Cost-effectiveness of tooth replacement strategies for partially dentate elderly: a randomized controlled clinical trial

OBJECTIVE: To conduct a cost-effectiveness analysis comparing two different tooth replacement strategies for partially dentate older patients, namely partial removable dental prostheses (RDP) and functionally orientated treatment based on the shortened dental arch concept (SDA).

METHODS: Ninety-two partially dentate older patients completed a randomized controlled clinical trial. Patients were randomly allocated to two treatment groups: the RDP group and the SDA group. Treatment effect was measured using impact on oral health-related quality of life (OHrQOL), and the costs involved in providing and maintaining care were recorded for all patients. Patients were followed for 12 months after treatment intervention. All treatment was provided by a single operator.

RESULTS: The total cost of achieving the minimally important clinical difference (MID) in OHrQOL for an average patient in the RDP group was €464.64. For the SDA group, the cost of achieving the MID for an average patient was €252.00. The cost-effectiveness ratio was therefore 1:1.84 in favour of SDA treatment.

CONCLUSION: With an increasingly ageing population, many patients will continue to benefit from removable prostheses to replace their missing natural teeth. From a purely economic standpoint, the results from this analysis suggest that the treatment of partially dentate older adults should be focused on functionally orientated treatment because it is simply more cost-effective.

Cost-effectiveness of ART restorations in elderly adults: a randomized clinical trial

BACKGROUND: As the world population ages, the requirement for cost-effective methods of treating chronic disease conditions increases. In terms of oral health, there is a rapidly increasing number of dentate elderly with a high burden of maintenance. Population surveys indicate that older individuals are keeping their teeth for longer and are a higher caries risk group. Atraumatic Restorative Treatment (ART) could be suitable for patients in nursing homes or house-bound elderly, but very little research has been done on its use in adults.

OBJECTIVES: To compare the cost-effectiveness of ART and a conventional technique (CT) for restoring carious lesions as part of a preventive and restorative programme for older adults.

METHODS: In this randomized clinical trial, 82 patients with carious lesions were randomly allocated to receive either ART or conventional restorations. Treatment costs were measured based on treatment time, materials and labour. For the ART group, the cost of care provided by a dentist was also compared to the cost of having a hygienist to provide treatment. Effectiveness was measured using percentage of restorations that survived after a year.

RESULTS: Eighty-two patients received 260 restorations, that is, 128 ART and 132 conventional restorations. 91.1% of the restorations were on one surface only. After a year, 252 restorations were assessed in 80 patients. The average cost for ART and conventional restorations was €16.86 and €28.71 respectively; the restoration survival percentages were 91.1% and 97.7%, respectively. This resulted in a cost-effectiveness ratio of 0.18 (ART) and 0.29 (CT). When the cost of a hygienist to provide ART was inserted in the analysis, the resulting ratio was 0.14.

CONCLUSIONS: Atraumatic restorative treatment was found to be a more cost-effective alternative to treat older adults after 1 year, compared to conventional restorations, especially in out of surgery facilities and using alternative workforce such as hygienists. Atraumatic restorative treatment can be a useful tool to provide dental care for frail and fearful individuals who might not access dental treatment routinely.

Communicating clinical trial outcomes: Effects of presentation method on physicians’ evaluations of new treatments

Physicians expect a treatment to be more effective when its clinical outcomes are described as relative rather than as absolute risk reductions. We examined whether effects of presentation method (relative vs. absolute risk reduction)
remain when physicians are provided the baseline risk information, a vital piece of statistical information omitted in previous studies. Using a between-subjects design, ninety five physicians were presented the risk reduction associated
with a fictitious treatment for hypertension either as an absolute risk reduction or as a relative risk reduction, with or without including baseline risk information. Physicians reported that the treatment would be more effective and that they would be more willing to prescribe it when its risk reduction was presented to them in relative rather than in absolute terms. The relative risk reduction was perceived as more effective than absolute risk reduction even when the baseline risk information was explicitly reported. We recommend that information about absolute risk reduction be made available to physicians in the reporting of clinical outcomes. Moreover, health professionals should be cognizant of the potential biasing effects of risk information presented in relative risk terms

