Intention to treat analysis versus per protocol analysis of trial data.
TL;DR: It was concluded that the self management of arthritis programme reduced anxiety and improved participants’ perceived self efficacy to manage symptoms, although it had no significant effect on pain, physical functioning, or …
Abstract: Researchers evaluated the effectiveness of a self management programme for arthritis on the overall function of patients with osteoarthritis in primary care. A randomised controlled trial study design was used. The intervention was attendance at six sessions of self management of arthritis, plus an education booklet. The control group received the education booklet only. Participants were patients aged 50 years or more who had osteoarthritis of the hips or knees (or both) and pain or disability (or both). In total, 812 patients were recruited and randomised to the intervention (n=406) or control (n=406).1
The primary outcome was quality of life, as assessed by the short form health survey (SF-36). Secondary outcomes included physical and psychosocial measures. Outcome measures were recorded by postal questionnaires, collected at baseline and 12 months. Analysis was performed on an intention to treat approach. The researchers reported that the intervention group showed a significant reduction on the anxiety subscore of the hospital anxiety and depression scale at 12 months (mean difference 0.62, 95% confidence interval 0.16 to 1.08). The intervention group also showed a significant improvement on the arthritis self efficacy scale for pain (0.98, 0.07 to 1.89) and self efficacy for other aspects of management (1.58, 0.25 to 2.90). Per protocol analysis produced similar results to the intention to treat analysis with respect to significant findings. It was concluded that the self management of arthritis programme reduced anxiety and improved participants’ perceived self efficacy to manage symptoms, although it had no significant effect on pain, physical functioning, or …
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02 Mar 2018
TL;DR: The evidence does not support the concern that e-cigarettes are a route into smoking among young people, and regular use is rare and is almost entirely confined to those who have smoked.
Abstract: The report covers e-cigarette use among young people and adults, public attitudes, the impact on quitting smoking, an update on risks to health and the role of nicotine It also reviews heated tobacco products
The main findings of PHE’s evidence review are that:
• vaping poses only a small fraction of the risks of smoking and switching completely from smoking to vaping conveys substantial health benefits
• e-cigarettes could be contributing to at least 20,000 successful new quits per year and possibly many more
• e-cigarette use is associated with improved quit success rates over the last year and an accelerated drop in smoking rates across the country
• many thousands of smokers incorrectly believe that vaping is as harmful as smoking; around 40% of smokers have not even tried an e-cigarette
• there is much public misunderstanding about nicotine (less than 10% of adults understand that most of the harms to health from smoking are not caused by nicotine)
• the use of e-cigarettes in the UK has plateaued over the last few years at just under 3 million
• the evidence does not support the concern that e-cigarettes are a route into smoking among young people (youth smoking rates in the UK continue to decline, regular use is rare and is almost entirely confined to those who have smoked)
360 citations
Cites methods from "Intention to treat analysis versus ..."
...Study validity is further undermined because the study used a per-protocol approach instead of intention to treat analysis which compromises the validity of randomisation (355) and is in contravention to trial standards outlined eg in the CONSORT statement (356)....
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TL;DR: Outpatient THA and TKA in a well-selected patient is feasible in an academic multidisciplinary tertiary care hospital, with complication rates approximating inpatient surgery.
Abstract: Background Interest in outpatient total hip arthroplasty (THA) and total knee arthroplasty (TKA) has increased recently as part of value-based care and early recovery protocols. Outpatient pathways require significant paradigm shifts, are not used widely, and are mostly implemented at outpatient surgery centers or orthopedic specialty hospitals. In this article, we report on the outcomes of implementation of an outpatient arthroplasty protocol at a tertiary care academic medical center. Methods We performed a retrospective review on a series of 105 consecutive patients who underwent THA or TKA following our newly implemented outpatient arthroplasty protocol. We compared these patients to a group of inpatient arthroplasty patients from the same time period. Results Eighty-three of 105 (79%) patients were successfully discharged home on the day of surgery. Successful same-day discharge was predicted by early ambulation (P = .01), TKA over THA (P = .04), and shorter duration of surgery (P = .01). General anesthesia correlated with better early ambulation distances (P = .03) and a lower incidence of urinary retention (P = .049). The outpatient readmission and complication rates were 0.95% and 1.9%, respectively, whereas the matched inpatient rates were 3.7% and 2.9%, respectively. Conclusions Outpatient THA and TKA in a well-selected patient is feasible in an academic multidisciplinary tertiary care hospital, with complication rates approximating inpatient surgery. The findings reported here can be used to further optimize outpatient arthroplasty protocols.
59 citations
TL;DR: Two or three H56:IC31 vaccinations at the lowest dose induced durable antigen‐specific CD4 T‐cell responses with acceptable safety and tolerability profiles in M.tb‐infected and M.Tb‐uninfected adults are shown.
Abstract: Rationale: Global tuberculosis (TB) control requires effective vaccines in TB-endemic countries, where most adults are infected with Mycobacterium tuberculosis (M.tb).Objectives: We sought to defin...
57 citations
TL;DR: Given the overall safety profile and similar technical performance, single-use duodenoscopes represent an alternative to reusable duodENoscopes for performing low-complexity ERCP procedures in experienced hands.
