---
title: "Analyzing Clinical Significance: The Combined Approach"
date: "`r Sys.Date()`"
output: rmarkdown::html_vignette
vignette: >
  %\VignetteIndexEntry{5. Combined Approach}
  %\VignetteEncoding{UTF-8}
  %\VignetteEngine{knitr::rmarkdown}
editor_options: 
  chunk_output_type: console
---

```{r, include = FALSE}
knitr::opts_chunk$set(
  collapse = TRUE,
  comment = "#>",
  fig.width = 7,
  fig.height = 5,
  fig.align = "center"
)
```

## Introduction

The combined approach represents the most rigorous method for assessing clinical significance. It provides a more nuanced picture of patient outcomes by requiring **two criteria** to be met simultaneously:

1.  **Magnitude of Change**: The change must be sufficiently large, either by being statistically reliable (distribution-based) or practically meaningful (anchor-based).
2.  **End-State Functioning**: The patient must cross the threshold from a dysfunctional or "clinical" population to a functional or "non-clinical" one (statistical approach).

This dual requirement allows for a richer classification of outcomes, distinguishing between patients who have merely "Improved" and those who have truly "Recovered". This vignette demonstrates how to use the `cs_combined()` function to apply these powerful models.

```{r setup}
library(clinicalsignificance)
```

## The Classic Jacobson & Truax (JT) Approach

The most common combined method, proposed by Jacobson and Truax (1991), integrates the **distribution-based** and **statistical** approaches. A patient's change is considered clinically significant if:

1.  The change is **reliable** (i.e., it exceeds the measurement error of the instrument).
2.  The patient's final score falls within the range of a functional population.

### Example Analysis

We will again use the `claus_2020` dataset. To perform this analysis, we need summary statistics for a functional (non-clinical) population on the BDI-II (`m_functional`, `sd_functional`) and an estimate of the instrument's reliability.

```{r jt-combined}
# Perform the JT combined analysis
jt_combined <- claus_2020 |>
  cs_combined(
    id = id,
    time = time,
    outcome = bdi,
    pre = 1,
    post = 4,
    m_functional = 7.69,
    sd_functional = 7.52,
    reliability = 0.801
  )

# Display the summary of results
summary(jt_combined)
```

### Visualizing the JT Approach

The plot for a combined analysis is particularly informative. It includes both the shaded area for reliable change (from the distribution-based approach) and the cutoff lines for population status (from the statistical approach).

* **Dashed Lines**: The cutoff separating the clinical (right/top) and functional (left/bottom) populations.
* **Shaded Area**: The zone of "no reliable change".

```{r jt-combined-plot}
plot(jt_combined, show_group = "category")
```

The resulting categories are interpreted as follows:
- **Recovered** (blue): Patients who showed a reliable improvement *and* ended up in the functional range.
- **Improved** (light green): Patients who showed a reliable improvement but remained in the clinical range.
- **Unchanged** (yellow): Patients with no reliable change, regardless of their population status.
- **Deteriorated** (orange): Patients who showed a reliable worsening but remained in the clinical range.
- **Harmed** (dark green): Patients who showed a reliable worsening *and* moved from the functional to the clinical range.


## The Claus, Wager & Bonnet (CWB) Approach

As an alternative, `clinicalsignificance` allows you to combine the **anchor-based** and **statistical** approaches. This method is useful when a well-established Minimal Important Difference (MID) is available and may offer a more practically interpretable criterion for change than statistical reliability.

Here, a patient's change is clinically significant if:
1. The change is **meaningful** (i.e., it meets or exceeds the MID).
2. The patient's final score falls within the range of a functional population.

### Example Analysis

We use the same functional population data as before but replace the `reliability` argument with `mid_improvement`.

```{r anchor-combined}
# Perform the anchor-based combined analysis
anchor_combined <- claus_2020 |>
  cs_combined(
    id = id,
    time = time,
    outcome = bdi,
    pre = 1,
    post = 4,
    m_functional = 7.69,
    sd_functional = 7.52,
    mid_improvement = 7
  )

# Display the summary of results
summary(anchor_combined)
```

Notice the subtle shift in classifications: with the MID as the criterion, more patients are categorized as "Improved" or "Recovered" compared to the stricter reliability criterion of the JT approach in this specific example.

### Visualizing the CWB Approach

The plot is interpreted similarly, but the shaded area is now defined by the MID instead of the Reliable Change Index.

```{r anchor-combined-plot}
plot(anchor_combined, show_group = "category")
```

## Summary and Next Steps

The combined approach offers a powerful and nuanced assessment of treatment outcomes by considering both the magnitude of change and the patient's final functional status.

* The **Jacobson & Truax (JT) approach** is the classic standard, requiring a reliable change and a shift in population status.
* The **Claus, Wager & Bonnet (CWB) approach** is a valuable alternative when a meaningful MID is known, defining change in practical rather than purely statistical terms.

Choosing between them depends on the available information (reliability vs. MID) and the specific research question.