Tag Archives: surrogate-endpoints

The Problem with Surrogate Endpoints

The Problem with Surrogate Endpoints – Alex Gertner – Twitter stream from @setmoreoff – Feb 2019

Mr. Gertner shows why you cannot measure drug use by counting various “surrogate outcomes” like those listed below and expect to get a realistic number.  Measurements can be dramatically skewed and lead to wildly inaccurate results when invalid surrogate endpoints are chosen.

1/ If you’d like to research the effect of a policy or program on drug use rates then you need to measure drug use.

  • ED overdose visits,
  • drug related arrests, and
  • overdose deaths

are not good measures of drug use rates. Thoughts from >10 years working in drug policy & research   Continue reading

Measurement of Chronic Pain and Opioid Use Evaluation

Measurement of Chronic Pain and Opioid Use Evaluation in Community-Based Persons with Serious Illnesses | Journal of Palliative Medicine – by Kathleen Puntillo, and Ramana K. Naidu – Mar 2018

I had high hopes for this paper after reading the abstract and finding this conclusion, which feels so spot-on:


Accountability for high quality care for community-dwelling patients requires selection of metrics that will capture the

  • burden of chronic pain and
  • beneficial use or misuse of opioids.

Continue reading

Misconceptions about Evidence-Based Medicine

Evidence-Based Medicine: Common Misconceptions, Barriers, and Practical Solutions – JAY SIWEK, MD, Georgetown University Medical Center, Washington – Sep 2018

More than 25 years have passed since the term evidence-based medicine (EBM) was introduced into the medical literature. Its original definition has been expanded to include not only the quality of the evidence, but also the two key players applying the available evidence—namely the clinician and patient.

A current working definition is: the integration of the best available evidence with clinical expertise and the individual patient’s values, preferences, and unique circumstances.

EBM is not dogmatic, “cookbook ” medicine.

Oh really? But that’s exactly how it’s being used. Continue reading

Behind the AHRQ Review of Alt Therapies for Pain

Behind the AHRQ Report – By Richard A. Lawhern, PhD and Stephen E. Nadeau, MD – October 3, 2018

In the current restrictive regulatory climate that governs opioid analgesic therapy for chronic pain, there is much discussion of “alternative” therapies and “integrative medicine.”

Unfortunately for proponents of such measures, the state of medical evidence in trials literature is very weak, reflecting weaknesses of trial design, execution, and size.

This is perhaps unintentionally illustrated by a major systematic review released in June 2018 by the Agency for Healthcare Research and Quality (AHRQ), an agency of the US Health and Human Services Department.   Continue reading

Human gut study questions probiotic health benefits

Human gut study questions probiotic health benefits — ScienceDaily – Sept 2018

Probiotics are found in everything from chocolate and pickles to hand lotion and baby formula, and millions of people buy probiotic supplements to boost digestive health. But new research suggests they might not be as effective as we think.

Through a series of experiments looking inside the human gut, researchers show that many people’s digestive tracts prevent standard probiotics from successfully colonizing them.

Furthermore, taking probiotics to counterbalance antibiotics could delay the return of normal gut bacteria and gut gene expression to their naïve state.   Continue reading

Those 2-Minute Walk Breaks? They Add Up

Those 2-Minute Walk Breaks? They Add Up – By GRETCHEN REYNOLDS MARCH 28, 2018

I’m glad to read that freq2uent short bursts of exercise (or any movement, even if not vigorous) can be as beneficial as longer, more intense sessions of exercise.

This is how I get most of my exercise: getting up from my desk when my 30-minute timer goes off. I just take a minute-long break, walking around and swinging my arms around, maybe doing some stretches (mainly backward to “open my hips” after so much sitting), or doing a quick burst of “20-steps” running in place.

Walk for two minutes. Repeat 15 times. Or walk for 10 minutes, thrice.   Continue reading

Surrogate endpoints in global health research

Surrogate endpoints in global health research: still searching for killer apps and silver bullets?March 2018

In clinical research, there is widespread acceptance that surrogate endpoints may not translate to long-term benefits.

Clinical epidemiologists highlight the hazards of surrogate measures (eg, biomarkers, laboratory test results and short-term improvements in health) that substitute for outcomes which are important for patients (eg, avoiding premature death or severe disability).

For example, in cardiovascular research, improvements in parameters such as blood pressure or cholesterol may not improve outcomes such as deaths.   Continue reading

Opioid dose (pain level) and risk of suicide

Opioid dose and risk of suicide – free full-text research article /PMC4939394/ – 2017 May

Suicide is a significant public health problem and preventing suicide is a national priority

Emerging evidence links chronic non-cancer pain to increased risk of suicide.

This evidence is consistent despite significant differences in methods of pain assessment (pain level or diagnosis, use of clinical records), the population examined (clinical samples, population surveys), and the primary outcome (non-fatal attempt, suicide death)   Continue reading

Understanding and misunderstanding RCTs

Understanding and misunderstanding randomized controlled trials – ScienceDirect


  • Randomization does not balance confounders in any single trial.
  • Unbiasedness is of limited practical value compared with precision.
  • Asymmetric distributions of treatment effects pose threats to significance testing
  • The best method depends on hypothesis tested, what’s known, and cost of mistakes.
  • RCT results can serve science but are weak ground for inferring ‘what works’.

Continue reading

Evidence for Health Decision Making — Beyond RCTs

Evidence for Health Decision Making — Beyond Randomized, Controlled Trials — NEJM

A core principle of good public health practice is to base all policy decisions on the highest-quality scientific data, openly and objectively derived.

Although randomized, controlled trials (RCTs) have long been presumed to be the ideal source for data on the effects of treatment, other methods of obtaining evidence for decisive action are receiving increased interest, prompting new approaches to leverage the strengths and overcome the limitations of different data sources.   Continue reading