Abstract: Objective Single-use duodenoscopes have been recently developed to eliminate risk of infection transmission from contaminated reusable duodenoscopes. We compared performances of single-use and reusable duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Design Patients with native papilla requiring ERCP were randomised to single-use or reusable duodenoscope. Primary outcome was comparing number of attempts to achieve successful cannulation of desired duct. Secondary outcomes were technical performance that measured duodenoscope manoeuvrability, mechanical-imaging characteristics and ability to perform therapeutic interventions, need for advanced cannulation techniques or cross-over to alternate duodenoscope group to achieve ductal access and adverse events. Results 98 patients were treated using single-use (n=48) or reusable (n=50) duodenoscopes with >80% graded as low-complexity procedures. While median number of attempts to achieve successful cannulation was significantly lower for single-use cohort (2 vs 5, p=0.013), ease of passage into stomach (p=0.047), image quality (p Conclusion Given the overall safety profile and similar technical performance, single-use duodenoscopes represent an alternative to reusable duodenoscopes for performing low-complexity ERCP procedures in experienced hands. Trial registration number Clinicaltrials.gov number: NCT04143698
55 citations
TL;DR: US-guided dual-target corticosteroid injection showed similar short-term efficacy to standard subacromial injections, but with an extended duration of symptom relief, and may be useful for shoulder-pain treatment in patients with SIS.
49 citations
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TL;DR: The self management of arthritis programme reduced anxiety and improved participants' perceived self efficacy to manage symptoms, but it had no significant effect on pain, physical functioning, or contact with primary care.
Abstract: Objective To evaluate clinical effectiveness of a self management programme for arthritis in patients in primary care with osteoarthritis.
Design Randomised controlled trial.
Setting 74 general practices in the United Kingdom.
Participants 812 patients aged 50 and over with osteoarthritis of hips or knees (or both) and pain or disability (or both).
Intervention Participants were randomised to six sessions of self management of arthritis and an education booklet (intervention group) or the education booklet alone (control group).
Main outcome measures Primary outcome was quality of life, as assessed by the short form health survey (SF-36). Several other physical and psychosocial secondary outcomes were assessed. Data were collected at baseline, four months, and 12 months.
Results Response rates were 80% and 76% at four and 12 months. The two groups showed significant differences at 12 months on the anxiety subscore of the hospital anxiety and depression scale (mean difference -0.62, 95% confidence interval -1.08 to -0.16), arthritis self efficacy scale for pain (0.98, 0.07 to 1.89), and self efficacy for other aspects of management (1.58, 0.25 to 2.90). Results were similar for intention to treat and per protocol analyses. No significant difference was seen in number of visits to the general practitioner at 12 months.
Conclusions The self management of arthritis programme reduced anxiety and improved participants' perceived self efficacy to manage symptoms, but it had no significant effect on pain, physical functioning, or contact with primary care.
Trial registration Current Controlled Trials ISRCTN79115352.
225 citations
TL;DR: It is reported that low dose high frequency ultrasound given weekly for 12 weeks during dressing changes in addition to standard care did not significantly increase ulcer healing rates, affect quality of life, or reduce ulcer recurrence.
Abstract: Researchers assessed the effectiveness of weekly delivery of low dose high frequency therapeutic ultrasound in conjunction with standard care for hard to heal venous leg ulcers. A multicentre pragmatic two arm randomised controlled trial study design was used. Ultrasound was delivered during weekly dressing changes, and the duration depended on the size of the ulcer. The control treatment was standard care alone, comprising low adherent dressings and four layer bandaging that was high compression, reduced compression, or no compression, depending on the patient’s tolerance. Treatment was delivered for a maximum of 12 weeks.1
Participants were 337 patients with at least one venous leg ulcer of more than six months’ duration or greater than 5 cm2 in area, and an ankle brachial pressure index of 0.8 or more. The primary outcome was time to healing of the largest eligible leg ulcer. Secondary outcomes included health related quality of life and adverse events. Participants were followed for a maximum of 12 months.
The researchers reported that low dose high frequency ultrasound given weekly for 12 weeks during dressing changes in addition to standard care did not significantly increase ulcer healing rates, affect quality of life, or reduce ulcer recurrence.
Which of the following statements, if any, are true?
Statements a and c are true, whereas b and d are false.
Clinical trials are described as explanatory or pragmatic. Explanatory trials generally measure efficacy—that is, the benefit of …
67 citations
TL;DR: All programmes except general practice and pharmacy provision resulted in significant weight loss at one year, and only the Weight Watchers programme resulted in significantly more weight loss.
Abstract: Researchers assessed the effectiveness of a range of weight management programmes for weight loss. A randomised controlled trial study design, incorporating eight treatment arms, was used. Each intervention—Weight Watchers, Slimming World, Rosemary Conley, a group based dietetics led programme, general practice one to one counselling, pharmacy led one to one counselling, and a choice of any of the six programmes—lasted for 12 weeks. The control treatment consisted of 12 vouchers enabling free entrance to a local leisure (fitness) centre. Participants were 740 obese or overweight men and women identified from general practice records.1
The primary outcome was weight loss at the end of the programme (12 weeks). Secondary outcomes included weight loss at one year. Baseline characteristics were available for all participants, whereas follow-up data were available for 658 (88.9%) participants at the end of the programme and 522 (70.5%) at one year.
Analyses were performed according to intention to treat, using “baseline observation carried forward” to account for missing data. All treatment programmes achieved significant weight loss from baseline to programme end. When compared with the control treatment at 12 weeks, the only programmes that resulted in significantly more weight loss were Weight Watchers (mean difference 2.53 kg, 95% confidence interval 1.30 to 3.76; P<0.001) and Rosemary Conley (2.18, 0.96 to 3.41; P=0.004). All programmes except general practice and pharmacy provision resulted in significant weight loss at one year. At one year, only the Weight Watchers programme resulted in significantly …
15 citations