to select the factors associated with SF-12v2 physical (PCS) and mental component summary (MCS) scores and SF-6D value. RESULTS: Over a 2-year observation period, the HRQOL (PCS: -0.626; MCS: -1.869; and SF-6D: -0.017 per year) scores decreased significantly with time. Female, unmarried, current smoker, no regular exercise, obesity, comorbid hypertension, chronic kidney disease (CKD) or cardiovascular disease (CVD) and insulin use were predictors of one or more poorer HRQOL scores after 12 or 24 months. Older age had a negative impact on PCS score and SF-6D value, but had a positive impact on MCS score. CONCLUSIONS: The HRQOL of Chinese T2DM patients under primary care declined significantly over time. Obesity, smoking and no regular exercise were found to be modifiable risk factors of the decline in HRQOL in T2DM, which strengthened the importance of these lifestyle changes in diabetes care. More attention should be given to T2DM patients who are female, older, unmarried, or on anti-hypertensive drugs or insulin, or have comorbid hypertension, CKD or CVD in minimizing the negative impact of illness on their life.

A systematic review of quality of thyroid-specific health-related quality-of-life instruments recommends ThyPRO for patients with benign thyroid diseases.

OBJECTIVES: To appraise the measurement properties of thyroid-specific health-related quality-of-life (HRQOL) instruments and to provide recommendations on the choice of HRQOL instruments. STUDY DESIGN AND SETTING: Systematic review of English-language literature published between 1993 and 2015 identified psychometric studies involving patients with thyroid disease through a search of Pubmed, Web of Science, Embase, and OVID MEDLINE. HRQOL instruments were graded on methodological quality and overall levels of evidence using a COSMIN checklist. RESULTS: After a review of 742 original studies, 23 studies reporting 14 standardized HRQOL instruments targeted for Graves' ophthalmopathy (n = 4), hypothyroidism (n = 3), thyroid cancer (n = 2), other thyroid disease (n = 3), and nonthyroid tumor sites (n = 2) were identified. Hypothesis testing was evaluated most frequently. The 84-item thyroid-specific patient-reported outcome measure (ThyPRO) and 16-item Graves' ophthalmopathy-specific Quality-of-Life (GO-QOL) instruments were the most extensively evaluated instrument. The highest number of positive ratings in overall level of psychometric evidence was found in ThyPRO, GO-QOL, and 11-item Thyroid Treatment Satisfaction Questionnaire (ThyTSQ) instruments. CONCLUSION: The ThyPRO is recommended for the assessment of HRQOL in patients with benign thyroid diseases while measurement properties of GO-QOL and ThyTSQ are satisfactory in measuring HRQOL of patients with Graves' ophthalmopathy and hypothyroidism, respectively.

Cost-effectiveness simulation and analysis of colorectal cancer screening in Hong Kong Chinese population: comparison amongst colonoscopy, guaiac and immunologic fecal occult blood testing.

BACKGROUND: The aim of this study was to evaluate the cost-effectiveness of CRC screening strategies from the healthcare service provider perspective based on Chinese population. METHODS: A Markov model was constructed to compare the cost-effectiveness of recommended screening strategies including annual/biennial guaiac fecal occult blood testing (G-FOBT), annual/biennial immunologic FOBT (I-FOBT), and colonoscopy every 10 years in Chinese aged 50 year over a 25-year period. External validity of model was tested against data retrieved from published randomized controlled trials of G-FOBT. Recourse use data collected from Chinese subjects among staging of colorectal neoplasm were combined with published unit cost data ($USD in 2009 price values) to estimate a stage-specific cost per patient. Quality-adjusted life-years (QALYs) were quantified based on the stage duration and SF-6D preference-based value of each stage. The cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER) represented by costs per life-years (LY) and costs per QALYs gained. RESULTS: In base-case scenario, the non-dominated strategies were annual and biennial I-FOBT. Compared with no screening, the ICER presented $20,542/LYs and $3155/QALYs gained for annual I-FOBT, and $19,838/LYs gained and $2976/QALYs gained for biennial I-FOBT. The optimal screening strategy was annual I-FOBT that attained the highest ICER at the threshold of $50,000 per LYs or QALYs gained. CONCLUSION: The Markov model informed the health policymakers that I-FOBT every year may be the most effective and cost-effective CRC screening strategy among recommended screening strategies, depending on the willingness-to-pay of mass screening for Chinese population. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02038283.

Patterns of health-related quality of life and associated factors in Chinese patients undergoing haemodialysis.

