Surgery compared with cast immobilization for adults with a bi-cortical fracture of the scaphoid waist (SWIFFT): a multicentre, pragmatic, open-label, parallel-group, two-arm randomised clinical trial

BackgroundScaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Immediate surgical fixation of this fracture has increased, in spite of insufficient evidence of improved outcomes over non-surgical management. We compared the clinical effectiveness of surgical fixation with cast immobilization and early fixation of those that fail to unite, for ≤2 mm displaced scaphoid waist fractures in adults. MethodsThis pragmatic, multicentre, open-label, parallel-group, two-arm randomised clinical trial included adults who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear, bicortical fracture of the scaphoid waist on radiographs. Participants were randomly assigned to early surgical fixation or below-elbow cast immobilization followed by immediate fixation of confirmed non-union. The primary outcome was the Patient Rated Wrist Evaluation (PRWE) total score at 52 weeks post-randomisation. Registration ISRCTN67901257. FindingsOf 439 randomised patients (mean age 33 years, 363 [83%] men), 408 (93%) were included in the primary analyses. There was no difference in PRWE score at 52 weeks (adjusted mean difference -2·1 points, 95% CI -5·8 to 1·6, p=0·27). There were no differences at 52 weeks for the PRWE pain or function subscales. More participants in the surgery group experienced a surgery-related potentially serious complication than in the cast group (n=31, 14% vs n=3, 1%), but fewer had cast-related complications (n=5, 2% vs n=40, 18%). The number experiencing a medical complication (n=4, 2% vs n=5, 2%) was similar in the two groups.” InterpretationAdult patients with ≤2 mm displaced scaphoid waist fracture should have initial cast immobilization and suspected non-unions confirmed and immediately fixed. This will help avoid risks of surgery and mostly limit its use to fixing non-union. FundingThis project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 11/36/37).<br

Cost-Effectiveness Analysis of Acupuncture, Counselling and Usual Care in Treating Patients with Depression: The Results of the ACUDep Trial

<div><p>Background</p><p>New evidence on the clinical effectiveness of acupuncture plus usual care (acupuncture) and counselling plus usual care (counselling) for patients with depression suggests the need to investigate the health-related quality of life and costs of these treatments to understand whether they should be considered a good use of limited health resources.</p><p>Methods and Findings</p><p>The cost-effectiveness analyses are based on the Acupuncture, Counselling or Usual care for Depression (ACUDep) trial results. Statistical analyses demonstrate a difference in mean quality adjusted life years (QALYs) and suggest differences in mean costs which are mainly due to the price of the interventions. Probabilistic sensitivity analysis is used to express decision uncertainty. Acupuncture and counselling are found to have higher mean QALYs and costs than usual care. In the base case analysis acupuncture has an incremental cost-effectiveness ratio (ICER) of £4,560 per additional QALY and is cost-effective with a probability of 0.62 at a cost-effectiveness threshold of £20,000 per QALY. Counselling compared with acupuncture is more effective and more costly with an ICER of £71,757 and a probability of being cost-effective of 0.36. A scenario analysis of counselling versus usual care, excluding acupuncture as a comparator, results in an ICER of £7,935 and a probability of 0.91.</p><p>Conclusions</p><p>Acupuncture is cost-effective compared with counselling or usual care alone, although the ranking of counselling and acupuncture depends on the relative cost of delivering these interventions. For patients in whom acupuncture is unavailable or perhaps inappropriate, counselling has an ICER less than most cost-effectiveness thresholds. However, further research is needed to determine the most cost-effective treatment pathways for depressed patients when the full range of available interventions is considered.</p></div

Complete case and imputed mean number of service use contacts over 12 months.

<p>Complete case and imputed mean number of service use contacts over 12 months.</p

Number of patients taking prescribed medication in the preceding 3 months.

a<p>All percentages given out of total number of patients with valid responses.</p

CONSORT flow diagram.

<p>CONSORT flow diagram.</p

Out-of-pocket costs and days of work for complete cases.

<p>Out-of-pocket costs and days of work for complete cases.</p

Unadjusted PHQ-9 mean scores from baseline to 12 months.

<p>Acupuncture, black line; counselling, grey line; usual care, dashed line.</p

Demographics and variables of interest at bastline.

<p>Percent given out of non-missing data, percent missing given out of applicable group total.</p><p>A BDI-II score of 20 or above was required to be eligible for the trial.</p

Effect of trial arm on PHQ-9 depression.

a<p>ANCOVA, effect of trial arm on imputed PHQ-9 at 3 months (adjusting for baseline PHQ-9).</p>b<p>Mixed, effect of trial arm on PHQ-9 over 12 months, (mixed effects model, including time, trial arm x time, baseline PHQ-9, baseline expectation of counselling and baseline expectation of allocated treatment. For the comparison between acupuncture and counselling, treatment time by 3 months and practitioner's empathy were additionally included.)</p>c<p>AUC, effect of trial arm on average PHQ-9 depression over 12 months (adjusting for Baseline PHQ-9).</p><p>SE, standard error.</p

Effect of trial arm on BDI-II depression.

a<p>ANCOVA, effect of trial arm on imputed BDI-II at 12 months (adjusting for baseline BDI-II, baseline expectation of counselling and baseline expectation of allocated treatment. For the comparison between acupuncture and counselling, treatment time by 3 months and practitioner's empathy were additionally included.)</p