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1.
Contemp Clin Trials ; 125: 107057, 2023 02.
Article in English | MEDLINE | ID: mdl-36539060

ABSTRACT

BACKGROUND: Effective recruitment and retention strategies are essential in clinical trials. METHODS: The MemAID trial consisted of 12 visits during 24 weeks of intranasal insulin or placebo treatment and 24 weeks of post-treatment follow-up in older people with and without diabetes. Enhanced retention strategies were implemented mid study to address high drop-out rate. Baseline variables used in Cox regression models to identify dropout risk factors were: demographics and social characteristics, functional measures, metabolic and cardiovascular parameters, and medications. RESULTS: 244 participants were randomized; 13 (5.3%) were discontinued due to adverse events. From the remaining 231 randomized participants, 65 (28.1%) dropped out, and 166 (71.9%) did not. The Non-retention group included 95 participants not exposed to retention strategies, of which 43 (45.2%) dropped out. The Retention group included 136 participants exposed to enhanced retention strategies, of which 22 (16.2%) dropped out. Dropout risk factors included being unmarried, a longer diabetes duration, using oral antidiabetics as compared to not using, worse executive function and chronic pain. After adjusting for exposure to retention strategies, worse baseline executive function composite score (p = 0.001) and chronic pain diagnosis (p = 0.032) were independently associated with a greater risk of dropping out. The probability of dropping out decreased with longer exposure to retention strategies and the dropout rate per month decreased from 4.1% to 1.8% (p = 0.04) on retention strategies. CONCLUSIONS: Baseline characteristics allow prediction of dropping out from a clinical trial in older participants. Retention strategies has been effective at minimizing the impact of dropout-related risk factors. TRIAL REGISTRATION: Clinical trials.gov NCT2415556 3/23/2015 (www. CLINICALTRIALS: gov).


Subject(s)
Chronic Pain , Diabetes Mellitus, Type 2 , Humans , Aged , Diabetes Mellitus, Type 2/drug therapy , Insulin/therapeutic use , Hypoglycemic Agents/therapeutic use , Administration, Intranasal
2.
Pain Physician ; 24(7): E973-E987, 2021 11.
Article in English | MEDLINE | ID: mdl-34704708

ABSTRACT

BACKGROUND: Headache is a very common condition that affects 5-9% of men and 12-25% of women in North America and Europe. Globally, the prevalence of active headaches among adults is 47%. The most common type of headache is tension headaches (38% of adults), followed by migraines (10%), and chronic headaches (3%). While the majority of headaches are benign, the disorder can severely negatively influence a patients' quality of life, which is directly reflected in societal costs. OBJECTIVE: The objective of this review was to summarize available evidence behind radiofrequency ablation (RFA) for headache, including pain outcome measures, secondary outcomes, and complications. STUDY DESIGN: Systematic review. SETTING: This systematic review examined studies that applied the use of RFA for management of headache. METHODS: This systematic review was reported following the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). Two reviewers independently scored the methodological quality of the selected studies. Due to heterogeneity of studies, a best-evidence synthesis of the available prognostic factors was provided. RESULTS: In the present investigation, we evaluated 18 studies composed of 6 randomized controlled trials (RCTs), 6 prospective studies, and 6 retrospective studies. All the studies assessed pain improvement with RFA in patients with headache. Most studies targeted the occipital nerve for treatment. Complications were mostly mild and self-limiting, including eyelid swelling, rash, superficial infection of the procedural site, and worsening of headache. LIMITATIONS: A large variability in definitions of trigeminal neuralgia, radiofrequency technique, and patient selection bias was observed in our selected cohort of studies. In addition, there is a paucity of strong longitudinal RCTs and prospective studies. CONCLUSION: Our review discusses several studies that suggest the efficacy of RFA in the treatment of headaches. Outcomes varied based on the difference in approaches regarding continuous radiofrequency versus pulsed radiofrequency, temperature, and duration of administration. The majority of the studies discussed in this review indicate a therapeutic benefit of RFA for headaches over a short-term period. Pain outcomes beyond one year are understudied and further studies are needed to determine the long-term effects of RFA for headaches.


Subject(s)
Catheter Ablation , Radiofrequency Ablation , Trigeminal Neuralgia , Adult , Female , Headache , Humans , Male , Prospective Studies
3.
Oxf Med Case Reports ; 2019(2): omy133, 2019 Feb.
Article in English | MEDLINE | ID: mdl-30800329

ABSTRACT

Metastatic neoplasms to the gastrointestinal (GI) tract are an uncommon entity and in extremely rare cases originate from the breast. The clinical manifestations of metastatic breast cancer into the GI tract are frequently non-specific, and the interval between the diagnosis of lobular carcinoma and GI metastasis can often delay up to 30 years. Here, we present a 73-year-old female with an unusual colonoscopy that revealed a submucosa nodular infiltrate throughout all the colon with a cobblestone-like appearance, which was later confirmed to be metastatic lobular carcinoma of the breast that was surgically removed 15 years early. A couple of months later, she developed malignant small bowel obstruction and laparotomy revealed extended small bowel and colonic metastatic involvement.

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