METHODS: We did a systematic review and meta-analysis of randomised controlled trials including IPD. We searched MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, MEDLINE Epub Ahead of Print, Embase, Science Citation Index, the Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, and Database of Abstracts of Review of Effects for literature from 1992 onwards (date of search, Aug 27, 2018). The following inclusion criteria were applied: (1) men aged 18 years and older with a screening testosterone concentration of 12 nmol/L (350 ng/dL) or less; (2) the intervention of interest was treatment with any testosterone formulation, dose frequency, and route of administration, for a minimum duration of 3 months; (3) a comparator of placebo treatment; and (4) studies assessing the pre-specified primary or secondary outcomes of interest. Details of study design, interventions, participants, and outcome measures were extracted from published articles and anonymised IPD was requested from investigators of all identified trials. Primary outcomes were mortality, cardiovascular, and cerebrovascular events at any time during follow-up. The risk of bias was assessed using the Cochrane Risk of Bias tool. We did a one-stage meta-analysis using IPD, and a two-stage meta-analysis integrating IPD with data from studies not providing IPD. The study is registered with PROSPERO, CRD42018111005.
FINDINGS: 9871 citations were identified through database searches and after exclusion of duplicates and of irrelevant citations, 225 study reports were retrieved for full-text screening. 116 studies were subsequently excluded for not meeting the inclusion criteria in terms of study design and characteristics of intervention, and 35 primary studies (5601 participants, mean age 65 years, [SD 11]) reported in 109 peer-reviewed publications were deemed suitable for inclusion. Of these, 17 studies (49%) provided IPD (3431 participants, mean duration 9·5 months) from nine different countries while 18 did not provide IPD data. Risk of bias was judged to be low in most IPD studies (71%). Fewer deaths occurred with testosterone treatment (six [0·4%] of 1621) than placebo (12 [0·8%] of 1537) without significant differences between groups (odds ratio [OR] 0·46 [95% CI 0·17-1·24]; p=0·13). Cardiovascular risk was similar during testosterone treatment (120 [7·5%] of 1601 events) and placebo treatment (110 [7·2%] of 1519 events; OR 1·07 [95% CI 0·81-1·42]; p=0·62). Frequently occurring cardiovascular events included arrhythmia (52 of 166 vs 47 of 176), coronary heart disease (33 of 166 vs 33 of 176), heart failure (22 of 166 vs 28 of 176), and myocardial infarction (10 of 166 vs 16 of 176). Overall, patient age (interaction 0·97 [99% CI 0·92-1·03]; p=0·17), baseline testosterone (interaction 0·97 [0·82-1·15]; p=0·69), smoking status (interaction 1·68 [0·41-6·88]; p=0.35), or diabetes status (interaction 2·08 [0·89-4·82; p=0·025) were not associated with cardiovascular risk.
INTERPRETATION: We found no evidence that testosterone increased short-term to medium-term cardiovascular risks in men with hypogonadism, but there is a paucity of data evaluating its long-term safety. Long-term data are needed to fully evaluate the safety of testosterone.
FUNDING: National Institute for Health Research Health Technology Assessment Programme.
OBJECTIVE: Our study objective was to evolve and test a colour coded client segmentation based public health approach to educate the community to deal with problem of hypertension.
METHODOLOGY: This cross-sectional pilot study was done in March 2020 among purposively approached in a primary health centre to 100 people aged above 18 years, among them 41 gave written consent for the study and their demographic information was noted. They were given colour coded cards as per the current blood pressure level and previous history of hypertension. On each colour coded card, specific advice was written for that category. For all the participants, blood pressure and treatment seeking behaviour was noted. For hypertensive patients, adherence to medication and non-pharmacological measures was noted.
RESULTS: Mean age of the participants was 46.5 ± 13.06 years. Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) of the participants were 135 ± 16.85 mm Hg and 86 ± 11.42 mm Hg, respectively. Among the participants, 10 (24.39%) had a known history of hypertension. Among them, as per the blood pressure levels measured on the day of the study 50% (5) had their blood pressure levels under control. Interestingly 16 (39%) participants were found hypertensive incidentally.
DISCUSSION: It is evident from the studies that colour coded approach is used in multiple ways, in multiple settings, for multiple diseases. To our knowledge, little focus has been given for hypertensive disorders in the community level. We merely bother about making their risk profiling, even in the digital age. Sometimes physicians in emergency become puzzled whenever patients collapsed in front of them and we missed the "Golden Hour" for the treatment by searching patients' medical details.
CONCLUSION AND RECOMMENDATIONS: The above problem can be solved by risk profiling of chronic patients by colour coded OPD/Health cards.