This study explored participants' experiences of randomized controlled trial (RCT) participation to examine their understanding of the trial design and whether their consent was indeed informed. A nested qualitative interview study was conducted with 38 participants from a sample of 282 who participated in a complex RCT evaluating the effectiveness of laser compared with needle acupuncture for chronic knee pain. Overall participants had a good understanding of the RCT, and concepts such as randomization and placebo. Their experiences of being in the trial were largely positive, even if they did not experience any knee pain improvement. Their responses to unblinding at the end of the study were accepting. Participants had a good functional understanding of the RCT, sufficient for valid informed consent.
Objective: To evaluate the effects of financial incentives on physical activity (PA). Data Sources: MEDLINE, Embase, 7 other databases, and 2 trial registries until July 17, 2019. Study Inclusion and Exclusion Criteria: Randomized controlled trials with adults aged ≥18 years assessing the effect of financial incentives on PA. Any comparator was eligible provided the only difference between groups was the incentive strategy. Data Extraction: Two independent reviewers extracted data and assessed study quality. Of 5765 records identified, 57 records (51 unique trials; n = 17 773 participants) were included. Data Synthesis: Random-effects models pooling data for each of the 5 PA domains. Results: Financial incentives increase leisure time PA (gym or class attendance; standardized mean difference [95% CI], 0.46 [0.28-0.63], n = 5057) and walking behavior (steps walked; 0.25 [0.13-0.36], n = 3254). No change in total minutes of PA (0.52 [−0.09 to 1.12], n = 968), kilocalories expended (0.19 [−0.06 to 0.44], n = 247), or the proportion of participants meeting PA guidelines (risk ratio [95% CI] 1.53 [0.53-4.44], n = 650) postintervention was observed. After intervention has ceased, incentives sustain a slight increase in leisure time PA (0.10 [0.02-0.18], n = 2678) and walking behavior (0.11 [0.00-0.22], n = 2425). Conclusions: Incentives probably improve leisure time PA and walking at intervention end, and small improvements may be sustained over time once incentives have ceased. They lead to little or no difference in kilocalories expended or minutes of PA. It is uncertain whether incentives change the likelihood of meeting PA guidelines because the certainty of the evidence is low.
BACKGROUND: Knee osteoarthritis (OA) is a global problem that causes significant pain and physical dysfunction, substantially impacting on quality of life and imposing enormous cost to the healthcare system. Exercise is pivotal to OA management, yet uptake by people with knee OA is inadequate. Limited access to appropriately skilled health professionals, such as physiotherapists, for prescription of an exercise program and support with exercise is a major barrier to optimal care. Internet-enabled video consultations permit widespread reach. However, services offering video consultations with physiotherapists for musculoskeletal conditions are scant in Australia where there is typically no Government or private health insurer funding for such services. The paucity of robust evidence demonstrating video consultations with physiotherapists are clinically effective, safe and cost-effective for knee OA is hampering implementation of, and willingness of healthcare policymakers to pay for, these services. METHODS: This is an assessor- and participant-blinded, two-arm, pragmatic, comparative effectiveness non-inferiority randomised controlled trial (RCT) conducted in Australia. We are recruiting 394 people from the community with chronic knee pain consistent with a clinical diagnosis of knee OA. Participants are randomly allocated to receive physiotherapy care via i) video-conferencing or; ii) face-to-face consultations. Participants are provided five consultations (30–45 min each) with a physiotherapist over 3 months for prescription of a home-based strengthening exercise program (to be conducted independently at home) and physical activity plan, as well as OA education. Participants in both groups are provided with educational booklets and simple exercise equipment via post. The co-primary outcomes are change in self-reported i) knee pain on walking; and ii) physical function, with a primary end-point of 3 months and a secondary end-point of 9 months. Secondary outcomes include changes in other clinical outcomes ...
In: Hinman , R S , Kimp , A J , Campbell , P K , Russell , T , Foster , N E , Kasza , J , Harris , A & Bennell , K L 2020 , ' Technology versus tradition : a non-inferiority trial comparing video to face-to-face consultations with a physiotherapist for people with knee osteoarthritis. Protocol for the PEAK randomised controlled trial ' , BMC Musculoskeletal Disorders , vol. 21 , no. 1 . https://doi.org/10.1186/s12891-020-03523-8
BACKGROUND: Knee osteoarthritis (OA) is a global problem that causes significant pain and physical dysfunction, substantially impacting on quality of life and imposing enormous cost to the healthcare system. Exercise is pivotal to OA management, yet uptake by people with knee OA is inadequate. Limited access to appropriately skilled health professionals, such as physiotherapists, for prescription of an exercise program and support with exercise is a major barrier to optimal care. Internet-enabled video consultations permit widespread reach. However, services offering video consultations with physiotherapists for musculoskeletal conditions are scant in Australia where there is typically no Government or private health insurer funding for such services. The paucity of robust evidence demonstrating video consultations with physiotherapists are clinically effective, safe and cost-effective for knee OA is hampering implementation of, and willingness of healthcare policymakers to pay for, these services. METHODS: This is an assessor- and participant-blinded, two-arm, pragmatic, comparative effectiveness non-inferiority randomised controlled trial (RCT) conducted in Australia. We are recruiting 394 people from the community with chronic knee pain consistent with a clinical diagnosis of knee OA. Participants are randomly allocated to receive physiotherapy care via i) video-conferencing or; ii) face-to-face consultations. Participants are provided five consultations (30-45 min each) with a physiotherapist over 3 months for prescription of a home-based strengthening exercise program (to be conducted independently at home) and physical activity plan, as well as OA education. Participants in both groups are provided with educational booklets and simple exercise equipment via post. The co-primary outcomes are change in self-reported i) knee pain on walking; and ii) physical function, with a primary end-point of 3 months and a secondary end-point of 9 months. Secondary outcomes include changes in other clinical outcomes ...