Trial contact

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A clinical diagnosis of gout was made by the GP without joint aspiration, blood tests, imaging or diagnostic criteria. Written informed consent was obtained prior to participation. Single initial dose of oral naproxen mg three mg tablets followed by mg one tablet every 8 hours for up to 7 days. Oral colchicine mcg one tablet every 8 hours for 4 days.

Participants prescribed a statin were advised to omit the statin during colchicine treatment. Randomisation was undertaken by the healthcare professional using web-access to a secure remote allocation system or, if this could not be accessed, a telephone randomisation service.

Clinicians did not know which treatment a participant would receive prior to randomisation ensuring allocation concealment. The GP prescribed the allocated medication. Participants and treating clinicians were aware of treatment allocation. Participants received a drug-specific advice leaflet that included advice about non-pharmacological treatment rest, application of ice and were offered reimbursement for prescription charges. Baseline data were collected by self-complete questionnaire prior to randomisation.

Outcome measures were collected by self-complete daily diary days 1—7 and a questionnaire at week 4. On study entry, participants chose between paper postal or web-based e-mail invitation follow-up. Reminders were sent during week 1 postcard or daily e-mail reminders. If diary data were not received by day 10, a blinded research nurse telephoned participants to capture key outcome data. Non-responders to the second reminder were telephoned by the research nurse and, if not successfully contacted, mailed a brief questionnaire.

Participants provided consent for review of their medical records over the 4-week study period to capture serious adverse events including hospitalisations and deaths. On days 0—7 and at week 4, participants rated the intensity of the worst pain experienced in the last 24 hours using a validated 0—10 Numeric Rating Scale NRS. Worst pain intensity in the last 24 hours, side effects, medication use for gout pain and treatment adherence were assessed daily during days 1—7 and at week 4.

EQ-5D-5L and patient global assessment of treatment response were assessed at day 7 and week 4. We aimed to assess the superiority of naproxen or colchicine two-tailed hypothesis testing. A sample size of participants per arm was required to detect a small standardised effect size ES of 0. The main analysis was by intention-to-treat ITT evaluating participants as per allocation assignment.

Mean change in worst pain intensity in the last 24 hours from baseline to each follow-up time point was calculated for each group. Analysis of the primary outcome was by linear mixed model with autoregressive covariance for repeated measures. Standardised between-group mean differences for pain were expressed as the estimated mean differences relative to the baseline SD of pain scores ES. In a sensitivity analysis, between-group differences in the primary outcome based on more inclusive baseline covariates including adjustment for first episode, age at first flare, location of gout, EQ-5D-5L, index of deprivation fixed factors and GP practice random factor were examined via MI evaluation imputation data set i above.

Analysis was performed when all participants had completed follow-up; no interim analysis was performed. Primary and secondary outcomes except per-protocol and health economic evaluations were analysed blind to treatment allocation. The primary endpoint analysis was independently analysed by two statisticians.

Resource use, costs and EQ-5D-5L scores were summarised using descriptive statistics. A regression approach controlled for imbalances in baseline EQ-5D-5L scores between treatment arms.

Incremental cost-effectiveness ratios were estimated by dividing the mean cost difference between arms by the difference in mean QALYs. Five thousand pairs of mean cost and QALY differences were estimated by non-parametric bootstrapping and presented on a cost-effectiveness plane.

Cost-effectiveness acceptability curves were plotted to determine the probability that naproxen was cost-effective. The human capital approach was used to estimate productivity costs from employment status and days off work due to health.

The average wage for each respondent was identified using UK Standard Occupational Classification coding and annual earnings data. This trial was developed with research users with gout who provided feedback on the proposed recruitment and consent processes and choice of trial outcomes.

Two patient representatives sat on the independent trial steering committee, playing a full part in monitoring trial progress and conduct, and provided advice on the design of questionnaires and Participant Information Leaflets. Between 29 January and 31 December , patients were mailed. Three-hundred and ninety-nine participants were randomised: to receive naproxen and to receive colchicine figure 1. Groups were similar at baseline although more people allocated to colchicine reported experiencing their first-ever gout flare table 1 , online supplementary table 1.

Primary outcome data were collected for Participant flow. ITT, intention-to-treat. Within-group improvements in the primary outcome were seen in both groups over days 1—7 figure 2. Unadjusted estimates and MI evaluation with extended covariate adjustment were similar. There was a small between-group difference favouring naproxen on day 2 only. Comparison of pain scores primary outcome measure at follow-up intention-to-treat analysis.

Per-protocol analysis 1 showed comparable between-group mean differences to the ITT evaluation online supplementary table 2. Per-protocol analyses 2 and 3 showed similar between-group differences to the ITT analysis overall and on days 1—6 but found small significant differences favouring naproxen at week 4.

There were no between-group differences in complete pain resolution or patient global assessment of treatment response at any time-point table 2 , online supplementary table 3.

Comparison of secondary outcome measures at day 7 and week 4 follow-up. Once you complete the form, CooperVision will send you a certificate for the trial lenses of your choice, which you can redeem at your local eye doctor. Alcon may be best known for their multiple color contact lenses, but they also offer a number of daily and monthly lenses as well.

Unlike Acuvue or CooperVision, Alcon has separate free trial programs for each of their different lenses. Below, you can find links to get a certificate from each of the programs.

Like other manufacturers, Alcon requires you to redeem the free trial certificate from a local eye doctor. Bausch and Lomb makes the popular BioTrue contact lens solution that so many of us use. This is due to the blood vessels expanding in an effort to absorb more oxygen. Eventually, this oxygen-deprived state can lead to serious eye diseases like macular degeneration.

Of course, if you sleep in trial lenses for the short period of time that you wear them, you probably won't see these issues. But it's not a good habit to get into. Do note that some contacts are FDA-approved for overnight wear. So if you want to sleep with your lenses on, ask your eye doctor about extended wear contact lenses. You may also be wondering if you can participate in water activities like swimming while using your trial lenses.

Any time water gets in your eye , it can introduce bacteria, which may cause infections. Normally, your eyes stay healthy thanks to their natural cleaning system. However, contact lenses increase the chance of infection. A contact lens can hold that bacteria on your eye for a longer period of time. The risk is further complicated if you continue using the same lens, especially if you don't clean it well.

The bottom line is that yes, you can wear your trial contact lenses when you go out on the water. Another possibility is if you have daily disposables. That way, you can throw the lenses out after use.