Under-representation of the elderly in osteoarthritis clinical trials

Peat, George; Birrell, Fraser; Cumming, Jo; Doherty, Michael; Simpson, H.; Conaghan, P. G.

doi:10.1093/rheumatology/keq332

Cited by 5 publications

(3 citation statements)

References 8 publications

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“…Despite decades of significant medical advances that have resulted in approval of novel prevention strategies, therapeutics, and medical devices, clinical trials continue to be challenged by underrepresentation of racial and ethnic minority participants [ 1 , 2 ]. Recent data demonstrate that overall participation rates among racial/ethnic minorities continue to lag behind those of other groups for various types of clinical trials [ 1 , 3 , 4 ]. Moreover, enrollment rates are lower among the elderly (typically defined as those ≥70 years) when compared to younger participants [ 5 , 6 , 7 ], and lower among women than men in cardiology trials [ 1 , 4 ].…”

Section: Introductionmentioning

confidence: 99%

Results of a Community Randomized Study of a Faith-Based Education Program to Improve Clinical Trial Participation among African Americans

Frew

Schamel

OʼConnell

et al. 2015

IJERPH

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This is a report of a cluster randomized clinical trial evaluating the effectiveness of a church-based educational intervention aimed at improving African Americans’ (AA) participation in clinical trials. Two hundred and twenty-one AA subjects ages ≥50 years from six predominantly AA churches were randomized to intervention or control condition. The intervention included three educational sessions about clinical trials and health disparities; control participants completed questionnaires. Primary endpoints of the study were differences in individual subjects' intentions to obtain clinical trial information and intention to join a clinical trial, as determined by 10 point scale items at baseline, three and six months. A statistically significant increase in the intention to obtain clinical trial information at the three and six month time points was observed in the intervention group, but not the control group. Older participants (65–95 years) were less likely than younger participants (50–64 years) to increase their motivation to seek clinical trial information by the three and six month time points. No significant increases were observed in intention to join clinical trials. This randomized trial shows that AA church-based educational interventions are likely to increase the motivation of AA subjects to obtain clinical trial information and are therefore potentially effective at ameliorating the underrepresentation of AA subjects in clinical trials.

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Section: Introductionmentioning

confidence: 99%

Results of a Community Randomized Study of a Faith-Based Education Program to Improve Clinical Trial Participation among African Americans

Frew

Schamel

OʼConnell

et al. 2015

IJERPH

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“…[ 69 – 71 ] These are most commonly reported in the older patient and are typically the result of minor trauma such as accidental trips causing falls. [ 72 ] Similarly, the site where the extensor mechanism of the knee fails varies with age [ 73 ], with avulsions occurring at the tibial tubercle/inferior pole of the patella in immature patients and at the superior pole of the patella in older adults.…”

Section: Discussionmentioning

confidence: 99%

Patterns of Hamstring Muscle Tears in the General Population: A Systematic Review

et al. 2016

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BackgroundHamstring tears are well recognised in the sporting population. Little is known about these injuries in the general population.PurposeEvaluating the rates, patterns and risk factors of non-sporting hamstring tears, compared to sporting related hamstring tears.Data SourcesMEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials (1989–2015).Study SelectionStudies reporting patients with a grade 2 or 3 hamstring muscle tear, identified clinically, confirmed by MRI imaging or direct visualisation during surgical exploration.Data Synthesis144 sets of linked data were extracted for analysis. Most injuries were in males (81.3%), where mean age at injury was lower (30.2, 95% CI 29.1–31.3) than in females (35.4, 95% CI 32.4–38.4) p = 0.06. Key differences were found in the proportion of non-sporting injuries in patients under and over the age 40 (p = 0.001). The proportion of non-sporting injuries was significantly higher in females compared to males (25.9% female non-sporting injuries, versus 8.5% male; p = 0.02). Avulsions were more frequently reported in non-sporting activities (70.5%). The proportion of such injuries was notably higher in females, though this failed to meet significance (p = 0.124). Grouped by age category a bimodal distribution was noted, with the proportion of avulsions greater in younger (age <15) and older patients (age > 40) (p = 0.008). 86.8% of patients returned to pre-injury activity levels with a similar frequency across all study variables; age, activity (sporting vs non-sporting) and injury type (avulsion vs tear).ConclusionThis review highlights a proportion of adults suffering grade 2 or 3 hamstring injuries from activities other than the classic sports trauma. The majority of these non-sporting injuries were avulsion injuries that clustered in older female and skeletally immature patients suggesting a potential link to bone mineral density.

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“…This study confirms the safety of 25 mg spironolactone daily in this specific older population with OA. The mean age of participants was 77 years, and there was no upper age limit; this lack of a limit contrasts with around 25% of OA‐related trials, which did impose upper age limits , a practice that is increasingly untenable. As most older people are multimorbid, the prospect of a safe, established medication with pleiotropic therapeutic effects is an attractive one.…”

Section: Introductionmentioning

confidence: 98%

Spironolactone for People Age 70 Years and Older With Osteoarthritic Knee Pain: A Proof‐of‐Concept Trial

McMurdo

Sumukadas

Donnan

et al. 2016

Arthritis Care & Research

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ObjectiveTo determine whether spironolactone could benefit older people with osteoarthritis (OA), based on a previous study showing that spironolactone improved quality of life.MethodsThis parallel‐group, randomized, placebo‐controlled, double‐blind trial randomized community‐dwelling people ages ≥70 years with symptomatic knee OA to 12 weeks of 25 mg daily oral spironolactone or matching placebo. The primary outcome was between‐group difference in change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. Secondary outcomes included WOMAC stiffness and physical function subscores, EuroQol 5‐domain (EQ‐5D) 3L score, and mechanistic markers. Analysis was by intent to treat, using mixed‐model regression, adjusting for baseline values of test variables.ResultsA total of 421 people had eligibility assessed, and 86 were randomized. Mean ± SD age was 77 ± 5 years and 53 of 86 (62%) were women. Adherence to study medication was 99%, and all participants completed the 12‐week assessment. No significant improvement was seen in the WOMAC pain score (adjusted treatment effect 0.5 points [95% confidence interval (95% CI) − 0.3, 1.3]; P = 0.19). No improvement was seen in WOMAC stiffness score (0.2 points [95% CI −0.6, 1.1]; P = 0.58), WOMAC physical function score (0.0 points [95% CI −0.7, 0.8]; P = 0.98), or EQ‐5D 3L score (0.04 points [95% CI −0.04, 0.12]; P = 0.34). Cortisol, matrix metalloproteinase 3, and urinary C‐telopeptide of type II collagen were not significantly different between groups. More minor adverse events were noted in the spironolactone group (47 versus 32), but no increase in death or hospitalization was evident.ConclusionSpironolactone did not improve symptoms, physical function, or health‐related quality of life in older people with knee OA.

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Under-representation of the elderly in osteoarthritis clinical trials

Cited by 5 publications

References 8 publications

Results of a Community Randomized Study of a Faith-Based Education Program to Improve Clinical Trial Participation among African Americans

Results of a Community Randomized Study of a Faith-Based Education Program to Improve Clinical Trial Participation among African Americans

Patterns of Hamstring Muscle Tears in the General Population: A Systematic Review

Spironolactone for People Age 70 Years and Older With Osteoarthritic Knee Pain: A Proof‐of‐Concept Trial

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