BACKGROUND: Haemodialysis (HD) is a life-saving but burdensome therapy for patients with end-stage renal disease (ESRD) which can have a detrimental impact on patients' quality of life and outcomes. There is currently little data on the health related quality of life (HRQOL) of Chinese ESRD patients undergoing HD and this study sought to examine the patterns of HRQOL and its associated factors within this population, as well as in comparison with the general local population. METHODS: A cross-sectional study of 244 ESRD patients receiving HD in the hospital and in the community in Hong Kong was conducted using the Short Form-12 Health Survey version 2 (SF-12v2). All study subjects were one-to-one matched with subjects in a Hong Kong general population database by sex and exact age. Independent t-tests were performed to compare the mean SF-12v2 scores between HD patients and the general population, followed by one-way analysis of variance with post hoc Tukey's HSD tests to compare community-based haemodialysis, hospital-based haemodialysis and the general population. Multiple linear regressions were used to identify the factors (socio-demographic, clinical characteristics and comorbidities) associated with the HRQOL scores of ESRD patients receiving HD. RESULTS: The SF-12v2 Physical Functioning, Role Physical, Bodily Pain, General Health and Physical Component Summary scores of HD patients were significantly lower than the age-sex adjusted general population. However, the SF-12v2 Mental Health and Mental Component Summary scores of HD patients were significantly higher than the corresponding general population. Poorer HRQOL was associated with being female, smoking, unemployment and hospital-based haemodialysis. CONCLUSIONS: HD patients had substantially poorer physical HRQOL but better mental HRQOL than the age-sex adjusted general population. Patients receiving HD in the community setting had better HRQOL. Reasons for these observations will need to be further investigated. Those patients who are female, smokers and unemployed may warrant more attention as their poorer HRQOL may be associated with poorer outcomes.

Systematic review recommends the European Organization for Research and Treatment of Cancer colorectal cancer-specific module for measuring quality of life in colorectal cancer patients.

OBJECTIVES: To critically appraise the measurement properties of standardized health-related quality of life (HRQOL) instruments for colorectal cancer (CRC) patients and to provide recommendations on the choice of HRQOL instruments. STUDY DESIGN AND SETTING: Systematic review of English language literature published between January 1985 and May 2014 identified through a database search of PubMed, Web of Science, Embase, and Ovid MEDLINE. HRQOL instruments were rated on methodological quality and overall levels of evidence using a Consensus-based Standards for the selection of health Measurement Instrument checklist. RESULTS: Internal consistency and hypothesis testing were evaluated most frequently in 63 studies identified. The Functional Assessment of Cancer Therapy-Colorectal (FACT-C) was the most extensively evaluated. The highest number of positive ratings in the overall level of evidence was found in the CRC-specific quality of life questionnaire module (QLQ-CR38) in European Organization for Research and Treatment of Cancer (EORTC) module, followed by the Memorial Sloan Kettering Cancer Center Bowel instrument, FACT-C, and Quick-FLIC. The EORTC QLQ-CR38 had the most positive ratings on measurement property and was recommended. CONCLUSION: The EORTC QLQ-CR38 was recommended to assess HRQOL in patients with CRC, regardless of disease stage and primary tumor site.

Improving the mapping of condition-specific health-related quality of life onto SF-6D score.

BACKGROUND: This study sought to improve the predicative performance and goodness-of-fit of mapping models, as part of indirect valuation, by introducing cubic spline smoothing to map a group of health-related quality of life (HRQOL) measures onto a preference-based measure. METHODS: This study was a secondary analysis of a cross-sectional health survey data assessing the HRQOL for patients with colorectal neoplasms. Mapping functions of condition-specific functional assessment of cancer therapy-colorectal (FACT-C) onto preference-based SF-6D measure were developed using a dataset of 553 Chinese subjects with different stages of colorectal neoplasm. The missing values of FACT-C were imputed using multiple imputation. Then three widely applicable models (ordinary least square (OLS), Tobit and two-part models) were employed for the mapping function after applying the cubic spline smoothing on the data. For the evaluation of the effectiveness of cubic spline smoothing and multiple imputation, the goodness-of-fit and prediction performance of each model were compared. RESULTS: Analyses showed that the models fitted with transformed data from cubic spline smoothing offered better performance in goodness-of-fit and prediction than the models fitted with the original data. The values of [Formula: see text] were improved by over 10%, and the root mean square error and the mean absolute error were both reduced. The best goodness-of-fit and performance were achieved by OLS model using transformed data from cubic spline smoothing. CONCLUSIONS: Cubic spline smoothing and multiple imputation were recommended for the mapping of HRQOL measures onto the preference-based measure. Among the three mapping models, the simple-to-use OLS model had the best performance.