Testing two different doses of tiotropium Respimat® in cystic fibrosis: Phase 2 randomized trial results

Background: Tiotropium is a once-daily, long-acting anticholinergic bronchodilator with the potential to alleviate airway obstruction in cystic fibrosis. Our objective was to evaluate the efficacy and safety of 2.5 and 5 μg once-daily tiotropium delivered via the Respimat Soft Mist Inhaler vs. placebo in people with cystic fibrosis. Methods: This phase 2, 12-week, randomized, double-blind, placebo-controlled parallel-group study of tiotropium Respimat as add-on to usual cystic fibrosis maintenance therapy included people with cystic fibrosis with pre-bronchodilator forced expiratory volume in 1 second (FEV₁) ≥25% predicted. Co-primary efficacy end points were change from baseline in percent-predicted FEV₁area under the curve from 0 to 4 hours (FEV₁AUC_0-4h), and trough FEV₁at the end of week 12. Findings: A total of 510 subjects with cystic fibrosis aged 5-69 years were randomized. Both doses of tiotropium resulted in significant improvement compared with placebo in the co-primary efficacy end points at the end of week 12 (change from baseline in percent-predicted FEV₁AUC_0-4h: 2.5 μg: 2.94%, 95% confidence interval 1.19-4.70, p = 0.001; 5 μg: 3.39%, 95% confidence interval 1.67-5.12, p = 0.0001; in percent-predicted trough FEV₁:2.5 μg: 2.24%, p = 0.2; 5 μg: 2.22%, p = 0.02). There was a greater benefit with tiotropium 5 vs. 2.5 μg. No treatment-related adverse events or unexpected safety findings were observed in patients taking tiotropium. Conclusions: Tiotropium significantly improved lung function in people with cystic fibrosis. The improvement was greater with the higher dose than the lower dose, with no difference in adverse events.

Hypofractionated radiotherapy versus conventionally fractionated radiotherapy for patients with intermediate-risk localised prostate cancer: 2-year patient-reported outcomes of the randomised, non-inferiority, phase 3 CHHiP trial

BACKGROUND: Patient-reported outcomes (PROs) might detect more toxic effects of radiotherapy than do clinician-reported outcomes. We did a quality of life (QoL) substudy to assess PROs up to 24 months after conventionally fractionated or hypofractionated radiotherapy in the Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy in Prostate Cancer (CHHiP) trial.

METHODS: The CHHiP trial is a randomised, non-inferiority phase 3 trial done in 71 centres, of which 57 UK hospitals took part in the QoL substudy. Men with localised prostate cancer who were undergoing radiotherapy were eligible for trial entry if they had histologically confirmed T1b-T3aN0M0 prostate cancer, an estimated risk of seminal vesicle involvement less than 30%, prostate-specific antigen concentration less than 30 ng/mL, and a WHO performance status of 0 or 1. Participants were randomly assigned (1:1:1) to receive a standard fractionation schedule of 74 Gy in 37 fractions or one of two hypofractionated schedules: 60 Gy in 20 fractions or 57 Gy in 19 fractions. Randomisation was done with computer-generated permuted block sizes of six and nine, stratified by centre and National Comprehensive Cancer Network (NCCN) risk group. Treatment allocation was not masked. UCLA Prostate Cancer Index (UCLA-PCI), including Short Form (SF)-36 and Functional Assessment of Cancer Therapy-Prostate (FACT-P), or Expanded Prostate Cancer Index Composite (EPIC) and SF-12 quality-of-life questionnaires were completed at baseline, pre-radiotherapy, 10 weeks post-radiotherapy, and 6, 12, 18, and 24 months post-radiotherapy. The CHHiP trial completed accrual on June 16, 2011, and the QoL substudy was closed to further recruitment on Nov 1, 2009. Analysis was on an intention-to-treat basis. The primary endpoint of the QoL substudy was overall bowel bother and comparisons between fractionation groups were done at 24 months post-radiotherapy. The CHHiP trial is registered with ISRCTN registry, number ISRCTN97182923.

