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Table 3 Clinical significance analysis of changes in main outcomes of depressiona, anxietyb, and post-traumatic stressc by treatment condition from baseline to post and to 3 months follow-up by success of surgery for women who met the criteria for distress at baseline

From: A nurse-delivered mental health intervention for obstetric fistula patients in Tanzania: results of a pilot randomized controlled trial

 

Post

3-month follow-up

 

Recoveredd

Reliably improved e

No change e

Reliably deteriorated e

Recoveredd

Reliably improved e

No change e

Reliably deteriorated e

Depressiona (N = 40)

(N = 29)

  Unsuccessful surgery

  Control

6/9 (66.7%)

9/9 (100.0%)

0/9 (0.0%)

0/9 (0.0%)

4/5 (80.0%)

4/5 (80.0%)

0/5 (0.0%)

1/5 (20.0%)

  Intervention

4/5 (80.0%)

4/5 (80.0%)

1/5 (20.0%)

0/5 (0.0%)

3/3 (100.0%)

3/3 (100.0%)

0/3 (0.0%)

0/3 (0.0%)

  Successful surgery

  Control

11/12 (91.7%)

11/12 (91.7%)

1/12 (8.3%)

0/12 (0.0%)

9/9 (100.0%)

9/9 (100.0%)

0/9 (0.0%)

0/9 (0.0%)

  Intervention

11/14 (78.6%)

11/14 (78.6%)

3/14 (21.4%)

0/14 (0.0%)

12/12 (100.0%)

12/12 (100.0%)

0/12 (0.0%)

0/12 (0.0%)

Anxietyb (N = 25)

(N = 19)

  Unsuccessful Surgery

  Control

4/5 (80.0%)

5/5 (100.0%)

0/5 (0.0%)

0/5 (0.0%)

2/3 (66.7%)

2/3 (66.7%)

1/3 (33.3%)

0/3 (0.0%)

  Intervention

4/4 (100.0%)

4/4 (100.0%)

0/4 (0.0%)

0/4 (0.0%)

3/3 (100.0%)

3/3 (100.0%)

0/3 (0.0%)

0/3 (0.0%)

  Successful surgery

  Control

9/9 (100.0%)

9/9 (100.0%)

0/9 (0.0%)

0/9 (0.0%)

7/7 (100.0%)

7/7 (100.0%)

0/7 (0.0%)

0/7 (0.0%)

  Intervention

6/7 (85.7%)

6/7 (85.7%)

1/7 (14.3%)

0/7 (0.0%)

6/6 (100.0%)

6/6 (100.0%)

0/6 (0.0%)

0/6 (0.0%)

PTSD symptomsc (N = 44)

(N = 32)

  Unsuccessful surgery

  Control

6/11 (54.5%)

8/11 (72.7%)

1/11 (9.1%)

2/11 (18.2%)

4/6 (66.7%)

5/6 (83.3%)

1/6 (16.7%)

0/6 (0.0%)

  Intervention

5/6 (83.3%)

5/6 (83.3%)

1/6 (16.7%)

0/6 (0.0%)

3/4 (75.0%)

3/4 (75.0%)

1/4 (25.0%)

0/4 (0.0%)

  Successful surgery

  Control

6/10 (60.0%)

7/10 (70.0%)

2/10 (20.0%)

1/10 (10.0%)

8/8 (100.0%)

8/8 (100.0%)

0/8 (0.0%)

0/8 (0.0%)

  Intervention

10/17 (58.8%)

11/17 (64.7%)

5/17 (29.4%)

1/17 (5.9%)

9/14 (64.3%)

10/14 (71.4%)

3/14 (21.4%)

1/14 (7.1%)

  1. aDepression measured by Center for Epidemiologic Studies Depression Scale (CES-D), sample includes women who met criteria (CES-D ≥ 16) at baseline (N = 40), of which (N = 29) returned at 3 months
  2. bAnxiety measure by Beck Anxiety Inventory (BAI), sample includes women who met criteria (BAI ≥ 10) at baseline (N = 25), of which (N = 19) returned at 3 months
  3. cPTSD Symptoms measure by PTS Checklist, sample includes women who met criteria (PTS Checklist ≥ 30) at baseline (N = 44), of which (N = 32) returned at 3 months
  4. dRecovered means that change in mental health score meets two criteria: (1) Follow-up score is below the predetermined cut-off point (\( \left({\overline{X_f}}^{\ast }{s}_f+{\overline{X_d}}^{\ast }{s}_d\right)/\left({s}_f+{s}_d\right) \) where \( \overline{X_f} \) and s f are the sample mean and sample standard deviation of the functional distribution and \( \overline{X_d} \) and s d are the sample mean and sample standard deviation of the dysfunction distribution; (2) The reliable change index (RCI) score is > − −1.96 where RCI is calculated as \( \left({X}_{post}-{X}_{baseline}\right)/\sqrt{2{\left({S}_E\right)}^2} \) where X post and X baseline are mental health score at baseline and post and S E is the standard error of measurement, calculated as \( {s}_f\sqrt{1-{r}_{xx}} \), where r xx is the test retest reliability of the mental health scale used
  5. eReliably improved defined as RCI < −1.96; No change defined as −1.96 ≤ RCI ≤ 1.96; Reliably deteriorated is RCI > 1.96
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Pilot and Feasibility Studies

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