FINDINGS: 2100 participants in the CHHiP trial consented to be included in the QoL substudy: 696 assigned to the 74 Gy schedule, 698 assigned to the 60 Gy schedule, and 706 assigned to the 57 Gy schedule. Of these individuals, 1659 (79%) provided data pre-radiotherapy and 1444 (69%) provided data at 24 months after radiotherapy. Median follow-up was 50·0 months (IQR 38·4-64·2) on April 9, 2014, which was the most recent follow-up measurement of all data collected before the QoL data were analysed in September, 2014. Comparison of 74 Gy in 37 fractions, 60 Gy in 20 fractions, and 57 Gy in 19 fractions groups at 2 years showed no overall bowel bother in 269 (66%), 266 (65%), and 282 (65%) men; very small bother in 92 (22%), 91 (22%), and 93 (21%) men; small bother in 26 (6%), 28 (7%), and 38 (9%) men; moderate bother in 19 (5%), 23 (6%), and 21 (5%) men, and severe bother in four (<1%), three (<1%) and three (<1%) men respectively (74 Gy vs 60 Gy, ptrend=0.64, 74 Gy vs 57 Gy, ptrend=0·59). We saw no differences between treatment groups in change of bowel bother score from baseline or pre-radiotherapy to 24 months.

INTERPRETATION: The incidence of patient-reported bowel symptoms was low and similar between patients in the 74 Gy control group and the hypofractionated groups up to 24 months after radiotherapy. If efficacy outcomes from CHHiP show non-inferiority for hypofractionated treatments, these findings will add to the growing evidence for moderately hypofractionated radiotherapy schedules becoming the standard treatment for localised prostate cancer.

FUNDING: Cancer Research UK, Department of Health, and the National Institute for Health Research Cancer Research Network.

Interventions to Promote Follow-up After Trabeculectomy Surgery in Rural Southern China: A Randomized Clinical Trial.

Importance:

Follow-up after trabeculectomy surgery is important to surgical success, but little is known about the effect of interventions on improving follow-up in low-resource areas.

Objective:

To examine whether text message reminders and free eye medications improve follow-up after trabeculectomy in rural southern China.

Design, Setting, and Participants:

This randomized clinical trial studied 222 consecutive patients undergoing trabeculectomy from October 1, 2014, through November 31, 2015, at 4 rural hospitals in Guangdong and Guangxi Provinces, China. Data from the intention-to-treat population were analyzed.

Interventions:

Patients undergoing trabeculectomy were randomized (1:1) to receive text message reminders 3 days before appointments at 1 and 2 weeks and 1 month after surgery and free topical corticosteroid medication (US$5.30) at each visit or to standard follow-up without reminders or free medication.

Main Outcomes and Measure:

Follow-up at 1 month postoperatively.

Results:

Among 222 eligible patients, 13 (5.9%) refused and 209 (94.1%) were enrolled, with 106 (50.7%) randomized to the intervention group (mean [SD] age, 64.4 [12.7] years; 56 women [52.8%]) and 103 (49.3%) to the control group (mean [SD] age, 63.0 [12.7] years; 53 women [51.5%]). A total of 6 patients (2.9%) were unavailable for follow-up. Attendance at 1 month for the intervention group (59 of 102 [57.8%]) was significantly higher than for the control group (34 of 101 [33.7%]) (unadjusted relative risk [RR], 1.72; 95% CI, 1.13-2.63; P = .01). Factors associated with 1-month attendance in multiple regression models included intervention group membership (RR, 1.65; 95% CI, 1.08-2.53; P = .02) and being told to return for suture removal (RR, 1.80; 95% CI, 1.06-3.06; P = .03). One-month attendance among controls not told about suture removal was 3 of 31 (9.7%), whereas it was 44 of 68 (64.7%) among the intervention group with suture removal (unadjusted RR, 6.69; 95% CI, 2.08-21.6; P = .001).

Conclusions and Relevance:

In this setting, low-cost interventions may significantly improve postoperative follow-up after glaucoma surgery, a potential opportunity for interventions known to improve surgical success.